Optimal management of the cold chain.

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1 Optimal management of the cold chain. Infosession BeQuinT June 5th, 2014 Jan Ceulemans, QA Manager, Belgian Red Cross Flanders Dominiek Vanaudenaerde, OPS Manager ProLog, Belgian Red Cross Flanders Rode Kruis

2 Optimal management of the cold chain What are the legal criteria? What is the cold chain? Monitoring the cold chain by state-of-the-art technology

3 Legal criteria Red cells must be kept at a controlled temperature between + 2 C to + 6 C Platelets : + 20 ºC to + 24 ºC under constant agitation. Fresh frozen human plasma, virus-inactivated : 12 months at below 25 C 3 months at 18 ºC to 25 ºC. Based on Belgian Legislation (KB April 4 th 1996) and the European Committee Guide to the Preparation, Use and Quality Assurance of Blood components (EDQM 2013)

4 Cold chain The cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. All systems and processes that might impact the safety, efficacy or quality of the blood product must be validated, including storage and distribution.

5 Cold chain from vein to vein Collection Transport Processing Storage Distribution Keeping the cold chain unbroken by using state-of-the-art technology... some real-life examples

6 T-controlled container Collection Transport Processing Storage Distribution

7 T-controlled container In the past the temperature of the whole blood was controlled during the transport from collection to production with cooling plates, providing a rapid cooling of the blood, followed by a further storage at a stable temperature of 20 c. Problem with low ambient temperatures : Under its control point of 20 C the plate loses its temperature stabilizing effect. Problem with high temperatures (30 C)

8 T-controlled container Solution : robust, T-controlled container on wheels Sufficient and quick cooling, even at high ambient temperatures Protection against strong cooling at low ambient temperatures Stable temperature between 20 C and 22 C from collecting until the processing of the whole blood Great storage volume (KCL 120 : 120 full blood bags) Simpler transportation On board T-monitoring and T-alarm

9 T-controlled container

10 T-controlled container Power plug in during transport Validation and temperature mapping

11 T-controlled container

12 T-controlled container Smaller version : KCS 48 : 48 blood bags

13 T-loggers Collection Transport Processing Storage Distribution

14 T-loggers Temperatures of internal and external transports are monitored via T-loggers T-loggers also used for T-mapping and validation purposes (see later)

15 Nitrogen Quick Freezer Collection Transport Processing Storage Distribution

16 Nitrogen Quick Freezer Plasma collected from whole blood must be frozen within 18 hours and plasma collected by apheresis must be frozen within 12 hours. The core temperature of the plasma must be less than -30 C within 60 minutes. Solution : Nitrogen Quick Freezer The evaporation of the nitrogen creates a cold and dense mist which cools the plasma directly. Capacity of bags per cycle of 1 hour

17 Nitrogen Quick Freezer

18 Nitrogen Quick Freezer

19 Central Monitoring System (CMS) Collection Transport Processing Storage Distribution

20 Central Monitoring System (CMS) 24/24 h electronic temperature monitoring of all critical rooms and equipment. Network-operated : can be consulted anywhere, anytime. In the event of netwerk outage : local data storage. Validated

21 Central Monitoring System (CMS)

22 Central Monitoring System (CMS) Two alert (pre-alarm) and two alarm levels Technical alarms : sensor broken, power loss, communication failure, Identifies location and device in case of T exceeding the maximum or minimum treshold. Central Red Cross dispatching unit forwards any alarm to the relevant person to follow-up. In addition to central dispatching : and text message Clear visualisation and reporting

23 Central Monitoring System (CMS) Cold Chain Central Monitoring System Central data storage

24 System Validation and T-mapping Collection Transport Processing Storage Distribution

25 System Validation and T-mapping Storage conditions for blood components are designed to preserve optimal viability and function during the whole storage period*. *European Committee Guide to the preparation, use en quality assurance of Blood components 2013

26 System Validation and T-mapping Whatever type of storage device is chosen, the following points should be considered before purchase: refrigerators and freezers must have surplus capacity. The space should be easy to inspect; the operation must be reliable and temperature distribution must be uniform within the unit; the equipment must have temperature recording and alarm devices; the equipment should be easy to clean and should withstand strong detergents. It should also conform to local safety requirements.* *European Committee Guide to the preparation, use en quality assurance of Blood components 2013

27 System Validation and T-mapping Storage at + 2 C to + 6 C* The space for each of the component types should be clearly indicated. The temperature within the unit should be recorded continuously. The sensor of the temperature monitoring device should be placed within a blood bag filled with antifrogen L solution to a volume of 250 ml or a volume equivalent to the normal volume of the stored component. The alarm system should preferably have both acoustic and optical signals and should be tested regularly. Refrigerators for blood components should ideally be connected to a back-up power unit as well as the main supply. *European Committee Guide to the preparation, use en quality assurance of Blood components 2013

28 System Validation and T-mapping Storage at + 20 C to + 24 C* Platelets are stored at + 20 C to + 24 C. A closed device that permits temperature control is recommended. If such a device is unavailable, the space chosen should be capable of maintaining the required constant temperature. The platelets should be stored in agitators. *European Committee Guide to the preparation, use en quality assurance of Blood components 2013

29 System Validation and T-mapping Storage of frozen plasma components* - 25 C Freezers with automatic defrosting should be avoided unless it can be guaranteed that the low temperature is maintained during defrosting. Freezers should ideally be connected to a back-up power unit as well as the main supply. *European Committee Guide to the preparation, use en quality assurance of Blood components 2013

30 System Validation and T-mapping All equipment used to maintain the cold chain must be validated. eg. fridges, cool chambers, production area, Local T-alarms (in addition to central CMS)

31 System Validation and T-mapping Calibration Alarm testing (local and CMS) part of Validation

32 System Validation and T-mapping The T-monitoring is done by means of an airsensor and productsensor, both of which generate alarms. The airsensor is placed in the air of the storage device and is used to prewarn in case of a T- problem. The productsensor is placed in a liquid of which the properties are similar to the product (as proven by validation). The location of both sensors is based on a detailed T-study of the cold room : T-mapping. Rode Kruis

33 System Validation and T-mapping Cold Room Validation by T-mapping 1) Positioning T-sensors (loggers) in the air, one in every corner and one in the middle. 2) Positioning T-sensors in productbags filled with antifrogen L solution : volume equivalent to the normal volume of the stored component. Rode Kruis

34 System Validation and T-mapping Cold Room Validation by T-mapping 3) Perform a 24h T-mapping with a minimum of products filled with antifrogen L solution to prove the temperature is constant in time and space and thus meets the target temperature dt + and dt 4) Perform a T-mapping were a power failure is simulated to see how the temperature of the product reacts and to determine the alarm limits.

35 System Validation and T-mapping Cold Room Validation by T-mapping 5) After the T-mapping the placement of airsensor and productsensor is determined : - the airsensor at the coldest place - the productsensor at the warmest place (if there is a difference). This way both the low limit and the high limit is covered.

36 System Validation and T-mapping Cold Room Validation by T-mapping 6) Perform an open door test to investigate the influence on the system. 7) After these test re-evaluate if: - The airsensor and the productsensor are placed at the right place. - The alarmlimits cover the criteria of the product during routine work.

37 Transport boxes Collection Transport Processing Storage Distribution

38 Transport boxes Blood components should be transported by a system which has been validated to maintain the recommended storage temperature of the component over the proposed maximum time and extremes of ambient temperature of transport* Blood components : - Red Blood Cells - Platelets - Fresh Frozen Plasma *European Committee Guide to the preparation, use en quality assurance of Blood components 2013

39 Transport boxes : Red Blood Cells Insulated box with a capacity of 16 blood bags Use of 4 cooled gel-packs Ambient T between 15 C and 25 C, the transport meets the acceptance criteria, for 4h45 ' with a minimum loading and during 7h10 ' at a maximum load Extreme ambient T of 50 C the transport meets the acceptance criteria, for 2h20 ' with a minimum loading and during 3h50 ' at a maximum load

40 Transport boxes : Platelets Insulated box with a capacity of 16 platelet bags, no gel-packs. 20 C - 24 C 18h15 at normal ambient temperature C 1h20 at ambient temperature of 50 C with a minimum loading and during 2h25 ' at a maximum load 1h05 at ambient temperature of 4 C with a minimum and maximum loading

41 Transport boxes : Plasma Insulated box with dry ice Fresh frozen plasma units in the internal compartment divisions, with 1 scoop dry ice pellets to 2 sides ensures - at a normal ambient temperature of 25 C - a temperature of < -25 C during 11h45

42 Temperature indicators Collection Transport Processing Storage Distribution

43 Temperature indicators It is recommended that some form of temperature indicator is used to monitor the transit temperature.* How can we be sure that the product is kept at the correct T-conditions? Looking for T-monitoring during transport for processoptimalisation : is the cold-chain closed? The solution is the application of a special label on the blood bag in combination with a good internal transport system. *European Committee Guide to the preparation, use en quality assurance of Blood components 2013

44 Temperature indicators Implementation of Temperature Indicators in the Austrian Tyrol. Harald Schennach, MD, Assoc. Prof. Head of Institute Central Institute for Blood Transfusion and Immunology (ZIB) TILAK- University Clinics - Regional Hospital Anichstrasse 35 - A-6020 INNSBRUCK

45 Questions?

46 Thank you

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