# Andelyn Biosciences — Hazardous Materials Safety Interpretation - **operation:** document - **citation:** 23-0067 - **title:** Andelyn Biosciences — Hazardous Materials Safety Interpretation - **source type:** guidance - **agency:** Pipeline and Hazardous Materials Safety Administration - **status:** guidance - **official:** true - **published on:** 2024-05-01 - **effective on:** Not available - **summary:** 23-0067 response to Andelyn Biosciences concerning 173.199, 178.601, 178.609. - **machine formats:** - **json:** https://regulus.evalyn.ai/document/phmsa-interpretation-23-0067.json - **markdown:** https://regulus.evalyn.ai/document/phmsa-interpretation-23-0067.md - **app url:** https://regulus.evalyn.ai/document/phmsa-interpretation-23-0067 - **source url:** https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2024-05/230067.pdf **body:** <<>> U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, DC 20590 May 1, 2024 Dave Curl Andelyn Biosciences 1180 Arthur E. Adams Dr. Columbus, OH 43221 Reference No. 23-0067 Dear Mr. Curl: This letter is in response to your July 6, 2023, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to infectious substances. In your email, you state that your company transports “UN3373, Biological substance, Category B, 6.2” with dry ice in a non-specification packaging in conformance with § 173.199. You note that this includes conformance with the § 178.609(d) drop tests, as required in § 173.199(a)(4). You state that your company would like to add additional mylar bags to the inner packaging that were not present when the drop tests were completed. You ask whether this modification to the inner packaging would require the entire package configuration to be retested. The answer is no. Section 173.199 prescribes the packaging requirements for a Division 6.2 Category B infectious substance. This section requires that a Category B infectious substance be packaged in a triple packaging that is designed, constructed, and maintained so that under conditions normally encountered in transportation, there will be no release of the hazardous material into the environment. The package must also be capable of passing the drop tests in § 178.609(d), in accordance with § 173.199(a)(4); however, it does not require retesting and is not subject to the design qualification testing, periodic retesting, or record retention (i.e., test report requirements) in § 178.601. It is the opinion of this Office that the minor revisions to the inner packaging configuration as described in your email would not require the entire package configuration to be retested. I hope this information helpful. Please contact us if we can be of further assistance. Sincerely, Steven Andrews Acting Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division <<>> Alexander Wolcott 23-0067 From: Dodd, Alice (PHMSA) To: Subject: Date: Jones, Jessie Jane CTR (PHMSA) FW: Packaging change review / Interpretation request Tuesday, July 18, 2023 5:09:31 PM Attachments: image001.png image002.png image004.png image005.png image006.png image007.png image008.png image009.png image010.png image011.png image012.png 22172U ThermoSafe.pdf 22173U ThermoSafe.pdf 22174U ThermoSafe.pdf From: INFOCNTR (PHMSA) Sent: Friday, July 14, 2023 1:53 PM To: Dodd, Alice (PHMSA) Cc: Hazmat Interps Subject: FW: Packaging change review / Interpretation request Hi Alice, Please see the below interpretation request. Let us know if you need anything. Regards, -Breanna From: Curl, Dave Sent: Friday, July 14, 2023 1:42 PM To: INFOCNTR (PHMSA) Subject: Packaging change review / Interpretation request CAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links or open attachments unless you recognize the sender and know the content is safe. Thanks! Dave <<>> From: Curl, Dave Sent: Thursday, July 6, 2023 11:42 AM To: infocntr@DOT.gov Subject: Packaging change review request To whom it may concern, My name is Dave Curl and I am the Logistics Manager for Andelyn Biosciences in Columbus, Ohio. We have been working closely with Sunoco Thermosafe to design a package to effectively handle our Gene Therapy products for ground and air shipments. I have attached the final testing reports for the 3 packages we are looking to move forward with. Our products will typically be UN3373 (Category B) on dry ice (UN1845). As you can see by the report, the packages will comply with all regulations spelled out in 49 CFR 173.199. The dilemma I have is that a large client of ours would like to add some additional layers of protection (mylar bags) in order to mitigate the risk of the Carbon Dioxide from the dry ice permeating their product. Below is a description of the changes we are proposing to the package and would appreciate your input as to whether or not there is a need for additional testing: What will be added are two mylar bags around a cryo box containing the product The first would be ziplocked and sealed with a tamper evident seal <<>> The product inside the first mylar back would then go inside of a 2nd mylar bag and heat sealed. Once heat sealed the product would then be placed into the 95kPa pressure bag with absorbent pads <<>> The 95kPa bag would then be sealed and placed into the payload box Finally the payload box gets placed into the Styrofoam cooler insert with dry ice and sealed up. <<>> The purpose of the request is to hopefully have your team review the additions to the package and provide some feedback on the proposed changes. We feel that the addition of the mylar bags just adds more layers of protection and really does not alter the effectiveness of the package. I would appreciate that you review the change and provide some guidance in order for us to proceed with meeting our customers expectations. Please feel free to reach out via email or phone if you have any additional questions or concerns. Thank you very much for your time!! Dave Curl Logistics Manager Andelyn Biosciences 1180 Arthur E. Adams Dr. Columbus, OH 43221 Phone: 614-332-0554 <<>> Email: dave.curl@andelynbiosciences.com Confidentiality Notice: The information contained in this email and any attachments are confidential and may contain privileged and/or proprietary information. It is intended solely for the use of the addressee(s) only. If you are not the intended recipient, you are strictly prohibited from copying, distributing or using this email or the information contained in it. If you received this email in error, please notify the sender immediately by email or telephone, and destroy any copies, electronic, paper or otherwise. <<>> TEST REPORT THERMOSAFE BRANDS ARLINGTON HEIGHTS, ILLINOIS TESTING OF FIBERBOARD BOX CONTAINING EIGHTY-ONE (81) 2-ml. PLASTIC TUBES PACKAGE MODEL: E3F4 FOR TRANSPORTATION OF LIQUID CATEGORY B BIOLOGICAL SUBSTANCES Job No.: 22172U Order No.: CP182471 Date: 07 / 20 / 22 GAYNES LABS, INCORPORATED 9708 Industrial Drive • Bridgeview, Illinois 60455 Member of “American Council of Independent Laboratories” Phone: 708-233-6655 Fax: 708-233-6985 Email: gayneslabs@aol.com Website: www.gaynestesting.com GAYNES LABS, INCORPORATED IS THE CURRENT DOT UN THIRD-PARTY CERTIFICATION AGENCY UNDER 107.403 1 of 24 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. TEST OBJECTIVE: To subject packages, designed to transport Liquid Category B Biological Substances, to the applicable tests described in the Technical Instructions for the Safe Transport of Dangerous Goods by Air, ICAO, and Code of Federal Regulations, Title 49, Transportation, as requested by ThermoSafe Brands. ITEMS TESTED: Corrugated Fiberboard Boxes, Containing Eighty-One (81) 2-ml. Plastic Test Tubes, Package Model E3F4. Refer to Photos No. 1 through 11 for details of the package assembly. TESTS PERFORMED AND RESULTS: The tests were conducted in accordance with Technical Instructions for the Safe Transport of Dangerous Goods by Air, ICAO, Packing Instruction 650, and Code of Federal Regulations, Title 49, Transportation (49 CFR). The test methods are shown in parenthesis following the test name. DROP TEST: (49 CFR 178.609(d), (f)) (ICAO 6;6.5.3, PI 650 6)) (d) Samples must be subjected to free-fall drops onto a rigid, non-resilient, flat, horizontal surface from a height of 1.2 meters. The drops must be performed as follows: Where the samples are in the shape of the box, five must be dropped in sequence: (1) Flat on the bottom; (2) Flat on the top; (3) Flat on the long side; (4) Flat on the short side; (5) On a corner (f) The samples must be conditioned in an atmosphere of -18° C (0° F) or less for a period of at least 24 hours and within 15 minutes of removal from that atmosphere be subjected to the drop test, described in paragraph (d). See Photos No. 12 and 13 for overview of drop orientations. 2 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. CRITERIA FOR PASSING THE TEST: (49 CFR 178.609(d)(4)) (ICAO 6;6.5.3, PI 650 6)) Following the appropriate drop sequence, there must be no leakage from the primary receptacle(s), which should remain protected by absorbent material in the secondary packaging. DROP TEST RESULTS: Five (5) packagings were tested. Each test tube was filled to 98% of its maximum capacity with antifreeze. The packages were assembled as for shipment. Five (5) packages were dropped after being conditioned to -18° C (0° F) for 24 hours. Drop After -18ºC (0ºF) Conditioning Sample Package Orientation Results 1 Flat Bottom No Damage/No Leakage - Pass 2 Flat Top No Damage/No Leakage - Pass 3 Flat Long Side (Adjacent to Mfg. Joint) No Damage/No Leakage - Pass 4 Flat Short Side (Adjacent to Mfg. Joint) No Damage/No Leakage - Pass 5 Bottom Corner (Mfg. Joint) Slight Distortion to Box at Corner/No Leakage - Pass VIBRATION TEST: (49 CFR. 178.608) (ICAO 4;4-(i) Note 4) Three (3) packages were tested. Each test tube was filled to 98% of its maximum capacity with water. The packages were assembled as for shipment. Land Vehicle Vibration: Three (3) complete packages were placed in their normal shipping orientation on the table of a vertical linear motion vibration machine, which has a displacement of one inch (peak to peak). Vertical fences were placed around packages in order to limit horizontal movement but not limit vertical movement (see Photo 14). The vibration frequency was adjusted to the minimum speed sufficient to cause the samples to leave the table momentarily so that a 1/16" shim could pass between the bottom of the packages and the machine table. The packages were subjected to a vibration frequency of 260 cycles per minute for a duration of one hour. Each package was inspected at the completion of the test. Aircraft Vibration: Three (3) packages as above were subjected to additional vertical linear motion vibration test. The packages were placed in their normal shipping orientation on the table of the vibration machine (see Photo No. 15) and subjected to the vibration at the frequencies and levels as described below. Each package was inspected at the completion of the test. A sweep of the frequencies/g levels shown was conducted over a duration of one hour. 7 – 25 Hz @ 1g 25 – 50 Hz @ 2g 50 – 100 Hz @ 4g 100 – 150 Hz @ 6g 150 – 200 Hz @ 8g 3 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. VIBRATION TEST REQUIREMENTS: The package must be capable of withstanding the effects of any acceleration, vibration or vibration resonance which may arise under conditions likely to be encountered in routine transport without any deterioration in the effectiveness of the closing devices on the various receptacles or in the integrity of the package as a whole. A packaging passes the vibration test if there is no rupture or leakage from any of the packages. No test sample should show any deterioration that could adversely affect transportation safety or any distortion liable to reduce packaging strength. VIBRATION TEST RESULTS: Land Vehicle Vibration: Sample No. Results 1 Slight Scuffing to Bottom of Box/No Leakage - Pass 2 Slight Scuffing to Bottom of Box/No Leakage – Pass 3 Slight Scuffing to Bottom of Box/No Leakage - Pass Aircraft Vibration: Sample No. Results 1 No Damage/No Leakage - Pass 2 No Damage/No Leakage - Pass 3 No Damage/No Leakage - Pass INTERNAL PRESSURE TEST: (ICAO Internal Pressure Variations Tests 4;4-(i) Note 3 and 4;4.8.6) Three (3) test tubes were placed inside the vacuum chamber, lying on their sides (see Photo No. 16). The pressure inside the vacuum chamber was gradually reduced to 5 kPa, creating and internal pressure inside the test tubes of 95 kPa. The pressure was maintained for a period of 30 minutes, while visually monitoring the samples for the appearance of leakage of contents. INTERNAL PRESSURE TEST REQUIREMENTS: The primary receptacle or the secondary packaging must be capable of withstanding, without leakage, an internal pressure, producing a pressure differential of not less than 95 kPa. 4 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. INTERNAL PRESSURE TEST RESULTS: Internal Pressure: Tube No. Results 1 No rupture or leakage – Meets Test Requirements 2 No rupture or leakage – Meets Test Requirements 3 No rupture or leakage – Meets Test Requirements CONCLUSION On the basis of the tests conducted, the submitted package type, described as a Corrugated Fiberboard Box Containing Eighty-One (81) 2-ml. Plastic Test Tubes, Package Model E3F4, meets the requirements for transport of Liquid Category B Biological Substances, described in the Technical Instructions for the Safe Transport of Dangerous Goods by Air, and Code of Federal Regulations, Title 49, Transportation Notes: The packagings used in testing are to represent the containers as prepared for actual transport. The use of any other packaging methods or components may render the package invalid and may be subject to fine by DOT. It is the shipper’s responsibility to comply with all pertinent requirements for specific material being shipped, including requirements for quantities of materials, various transportation modes and any additional requirements, which may be imposed by various carriers. 5 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. INSTRUMENTATION SHEET MODEL SERIAL CALIBRATION INSTRUMENT/EQUIPMENT MANUFACTURER NUMBER NUMBER DATE Free Fall Drop Tester Gaynes 150DT G69676 Operational Digital Gram Scale Setra 5000c 161452 09-30-21 Electronic Scale Cardinal 708 9610-149 10-13-21 Vibration Machine Gaynes 6000 VL 4631 Operational Strobotac Gen. Radio 1531-A 514488 08-11-21 Temperature Chamber CSZ ZH32-2-2-H/AC Z0023378/1 08-24-21 Chart Recorder Honeywell DR45AT A472 04-12-22 Vacuum Chamber Tenney Engr. 8 S 3080 Operational Vacuum Gauge Trimount 20-30 15544 In Hg Shaker UD 208 238 Operational Controller VRC VibView 359074210 10-13-21 Accelerometer PCB J353B33 103490 11-01-21 Controlled Environment Gaynes - - - - - - - - - - - - Operational Room 23° C (73° F), 50% R. H. 6 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. DATA SHEET FOR PACKING MATERIAL PACKAGE DESCRIPTION: Corrugated Fiberboard Box Containing One Hundred Sixty-Two (162) 2-ml. Plastic Test Tubes BOX INFORMATION Manufacturer: Sonoco Products Company, Arlington Heights, IL Part Number: 15258986 [910-10KD6] Style: Regular Slotted Container (RSC) Outside Dimensions cm (in): 40.01 x 42.55 x 40.96 high (15.75 x 16.75 x 16.125) Inside Dimensions cm (in): 39.37 x 41.91 x 40.01 high (15.5 x 16.5 x 15.75) Flap Gaps: Top Inner – 1.91 cm (0.75”), Top Outer - Meet, Bottom Inner – 1.91 cm (0.75”), Bottom Outer - Meet Material: Single Wall Corrugated Fiberboard, C Flute, White Exterior and Natural Brown Interior Board Caliper: 3.96 mm (0.156”) Empty box weight: 648.8 gr. Mfg. Joint: 3.18 cm (1.25”) Inside Tab Glued Closures: Top - Taped with single strips of 3” wide clear plastic tape extending at least 2” on the sides. Data Per Box Cert.: Data as Tested: Edge Crush Test 32 Lbs Per Inch Basis Weight 33 – 23 – 33 lbs./1000 sq. ft. Basis Weight 35.0-22.8-33.1 lbs./1000 sq. ft. (outer - C flute - inner) Combined Board Weight 100.8 lbs./1000 sq. ft. Markings: Short and Long Sides – Product and Mfg. Info., Both Short Sides - ­Bottom – Box Cert., 910-10KD, 16.37 x 15.37 x 15.62, 15044990 7 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. DATA SHEET FOR PACKING MATERIALS INNER PACKAGING INFORMATION Description: 2 ml. Cylindrical Plastic Tube Supplier: Sarstedt, Inc., Nümbrecht, Germany Order Number: 72.694.006 Overall Dimensions: 1.00 cm (0.392") dia. body, 4.50 cm (1.770") long without the closure, 4.67 cm (1.837") long with closure installed Material: Transparent Polypropylene (per drawing, chemical analysis was not conducted) Wall Thickness: 0.843 mm (0.0332") min., 0.958 mm (0.0377") max. Empty weight: 1.3 gr. Overflow Capacity: 2 ml. (With closure installed) Markings: Printed on the side – Graduated Markings Closure Information: Natural color polypropylene crew-on cap, 1.28 cm (0.504") dia., 0.61 cm (0.240") high, 0.3 gr. with a 0.81 mm (0.032”) thick, 1.00 cm (0.395”) dia. EPDM O-ring. Embossed on Bottom – Mfg. logo, 10.10 ABSORBENT PAD INFORMATION Supplier: Brady Corporation, Milwaukee, WI Part No.: SRPH144 Overall Dimensions: 10.16 cm x 11.43 cm (4" x 4. 5") Weight: 3.5 gr. PLASTIC PRESSURE BAG Supplier: Vonco Products Co., Villa Park, IL Part No.: KPA95B-002 Overall Dimensions: 29.53 cm x 37.15 cm x 0.198 mm thick (11.625" x 14.625" x 0.0078") Weight: 52.2 gr. 8 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. EPS COOLER INFORMATION: Supplier: Sonoco Products Company, Arlington Heights, IL Part Number: 15061796 (Body), 15061829 (Lid) Material: Expanded polystyrene (EPS) Outside Dimensions cm (in): 38.26 x 40.80 x 39.37 high (15.0625 x 16.0625 x 15.5) Inside Dimensions cm (in): 25.56 x 28.10 x 26.67 high (10.0625 x 11.0625 x 10.5) Weight: 1207.7 gr. Measured Density: 1.95 lbs./ft3 INNER FIBERBOARD BOX INFORMATION: Supplier: Westrock, Chattanooga, TN Project #: 22CG0162 Style: Regular Slotted Container (RSC) Outside Dimensions cm (in): 21.27 x 23.18 x 7.62 high (8.375 x 9.125 x 3) Inside Dimensions cm (in): 20.64 x 22.70 x 6.03 high (8.125 x 8.9375 x 2.375) Flap Gaps: Top Inner – 3.18 cm (1.25”), Top Outer - Meet, Bottom Inner – 3.18 cm (1.25”), Bottom Outer - Meet Material: Single Wall Corrugated Fiberboard, C Flute, Natural Brown Interior and Exterior Board Caliper: 3.91 mm (0.154”) Empty box weight: 110.9 gr. Mfg. Joint: 3.18 cm (1.25”) Inside Tab Glued Data as Tested: Basis Weight 32.7-23.8-32.3 lbs./1000 sq. ft. (outer - C flute - inner) Combined Board Weight 99.0 lbs./1000 sq. ft. Markings: None 9 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. CRYO BOX INFORMATION: Supplier: Thermo Scientific, Waltham, MA Part Number: 820002 Outside Dimensions cm (in): 13.18 x 13.18 x 5.08 high (5.1875 x 5.1875 x 2) Inside Dimensions cm (in): 12.70 x 12.70 x 4.76 high (5 x 5 x 1.875) Board Caliper: 1.14 mm (0.045”) Empty box weight: 56.4 gr. Markings: None CRYO BOX DIVIDER INFORMATION: Supplier: Thermo Scientific, Waltham, MA Part Number: 820002 Dimensions cm (in): 12.38 x 12.38 x 3.18 high (4.875 x 4.875 x 1.25) Thickness: 1.14 mm (0.020”) Weight: 23.7 gr. Package Assembly: One cryo box divider is assembled and placed in the cryo box. One (1) 2-ml. test tube is placed inside each of the cells of the 81-cell divider. The cryo box is then placed in a pressure bag. Four absorbent pads are then packed with the cryo box inside the pressure bag. The pressure bag is then placed in the corrugated fiberboard inner box. The EPS cooler is placed at the bottom of the corrugated fiberboard outer box. The inner box is sealed, then placed at the bottom of the EPS cooler. 20 lbs. of dry ice pellets are added into the EPS cooler, then the EPS lid is applied and the box is sealed. 10 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. Photo No. 1 – Overview of the Cryo Box Photo No. 2 – Placement of the Divider in the Cryo Box 11 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. Photo No. 3 – Placement of the Vials in the Cryo Box Photo No. 4 – Placement of the Cryo Box and Absorbent Pads in the Pressure Bag 12 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. Photo No. 5 – Overview of the Corrugated Fiberboard Inner Box Photo No. 6 – Placement of the Pressure Bag in the Inner Box 13 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. Photo No. 7 – Overview of the Outer Box Photo No. 8 – Placement of the EPS Cooler in the Outer Box 14 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. Photo No. 9 – Placement of the Inner Box in the EPS Cooler Photo No. 10 – Placement of the Dry Ice in the EPS Cooler 15 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. Photo No. 11 – Placement of the Lid on the EPS Cooler Photo No. 12 – Corner Drop Test Setup 16 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. Photo No. 13 – Flat Drop Test Setup Photo No. 14 – Land Vehicle Vibration Test Setup 17 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. Photo No. 15 – Aircraft Vibration Test Setup Photo No. 16– Internal Pressure Test Setup 18 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. GENERAL STATEMENT COVERING THIS REPORT This report is submitted for the exclusive use of ThermoSafe Brands. Its significance is subject to the representative nature of the samples submitted and the tests and examinations made. No quotations from this report or use of the Gaynes Labs, Inc., name is permitted except as expressly authorized by Gaynes Labs, Inc. in writing. The Third Party approval mark furnished indicates only that Gaynes Labs, Inc., as a third party certification agency, is certifying that the design type they tested is capable of withstanding the prescribed performance tests. The third party mark does not mean that Gaynes Labs, Inc. is responsible for ensuring that each packaging manufactured after they have certified the design type is capable of withstanding the prescribed tests. The actual manufacturing of the packaging can be identified through the test number marked on the packaging in association with the third party designator. By continuing to place the U.N. Markings on Packagings, the packaging manufacturer or shipper is certifying that each packaging is constructed in the same manner as the originally tested and certified packaging, and that each packaging is capable of withstanding the prescribed performance tests. Gaynes Labs, Inc., assumes no responsibility for the result of the observance or non-observance by ThermoSafe Brands of the package standard contained in this report or upon the relations between ThermoSafe Brands and any party or parties arising out of the sale or use of the package or otherwise. ThermoSafe Brands shall indemnify and hold harmless the Gaynes Labs, Inc., its employees and agents from any and all claims, demands, actions, and costs that may arise out of the following conditions: a) Any dangerous defect or content in the package being tested, whether apparent or not, which dangerous defect or content was not disclosed in writing to Gaynes by ThermoSafe Brands at the time the package was submitted for testing. b) c) Differences between the package actually tested and a package previously or subsequently produced which is purported to be identical to the package tested. Any use of the tested package, whether by ThermoSafe Brands or a third party following its return to ThermoSafe Brands from Gaynes Labs, Inc. 19 Page of 31 <<>> Thermosafe Brands 10 9 7 8 6 5 4 3 2 1 Job No. 22172U REVISION RECORD REV DESCRIPTION NAME DATE 19-Jul-22 1 IR DWH H H 65+5/8 [ 1666.87] G 1+1/2 [ 38.1] 16+1/2 [ 419.1] 15+9/16 [ 395.29] 16+9/16 [ 420.69] 15+1/2 [ 393.7] G 7+13/16 [ 198.44] F F E 15+15/16 [ 404.81] 31+9/16 [ 801.69] E FLUTE 1/4 [ 6.35] D D GAYNES LABS, INC. B CONFIDENTIAL B PART #: 15258986 [910-10KD6] CUST. NAME: THERMOSAFE Size Material A 32 ECT 16.37 x 15.37 x 15.62 Flute C Style Outer Liner Unit RSC Joint Oyster INCH Dir. of Corr. vertical In of Rule Ink Color Blank 477.041 65.62 x 31.56 TOLERANCE: UNLESS OTHERWISE SPECIFIED +/- 1/8" INSIDE TBD THIS DRAWING CONTAINS PROPRIETARY DESIGN INFORMATION & REMAINS ALONG WITH THE PRODUCTS OR PRODUCTS REPRESENTED HEREIN THE PROPERTY OF SONOCO CORPORATION. THIS DOCUMENT & THE INFORMATION IT CONTAINS MAY NOT BE COPIED, TRANSMITTED TO, OR USED BY ANY THIRD PARTY WITHOUT THE EXPRESS WRITTEN APPROVAL OF SONOCO CORPORATION. DATE: 07/19/2022 CUST. PART #: PAGE: PAGE SIZE: 1 OF 1 A DO NOT SCALE N/A DRAWN BY: DAVE HARRISON A APPROVED BY: CARLOS S TECH CENTER: ARLINGTON HEIGHTS FILE: 15258986 [910-10KD6].ARD 9 10 7 8 6 5 4 3 2 1 20 Page of 31 3/16 [ 4.76] 7+13/16 [ 198.44] C 3/16 [ 4.76] OUTSIDE: VIEW NOTE: 1.) BASIS WEIGHT OF 33-23-33. C <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. 21Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. H G F E D C B A 10 9 8 7 15.063 382.59 16.063 407.99 B A A B 13.063 331.79 .750 19.05 10.000 254 13.000 330.20 2.500 63.50 TYP. 9.722 246.94 10 SECTION A-A 9 8 7 6 5 4 3 2 1 REVISION RECORD REV DESCRIPTION NAME DATE A DRAFT VVK 22-May-13 CHANGED HEIGHT CAVITY ID TO 0.03125, MOVED SECTION VIEW TO SHOW WALL STOCK B MOVED MOLD NUMBER AND PART NUMBER OFF DWH 28-May-13 OF RADIUS C REVISED FILLET RADII ON LIP AS PER STOROPAC SUGGESTIONS VVK 06-Jun-13 D REMOVED "NOT RELEASED FOR PRODUCTION" FROM DRAWING DWH 07-Apr-14 E ADD ORACLE PART NUMBER TO DRAWING DWH 16-May-17 MOLD NO. CAVITY ID. 12.063 306.39 8.722 221.54 SECTION B-B PART NO. LOT CLOCKS 2.500 63.49 TYP. CONFIDENTIAL THIS DRAWING CONTAINS PROPRIETARY DESIGN INFORMATION & REMAINS ALONG WITH THE PRODUCT OR PRODUCTS REPRESENTED HEREIN THE PROPERTY OF SONOCO CORPORATION. THIS DOCUMENT & THE INFORMATION IT CONTAINS MAY NOT BE COPIED, TRANSMITTED TO, OR USED BY ANY THIRD PARTY WITHOUT THE EXPRESS WRITTEN APPROVAL OF SONOCO CORPORATION. 6 5 TOLERANCE: PART #: Dimensional: UNLESS OTHERWISE SPECIFIED 15061796 [910-10BX] +/- 1/32" (0.00 TO 2.999) +/- 1/16" (3.00 TO 5.999) CUST. NAME: THERMOSAFE +/- 1% ≥ 6" Weight:+/-10% UNIT: INCH & [mm] WEIGHT: 2.099 lb VOLUME: 1813.406 in^3 DENSITY: 2.00 lb/ft^3 MATERIAL: 2.00 PCF EPS 4 PAGE: PAGE SIZE: SCALE: DATE: 1:8 5/16/2017 1 1 OF A CUST. PART#: N/A DRAWN BY: DAVE H APPROVED BY: JON P TECH.CENTER: ARLINGTON HEIGHTS FILENAME: 15061796 [910-10BX] 3 2 1 H G F E D C B A 22 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. H G F E D C B A 10 9 8 16.063 407.99 7 6 A A 15.063 382.59 B B 5 1.500 38.09 12.063 306.39 SECTION B-B 4 PART NO. 3 2 1 REVISION RECORD REV DESCRIPTION NAME DATE A DRAFT VVK 22-May-13 DRAFTCHANGED SCALE TO 1:8, SET WEIGHT B TOLERANCE ALSO REMOVED UNDER CUT IN DWH 28-May-13 HANDDLES C CHANGED DOME FILLET RADII BASE ON STOROPACK SUGGESTIONS VVK 06-Jun-13 D REMOVED "NOT RELEASED FOR PRODUCTION" FROM DRAWING DWH 07-Apr-14 E ADD ORACLE PART NUMBER TO DRAWING DWH 16-May-17 CAVITY ID. MOLD NO. LOT CLOCKS 3.250 82.55 2.500 63.50 13.063 331.79 SECTION A-A 10 9 8 7 6 CONFIDENTIAL THIS DRAWING CONTAINS PROPRIETARY DESIGN INFORMATION & REMAINS ALONG WITH THE PRODUCT OR PRODUCTS REPRESENTED HEREIN THE PROPERTY OF SONOCO CORPORATION. THIS DOCUMENT & THE INFORMATION IT CONTAINS MAY NOT BE COPIED, TRANSMITTED TO, OR USED BY ANY THIRD PARTY WITHOUT THE EXPRESS WRITTEN APPROVAL OF SONOCO CORPORATION. 5 TOLERANCE: PART #: UNLESS OTHERWISE SPECIFIED 15061829 [910LID] Dimensional: +/- 1/32" (0.00 TO 2.999) +/- 1/16" (3.00 TO 5.999) CUST. NAME: THERMOSAFE +/- 1% ≥ 6" Weight: +/-10% UNIT: INCH & [mm] WEIGHT: 0.654 lb VOLUME: 565.018 in^3 DENSITY: 2.00 lb/ft^3 MATERIAL: 2.00 PCF EPS 4 PAGE: PAGE SIZE: SCALE: DATE: 1:8 5/16/2017 1 1 OF A CUST. PART#: N/A DRAWN BY: DAVE H APPROVED BY: JON P TECH.CENTER: ARLINGTON HEIGHTS FILENAME: 15061829 [910LID] 3 2 1 H G F E D C B A 2.00° 23 Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. 24Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. 25Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. 26Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. 27Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. 28Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. 29Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. 30Page of 31 <<>> Thermosafe Brands Job No. 22172U GAYNES LABS, INC. 31Page of 31 <<>> TEST REPORT THERMOSAFE BRANDS ARLINGTON HEIGHTS, ILLINOIS TESTING OF FIBERBOARD BOX CONTAINING ONE HUNDRED SIXTY-TWO (162) 2-ml. PLASTIC TUBES PACKAGE MODEL: E6F4 FOR TRANSPORTATION OF LIQUID CATEGORY B BIOLOGICAL SUBSTANCES Job No.: 22173U Order No.: CP182471 Date: 07 / 20 / 22 GAYNES LABS, INCORPORATED 9708 Industrial Drive • Bridgeview, Illinois 60455 Member of “American Council of Independent Laboratories” Phone: 708-233-6655 Fax: 708-233-6985 Email: gayneslabs@aol.com Website: www.gaynestesting.com GAYNES LABS, INCORPORATED IS THE CURRENT DOT UN THIRD-PARTY CERTIFICATION AGENCY UNDER 107.403 <<>> Thermosafe Brands Job No. 22173U GAYNES LABS, INC. TEST OBJECTIVE: To subject packages, designed to transport Liquid Category B Biological Substances, to the applicable tests described in the Technical Instructions for the Safe Transport of Dangerous Goods by Air, ICAO, and Code of Federal Regulations, Title 49, Transportation, as requested by ThermoSafe Brands. ITEMS TESTED: Corrugated Fiberboard Boxes, Containing One Hundred Sixty-Two (162) 2-ml. Plastic Test Tubes, Package Model E6F4. Refer to Photos No. 1 through 11 for details of the package assembly. TESTS PERFORMED AND RESULTS: The tests were conducted in accordance with Technical Instructions for the Safe Transport of Dangerous Goods by Air, ICAO, Packing Instruction 650, and Code of Federal Regulations, Title 49, Transportation (49 CFR). The test methods are shown in parenthesis following the test name. DROP TEST: (49 CFR 178.609(d), (f)) (ICAO 6;6.5.3, PI 650 6)) (d) Samples must be subjected to free-fall drops onto a rigid, non-resilient, flat, horizontal surface from a height of 1.2 meters. The drops must be performed as follows: Where the samples are in the shape of the box, five must be dropped in sequence: (1) Flat on the bottom; (2) Flat on the top; (3) Flat on the long side; (4) Flat on the short side; (5) On a corner (f) The samples must be conditioned in an atmosphere of -18° C (0° F) or less for a period of at least 24 hours and within 15 minutes of removal from that atmosphere be subjected to the drop test, described in paragraph (d). See Photos No. 12 and 13 for overview of drop orientations. 2 Page of 31 <<>> Thermosafe Brands Job No. 22173U GAYNES LABS, INC. CRITERIA FOR PASSING THE TEST: (49 CFR 178.609(d)(4)) (ICAO 6;6.5.3, PI 650 6)) Following the appropriate drop sequence, there must be no leakage from the primary receptacle(s), which should remain protected by absorbent material in the secondary packaging. DROP TEST RESULTS: Five (5) packagings were tested. Each test tube was filled to 98% of its maximum capacity with antifreeze. The packages were assembled as for shipment. Five (5) packages were dropped after being conditioned to -18° C (0° F) for 24 hours. Drop After -18ºC (0ºF) Conditioning Sample Package Orientation Results 1 Flat Bottom No Damage/No Leakage - Pass 2 Flat Top No Damage/No Leakage - Pass 3 Flat Long Side (Adjacent to Mfg. Joint) No Damage/No Leakage - Pass 4 Flat Short Side (Adjacent to Mfg. Joint) No Damage/No Leakage - Pass 5 Bottom Corner (Mfg. Joint) Slight Distortion to Box at Corner/No Leakage - Pass VIBRATION TEST: (49 CFR. 178.608) (ICAO 4;4-(i) Note 4) Three (3) packages were tested. Each test tube was filled to 98% of its maximum capacity with water. The packages were assembled as for shipment. Land Vehicle Vibration: Three (3) complete packages were placed in their normal shipping orientation on the table of a vertical linear motion vibration machine, which has a displacement of one inch (peak to peak). Vertical fences were placed around packages in order to limit horizontal movement but not limit vertical movement (see Photo 14). The vibration frequency was adjusted to the minimum speed sufficient to cause the samples to leave the table momentarily so that a 1/16" shim could pass between the bottom of the packages and the machine table. The packages were subjected to a vibration frequency of 260 cycles per minute for a duration of one hour. Each package was inspected at the completion of the test. Aircraft Vibration: Three (3) packages as above were subjected to additional vertical linear motion vibration test. The packages were placed in their normal shipping orientation on the table of the vibration machine (see Photo No. 15) and subjected to the vibration at the frequencies and levels as described below. Each package was inspected at the completion of the test. A sweep of the frequencies/g levels shown was conducted over a duration of one hour. 7 – 25 Hz @ 1g 25 – 50 Hz @ 2g 50 – 100 Hz @ 4g 100 – 150 Hz @ 6g 150 – 200 Hz @ 8g 3 Page of 31 <<>> Thermosafe Brands Job No. 22173U GAYNES LABS, INC. VIBRATION TEST REQUIREMENTS: The package must be capable of withstanding the effects of any acceleration, vibration or vibration resonance which may arise under conditions likely to be encountered in routine transport without any deterioration in the effectiveness of the closing devices on the various receptacles or in the integrity of the package as a whole. A packaging passes the vibration test if there is no rupture or leakage from any of the packages. No test sample should show any deterioration that could adversely affect transportation safety or any distortion liable to reduce packaging strength. VIBRATION TEST RESULTS: Land Vehicle Vibration: Sample No. Results 1 Slight Scuffing to Bottom of Box/No Leakage - Pass 2 Slight Scuffing to Bottom of Box/No Leakage – Pass 3 Slight Scuffing to Bottom of Box/No Leakage - Pass Aircraft Vibration: Sample No. Results 1 No Damage/No Leakage - Pass 2 No Damage/No Leakage - Pass 3 No Damage/No Leakage - Pass INTERNAL PRESSURE TEST: (ICAO Internal Pressure Variations Tests 4;4-(i) Note 3 and 4;4.8.6) Three (3) test tubes were placed inside the vacuum chamber, lying on their sides (see Photo No. 16). The pressure inside the vacuum chamber was gradually reduced to 5 kPa, creating and internal pressure inside the test tubes of 95 kPa. The pressure was maintained for a period of 30 minutes, while visually monitoring the samples for the appearance of leakage of contents. INTERNAL PRESSURE TEST REQUIREMENTS: The primary receptacle or the secondary packaging must be capable of withstanding, without leakage, an internal pressure, producing a pressure differential of not less than 95 kPa. 4 Page of 31 <<>> Thermosafe Brands Job No. 22173U GAYNES LABS, INC. INTERNAL PRESSURE TEST RESULTS: Internal Pressure: Tube No. Results 1 No rupture or leakage – Meets Test Requirements 2 No rupture or leakage – Meets Test Requirements 3 No rupture or leakage – Meets Test Requirements CONCLUSION On the basis of the tests conducted, the submitted package type, described as a Corrugated Fiberboard Box Containing One Hundred Sixty-Two (162) 2-ml. Plastic Test Tubes, Package Model E6F4, meets the requirements for transport of Liquid Category B Biological Substances, described in the Technical Instructions for the Safe Transport of Dangerous Goods by Air, and Code of Federal Regulations, Title 49, Transportation Notes: The packagings used in testing are to represent the containers as prepared for actual transport. The use of any other packaging methods or components may render the package invalid and may be subject to fine by DOT. It is the shipper’s responsibility to comply with all pertinent requirements for specific material being shipped, including requirements for quantities of materials, various transportation modes and any additional requirements, which may be imposed by various carriers. 5 Page of 31 <<>> Thermosafe Brands Job No. 22173U GAYNES LABS, INC. INSTRUMENTATION SHEET MODEL SERIAL CALIBRATION INSTRUMENT/EQUIPMENT MANUFACTURER NUMBER NUMBER DATE Free Fall Drop Tester Gaynes 150DT G69676 Operational Digital Gram Scale Setra 5000c 161452 09-30-21 Electronic Scale Cardinal 708 9610-149 10-13-21 Vibration Machine Gaynes 6000 VL 4631 Operational Strobotac Gen. Radio 1531-A 514488 08-11-21 Temperature Chamber CSZ ZH32-2-2-H/AC Z0023378/1 08-24-21 Chart Recorder Honeywell DR45AT A472 04-12-22 Vacuum Chamber Tenney Engr. 8 S 3080 Operational Vacuum Gauge Trimount 20-30 15544 In Hg Shaker UD 208 238 Operational Controller VRC VibView 359074210 10-13-21 Accelerometer PCB J353B33 103490 11-01-21 Controlled Environment Gaynes - - - - - - - - - - - - Operational Room 23° C (73° F), 50% R. H. 6 Page of 31 <<>> Thermosafe Brands Job No. 22173U GAYNES LABS, INC. DATA SHEET FOR PACKING MATERIAL PACKAGE DESCRIPTION: Corrugated Fiberboard Box Containing One Hundred Sixty-Two (162) 2-ml. Plastic Test Tubes BOX INFORMATION Manufacturer: Sonoco Products Company, Arlington Heights, IL Part Number: 15258985 [910-15KD4] Style: Regular Slotted Container (RSC) Outside Dimensions cm (in): 40.01 x 42.23 x 53.98 high (15.75 x 16.625 x 21.25) Inside Dimensions cm (in): 39.37 x 41.75 x 52.07 high (15.5 x 16.4375 x 20.5) Flap Gaps: Top Inner – 2.22 cm (0.875”), Top Outer - Meet, Bottom Inner – 2.22 cm (0.875”), Bottom Outer - Meet Material: Single Wall Corrugated Fiberboard, C Flute, White Exterior and Natural Brown Interior Board Caliper: 3.91 mm (0.154”) Empty box weight: 753.6 gr. Mfg. Joint: 3.49 cm (1.375”) Inside Tab Glued Closures: Top - Taped with single strips of 3” wide clear plastic tape extending at least 2” on the sides. Data Per Box Cert.: Data as Tested: Edge Crush Test 32 Lbs Per Inch Basis Weight 33 – 23 – 33 lbs./1000 sq. ft. Basis Weight 34.7-22.6-34.5 lbs./1000 sq. ft. (outer - C flute - inner) Combined Board Weight 101.5 lbs./1000 sq. ft. Markings: Short and Long Sides – Product and Mfg. Info., Both Short Sides - ­Bottom – Box Cert., 910-15KD, 16.37 x 15.37 x 20.62, 15044991 7 Page of 31 <<>> Thermosafe Brands Job No. 22173U GAYNES LABS, INC. DATA SHEET FOR PACKING MATERIALS INNER PACKAGING INFORMATION Description: 2 ml. Cylindrical Plastic Tube Supplier: Sarstedt, Inc., Nümbrecht, Germany Order Number: 72.694.006 Overall Dimensions: 1.00 cm (0.392") dia. body, 4.50 cm (1.770") long without the closure, 4.67 cm (1.837") long with closure installed Material: Transparent Polypropylene (per drawing, chemical analysis was not conducted) Wall Thickness: 0.843 mm (0.0332") min., 0.958 mm (0.0377") max. Empty weight: 1.3 gr. Overflow Capacity: 2 ml. (With closure installed) Markings: Printed on the side – Graduated Markings Closure Information: Natural color polypropylene crew-on cap, 1.28 cm (0.504") dia., 0.61 cm (0.240") high, 0.3 gr. with a 0.81 mm (0.032”) thick, 1.00 cm (0.395”) dia. EPDM O-ring. Embossed on Bottom – Mfg. logo, 10.10 ABSORBENT PAD INFORMATION Supplier: Brady Corporation, Milwaukee, WI Part No.: SRPH144 Overall Dimensions: 10.16 cm x 11.43 cm (4" x 4. 5") Weight: 3.5 gr. PLASTIC PRESSURE BAG Supplier: Vonco Products Co., Villa Park, IL Part No.: KPA95B-004 Overall Dimensions: 29.21 cm x 42.23 cm x 0.208 mm thick (11.5" x 16.625" x 0.0082") Weight: 66.1 gr. 8 Page of 31 <<>> Thermosafe Brands Job No. 22173U GAYNES LABS, INC. EPS COOLER INFORMATION: Supplier: Sonoco Products Company, Arlington Heights, IL Part Number: 15061795 (Body), 15061829 (Lid) Material: Expanded polystyrene (EPS) Outside Dimensions cm (in): 38.26 x 40.80 x 52.07 high (15.0625 x 16.0625 x 20.5) Inside Dimensions cm (in): 25.56 x 28.10 x 39.37 high (10.0625 x 11.0625 x 15.5) Weight: 1661.7 gr. Measured Density: 1.95 lbs./ft3 INNER FIBERBOARD BOX INFORMATION: Supplier: Westrock, Chattanooga, TN Project #: 22CG0163 Style: Regular Slotted Container (RSC) Outside Dimensions cm (in): 20.96 x 23.81 x 13.97 high (8.25 x 9.375 x 5 - **truncated:** true - **body characters:** 72992