# Inmark Packaging — Hazardous Materials Safety Interpretation - **operation:** document - **citation:** 15-0170 - **title:** Inmark Packaging — Hazardous Materials Safety Interpretation - **source type:** guidance - **agency:** Pipeline and Hazardous Materials Safety Administration - **status:** guidance - **official:** true - **published on:** 2016-02-10 - **effective on:** Not available - **summary:** 15-0170 response to Inmark Packaging concerning 178.609. - **machine formats:** - **json:** https://regulus.evalyn.ai/document/phmsa-interpretation-15-0170.json - **markdown:** https://regulus.evalyn.ai/document/phmsa-interpretation-15-0170.md - **app url:** https://regulus.evalyn.ai/document/phmsa-interpretation-15-0170 - **source url:** https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2016/150170.pdf **body:** <<>> U.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 <<>> Goodall, 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 <<>> 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. 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 <<>> From: 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 <<>> Do 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 <<>> CAN/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 <<>> f-" 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 <<>> I 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 <<>> tue 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 <<>> 4.7 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 <<>> d. 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 <<>> ©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 <<>> CAN/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 <<>> CAN/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 <<>> CAN/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 <<>> CAN/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 <<>> FOR PUBLIC REVIEW ONLY <<>> CAN/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 <<>> CAN/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 <<>> CAN/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 <<>> CAN/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 <<>> CAN/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 anim - **truncated:** true - **body characters:** 83011