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Optimal Management of The Cold Chain.

This document summarizes an information session on optimal management of the cold chain for blood products. It discusses legal criteria for storage temperatures of blood components, defines the cold chain as an uninterrupted series of storage and distribution activities maintaining a given temperature range, and provides examples of state-of-the-art technology used by the Belgian Red Cross to monitor and ensure an unbroken cold chain, including temperature-controlled containers, loggers, quick freezers, central monitoring systems, and validation of storage systems through temperature mapping.

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Mohamed Zhran
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64 views

Optimal Management of The Cold Chain.

This document summarizes an information session on optimal management of the cold chain for blood products. It discusses legal criteria for storage temperatures of blood components, defines the cold chain as an uninterrupted series of storage and distribution activities maintaining a given temperature range, and provides examples of state-of-the-art technology used by the Belgian Red Cross to monitor and ensure an unbroken cold chain, including temperature-controlled containers, loggers, quick freezers, central monitoring systems, and validation of storage systems through temperature mapping.

Uploaded by

Mohamed Zhran
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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
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
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 4th 1996)
and the European Committee Guide to the
Preparation, Use and Quality Assurance of Blood
components (EDQM 2013)
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.
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…
T-controlled container

Collection Transport Processing Storage Distribution


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)
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
T-controlled container
T-controlled container

Power plug in during transport

Validation and temperature mapping


T-controlled container
T-controlled container

 Smaller version : KCS 48 : 48 blood bags


T-loggers

Collection Transport Processing Storage Distribution


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)
Nitrogen Quick Freezer

Collection Transport Processing Storage Distribution


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 300-350 bags per cycle of 1 hour
Nitrogen Quick Freezer
Nitrogen Quick Freezer
Central Monitoring System (CMS)

Collection Transport Processing Storage Distribution


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
Central Monitoring System (CMS)
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 : e-mail and text
message
 Clear visualisation and reporting
Central Monitoring System (CMS)

Cold Chain Central Monitoring System

Central data storage


System Validation and T-mapping

Collection Transport Processing Storage Distribution


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
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
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
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
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
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)
System Validation and T-mapping

 Calibration
 Alarm testing (local and CMS) – part of Validation
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
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
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.
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.
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.
Transport boxes

Collection Transport Processing Storage Distribution


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
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
Transport boxes : Platelets

 Insulated box with a capacity of 16 platelet


bags, no gel-packs.
 20 °C - 24 °C
 18h15 at normal ambient temperature 15-25 °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
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
Temperature indicators

Collection Transport Processing Storage Distribution


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 process-
optimalisation : 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
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
Questions ?

[email protected]
Thank you [email protected]

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