Inmark Packaging — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, D.C. 20590 FEB l O 2016 Mr. Jay Johnson Regulatory Compliance Inmark Packaging 675 Hartman Road, Suite 100 Austell, GA 30168 Ref. No.: 15-0170 Dear Mr. Johnson: This is in response to your August 5, 2015 email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) concerning the testing of specification packagings. Specifically you seek confirmation of your understanding that packagings for Category A infectious substances tested with liquids can be used with a solid material. For the purposes of testing a packaging for infectious substances, each primary receptacle must be filled with a liquid even ifthe package is intended to contain a solid material. In accordance with§ 178.609(b) samples of each packaging must be prepared as for transport except that a liquid or solid infectious substance should be replaced by water or where conditioning at -18 °C (0 °F) is specified by water/antifreeze. I hope this information is helpful. If you have further qu~stions, please do not hesitate to contact this office. Sincerely, ~~~ ~. lftC-l Duane A. Pfund V \ International Standards Coordinator Standards and Rulemaking Division#

Page 2Goodall, Shante CTR (PHMSA) From: Sent: To: Subject: Attachments: Foster, Glenn (PHMSA) Friday, August 07, 2015 11:22 AM Dodd, Alice (PHMSA); Goodall, Shante CTR (PHMSA) Question about Category A infectious packaging 043-0125-e-ne-cd-01_2015-05-15.pdf; TC CGSB 43-125-99.pdf Alice /Shante, Jay Johnson replied with his missing attachment per my request below. Please use this email and the supporting documentation to create and assign a new lnterp letter. Thanks, Glenn From: Jay Johnson [mailto:jayj@inmarkinc.com] Sent: Friday, August 07, 2015 11:12 AM To: Foster, Glenn (PHMSA) Subject: RE: Question about Category A infectious packaging Hello Glenn Here are the attachments. Kind Regards, Jay Johnson, DGSA I Regulatory Compliance Manager IEXAKTl.il!1.:I AN INMARK BRAND 675 Hartman Road, Suite 100 Austell GA 30168 o 770-373-3300 Id 770-373-3356 I m770-377-0205 If 770-373-3357 f e iayj@inmarkpackaging.com Follow us at: C!fmO Visit our website or lnmarkPackaging.com to learn more about our products and services. Please consider the environment before printing this e-mail. Confidentiality Notice: This communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18 U.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission, and any attachments, may contain confidential information. If you are not the intended recipient, any disclosure, copying, distribution or use of any of the information contained in or 1#

Page 3attached to this transmission is STRICTLY PROHIBITED. Please contact us immediately by return e-mail or at +1-770-373-3300 and destroy the original transmission and its attachments without reading or saving in any manner. From: Glenn.Foster@dot.gov [mailto:Glenn.Foster@dot.gov] Sent: Thursday, August 06, 2015 12:16 PM To: Jay Johnson Subject: RE: Question about Category A infectious packaging Jay, The scan you mentioned attaching did not come through. Can you re-send? Thanks, Glenn From: Jay Johnson [mailto:jayj@inmarkinc.com] Sent: Wednesday, August 05, 2015 12:38 PM To: Foster, Glenn (PHMSA); Stevens, Michael (PHMSA); Supko, Ben (PHMSA) Cc: Betts, Charles (PHMSA); Frank Orvino; David Creighton; Goodall, Shante CTR (PHMSA); Dodd, Alice (PHMSA) Subject: RE: Question about Category A infectious packaging Hey Glenn, Thanks for addressing this question of Canadian Approval. I have attached a scan of the CGSB 43.125-99. I believe the section they are currently looking at is 4.2.2.1. There is an update in the review process (also attached). The update clearly outlines the liquid/solid situation in 7.2.1.2 of the Canadian Regulations on page 17 by requiring that infectious packaging (liquid or solid) be tested with water. "7.2.1.2 Each primary receptacle shall be filled not less than 98% of its capacity. Liquid or solid infectious substance shall be replaced by water or, where conditioning at-18°C is specified, by water/antifreeze with a minimum specific gravity of 0.95." Best regards, Jay From: Glenn.Foster@dot.gov [mailto:Glenn.Foster@dot.gov] Sent: Wednesday, August 05, 2015 12:20 PM To: Jay Johnson; michael.stevens@dot.gov; Ben.Supko@dot.gov Cc: charles.betts@dot.gov; Frank Orvino; David Creighton; shante.goodall.ctr@dot.gov; Alice.Dodd@dot.gov Subject: RE: Question about Category A infectious packaging Hello Jay, We will have your inquiry checked in as a request for a letter of Interpretation. Thanks, Glenn 2#

Page 4From: Jay Johnson [mailto:iavi(a)inmarkinc:.com] Sent: Wednesday, August 05, 2015 11:56 AM To: Stevens, Michael (PHMSA); Supko, Ben (PHMSA); Foster, Glenn (PHMSA) Cc: Betts, Charles (PHMSA); Frank Orvino; David Creighton Subject: Question about Category A infectious packaging Good Morning, I have a quick question about UN specification packaging. We have an infectious packaging system (STP-100) that has been UN certified in Canada for 30 plus years. The packaging system relies on a secondary pressure canister and has been tested with a wide variety of primaries. The system successfully passed all of the test requirements with liquid inside the primaries without failure. We have been asked by a DOT Inspector in TX if our packaging system can be used to ship solid media cultures since it was tested with liquids instead of solid cultures. I sent he following question to Transport Canada about our Division 6.2 packaging system certified in Canada: We have been asked by a DOT inspector if the packaging system can be used to ship solid media cultures since it was tested with liquids instead of solid cultures. The stringent requirements for Category A infectious substance packaging do not differentiate between liquid and solid on the UN specification marking for 4G so the question to you would be: Can shippers use all the different primaries that were tested in the system with the volume limitations indicated in the packaging instructions but fill the vials with solid/semi-solid culture media instead of liquid? Here is the response from Transport Canada: From: Bernier, France [mailto:france.bernier@tc.gc.ca] Sent: Wednesday, August 05, 2015 9:02 AM To: Jay Johnson Cc: Garneau, Stephane Subject: RE: Question about category A infectious packaging Good morning Mr. Johnson, Yes, it is possible. There is no prohibition in the CGSB-43.125-99 standard against using a packaging tested for liquids to transport solids. Regards, France Bernier Dangerous Goods Container Specialist I Specialiste de contenants pour les marchandises dangereuses Ph/Tel: (613) 998-0798 france.bernier@tc.gc.ca Transport Canada, Transport Dangerous Goods I Transports Canada, Transport des marchandises dangereuses Place de Ville tower "C' 9th floor I tour "C" 9ieme etage 330 Sparks Street 1330 rue Sparks, Ottawa ON K1A ON5 I.I iran:spcrl Tfansporis Canada C3nada Does this answer from Canada satisfy the question from the DOT Inspector in TX about how our infectious packaging was tested and approved in Canada for use with solids while tested with a liquid? 3#

Page 5Do any of the US regulations contradict this answer or require us to do anything different when using this Canadian Approved UN specification packaging in the United States? Kind Regards, Jay Johnson, DGSA I Regulatory Compliance Manager IEXAKTI iltl :1 AN INMARK BRAND 675 Hartman Road, Suite 100 Austell GA 30168 o 770-373-3300 I d 770-373-3356 I m770-377-0205 If 770-373-3357 I e jayj@inmarkpackaging.com Follow us at: mono Visit our website or lnmarkPackaging.com to learn more about our products and services. Please consider the environment before printing this e-mail. Confidentiality Notice: This communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18 U.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission, and any attachments, may contain confidential information. If you are not the intended recipient, any disclosure, copying, distribution or use of any of the information contained in or attached to this transmission is STRICTLY PROHIBITED. Please contact us immediately by return e-mail or at +1-770-373-3300 and destroy the original transmission and its attachments without reading or saving in any manner. 4#

Page 6CAN/CGSB-43.125-99 Supersedes CAN/CGSB-43.l 25-M90 CANADIAN GENER-\L STANDARDS BOARD PACKAGING OF INFECTIOUS SUBSTANCES, DIAGNOSTIC SPECIM:ENS, BIOLOGICAL PRODUCTS AND BIOl\1EDICAL \VASTE FOR TRANSPORT 1. SCOPE 1. I This standard contains requirements for the design, manufacturing and marking for three types of means of containment used for the transportation of Class 6.2 dangerous goods (infectious substances), diagnostic specimens, biological products and biomedical waste. Type IA (high integrity) Type 1 B (routine) Type JC (waste). 1.2 This standard includes the performance-based design criteria and marking requirements from Chapter 6.3 of the UN Recommendations on the Transpdn of Dangerous Goods, Model Regulations. 1.3 This standard does not inform shippers as to which of these packaging types must be used for their particular shipment. The l4TA Dangerous Goods Regulations (for international or domestic air transport) or the TDC Regulations (for domestic transport, all modes) must be consulted to determine which packaging type (IA, IB, l C) is required. 1 A The testing and evaluation of a product against this standard may require the use of materials and/or equipment that could be hazardous. This document does not purport to address all the safety aspects associated with its use. Anyone using this standard has the responsibility to consult the appropriate authorities and to establish appropriate health and safety practices in conjunction with any applicable regulatory requirements prior to its use. 2. REFERENCED PUBLICATIONS 2.1 The following publications are referenced in this standard: 2.1.1 Canadian General Standards Board (CGSB) CAN/CGSB-43.150-97 - Performance Packagings for Transportation of Dangerous Goods. 2.1.2 Canadian Standards Association (CSA) CAN/CSA-ISO 9003-94 - CSA Z3l 6.6-95 - Quality Systems - Model for Quality Assurance in Final Inspection and Test Evaluation of Single Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste. 2.1.3 Department of Transport {Transport Canada) Transportation of Dangerous Goods Act, 1992 (including amendments) Transportation of Dangerous Goods Regulations (including amendments). 2.1.4 Railway Association of Canada (RAC) RAC 6000-A -- Railway Packaging Standards. 2.1.5 American Society for Testing and Materials (AS1M) D 951-94 - Standard Test Method for Water Resistance of Shipping Containers by Spray Method D 1709-97 - Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method l#

Page 7f-" 1922-94a --- Standard Test Method for Propagar.ion Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method D 499 -94 - Standard Tes! Method for Leakage Testing of Empty Rigid Containers by Vacuum Method D 5276-94 - S1andard Test Method for Drop Tesr of Loaded Containers by Free Fall. 2.1.6 International Air Transport Association (IATA) Dangerous Goods (39th edition). 2.1.7 Technical Association of Pulp and Paper Industry (TAPPI) T802 OM-91 - Drop Test for Fibreboard Shipping Containers T8!0 OM-92 - Strength of Corrugated and Solid Fiberboard T8 l 1 OM-95 - Edgewise Compressive Strength of Corrugated Fiberboard (Short Column Test). 2.1.8 United Nations Recommendations on the Transport of Dangerous Goods, Model Regulations (tenth revised edition). 2.1.9 United States Department of Defense MIL-D-6055C-1970 - Drums, Metal. Reusable Shipping and Storage (Capacity from 88 to 510 Cubic Inches). 2.2 The sources of these publications are shown in the Notes section. 3. DEFL'\IITIONS The following definitions apply in this standard. Where there is a conflict between the definition in this standard and that of the TDG Regulations, the definition in the TDG Regulations shall apply. Biological Product (Produit biologique) A product derived from living organisms that is used to prevent, treat or diagnose disease in humans or animals or that is used for developmental, experimental or investigational purposes. Biomedical Waste (Dechets b10medicaux) Medical waste that is derived from animals or humans or from bio-research; Combination Packaging (Emballage combine) A packaging consisting of one or more inner packagings contained in an outer packaging for transport. Diagnostic Specimen (Echantillon de diagnostic) Any human or animal material including excreta, secreta, blood and its components, tissue and tissue fluids that is being offered for transport. Director (Directeun Director, Regulatory Affairs Branch, Transport Dangerous Goods Directorate, Transport Canada. Infectious Substances (Matieres infectieuses) Substances known or reasonably expected to contain pathogens that are micro-organisms that are known or reasonably expected to cause disease in humans or animals as defined by the TDC Regulations. Inner Packaging (Emballage interieur) A packaging for which an outer packaging is required for transport. Medical Professional (Professionnel de la same) A doctor, scientist. veterinarian, epidemiologist, genetic engineer, microbiologist, pathologist, nurse, coroner, laboratory technologist or laboratory technician. Outer Packaging (Emballage extfoeur) The outer protection of a combination packaging (excluding an overpack) together with any absorbent materials, cushioning and any other components necessary to contain and protect primary receptacles or inner packagings. 2 CAN/CGSB-43.125-99#

Page 8I The of the packing operation, consis1ing of the packaging and its contents prepared for transport. Packaging (EmballageJ A receptacle and any other components or material~ necessary for the receptacle to perform its containment function. Package Design type d'emballage) Packaging of the same design size, materials and thickness, manner of construction (including the inner and outer packagings) and packing. Primary Receptacle primaire) A receptacle in contact with the substances or articles w be shipped. Risk (Groupes de risques) A group into which infectious substances are assigned in accordance with the TDG Regulations based on ability to cause disease, their ability to spread that disease and the severity of that disease. their Secondary Inner (Emballage interieur secondaire) An inner packaging that provides additional protection for the primary receptacle(s) and the absorbent material. 4. REQUIREMENTS FOR TYPE IA 4.1 Description - Type IA is used where a high integrity package is required. Type IA is based on the design and marking requirements of Chapter 6.3 and Packing Instruction 620 of the UN Recommendations on the Transport of Dangerous Goods, Model Regulations and Packing Instruction 602 of the JATA Dangerous Goods _Regulations. 4.2 Components 4.2.1 The package shall include: a. An inner packaging comprising: L watertighi primary receptacle(s) ii. watertight secondary packaging m. absorbent material in sufficient quantity to absorb the entire contents of the primary receptacle(s), which is placed between the primary receptacle(s) and the secondary packaging. If multiple primary receptacles are placed in a single secondary packaging, they shall be individually wrapped or separated to prevent contact between them. The manufacturer shall notify the purchaser (user of the container) of this requirement and, where the manufacturer provides the absorbent, of its adsorption properties; and b. an outer packaging of adequate strength for its capacity, mass and intended use of which the smallest external dimension is at least l 00 mm. 4.2.2 Other than for exceptional consignments (e.g. whole organs that require special packaging), substances shall be packed in accordance with the following. 4.2.2. J Liquid or Solid Substances Substances Consigned at Ambient Temperature or Higher -- The primary receptacles shall be made of glass, metal or plastics. A positive means of ensuring a leakproof seal shall be provided. Subsiances Consigned Refrigerated or Frozen - Ice or dry ice shall be placed outside the secondary packaging(s). Interior suppons shall be provided w secure secondary packaging(s) in position after the ice or dry ice has dissipated. If ice is used, the outer packaging shall be leakproof. If dry ice is used, the outer packaging shall permit tbe release of carbon dioxide gas. The primary receptacle and the secondary packaging shall maintain their integrity at the temperature of the refrigerant used. Substances Consigned in Liquid Nitrogen - Plastic primary receptacles shall be capable of withstanding very low temperatures. The secondary packaging shall also be capable of withstanding very low temperatures. Provisions for CAN/CGSB-43.125-99 3#

Page 9tue consignment of nitrogen shall also be fulfilled. The primary recepmcl e and the secondary packaging shall maintain their rntegrity at the temperature of the liquid nitrogen. 4.3 Temperature Resistance - Whatever the intended temperature of the consignment, the primary receptacle or the secondary packaging shall be capable of withstanding temperatures in the range of -40 to +55°C 1 • 4.4 Internal Pressure - The primary receptacle or the secondary packaging shall withstand an internal air pressure or pressure differential of not less than 95 kPa without leakage when tested in accordance with ASTM D 4991-94 for rigid packaging or in accordance with par. 7.1. 4.5 Drop and Impact Resistam:e 4.5.1 Packages shall be subjected to the tests .in Table 1, which for test purposes categorizes packagings according to their material characteristics. For outer packagings, the headings in the table relate to fibreboard or similar materials whose performance may be rapidly affected by moisture; plastics that may embrittle at low temperatures; and other materials (such as metal) whose perfonnance !snot affected by moisture or temperature. If a primary receptacle and a secondary packaging of an inner packaging are made of different materials, the material of the primary receptacle determines the appropriate test. When a primary receptacle is made of two materials, the material most liable to damage detem1ines the appropriate test TABLE I Drop and Impact Tests for Type IA Packages Component of Combination Packaging Requirernents 1 I Inner Impact Test Outer Packaging I Packaging Drop Tests (par. 7.3) I Fibre- board Plastic Other Plastic Other (par. 7.2.2) (par. 7.2.3) (par. 7 .2.4) (par. 7.2.5) x - - x - x x x to be x x x x x conducted x - - - - when dry - x - x - x - x ice is used x - x ! - - x i x - x x - - x x - x - x x I - - x - x x - - x Note: 4.5.2 1 Prior to conducting the drop rests and impact test, paclwges shail be prepared in accordance with par. 72.J. Drop Resistance - There shall be no leakage from the primary receptacle(s) which shall remain protected by absorbent material in the secondary packaging after conducting the appropriate drop sequence in accordance with par. 7.2.2. 4.5.3 Impact Resistance - Following each impact of the steel rod, penetration of the secondary packaging is acceptable provided that there is no leakage from the primary receptacle(s) after conducting the test in accordance with par. 7.3. 4.6 Quality Assurance 4.6.1 The requirements of this paragraph apply to all packages manufactured after December 31, 1993. 4.6.2 A Package Design Report shall be completed in the form prescribed in Appendix A for each package design type meeting the requirements for a Type lA packaging. 4.6.3 Every manufacturer of a Type l A package meeting this standard shall ensure that the details of the design specified in the Package Design Report are maintained during production by having and maintaining a quality assurance 1 It is not required to perfonn the tests at these temperatures. 4 CAN/CGSB-43.125-99#

Page 104.7 4. 7. J 4.7.2 4.7 .3 4. 7.4 4.8 4.8.1 4.8.2 system for each facility manufact.uring the packages. The quality assurance system shall meet the requirements of CAN/CSA-ISO 9003-94. Department of (Transport Canada) Certificate of Registration A Certificate of Registration shall be issued by the Director or a person designated by the Director, to manufacturers of packages meeting the design and production requirements for Type lA packages. 111e Director may issue a provisional Cenificate of Registration. Conformance with the requirements of this standard shall be assessed by ·Transport Canada or a competent facility designated by the Director. Requests for registration of designs shall be sent to the Director, Regulatory Affairs Branch (ASDD), Department of Transport, Ottawa, Ontario KIA ONS. Production of packages, other than test samples, shall not begin umil the manufacturer has been issued a Certificate of Registration for the design by Transpon Canada. Production of packages shall not continue more than three years past the date of issue of the Certificate of Registration for the design unless a renewal of the certificate has been issued by the Department of Transport. If an application for the renewal of the Certificate of Registration has been filed at least 60 days prior to its expiration, the production of packages may continue until notification is received from the Department of Transport relating to the renewal. Packages produced up to the receipt of the notice may be used up. Variations within a Desi.gn Type Provided that an equivalent level of perfonnance is maintained, the following variations in the primary receptacles placed within a secondary packaging are allowed without further testing of the completed package; a. Primary receptacles of equivalent or smaller size as compared to the tested primary receptacles may be used provided: L the primary receptacles are of similar design to the tested primary receptacle (e.g. shape: round, rectangular, ere.); II. the material of construction of the primary receptacle (glass, plastics, metal, etc.) offers resistance to impact and stacking forces equal to, or greater than, that of the originally tested primary receptacle; iii. the primary receptacles have the same or smaller openings and the closure is of similar design (e.g. screw cap, friction lid, etc.); iv. sufficient additional cushioning material is used to take up void spaces and to prevent significant movement of the primary receptacles; and v. primary receptacles are oriented within the secondary packaging in the same manner as in the tested package. b. A lesser number of the tested primary receptacles, or of the alternative types of primary receptacles identified in par. 4.8.1 a., may be used provided sufficient cushioning is added to fill the void space(s) and to prevent significant movement of the primary receptacles. Inner receptacles of any type may be assembled within a secondary packaging and transported without testing in the outer packaging under the following conditions: a. The secondary and outer packaging combination shall have been successfully tested in accordance with par. 7.3 with fragile (e.g. glass) inner receptacles; b. The total combined gross mass of inner receptacles shall not exceed one half the gross mass of inner receptacles used for the test mentioned in par. 4.8.2 a.; c. The thickness of cushioning between inner receptacles and between inner receptacles and the outside of the secondary packaging shall not be reduced below the corresponding thicknesses in the originally tested packaging; and if a single inner receptacle was used in the original test, the thickness of cushioning between inner receptacles shall not be less than the thickness of cushioning between the outside of the secondary packaging and the inner receptacle in the original test. When either fewer or smaller inner receptacles are used (as compared to the inner receptacles used in rhe drop test), sufficient additional cushioning material shall be used to take up the void; CAN/CGSB-43.125-99 5#

Page 11d. rhe empty outer packaging shall have successfully passed the stacking test in par- 9.6 of CA..L""l/CGSB-43.150-97. The totai mass of identical packages shall be based on the combined mass of inner receptacles used in the test mentioned in par. 4.8.2 a.; e. For inner receptacles containing liquids, an adequate quantity of absorbent material to absorb the entire liquid content of the inner receptacles shall be present; f. If the outer packaging is intended to contain inner receptacles for liquids and is not leakproof, or is intended to contain inner receptacles for solids and is not siftproof, a means of containing any liquid or solid contents in the event ofleakage shall be provided in the form of a leakproofliner, plastic bag or other equally effective means of containment. 4.9 Marking 4.9 .1 The outer surface of a package that meets the requirements of par. 4.1 to 4.8 shall be marked with: a. the United Nations packaging symbol; b. the code designating the type of package in accordance with the provisions of section 8 of CA.N/CGSB-43.150-97; c. the text - "CLASS 6.2"; d. the last two digits of the year of manufacture of the package; e. the st;;ite authorizing the allocation of the mark (e.g. "CAN" for packages manufactured in Canada); f. the name or symbol of the manufacturer and the Transport Canada Design Registration Number; g. for packages meeting the requirements of par. 4.8.2, the letter "U" shall be inserted immediately following the marking required in par. 4.9J b. Examples of marking: ® 4G/CLASS 6.2/98 (as in par. 4.9. I a., b., c. and CAN/ABC 8-999 (as in par. 4. 9. J e. and f) 4.9.2 Symbols used shall be registered with the Department of Transport, Transport of Dangerous Goods, Ottawa, Ontario KIA ON5. 5. REQUIREMENTS FOR TYPE 1B 5, l Description - Type 1B is suitable for routine shipments (e.g. diagnostic specimens) and is based on Packing Instruction 650 of the IATA Dangerous Goods Regulations. 5.2 Components 5.2.l The package shall consist of the following components: a. watertight primary receptacle(s); b. watertight secondary packaging; c. absorbent material between· the primary receptacle(s) and the secondary packaging. Several primary receptacles may be inside a single secondary inner packaging if each is wrapped individually or separated to prevent contact between them. Enough absorbent material, such as cotton wool, shall be used to absorb the entire contents of the primary receptacles; and d. strong outer packaging. 6 CAN/CGSB-43.125-99#

Page 12©CGSB 2015 - All rights reserved CD-01 Draft Date: 2015-05-15 CAN/CGSB-43.125-20XX Supersedes CAN/CGSB-43.125-2003 CGSB Committee 43/27.8 Packaging of Category A and Categ 6.2) and clinical a ectious substances (Class medical waste JCS 13.300#

Page 13CAN/CGSB-43.125-20XX CD-01 Warning This document is not a National Standard of Canada. It is a draft distributed to CGSB committee members and other interested persons for review and comment. This draft is subject to change without notice and shall not be referred to as a National Standard of Canada. Recipients of this document are invited to submit their comments, to advise the CGSB commit e of any relevant patent rights that they are aware of, and to provide supporting documenta · This information should be provided on or before 2015-07-13, to: Robert Long Canadian General Standards Board Ottawa, ON KlA 1G6 ©CGSB 201S -All rights reserved#

Page 14CAN/CGSB-43.125-20XX CD-01 Copyright notice ©HER MAJESTY THE QUEEN IN RIGHT OF CANADA, as represented by the Minister of Public Works and Government Services, the Minister responsible for the Canadian General Standards Board 2015. This Canadian General Standards Board (CGSB) document is a draft standard. Thi may be reproduced by CGSB committee members participating in its develo purposes of this development only. No other reproduction, transmission, t or publication of whole or any part of this document may be undert written permission of CGSB. Requests for permission to reproduce, transmit, communic publish or otherwise exploit the copyright in the whole be addressed to CGSB at the address or co-ordinates s Manager, Strategic Standardization Group Canadian General Standards Board Gatineau (Quebec) KlA 1G6 CANADA t lating to the reproduction or publication of the whole or any part of this t for purposes of sale may be made conditional upon the requester's entering into a censing agreement and the payment of royalties. ©CGSB 2015 -All rights reserved iii#

Page 15CAN/CGSB-43.125-20XX CD-01 Contents Page Introduction ............................................................................................................................................ v 1 Scope......................................................................................................................... .. ............ 1 2 Normative references .................................................................................................... . .......... 2 3 Terms and Definitions ................................................................................... .. .. ............... 4 4 General requirements ........................................................................ . 5 Certification safety mark .................................................................. .. ............................. 10 6 Construction.......................................................................... .. ....................................... 13 7. Testing.......................................................................... .. ........................................... 17 8 Permitted design variations .................................... .. ................................................. 26 9. Quality management system........................... . ............................................................. 27 10. Registrat.ion ............................................... . . .................................................................. 27 11 General requirements ........................ .. ........................................................................ 30 12 General ..................................... . ......................................................................................... 32 0 packagings ................................................................ 39 iv ©CGSB 2015 -All rights reserved#

Page 16CAN/CGSB-43.125-20XX CD-01 Introduction This is the fourth edition of CAN/CGSB-43.125, Packaging of Category A and Category Bi substances (Class 6.2) and clinical and (bio) medical waste It supersedes the previous e in 2003 Design and Manufacture of Packaging for the Transportation of Infectious Diagnostic Specimens, Biological Products or (Bio) Medical Waste that has neve Transportation of Dangerous Goods (TOG) Regulations. This standard is intended for incorporation by reference into the TD differences between the requirements ofthe TOG Regulations an prevail, unless specified otherwise, to the extent of the differ to adopt this edition of the standard, an earlier edition ma b ns. Where there are ard, the TOG Regulations he Regulations are amended e legally in effect in Canada. This standard sets out requirements for designing, m containment for the transportation of Category clinical and (bio) medical waste. It is based on t Goods, Model Regulations, 18th edition, p . hed ry B infectious substances in Class 6.2 and mendations on the Transport of Dangerous the United Nations (UN). ©CGSB 2015 -All rights reserved v#

Page 17FOR PUBLIC REVIEW ONLY#

Page 18CAN/CGSB-43.125-20XX CD-01 Packaging of Category A and Category B infectious substances (Class 6.2) and clinical and (bio) medical waste 1 Scope 1.1 Organization and content This standard sets out requirements for designing, manufacturing, marking, testing and containment for the transportation of Category A and Category B infectious subst clinical and (bio) medical waste. This standard consists of three parts and one a Part I contains the requirements for the design, test and manufacture of infectious substances of category A and category B. s of containment for Part II contains the requirements for the selection and use of substances of Category A and Category B. Part Ill contains the requirements for the selection an of containment for the transport of Category A an disposal as well as (bio) medical and clinical wa ndardized and non-standardized means infectious substances intended for Annex A contains a design report for typ ackagings. 1.2 Application This standard applies to both sta the TDG Regulations. nd non-standardized means of containment as defined in 1.3 Minimum requireme, This standard sets o testing of means of co judgment in inimum requirements for designing, manufacturing, selecting, using, and nment. It is essential to exercise competent technical and engineering ction with this standard. on of Dangerous Goods Act and Regulations prevalence 992, and the TDG Regulations may call for additional requirements regarding the design, ure, selection, use, and test of means of containment. Where there is an inconsistency between the requirements of this standard and those of the TDG Act or TDG Regulations, the Act or Regulations prevail to the extent of the inconsistency. 1.5 Safety - The testing and evaluation of a product against this standard may require the use of materials and/or equipment that could be hazardous. This document does not purport to address all the safety aspects associated with its use. Anyone using this standard has the responsibility to consult the ©CGSB 2015 -All rights reserved 1#

Page 19CAN/CGSB-43.125-20XX CD-01 appropriate authorities and to establish appropriate health and safety practices in conjunction with any requirements prior to its use. 1.6 Units Quantities and dimensions used in this standard are given in metric units. 1.7 Interpretation ofTables and Figures Notes to tables and figures are considered part of the table or figure and may be written as requirements. 1.8 Classification Dangerous goods are classified in accordance with Part 2 of the TOG Regulatio shipping names and -corresponding particulars (UN number and descriptio packing group, as applicable) selected from Schedule 1 of the TDG Re u 2 Normative references The following normative documents contain provision provisions of this National Standard of Canada. The sources noted below. NOTE The addresses provided below were v An undated reference is to the latest e ho· ugh reference in this text, constitute documents may be obtained from the of publication of this standard. evision of the reference or document in question, pplying this method. A dated reference is to the specified esign, manufacture and use of intermediate bulk containers and fuel ment for the transportation of dangerous goods Th e may be obtained from the Canadian General Standards Board, Sales Centre, Gatineau, 1A 1G6. Telephone 819-956-0425 or 1-800-665-2472. Fax 819-956-5740. E-mail ncr.cgsb- ongc@tpsgc-pwgsc.gc.ca. Web site www.tpsgc-pwgsc.gc.ca/ongc-cgsb. 2.2 Canadian Standards Association (CSA) CSA Z316.6-95 - waste. Evaluation of single use medical sharps containers for biohazardous and cytotoxic 2 ©CGSB 2015 -All rights reserved#

Page 20CAN/CGSB-43.125-20XX CD-01 2.2.1 Source The above may be obtained from CSA Group, Standards Sales, 178 Rexdale Blvd., Toronto, Ontario M9W 1R3 Canada. Telephone 416-747-4000or1-800-463-6727. Fax 416-747-2473. E-mail sales@csagroup.org. Web site csagroup.org. 2.3 Transport Canada Transportation of Dangerous Goods Act, 1992 (including amendments) Transportation of Dangerous Goods Regulations (including amendments) TP 14850 - Small Containers for Transport of Dangerous Goods, classes 3, 4, 5, 6 Canada Standard. 2.3.1 Source The above may be obtained from the Publications page of the Tra tc.gc.ca/eng/publications-menu.htm. The Transport Canada pu the Transport Canada Publications Order Desk at tc.gc.ca/en ada Web site 14850 may be ordered from 2.4 ASTM International D951-99(2010) -Standard test method for wate D1709-15 -Standard test methods for im of shipping containers by spray method ce of plastic film by the free-falling dart method on test resistance of plastic film and thin sheeting by pendulum method itioning Containers, Packages, or Packaging Components for Testing method for leakage testing of empty rigid containers by vacuum method ndard test method for drop test of loaded containers by free fall. Th e may be obtained from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 59, U.S.A., Web site www.astm.org, or from IHS Global Canada Ltd., 200-1331 Macleod Trail SE, Calgary, Alberta T2G OK3, telephone 613-237-4250 or 1-800-267-8220, fax 613-237-4251,Web site www.global.ihs.com. 2.5 Technical Association of the Pulp and Paper Industry (TAPPI} T802 OM-12 - Drop test for fiberboard shipping containers ©CGSB 2015 -All rights reserved 3#

Page 21CAN/CGSB-43.125-20XX CD-01 T810 OM-11- Bursting strength of corrugated and solid fiberboard T811 OM-11- Edgewise compressive strength of corrugated fiberboard (short column test) T839 OM-12 - Edgewise compressive strength of corrugated fiberboard using the clamp method (short column test). 2.5.1 Source The above may be obtained from Technical Association of the Pulp and Paper Industry, T Box 933644, Atlanta, GA 31193-3644, U.S.A., telephone 1-800-446-9431 (Canada), 1-8 (U.S.A.), 770-446-1400 (Worldwide), fax 770-209-7206, e-mail memberconnection www.tappi.org/. 2.6 United Nations (UN) Recommendations on the Transport of Dangerous Goods, Mo_del R 2.6.1 Source The above may be obtained from distributors of un· Publications Customer Service, PO Box 960, Her 1-703-996-1010. E-mail order@un.org. Web site http://www.unece.org/trans/danger/publ" rec/re 3 Terms and Definitions s Publications or from the United Nations 172, U.S.A. Telephone 1-703-661-1571. Fax of Canada, the following terms and definitions apply. Where efinition in this standard and that of the TOG Regulations, the there is a conflict between definition in the TOG Re 3.1 all apply. "nica astes imals or humans or from bio-research. infectious substance that is transported in a form such that, when it is released outside of its means of containment and there is physical contact with humans or animals, it is capable of causing permanent disability or life-threatening or fatal disease to humans or animals. [SOURCE: Transportation of Dangerous Goods Regulations (including amendments)]3.3 category B 4 ©CGSB 2015 -All rights reserved#

Page 22CAN/CGSB-43.125-20XX CD-01 infectious substance that does not meet the criteria for inclusion in Category A. [SOURCE:Transportation of Dangerous Goods Regulations (including amendments)] 3.4 culture result of a process by which pathogens in a specimen are intentionally propagated. This definition does not include specimens taken from a human or animal patient and that are intended to be proce laboratory. [SOURCE:Transportation of Dangerous Goods Regulations (including amendments)] 3.5 combination packaging packaging consisting of one or more inner packagings contained in an o ackaging for transport. [SOURCE: CGSB-43.125-99]3.6 director director, Regulatory Affairs Branch, Transport Dangerous Goo [SOURCE: CGSB-43.125-99] 3.7 infectious substances substance known or reasonably believed rickettsia, parasites, fungi and other a cause disease in humans or anima n in viable micro-organisms such as bacteria, viruses, as prions that are known or reasonably believed to [SOURCE:Transportation of oods Regulations (including amendments)] 3.8 inner packaging packaging for w ter packaging is required for transport. g consisting of an outer packaging which contains articles or inner packagings and which: a) is designed for mechanical handling; and b) exceeds 400 kg net mass or 450 litres capacity but has a volume of not more than 3 m3 • ©CGSB 2015 - All rights reserved 5#

Page 23CANjCGSB-43.125-20XX CD-01 [SOURCE: Recommendations on the Transport of Dangerous Goods, Model Regulations (18th revised edition)] 3.10 leakproof transport. [SOURCE: N/A] impermeable to liquid contents or to solids that may become liquids under normal condition of 3.11 outer packaging outer protection of a combination packaging (excluding an overpack) t absorbent materials, cushioning and any other components necessary primary receptacles or inner packagings. [SOURCE: CGSB-43.125-99] 3.12 packaging receptacle and any other components or materials n containment function. [SOURCE: CGSB-43.125-99] 3.13 package design type design specification for the , standard and as described i packaging successfully tested in accordance with this - Design report for type P620 packagings [SOURCE: N/A] 3.14 [S contact with the regulated good. B-43.125-99, modified - updated for clarity] secondary inner packaging inner packaging that provides additional protection for the primary receptacle(s) including absorbent material as required. [SOURCE: CGSB-43.125-99] 6 ©CGSB 2015 -All rights reserved#

Page 24CAN/CGSB-43.125-20XX CD-01 3.16 sift-proof impermeable to dry contents, including any fine solid material produced during transport. [SOURCE: TP14850] 3.17 type P620 packaging packaging intended to transport an infectious substance of Category A in a form of c infectious substance of Category A meeting the requirements of 2.36 (3) in the TDG Re [SOURCE: N/A] 3.18 type P650 packaging packaging intended to transport an infectious substance of Catego[ of Category A that does not meet par. 11.1.1. fectious substance [SOURCE: N/A] 3.19 UN packaging symbol [SOURCE: TP14850] ©CGSB 2015 -All rights reserved 7#

Page 25CAN/CGSB-43.125-20XX CD-01 Part I Design and manufacture of packagings for infectious substances of Category A and Category B 4 General requirements 4.1 Design, test and manufacture A person shall not design, test or manufacture a packaging intended for the transporta · substances of Category A or Category B unless these activities are done in accordan standard. 4.2 Certification safety marks 4.2.1 A person shall not apply a UN marking on a type P620 packagin a) the UN markings conform to the requirements of 5.1; b) the packaging was designed in accordance with 4.3.1. c) a representative prototype of the packaging has the requirements of section 7 and Table 2A; d) the packaging was manufactured 9.1.1; and y management system in accordance with he Director in accordance with the requirements of ing on a type P650 packaging unless: a) the markings co e prototype of the packaging has been successfully tested in accordance with ents of section 7 and Table 2B; ackaging was manufactured under a quality management system in accordance with 9.1.2. 4.3 Packaging Design 4.3.1 Performance 4.3.1.1 Type P620 packaging 8 ©CGSB 2015 -All rights reserved#

Page 26CAN/CGSB-43.125-20XX CD-01 The packaging shall conform to a registered design for which a representative prototype has been tested and found to meet the applicable performance requirements set out in section 7 and Table 2A of this standard, except for design variations permitted in section 8 or Part 2 ofthis standard. 4.3.1.2 Type P650 packaging The packaging shall conform to a representative prototype that has been tested and found meet the applicable performance requirements set out in section 7 and Table 2B of this sta except for design variations permitted in section 8 or Part 2 of this standard. 4.3.2 Internal Pressure 4.3.2.1 Type P620 packaging The primary receptacle or the secondary inner packaging shall be ca pa bl leakage a pressure differential of not less than 95 kPa in accordance 4.3.2.2 Type P650 packaging For shipment by aircraft, the primary receptacle or t substances shall be capable of withstanding withou than 95 kPa in accordance with 7.5. ithstanding without pressure differential of not less 4.3.3 Temperature resistance Whatever the intended temperature of packaging of a type P620 packagin shal +55°C. 4.3.4 Refrigerants nment, the primary receptacle or the secondary inner able of withstanding temperatures in the range of -40 to secondary inner packaging of packagings intended to contain a their integrity at the temperature of the refrigerant used as well as at pressures which could result if refrigeration were lost. Un ise specified in Table l, the net mass shall be equal to or less than 400 kg and the capacity shall be equal to or less than 450 L. 4.4 Packaging Information 4.4.1 When made available as a kit, the packaging manufacturer and subsequent distributor shall provide the following information to the customer in relation to each packaging design: a) a procedure and list of components with sufficient information to allow the user to assemble, fill and close the packaging in the same fashion as it was tested; ©CGSB 2015 -All rights reserved 9#

Page 27CAN/CGSB-43.125-20XX CD-01 b) the maximum capacity of the tested primary receptacles; and c) the tare weight, maximum gross mass and maximum capacity based on the packaging and capacities used for the drop test. 4.4.2 The packaging manufacturer and distributor shall provide the packaging information to a packaging purchaser at each initial purchase of the corresponding packaging. 4.4.3 The packaging manufacturer and distributor shall provide the packaging information packaging user upon request. 5 Certification safety mark 5.1 Marking on a type P620 packaging 5.1.1 General 5.1.1.1 Required marking The marking shall be durable, legible, placed in a location and 5.1.1.2 Location of marking For packagings with a gross mass of more than on the top or side of the packaging. 5.1.1.3 Size of marking a size as to be readily visible. arking (or.a duplicate thereof) shall appear e markings shall be at least 12 mm high, except that: maximum capacity or 30 kg net mass or less shall be at least 6 mm a) the markings on packagin high; and b) the markings on high. ings of 5 L maximum capacity or 5 kg net mass or less shall be at least 3 mm Th markings are required and shall be displayed in the following sequence with each of the a) the UN packaging symbol; b) the packaging code listed in Table 1 and, when applicable, the letter "V" or "W" assigned to the packaging code in accordance with 5.1.4; c) the text: "CLASS 6.2"; d) the last two digits of the year of manufacture of the package; 10 ©CGSB 2015 -All rights reserved#

Page 28CAN/CGSB-43.125-20XX CD-01 e) f) g) the three-letter country code "CAN."; the name or symbol of the manufacturer; and the Transport Canada Design Registration Number. 5.1.3 Examples of marking: 5.1.3.1 Solid plastic box: 4H2/CLASS6.2/15 CAN/ ABC 8-9999 as in 5.1.2 a, b, c, d and e as in 5.1.2 f and g for infectious substances nC! manufactured in 2015. was registered in Canada, by acturer identified as ABC under 5.1.3.2 Special packaging ("V" marking): 4GV /CLASS6.2/15 CAN/ ABC 8-9999 For a special packaging with a fibreboard box outer packaging, for infectious substances of Category A and manufactured in 2015. The design was registered in Canada, by the manufacturer identified as ABC under the registration number 8-9999. assigned to the packaging code ("V" or "W" marking) he letter "V" shall not be assigned to the packaging code unless: a) The rigid outer packaging has been successfully drop tested in accordance with 7.3 with fragile (e.g. glass) primary receptacles; ©CGSB 2015 -All rights reserved 11#

Page 29CAN/CGSB-43.125-20XX CD-01 b) The total combined gross mass of primary receptacles shall not exceed one half the gross mass of primary receptacles used for the drop test in 7.3; and c) The rigid outer packaging has successfully passed the stacking test in accordance with 7.5 ofTP14850 while empty. The stacking test load shall be based on the combined mass of the filled inner packaging(s) used for the drop test. 5.1.4.2 The letter "W" shall not be assigned to the packaging code unless it was assigned in a with 10.9. 5.2 Marking on a type P650 packaging 5.2.1 Required marking The marking shall be durable, legible, placed in a location and of such a s·z \ 5.2.2 Location of marking The marking shall be displayed on the external surface of the contrasting colour. 5.2.3 Content and size of marking The marking shall be in the form of a square set having a length of at least SO mm; the wid numbers shall be at least 6 mm high. , e shall be at least 2 mm and the letters and 12 ©CGSB 2015 -All rights reserved#

Page 30CAN/CGSB-43.125-20XX CD-01 6 Construction 6.1 Type P620 packaging 6.1.1 Components The packaging shall consist of the following components: a) Inner packagings comprising: b) i. leakproof primary receptacle(s); ii. leakproof secondary packaging; a rigid outer packaging of adequate strength for its capacity, mass smallest external dimension is at least 100 mm. The outer pac ended use of which the be selected from Table 1. Table, 1- Packaging co Type Material Code Maximum capacity or maximum net mass 1. Drums A. Steel lAl 450 L removable head 1A2 450 LI 400 kg non-removable lBl 450 L head removable head 1B2 450 L/ 400 kg lD 250 L/400 kg lG 400 kg G. Fibre H. Plastic non-removable head removable head lHl 450 L 1H2 450 L/ 400 kg 1 The construction requirements for these packaging codes may be found in the TP14850 standard. ©CGSB 2015 -All rights reserved 13#

Page 31CAN/CGSB-43.125-20X)_C CD-01 3. Jerricans A. Steel N. Metal, other non-removable 1N1 450 L than steel or head aluminum removable head 1N2 450 L / 400 kg non-removable 3A1 60 L head removable head 3A2 B. Aluminum non-removable head removable head 3B1 H. Plastic non-removable head 60 L 60 L/120 kg 4. Boxes A. Steel 4A 400 kg B. Aluminum 4B 400 kg 4C1 400 kg with sift-proof walls 4C2 400 kg 40 400 kg 4F 400 kg G. Fibreboard 4G 400 kg H. Plastic expanded solid 4H1 60 kg 4H2 400 kg 6.1.2 Absorbent 14 ©CGSB 2015 -All rights reserved#

Page 32CAN/CGSB-43.125-20XX CD-01 Other than for solid infectious substances, an absorbent material shall be placed between the primary receptacle(s) and the secondary inner packaging and in sufficient quantity to absorb the entire content of the primary receptacle(s). 6.1.3 Primary Receptacle Primary receptacles intended for the transportation of: a) Substances consigned at ambient temperature or at a higher temperature shall be ma e glass, metal or plastic; b) Substances consigned in liquid nitrogen shall be made of plastic and capable of wi g very low temperature; or c) Lyophilized substances may be consigned in flame~sealed glass ampo stoppered glass vials fitted with metal seals. 6.1.4 Closures For substances consigned at ambient or higher temperature leakproof seal shall be provided, e.g. heat seal, a skirted sto caps are used, they shall be manufactured locking closure. 6.1.5 Multiple Primary Receptacles If multiple fragile primary receptacles ar receptacles shall be individually wrap, them. 6.1.6 Refrigerants e means of ensuring a etal crimp seal. If screw paraffin sealing tape or aced 1 a secondary inner packaging, the primary erwise separated to prevent contact between rigerant such as ice, dry ice or liquid nitrogen shall conform to the following requir b) c) rior supports shall be provided to secure secondary inner packaging(s) or packages in the original position after the refrigerant has dissipated. In the case of ice, the outer packaging or overpack shall be leakproof. d) In the case of dry ice or liquid nitrogen, the outer packaging or overpack shall permit the release of carbon dioxide gas. ©CGSB 2015 -All rights reserved 15#

Page 33CAN/CGSB-43.125-20XX CD-01 6.2 Type P650 packaging 6.2.1 Components The packaging shall consist of the following components: a) Inner packagings comprising: i. leakproof or siftproof primary receptacle(s); ii. leakproof or siftproof secondary packaging; b) An outer packaging of which either the secondary or the outer packaging shall surface of the outer packaging shall have a minimum dimension of 100 m 6.2.2 Absorbent Absorbent material shall be placed between the primary receptacle(s) a packaging. The absorbent material shall be in quantity sufficient t ~ primary receptacle(s) so that any release of the liquid substance cushioning material or of the outer packaging. If there is any may be present in the primary receptacle during transp including absorbent materials, shall be used. secondary inner he entire content of the om promise the integrity of the o whether or not residual liquid 6.2.3 Multiple primary receptacles If multiple fragile primary receptacles are shall be individually wrapped or other ed in a secondary inner packaging, the primary receptacles ted to prevent contact between them. 6.2.4 Refrigerants erant such as ice, dry ice or liquid nitrogen shall conform to the a) efrigerant shall be placed e secondary inner packaging(s) or he outer packaging or an overpack b) ·or supports shall be provided to secure secondary inner packaging(s) or packages in the original position after the refrigerant has dissipated. c) In the case of ice, the outer packaging or overpack shall be leakproof. d) In the case of dry ice or liquid nitrogen, the outer packaging or overpack shall permit the release of carbon dioxide gas. 16 ©CGSB 2015 -All rights reserved#

Page 34CAN/CGSB-43.125-20XX CD-01 7. Testing 7 .1 General requirements 7 .1.1 Test schedule Packagings selected for testing shall be representative of the design intended for production. The tests required for type P620 packagings are set out in 7.2 to 7.5 and Table 2A of this standard and required for type P650 packagings are set out in 7.2, 7.3, 7.5 (if applicable) and Tabl~ standard. 7 .1.2 Variations Tests shall be repeated after each variation of the design, material or ma packaging unless the variations are permitted in section 8. design report. sha 7 .2 Preparation for testing 7 .2.1 Preparation 7.2.1.1 Fill and close the packagings for testing in the installed as specified by the closure manufacture 7.2.1.2 Each primary receptacle shall be infectious substance shall be replaced ot less than 98% of its capacity. Liquid or solid or, where conditioning at -18°C is specified, by ©CGSB 2015 -All rights reserved 17#

Page 35CAN/CGSB-43.125-20XX CD-01 Table 2A -Test requirements - Testing required on a P620 packaging Condit ion i ng Type of packaging a Tests required Special preparation Ambient Cold Primary temperature Water Dry icec Internal receptacleb conditio Drop ncture spray ning pressure• Rigid outer packaging Number Number Number Plasti Number of Other of of of of c samples samples samples samples samples Fibreboard x 0 5 5 1 3 2 3 box x 0 5 0 1 3 2 3 Fibreboard x 0 3 3 1 3 2 3 drum x 0 3 1 3 2 3 x 0 5 1 3 2 3 Plastic box x 0 1 5 1 3 2 3 Plastic x drum/ Jerri can x 3 1 3 1 3 2 3 3 1 3 1 3 2 3 Box of x other material 0 5 1 5 1 3 2 3 0 0 1 5 1 3 2 3 5 0 3 1 3 1 3 2 3 x 5 0 0 1 3 1 3 2 3 18 ©CGSB 2015 -All rights reserved#

Page 36CAN/CGSB-43.125-20XX CD-01 The material of the secondary inner packagings is not taken into consideration when selecting the test or conditioning for the test. Where a primary receptacle is made oftwo or more materials, the material most liable to damage determines the appropriate est. Additional drop test required when the packaging is intended to contain dry ice (see 7.3.5.3). Required when testing a special packaging "V" (see 11.5}. Required when testing a Type P620 packaging for solids or liquids (see 4.3.2.1). ©CGSB 2015 -All rights reserved 19#

Page 37CAN/CGSB-43.125-20XX CD-01 Table 28 - Test requirements - Testing required on a PGSO packaging#

Page 38CAN/CGSB-43.125-20XX CD-01 7.3 Drop test P620 and P650 packagings shall be subjected to the drop test in accordance with this section. 7 .3.1 Test method 7.3.1.1 Perform the drop test in accordance with ASTM 05276 using the ap orientation as specified in 7.3.5 and the appropriate number of packagings i Tables 2A and 2B. Where more than one orientation is possible for a gi orientation most likely to result in failure of the container shall be used. 7.3.1.2 Where the packaging is intended to contain dry ice, one ad and 2B) shall be carried out. 7.3.1.3 For fibreboard boxes (4G), the drop test may be c in accordance with TAPP! T802. 7.3.1.4 Except for flat drops, the centre of gravit tically over the point of impact. 7.3.1.5 The test containers shall be droppe ·d, non-resilient, flat, massive and horizontal surface. 7.3.1.6 The drop test shall be pe specified in 7.3.2, or within 15 ith the containers in the conditioning atmosphere, val from the conditioning atmosphere. 7.3.2 Conditioning !i)erature conditioning ng ambient temperature conditioning shall be conditioned in accordance with ASTM pecial preparation of test sample for the drop test 7.3.2.2.1 Fibreboard outer packagings - Water spray test Subject the packagings to a water spray that simulates exposure to a rainfall of approximately 5 cm per hour for at least one hour in accordance with ASTM 0951. 7.3.2.2.2 Primary receptacles or outer packagings made of plastic - Cold conditioning ©CGSB 2015 -All rights reserved 21#

Page 39CAN/CGSB-43.125-20XX CD-01 Subject the packaging to a temperature of -18°C or lower for a period of not less than 24 h in accordance with ASTM 04332. If the sample contains dry ice, then the conditioning period may be reduced to 4 h. 7.3.2.2.3 Packaging intended to contain dry ice One packaging shall be stored until all the dry ice has dissipated. 7.3.3 Procedure 7.3.3.1 After the drop test examine each primary receptacle for evidence of leakage 7.3.3.2 Examine ifthe primary receptacle(s) remained protected by cushioning the secondary inner packaging. 7.3.4 Drop Height 7.3.4.1 Type P620 packagings shall be dropped from a minim packagings from a minimum height of 1.2 m 7.3.5 Orientation 7.3.5.1 Where the samples are in the shap orientations: box 2 - flat on the to he samples are in the shape of a drum; three shall be dropped one in each of the fol box 1 - impact box 2 - box 3 - diagonally on the top chime, with the centre of gravity directly above the point of diagonally on the base chime flat on the side. 22 ©CGSB 2015 -All rights reserved#

Page 40CAN/CGSB-43.125-20XX CD-01 7.3.5.3 Sample of a packaging intended to contain dry ice Drop one packaging in one of the orientation described in 7.3.5.1 or 7.3.5.2 which shall most likely result in failure of the packaging. 7 .3.6 Criteria of a successful test There shall be no release of the contents from the primary receptacle(s) which shall rema~z;i protected by cushioning/absorbent material in the secondary inner packaging. The seco~Cla, inner packaging shall be retained within the outer packaging. A minor exposure of the~~ inner packaging is acceptable if it is not possible to withdraw the secondary inner p ii\i., da~y ,r{m the outer packaging. 7.4 Puncture test Type P620 packagings shall be subjected to the puncture test in acco h this section. 7.4.1 Test method 7.4.1.1 Packagings with a gross mass of 7 kg or less The packaging shall be placed on a level hard surface a vertical free fall position and be capable of pe 7.4.1.2 Packagings with a gross mass exceeding 7 k The puncture device shall be set vertl0 @o dropped in a vertical free fall posi~ion. T primary receptacle(s). level hard surface and the packaging shall be puncture device shall be capable of penetrating the 7.4.2 Procedure Examine the primar ce shall be a cylindrical steel rod having a diameter of 38 mm, a mass of 8.0 ± en 36 impact equal mm. <lR ©CGSB 2015 -All rights reserv1 23#

Page 41CAN/CGSB-43.125-20XX CD-01 tu re device shall be dropped from a height of 1 m, measured from the impact end of the the impact surface of the packaging. 7.4.4.2 Packaging of more than 7 kg Packaging shall be dropped from a height of 1 m, measured from the impact surface of the packaging to the top of the puncture device. 7.4.5 Orientation 24 ©CGSB 2015 -All rights reserved#

Page 42CAN/CGSB-43.125-20XX CD-01 7.4.5.1 Packaging of 7 kg or less The impact end of the puncture device shall strikes a location a) on the top of the first packaging; and b) on the side of a second packaging. 7.4.5.2 Packaging of more than 7 kg The packaging shall be dropped on top of the puncture device so that a) the top face of the first packaging strikes the impact end of the puncture devi b) the side of the second packaging strikes the impact end of the puncture 7.4.5.2.1 The puncture device shall protrude from the surface a di between the centre of the primary receptacle(s) and the outer with a minimum of 200 mm. east equal to that the outer packaging 7 .4.6 Criteria of a successful test There shall be no release of the contents from th of the secondary inner packaging is acceptable receptacle(s). ceptacle(s). However, penetration at there is no leakage from the primary 7.5 Internal pressure test The primary receptacle or the se solids and the primary recept er packaging of a type P620 packaging for liquids and secondary inner packaging of a type P650 packaging for jected to the pressure test in accordance with this section. 7.5.1 Test method pro ate fitting into three containers in such manner that the performance of the ed. packagings, the pressure test shall be conducted in accordance with ASTM 04991. 7.5. 7.5. The pressure shall be measured by using a gauge or other device of suitable range and accuracy. NOTE Various means of pressure measurement calibration may be used as long as a procedure is established for ensuring that instruments are maintained and calibrated, and they operate within suitable parameters. A record shall be kept identifying the instrument, the method of calibration, its calibration frequency, and the date of its last calibration. ©CGSB 2015 -All rights reserved 25#

Page 43CAN/CGSB-43.125-20XX CD-01 7 .5.3 Procedure 7.5.3.1 Restrain the containers, including their closures, under the surface of water for a period of 10 min while an internal air pressure of not less than 95 kPa is applied. The restraints shall not affect the results of the test. 7.5.3.2 Examine all surfaces and seams of the containers for leakage as evidenced by the format' bubbles while the container is under water and under constant air pressure. 7.5.3.3 Other methods, at least equally effective, may be used if written procedures pr the test method and there is suitable data to validate the test method. Such metho detection (e.g. helium testers), pressure differential test or soap solution applie entire container. The appropriate test method shall be selected based on cont 7.5.4 Criteria for a successful test Tested containers shall not leak. 8 Permitted design variations 8.1 Design variation requiring no testing Provided that an equivalent level of performanc packagings within a secondary inner packaging ar ned, the following variations of inner wed without further testing. 8.1.1 Primary receptacles of equiva Primary receptacles of equivalent used provided: size as compared to the tested primary receptacles may be a) similar design to the tested primary receptacle (e.g. shape: round, b) ruction of the primary receptacle (glass, plastic, metal, etc.) offers resistance g forces equal to, or greater than, that of the originally tested primary c) receptacles have the same or smaller openings and the closure is of similar design (e.g. , friction lid, etc.); nt additional cushioning material is used to take up void spaces and to prevent significant movement of the primary receptacles; and e) primary receptacles are oriented within the secondary inner packaging in the same manner as in the tested package. 8.1.2 Quantity of primary receptacles 26 ©CGSB 201S -All rights reserved#

Page 44CAN/CGSB-43.125-20XX CD-01 A lesser number of the tested primary receptacles, or of the alternative types of primary receptacles identified in 8.1 a., may be used provided sufficient cushioning is added to fill the void space(s) and to prevent significant movement of the primary receptacles. 9. Quality management system 9.1 General 9.1.1 Type P620 packaging Packagings shall be manufactured under a quality management system capable of ensu packagings are in accordance with the tested and registered design specified int . requirements of this standard and the TOG Regulations. 9.1.2 Type PGSO packaging Packagings shall be manufactured under a quality management sy packagings are in accordance with the tested design specified i this standard and the TOG Regulations. n report, the requirements of 10. Registration 10.1 General This section applies to type P620 packagin registered with the Director. 10 .. 1.1 Registration by the Direc A person shall not manufact facility and the packagin P620 packaging under this standard unless the manufacturing ve been registered by the Director. · 'ty is registered upon issuance, by the Director, of a certificate of registration. The ration remains valid until its indicated expiry date or its revocation for cause. · 620 packaging design is registered upon issuance, by the Director, of a Design Registration Number. The Design Registration Number remains valid until its revocation for cause. 10.1.4 Application for registration 10.1.4.1 Manufacturing facility ©CGSB 2015 -All rights reserved 27#

Page 45CAN/CGSB-43.125-20XX CD-01 An application for registration of a manufacturing facility shall be submitted to the Director and, at a minimum, shall include the following information: a. the packaging manufacturer's name and address; b. the manufacturing facility locations where the packaging will be produced; 10.1.4.2 Packaging design An application to manufacture a new P620 packaging design shall be submitted to the Di minimum, shall include the following information: a. the packaging manufacturer's name and address; b. the manufacturing facility locations where the packaging will be pr·· c. when different from the packaging manufacturer, the nam has performed the performance testing; s of the company that d. the packaging information as required in 4.4; e. proposed markings as required in 5.1; f. the design report in accordance with an g. a statement declaring that all req and signature of the officer res packaging manufacturer. If ents f this standard have been met, including the date r compliance to this standard on behalf of the acturer did not perform the testing, the statement shall sponsible officer of the company that has performed the testing. rer shall keep a copy of every application for registration of the manufacturing UN standardized packagings are manufactured and at least two years thereafter. for ufacturer shall keep a copy of every application to manufacture a packaging design standardized packaging is manufactured and at least two years thereafter . .. egistration and compliance A Certificate of Registration and Design Registration Number shall be issued by the Director, for a manufacturing facility ifthe Director is satisfied that: a. the packagings manufactured and marked are representative of the registered design; b. the packaging manufacturer conforms to the applicable requirements of this standard; and 28 ©CGSB 2015 -All rights reserved#

Page 46CAN/CGSB-43.125-20XX CD-01 c. the manufacturer is capable of consistently complying with the requirements of this standard. 10.1.6 Revocation for cause 10.1.6.1 Certificate of Registration The Director may revoke a Certificate of Registration if the Director is satisfied that: a. the packagings, as manufactured, are not representative of the registered designs or . comply to the applicable requirements of this standard; b. the manufacturer is not capable of complying with the requirements of this c. the manufacturer is not complying with the requirements of this stand 10.1.6.2 Design Registration Number The Director may revoke a Design Registration Number if the Dire a. the packaging, as manufactured, is not representativ the Design Report; or istered design as described in b. the packaging does not comply with the re 10.1. 7 Renewal of Certificate of Registration The manufacture of packagings shall n past the expiry date of the Certificate of Registration. 10.1.8 Application for renewal as the initial application renewal shall also in ate of Registration is subject to the same process and conditions e of Registration relating to the manufacturer. The application for fall currently registered packaging designs identified either as actively issue a Registration Number for a packaging design that, although of a type described in anufactured to a different specification if the Director is satisfied that the packaging is equi d(nt to a container that conforms to the requirements of this standard. The Director shall assign the capital letter "W" to the packaging code. 10.1.10 Design modifications Any change in packaging design that results in the information of the previously submitted design report to no longer be accurate shall be submitted to the Director as an application to manufacture a new packaging design. If the new design is within the permitted design variations such that no new testing is ©CGSB 2015 -All rights reserved 29#

Page 47CAN/CGSB-43.125-20XX CD-01 required, the application shall identify the previously tested design. If limited testing of the modified design is required, the design report shall include the relevant results. 10.1.11 Transition from CAN/CGSB-43.125-99 A Certificate of Registration issued in accordance with the CAN/CGSB-43.125-99 standard for a container design shall be deemed to be registered as a manufacturing facility and for packaging design pur uant to chapter 10 of this standard unless the certificate has expired or been revoked. Part II Selection and use of packagings for infectious substances of Categor 11 General requirements 11.1 Selection and use 11.1.1 Infectious substances that are included in Category A in a (3) in the TDG Regulations shall be handled, offered for trans packaging. 11.1.2 Other infectious substances that are include handled, offered for transport or transported a 11.2.3 Infectious substances that are incl transported in a type P650 packaging. 11.2 Filling and closing culture or meet criteria 2.36 sported in a type P620 ry A but do not meet 11.1.1 may be in a type P650 packaging. gory B shall be handled, offered for transport or ackagings that have an appropriate resistance to the internal normal ·conditions of transport and meets the requirements set out in pressure that may devel 4.3.2; and emb g or closing a container shall assemble and close the container as instructed in ed by the container manufacturer or distributor in accordance with 4.4. shall not handle, offer for transport or transport by aircraft infectious substances in a packaging unless it is done in accordance with the applicable requirements set out in Part 12 of the TDG Regulations. 11.4 Marine transport 30 ©CGSB 2015 -All rights reserved#

Page 48CAN/CGSB-43.125-20XX CD-01 A person shall not handle, offer for transport or transport by ship infectious substances in a packaging unless it is done in accordance with the applicable requirements set out in Part 11 of the TDG Regulations. 11.5 Special packaging ("V" marking) A person may assemble a P620 packaging, marked in accordance with 5.1.2 band 5.1.4.1 with t "V", for primary receptacles of any type, for solids or liquids, if; a) the cushioning thickness between primary receptacles and between prima[ the outside of the secondary inner packaging has not been reduce cle and a to the successfully tested design. If a single primary receptacle was used · thickness of cushioning between primary receptacles shall not be I cushioning between the outside of the secondary inner packagi in the original test. When either a fewer number of packagings are used (as compared to the inner packa kagings or smaller inner in the drop test), sufficient additional cushioning material shall be used to take u b) primary receptacles containing liquid are complet absorbent material to absorb the entire conte c) for an outer packaging that is not siftproof equally effective means is inserted in primary receptacles; and proof, a leakproof liner, plastic bag, or other ckaging to contain any release of solids or liquids, as applicable, from the inner p ©CGSB 2015 -All rights reserved 31#

Page 49CAN/CGSB-43.125-20XX CD-01 Part Ill Selection and use of containers for the transport of infectious substances of Category A and Category B intended for disposal and clinical and (bio) medical waste 12 General 12.1 Category A infectious substances intended for disposal and meeting the requireme 2.36(3) in the TOG Regulations shall always be handled, offered for transport or transpo ted in a Type P620 Packaging. 12.2 Substance intended for disposal and containing Category A (other than requirements of 2.36(3) in the TOG Regulations) or Category B infectious s medical or clinical waste shall be transported in any of the following mean a) UN standardized small container for packing group I or II, for Ii If the container is not leakproof, a plastic bag meeting the r inserted in the container to contain any possible release of Ii s listed in Table 3. s of Table 5 shall be The containers associated to the UN packaging code containers that meet the requirements applicable to or the UN Recommendations and the Regulati and are marked accordingly. of container as set out in TP14850 ountry of origin, as the case may be, Type des for UN standardized small containers Category Packaging code 1. Drums non-removable head B. Aluminum removable head non-removable head removable head D. Plywood G. Fibre H. Plastic non-removable head ~------~----------~·---------------------------------------------------- lAl 1A2 lBl 1B2 lD lG lHl ------------------------- 32 ©CGSB 2015 -All rights reserved#

Page 50CAN/CGSB-43.125-20XX CD-01 .---------r------------"""T---------------------------------------------------- --------"----------------- removable head 1H2 N. Metal, other than steel or aluminum non-removable head removable head 3. Jerricans A. Steel non-removable head removable head lNl 1N2 3Al 3A2 B. Aluminum non-removable head H. Plastic 4. Boxes A. Steel B. Aluminum C. Natural wood D. Plywood expanded solid N. Metal, other than steel or aluminum H. Plastic inner receptacle 3H2 4A 4B 4Cl 4C2 4D 4F 4G 4Hl 4H2 4N 6HA1 in steel drum in steel crate or box 6HA2 6HB1 in aluminum drum in aluminum crate or box 6HB2 ©CGSB 2015 -All rights reserved 33#

Page 51CAN/CGSB-43.125-20XX CD-01 in wooden box 6HC in plywood drum 6HD1 in plywood box 6HD2 in fibre drum 6HG1 in fibreboard box 6HG2 in plastic drum in solid plastic box P. Glass, porcelain or stoneware inner receptacle in steel drum 6PA2 6PB1 6PB2 6PC in plywood box 6PD1 in wickerwork hamper 6PD2 in fibre drum 6PG1 in fibreboard box 6PG2 in expanded plastics outer 6PH1 packaging in solid plastic outer 6PH2 packaging b) UN standardized IBC for packing group I or II, for liquids or solids listed in Table 4. The containers associated to the UN IBC code listed in the above table shall be UN standardized IBCs that meet the requirements applicable to this type of container as set out in CAN/CGSB- 43.146 or the UN Recommendations and the Regulations of the country of origin, as the case may be, and are marked accordingly. 34 ©CGSB 2015 -All rights reserved#

Page 52CAN/CGSB-43.125-20XX CD-01 Table 4 - Selected packaging codes for UN standardized IBCs Type Type of IBC Design characteristics Code Flexible (13) Plastic (H) Woven plastic with liner 13H3 Woven plastic, coated and 13H4 with liner Coated with liner Textile (L) Rigida For solids, loaded (11, 21 and 31) by gravity (lla) Fitted with structural equipment 11A, 11B, 11N, 11H2 With liners: 11C, 11D, llF, llG 31Hl Fitted with structural equipment Free-standing Composite with For solids, loaded or discharged by gravity, with rigid plastic inner receptacle 31A, 31B, 31N,31H2 Such as: llHAl and llHHl placeholder for the material code of the outer frame) For solids, loaded or discharged by gravity, with flexible plastic inner receptacle Such as: 11HA2 and 11HH2 ©CGSB 2015 -All rights reserved 35#

Page 53CAN/CGSB-43.125-20XX CD-01 31HZa For liquids, with rigid plastic inner receptacle Such as: 31HA1 and 31HH1 For liquids, with flexible plastic inner receptacle Such as: 31HA a The single capital letter following the rigid IBC numerical codes or the letter "Z" foll "H" in composite IBC with plastic inner receptacle codes stands for the capital lett the following list that represents the material of either the body of the rig the outer frame body o.f a composite IBC: A- Steel B-Aluminum C - Natural wood D - Plywood F - Reconstituted wood G - Fibreboard H - Plastic or rubber L-Textile ndardized rigid and leakproof Large Packagings for packing group II, for liquids or solids the requirements of Chapter 6.6 in UN Recommendations and the Regulations of the country of origin and marked accordingly. d) a non-standardized combination packaging consisting of a securely-closed plastic bag that meets the requirements of Table 5 and is contained in a securely closed outer packaging that is 36 ©CGSB 2015 - All rights reserved#

Page 54CAN/CGSB-43.125-20XX CD-01 i. rigid, leakproof and designed for repeated use; or ii. a fibreboard box that meets the requirements of columns 1, 2 and 3 or columns 1, 2 and 4 of Table 6 12.4 Sharp objects Packaging intended to contain sharp objects such as broken glass and needles shall: a. meet the requirements of CSA Z316.6, or JEW Table 5 - Plastic bag Test Test standard Nominal value Elmendorf tear strength ASTM D1922 480g MD 480 g TD Dart impact strength ASTM D1709 165 g B Table -Fireboard box "Column 1 Column 2 Column 3 Column 4 Type of fibreboard 2 Maximum weight Maximum outside of box and dimensions Minimum bursting Minimum edge contents L+W+H strength crush test (ECT) kg (Ib) ст (in) kPa (Ib/in?) kN/m (lb/in) Singlewall 16 (35) 190 (75) 1380 (200) 5.6 (32) 23 (50) 216(85) 1720 (250) 7.0 (40) 30 (65) 241 (95) 1900 (275) 7.7 (44) 30 (65) 267(105) 2410 (350) 9.6 (55) ©CGSB 2015 - All rights reserved 37#

Page 55CAN/CGSB-43.125-20XX CD-01 Doublewall 30 (65) 216 (85) 1380 (200) 7.4 (42) 30 {65) 241 {95) 1900(275) 8.4 (48) 30 {65) 267 (105) 2410 {350) 8.9 (51) T e Minimum Bursting Strengt tests a econ ucte m accor ance Wit TAPPI T810. The Edge Crush Test (ECT) shall be conducted in accordance with TAPPI T811 or TAPPI T839. 38 ©CGSB 2015 -All rights reserved#

Page 56CAN/CGSB-43.125-20XX CD-01 Annex A (Normative) Design report for type P620 packagings Al. The following are the minimum requirements for the completion of test reports sub to the Director in accordance with this standard. Information provided in the report confidential. A2. The report should be dated, display a unique identification number and i following headings and information. A2.1 Introduction a) The manufacturer's name, address and telephone number b) A general description of the package types c) The plant locations where the package will be produced. A2.2 Design (Prototypes) A2.2.1 Drawings At least one drawing of the completed pa sequence, overall dimensions, materia valves, etc., if applicable. (Photogr hs e e.g. ssembly drawing) showing assembly method and ral construction, inner and outer packagings, liners, arification should be included.) A2.2.2 Materials and canst The materials and con absorbent material, r the outer and inner packagings and any other components (e.g. nmg, dividers, coatings, closures, liners, pads, gaskets). a) he composition (nominal basis weight of solid or linerboard and corrugating medium, flute type, adhesive [i.e. regular or water resistant]), minimum burst strength, puncture ngth or edge crush strength of the solid or corrugated board. b) Metal - The material type and specification (e.g. ASTM or ISO); the nominal thickness. c) Plastic - The resin type, density, strength properties for film. A2.2.2.2 Construction a) Fabrication and closure methods, fasteners, fastener spacing, closure torque, coatings, etc. As applicable. ©CGSB 2015 -All rights reserved 39#

Page 57CAN/CGSB-43.125-20XX CD-01 b) Fibreboard i) the box style ii) iii) iv) the drawings of liners and dividers, the boxmaker's drawing or sketch showing board inside dimensions (flat) and direction of corrugations the type of manufacturer's joint (glued, stitched or taped) The closure types: glued, stitched or taped 1) Glued : type and coverage of glue 2) Stapled : type, size, number and pattern of staples 3) Taped : type, dimensions and location of tape c) Metal -The type of seam, seaming compound and weld. A2.2.2.3 The detailed material data may be provided on part Ii drawings may be included with the report or referenced on a applies to the prototype design. If drawings are referred the manufacturer and made available to the Director shall also be retained by the manufacturer. A2.3 Qualification testing A2.3.1 Test required A reference to the applicable se ing the drawing revision that included, copies shall be retained by a) b) c) d) pacity, etc. of the equipment used h justification, from the test methods prescribed by this standard n of the test specimen replicates including contents, net and gross mass as tested. tatement that the specimens tested were randomly selected (if selected from uction) and represent the package intended for manufacture. A2.3.3 Test Results a) The test results in terms of the pass/fail criteria of the specific test and replicate tested. (Results may be displayed in tabular form.) b) A description of the damage in detail. 40 ©CGSB 2015 - All rights reserved#

Page 58CAN/CGSB-43.125-20XX CD-01 c} d} The results listed in a sequence corresponding to "Test Required". Photographs and/or videos of the replicates should be taken during/after testing. A2.4 Certification a} b} c} A statement declaring that all requirements of CAN/CGSB-43.125 have been met. Name, address, telephone number and signature ofthe person who conducted the his employer, if different from the package manufacturer. Signature of the responsible officer for the manufacturer. A2.S Documentation A copy of the packaging information in accordance with 4.4. A2.6 Marking An indication of the proposed marking in accordance with 5. ©CGSB 2015 -All rights reserved 41#