Shipper Validation Ambient Test Temperature Profile

Transcription

1 Shipper Validation Ambient Test Temperature Profile Summer and Winter Profiles (Australia Wide) Table of Contents 1 About this document Purpose Review Approval Document history Referenced documents Business context Target results and required behaviours Trip Segment Time and Temperature Profile Example Trip Segment Time and Temperature Profiles Proposed Trip Segment Time and Temperature Profiles Rationale for Trip Segment Time and Temperature Profile & Testing Recommendation Rationale for Trip Segment Time and Temperature Profile Testing Recommendation... 6 Shipper Validation Ambient Test Temperature Profile: Version 2.0 Page 1 of 6

2 1 About this document 1.1 Purpose This document serves to provide a characteristic ambient temperature summer and winter profile that is representative of the environmental temperature conditions that the Blood Service shippers are exposed to during the transport of Blood In and Blood Out throughout the supply chain. This profile information will then allow for the objective thermal performance testing of Blood Service shippers using this data to reproduce worst case trip segment time and temperature ranges. 1.2 Review The intended reviewers of this document are listed below. Name Position Division 1.3 Approval The intended approver/s of this document are listed below. Name Position Division Approval may be by or meeting minutes. 1.4 Document history Version Date Author Change summary /02/2015 Paul Barnard Original Document /05/2015 Paul Barnard Updated test temperature profile page Referenced documents The following documents are referenced by this document: Practical Application of ISTA Lane Data to Pharmaceutical Cold Chain Strategies (ISTA, January 2012) Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products (2013) Guide to the preparation, use and quality assurance of blood components (14 th ed) International Safe Transit Association (ISTA) standard 7E (2010) Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment. Shipper Validation Ambient Test Temperature Profile: Version 2.0 Page 2 of 6

3 2 Business context The current Blood Service shippers have been validated using a constant temperature methodology to simulate hot and cold ambient temperatures (+42 C and +4 C) without consideration for trip segment 1 time and temperature variations. This has led to the shipper validated times being inaccurately defined due to the extreme differential between the test constants. Using trip segment time and temperature data to determine the transit temperature profiles will result in a more accurate validated transit time as the outcome will provide confidence-based testing profiles representative of the Blood Service supply chain. The most recent Blood Service validation data (July 2011) replicates only extreme constant temperatures which are not representative of our supply chain temperature profiles and severely constrains our ability to make informed decisions around validation times. Trip segment time and temperature performance testing is defined in the International Safe Transit Association (ISTA) White Paper dated January 2012 and titled Practical Application of ISTA Lane Data to Pharmaceutical Cold Chain Strategies. 3 Target results and required behaviours The target result is three fold Ensure the safe transit of all blood components including whole blood within the temperature ranges necessary to meet the Australian regulatory requirements : o Australian code of good manufacturing practice (cgmp) for human blood and blood components, human tissues and human cellular therapy products o Guide to the preparation, use and quality assurance of blood components (COE). Ensure appropriate and confident validation of the Blood Service shippers so as to limit the requirement to place temperature data loggers in individual shippers (a costly, time consuming process not representative of a lean customer focused organisation). Ensure a robust test methodology and subsequent results that will withstand scrutiny by the Australian regulatory authorities and will meet internationally recognised benchmarks. The use of this data must not be constrained by current methodology, materials or practices. 4 Trip Segment Time and Temperature Profile The following profile was developed using a combination of trip segment times (also referred to as lanes) and temperature data extrapolated using the following information and assumptions Known Blood Service Blood In and Blood Out routes. Ambient temperature data derived from the Bureau of Metrology seasonal historic data bases. Maximum and minimum ambient temperature data derived from the Bureau of Metrology historic data base. Airline Information pertaining to aircraft freight hold temperatures. Known Blood Service facility controlled ambient temperatures. Informed assumptions were made around transport conditions and stop/go points in the supply chain. The Blood Service supply chain requirements for transport times for Blood In and Blood Out. Regional ambient temperature data accumulated by the Logistics team using data from logged live shipments and Bureau of Metrology data. Refer to the attached Excel file below (reference only). Australian Ambient Temperature Profiles. The following Bureau of Metrology reports were also used in this assessment BOM National Reports Dec 2013 & 2014; July 2013 & The trip segments illustrate the range of temperatures and times that may be found in each segment and are representative of the range of temperatures measured and the total time of exposure. Shipper Validation Ambient Test Temperature Profile: Version 2.0 Page 3 of 6

4 4.1 Example Trip Segment Time and Temperature Profiles Darwin ex Sydney Distance Time - hours Summer temp Winter temp Sydney PC Sydney PC to airport Time at Sydney airport Time travelled to storage for missed flight If flight missed additional time at Sydney time travelled back to airport Time in cargo hold Flight duration Time on Darwin tarmac Time at Darwin airport Darwin airport to PC Unloaded Unpacked Dubbo - Unit Darling Street, Dubbo NSW 2830 Distance Time - hours Summer temp Winter temp Dubbo donor centre Donor centre to dubbo airport 6.3km Time at dubbo airport Time in cargo hold Flight duration Time on sydney tarmac Time at sydney airport Sydney airport to PC 3.5km Unloaded Unpacked The above are provided for reference only. Shipper Validation Ambient Test Temperature Profile: Version 2.0 Page 4 of 6

5 Proposed Trip Segment Time and Temperature Profiles Time - Hours Summer Ambient Temp C Winter Ambient Temp D 35 E G R E 30 E S 25 C E L S 20 I U S Transfer to vehicle. Packed at DC & held in controlled environment at dispatch point. Held at carrier depot or on road transit. Allowing for ambient variation. Summer Ambient Temp C On tarmac or moved HOURS IN TRANSIT FROM DISPATCH TO RECEIPT Winter Ambient Temp Reflects air transit in aircraft hold On tarmac /moved by carrier Delivery to destination receipiant and unpacked. Shipper Validation Ambient Test Temperature Profile: Version 2.0 Page 5 of 6

6 5 Rationale for Trip Segment Time and Temperature Profile & Testing Recommendation 5.1 Rationale for Trip Segment Time and Temperature Profile This is a confidence based profile which reflects expected extremes in both warm and cold weather. Temperature extremes occur when freight transits through external ambient environments and during flights. The profile has accounted for summer spikes on airport tarmacs caused by reflective and radiant heat. The profile has accounted for winter wind chill factors on airport tarmacs. When transiting in vehicles or held at the Blood Service or carrier facilities the freight is not subjected to the same extremes as external ambient temperatures. The temperature profile shown to hour 16 is also representative of general road courier transit. The aircraft hold segment will allow an informed analyses of the data in relation to the affect poor temperature controlled aircraft holds may have on the internal shipper temperatures. This sector profile also allows for conditions often found in smaller regional aircraft holds. The 24 hour test period provides an informed timeline corresponding to both Blood In and Blood Out requirements. The suggested profile has been scrutinised by Global Cold Chain Solutions who have reverted with the following comment Please also find attached the temp profile we discussed; I have gone through this with my team and it appears to be the most relevant based your requirements. 5.2 Testing Recommendation The testing will involve the following Each shipper to be tested using the following volume of placebo blood packs 1, 5 and 8. Each profile test is to be simulated three times to ensure uniformity of the performance of the shippers. This conforms to the International Safe Transit Association (ISTA) standard 7E (2010) Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment. The three uniformity tests can be conducted concurrently in the same test chamber. If Global Cold Chain Solutions (CGGS) are contracted to carry out the tests then the total number of shippers to be tested for each profile equals twenty seven Nine of the Blood Service shippers (Blood Service cost) Nine CGGS TPC-15 expanded polystyrene shippers (Blood Service cost) Nine CGGS VH-7 high grade polystyrene shippers (GCCS cost) Testing concurrently will require the test chamber for two by twenty four hour periods; one to simulate the summer profile and one to simulate the winter profile. Shipper Validation Ambient Test Temperature Profile: Version 2.0 Page 6 of 6