How to Validate Temperatures Within the Supply Chain
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This document discusses how to validate temperatures within the supply chain for pharmaceuticals. It covers standards and regulations, the validation process including developing a protocol, packaging design and testing. Specific topics covered include trailer validation variables, Health Canada Guide 0069 requirements, ISTA testing standards, and how to design packaging and conduct validation testing. The goal is to document that temperatures are controlled throughout the logistics process.
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How to Validate Temperatures Within the Supply Chain
- 1. 1 How to Validate Temperatures Within the Supply Chain Pharmaceutical and Personal Care Logistics Association PPCLA
- 2. PPCLA 2 Agenda • Introduction • Standards and Regulations • 1) Validation process • Protocol • Packaging design • Testing • 2) Trailer validation • Variables • Health Canada / Guide 0069
- 3. PPCLA 3 About Us: • Third party material test laboratory • Staff includes 2 MSc. Chemists, 1 mechanical Engineer, lab technicians. • 11 000 sq. feet test facility. • Involved in cold Chain validation for the Pharmaceutical Industry since 2001. • CGMP Adherence • Approved Laboratory for various types of transit test services (ISTA, NCC, Transport Canada/HAZMAT). • CGSB approved Laboratory for various tests • Bombardier approved test laboratory (Mass Transit, Recreational) • Health Canada / Hazardous Product Act
- 5. 5 How to Validate Temperatures Within the Supply Chain Documenting through testing and monitoring that we are in control of our logistics process from a temperature standpoint. PPCLA
- 6. PPCLA 6 Current Standards and Regulations: • Health Canada, guide 0069 (nov. 2005) • USP 1079 (June 2005) • ASTM D-3103-99 (1999) • ISTA 5B • ISTA 7D • Transport Canada / Hazmat
- 7. PPCLA 7 Health canada, guide 0069 • Applies also to clinical trial drugs and promotional samples • 1.2 Warehousing & Storage vs. packaging • « Monitoring …temperature mapping ». • 2.1 « The transport process and containers should prevent damage and maintain the integrity and quality of the drug product ».
- 8. PPCLA 8 ASTM D-3103-99 Standard Test Method for Thermal Insulation Quality of Packages. • Widely called up in various test protocols for cold chain validation • Needs to be tightened up for: - Thermocouple tolerance - Environmental chamber tolerances - Number of data points required • Revision currently in the works
- 9. PPCLA 9 ISTA - Mission Provide economical and environmental benefits by preventing product damage and over packaging during the physical distribution of products as a result of creating, advocating and providing performance testing standards, training, education and certification.
- 10. PPCLA 10 International Safe Transit Association • Simulate shipping hazards • Based on ASTM procedures • Added pass/fail criteria • Mass • Shape • Dimensions • Logistics
- 11. PPCLA 11 ISTA 5 B • 5B - Focused Simulation Guide for Thermal Performance testing of temperature controlled transport packaging. - References ASTM D-3103 - Good starting point for developing a test protocol for cold chain validation including how to create the temperature profile. - Requirements need to be tightened up.
- 12. PPCLA 12 ISTA 7D • Complete test sequence including actual temperature cycling combined with mechanical testing to simulate shipping hazards
- 13. PPCLA 13 ISTA 7 D – test sequence
- 14. PPCLA 14 Validation Protocol Development (1) Purpose Objectives Definitions, reference documents Equipment/Product requirements Testing procedure
- 15. PPCLA 15 Validation Protocol Development (2) Purpose To establish documented evidence that the shipping containers used provide an adequate State of Control. Packaging Trailer Refrigerator Warehouse
- 16. PPCLA 16 Validation Protocol Development (3) Objectives. Test pack outs under controlled conditions simulating foreseeable temperature extremes seen in “real world”. To have proper documentation for operating, maintaining, and/or repeating any part of the testing performed. To have proper documentation for packing the product according to a successful pack out scheme. Verify that packaging maintains product within acceptable temperature limits under specified shipping conditions.
- 17. PPCLA 17 Validation Protocol Development (4) Definitions, reference documents Terminology used within protocol (#3 box, -10 pcm) Test methods and SOPs Equipment/Product requirements materials required to complete the testing Packaging, icing, dunnage… Pack out assembly instructions Test equipment (chamber, data logger…)
- 18. PPCLA 18 Equipment requirements example: 1. Gel Conditionning Freezer Inventory # MI-EQ-087 Manufacturer: So-Low Model: A18-120, Serial# 91928/37 Controller: Fenwal model 400 Type T 20AWG thermocouple Inventory # MI-EQ-223 Digital temperature reader Inventory # MI-EQ-204 Manufacturer: Fluke Model 714, Serial # 7013190 Validation Protocol Development (5)
- 19. PPCLA 19 Validation Protocol Development (6) Test Equipment Calibration Temperatures profiles • Winter, summer, fall/spring • Sources • Public databases • Courier databases • Actual shipment monitoring Packaging configurations/thermocouple placement Pack out must reflect actual practice Test Procedure:
- 20. PPCLA 20 Packaging design (1): Know your product Physical properties Temperature stability Allowable excursions Quantities shipped per day, weeks Min/max loads
- 21. PPCLA 21 Packaging design (2): Know your shipping environment: Road, air, vibration Shipment duration Extreme ambient temperature during each segment of the shipping route
- 22. PPCLA 22 Packaging design (3): • Protective / secondary container Insulating container Payload configuration Inserts Dunnage (very important) Temperature monitor Icing Type (Ice, Gel, PCM, Dry Ice) Location, combination
- 24. PPCLA 24 Carton Tray 5 requ. Notes: 1. Provide Air Bag dunnage as required to stabilize load. 2. Provide corrugated sheets between PCM’s and product. (3 required) 3. Representative Products tested: ABC45 AIR BAGS See note 1 PCM 18 OZ. FROZEN Shown in blue (4 REQU.) INSULATED SHIPPER CORRUGATED PADS See note 2 LID PCM 18 OZ. REFRIGERATED Shown green (16 REQU.) Outside of Liner Validation test package configuration Courtesy of Joe Villa, Thermal Packaging Solutions
- 25. PPCLA 25 Validation testing (1): Sample reception Sample conditioning Equipment Walk in chamber (Thermal mapping +/- 0,5 C) Temperature data-logger; pre and post-test calibration (+/- 0,5 C) Calibration NIST traceable
- 26. PPCLA 26 Box Gel # 6 - Maximum Load -15 -13 -11 -9 -7 -5 -3 -1 1 3 5 7 9 11 13 15 17 19 21 23 25 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 Time (h) Temperature(°C) temp_81 temp_82 temp_83 temp_84 temp_85 temp_86 temp_87 temp_88 temp_89 temp_90 temp_91 temp_92 temp_93 temp_94 temp_95 temp_96 temp_97 temp_98 temp_107 temp_108 START END
- 27. PPCLA 27 Pre-validated containers Cold chain validation is geared toward your product as a function of: The product physical & chemical characteristics Shipping logistics Ambient temperature Duration Transport mode Temperature controlled Quantities shipped In vial In box Pallet
- 29. PPCLA 29 Trailer validation – Caracteristics (2) • Temperature stratification • Ambient temperature • Wind • Truck speed • Sunlight • Longitudinal shape • Defrost cycle • Vibrations
- 30. PPCLA 30 Trailer Validation – Guide 0069 (3) • Section 1: • Well maintained. • Free from frost build up. • Adequate air distribution. • Loading configurations should allow efficient air distribution. • Multipoint temperature monitoring and alarms at points representing temperature extremes.
- 31. PPCLA 31 Trailer Validation – Guide 0069 (4) • Section 2: • Needs to be validated for proper temperature range (2.4). • Needs to be mapped and monitored only if it provides the primary means for environmental control
Editor's Notes
- Thanks: PPCLA Mr. Gibson (astra) Mr. Rochon (Sire) Questions at the end. Presentation available on website
- Validation Process for trailers is based on the same milestones as for packaging
- What’s Mjcom? Well, we are a third party material testing laboratory Located in Dorval, Montreal We are In business since 1999 Personally I have been in the third party laboratory business for the past 20 years
- Goals of this presentation: give overall understanding of the underlying issues of the temperature chain validation process. Each link of the chain, even though it morphs slightly from link to link, requires the overall same information package. Indeed, whether the payload is in your refrigerated warehouse, in a temperature controlled truck, at a distributor, at a pharmacist’s or at doctor’s or in the patient’s refrigerator. The issues are basically the same the weakest link is where the chain will break. Each product comes with a bank account: “allowable excursions” . Every time it is used, it leaves less time capital to the end user that is likely to be the weakest link. Concern: ambient temperatures, say 15 to 30C. As you will see whether it is for that temperature bracket or another, the issues are the same. Nonetheless, I have oriented my presentation in that direction. [next slide]
- we are all experts at temperature chain management Winter Coat Hot shots Summer light clothing air conditioning. We all have refrigerators to protect perishable food… We all do it! So what’s different? The difference is that to have a complete validation process, [LIRE TEXTE] Chicken story LIEN: SO, HOW DO WE DO THAT? [next slide]
- Well There are guidelines and standards to help us in this endeavour. On this slide you can see the current standards and guidelines that apply to your product depending of its properties and also which link you are un the chain (manufacturer, distributor, carrier). I don’t have the time to go through those documents in details today. But I will try to show how these documents can help assist in validating your temperature chain. LIEN: I am sure everybody heard of the New Health Canada guidelines ^(NEXT SLIDE)
- The requirements under the heading « Warehousing and storage » are the exact same thing that we are doing when we validate a pack out, only on a smaller scale. b)2.1 is why I have added ISTA 7D to this list of standard Dewar story withstand the test of reality; shipping, handling… and there are some tests for validating that.
- Chamber tolerance is +/- 3 C; should go to at least +/- 1C. Thermocouples accuracy needs to go down to 0,5 degrees If you need to validate a product that needs to be within 1 to 45 C, it may not be critical to have better accuracy than what is required in ISTA and ASTM. However, if you need to maintain 2-8C or 37C for skin samples, for example, these requirements are way to wide and you will likely end up in a situation where you are not sure if your pack out or your storage facility provides you with a proper temperature control or not as the answer will be hidden by the instrumental accuracy. Some environmental chambers also have a defrost cycle which, for the sake of de-icing the cooling coil warm up the complete chamber by a few degrees. This may be acceptable for some products with a wider tolerance but may be critical in some specific applications of for samples a proximity of the air outlet if a poor chamber layout is used and an improper chamber mapping has been done.
- ISTA standards; relate to section 2.1 of guide 0069 ISTA stands for International Safe Transit Association. 21 ISTA test schedules
- All ISTA schedules simulate the mechanical hazards a packaged product may encounter during its shipping: vibrations, drops, impacts, stacking, vibrations and in some cases temperature. These schedules are based on ASTM test procedures to which they have added pass/fail criteria as a function of the product mass, shape and dimensions.
- 5B is a very useful guide in that it helps define the temperature validation test protocols. It is not a test protocol per se contrary to the other ISTA schedules in that is does not give specific test conditions, nor does it give any pass/fail criteria.
- Based on our experience, the use of that protocol is not widely spread. However, from a technical stand point, it would make sense to apply this test protocol for the validation of temperature chain pack outs. This is also in line with the requirements of guide 0069 from Health Canada (section 2.1).
- So on this slide you can see the test sequence specified in ISTA. What this sequence suggests is basically to run a temperature profile twice before and after mechanical testing. This requires reconditioning between the two temperatures profile; I don’t believe this represents real life. It would be more appropriate to run half of the. I believe this lack of practicality of the reason why this protocol is not used. It would be more appropriate to run half of the temperature cycle and then do the mechanical tests and then complete the temperature profile.
- The main ingredients a Validation protocol should cover the following:
- non foreseeable; too expensive. If the drug you are shipping is critically sensitive or has a high value; use temperature monitors in each pack out; this is a cost / benefit / risk assessment exercise.
- As for any validation test protocol, the equipment used need also to have been validated. Réviser les détails et commenter all of this information is also part of the quality system
- Calibration should be done before and after test We use a NIST traceable Kaye IRTD (0.005 C) and a thermo stated bath temperature mapped in 15 locations
- The less you know, the tighter the pass/fail criteria should be
- FTIR story in India?
- EPS, Urethane, others; Cost factor Performance factor Disposal cost & environmental issues (urethane leaches) Donnage helps prevent content from moving around during shipment
- Combination frozen non frozen to achieve: Target temperature window Duration Symmetry very important Tight fit to prevent movement: Uneven temperatures Stress concentration points
- We are now at the second portion of the presentation: trailer validation. As you all know this is also covered by guide 0069 from Health Canada. A temperature controlled trailer is a mobile controlled environment: Warehousing requirements apply and then additional criteria need to be added; section #2 (of 0069) LIEN: The following characteristics a some of the main factors that need to be addressed in the validation process
- A temperature controlled trailer is a controlled environment more difficult to control properly than a warehouse.
- A) Validation needs to be focused as a function of the proper product temperature interval; i.e.: If you need to keep goods at ambient, 2-8 C , -78 C , +37 C.