1. Innovations in Cold Chain Management to meet the GLP requirements of Modern Laboratories by AJIT TAMHANE Director Lisaline Lifescience Technologies LLC.

2. Laboratory Services Industrial Laboratories Quality Control
Quality Assurance
Product development
Clinical Laboratories
Diagnostic
Clinical testing
Screening
Reference Lab
Physicians office testing
Research Laboratories
Clinical research
Non clinical studies
Analytical
Basic Research
Testing Laboratories
Material testing
Sample analysis
Forensic test
Calibration
Pre dispatch certification
Laboratory Services

3. Laboratory Services & Quality
Consistency
Accuracy
Precision
Right result
First time
Every time

4. Consequences of poor quality
Inappropriate action
Over-investigation
Over-treatment
Mistreatment
Inappropriate inaction
Lack of investigation
No treatment
Delayed action
Loss of credibility of laboratory
Legal action

5. Quality Standards based on type of Lab

6. GLP: GOOD LABORATORY PRACTICE
GLP is an FDA regulation.
Definition: GLP embodies a set of principles that provides a framework within which laboratory studies are planned performed, monitored, reported and archived.

7. Objectives of GLP
GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study.
GLP also makes sure that data is traceable.
Promotes international acceptance of tests.

8. Mission of GLP Test systems Archiving of records and materials.
Apparatus, Sample, material , reagent, facilities.
Quality assurance programs.
Performance of the study.
Reporting of study results.
Standard operating procedures (SOP)
Personnel and test facility organization

9. Factors influencing Lab quality
Reagent
Transport
Sample
Transport
Sample/ Reagent
Storage
Sample
handling
Testing
Facility parameters
Sample
Collection
Outside laboratory
Within laboratory
Analysis
Testing site
Results
Various factors influence the quality of the laboratory results. These could be pre-analytic, analytic or post-analytic. Naturally, some of these factors are not within the scope of the laboratory. The cycle begins with the initiation of the request by the doctor for laboratory investigation (right or wrong choice of test), selection of proper test as related to the timing of the illness, proper completion of requisition form, adequate preparation of the patient for collecting representative clinical sample and proper collection, handling and transport of the sample to the laboratory. The analytical factors include quality of laboratory materials, equipment and performance of laboratory personnel. Post-analytical factors include transcriptional errors, incomplete reports and subjective interpretation.
Requisition
Test
Sponsor
Reports 2

10. Sample Handling and Transportation
Samples are the key component of any laboratory test.
The quality samples leads to quality test and accurate results.
Quality of samples depends on
Collection of sample.
Handling of sample in terms of its integrity and activity.
Transportation of sample
Safe and timely receipt of the sample
Labeling of sample
Appropriate storage of sample
Maintaining the sample after testing as desired
Easy retrieval of stored sample

11. Reagents and solutions handling
Quality reagents provides reproducible, accurate test results.
Quality of reagents depend on
Source
Shelf life
Efficacy
Transport Conditions
Storage Conditions
What if,these samples, reagents , solutions are TIME & TEMPERATURE SENNSITIVE PRODUCTS ( TTSP)?

12. Time & Temperature Sensitive products
Time Temperature Sensitive Products (TTSP) are vulnerable to heat and some times to freeze exposure.
TTSP have risks of loosing its efficacy, activity when exposed to temperatures beyond its storage conditions.
Types of TTSP products used in lab are
Hence effective COLD CHAIN MANAGEMENT is the essence of modern laboratories
Test Samples
Blood samples
Other biological samples
Food samples
Pharmaceutical products
Forensic samples
Contamination test samples
Reagents & solutions
Diagnostic kits
Biological reagents
Control samples
Specialty chemicals

13. What is Cold Chain ? A Cold Chain is
a popular term for the continuous maintenance of low temperature required for temperature sensitive products from the time of manufacture to shipping, warehousing, and storing before use.
the system used to protect heat-labile products from deterioration due to exposure to undesired temperature during storage and transportation.
a temperature-controlled supply chain. It is used to help extend and ensure the shelf life of products which are heat labile.
Supply Chain developed for temperature sensitive , heat and/or freeze labile products.

14. Cold chain Management in the Lab?
Main focus of GLP Lab is
To maintain cold chain for
Samples : from collection to testing
Reagents and chemicals: from manufacturing till its use.
To maintain Controlled environment for testing
For storage equipments
Testing equipments
Laboratory environments

15. Important aspects of cold chain
Temperature of sensitive products
Time of exposure.
Protect products from deterioration
Storage and transportation.
Stability of the product
Shelf life of products.
Heat and/or freeze labile products.
Supply chain

16. Central Testing facility
Laboratory cold chain
Periphery
Sample Collection at peripheral centers
Sample Storage at peripheral centers
Central Testing facility
Sample Receiving
Sample Separation
Storage of Samples, reagents
Testing of samples
Transportation of sample and other Components

17. Approach for Cold chain Management
Cold Chain Monitoring
Cold Chain Maintaining
Product Monitoring
With active cooling system
Facility Monitoring
With passive cooling system
Shipment Monitoring
Transport Monitoring

18. Cold Chain Monitoring Product Monitoring
Condition Indicators – for short timer exposure, during transportation
Cumulative Time temperature indicators
Freeze Indicators – Indicating freezing event
Threshold indicator – Indicating short time heat exposure as per threshold limits.
Combination of above two indicators

19.         Cold Chain Monitoring Product Monitoring
Four Core Technologies
HEATmarker® Cumulative Time- Temperature Indicator (TTI) for single unit monitoring throughout shelf life  
LIMITmarker™ - Time delayed threshold Indicators for multiple unit monitoring during transportation  
DEGmarker™ - Instantaneous threshold indicator for single and multiple unit monitoring during storage and transportation  
FREEZEmarker® - Freeze event Indicator for multiple unit monitoring of freezing during storage and transportation  

20.   Threshold Indicator -
A monitor that changes color when above 9⁰C with time delay for maximum 30 minutes .
Used for blood bag monitoring during storage and transportation   25 20 15 10 5 -5
10°C
TIME

21. Threshold Indicator -

22. A Cumulative Time Temperature Indicator (TTI)
Active Indicator
Reference Ring
Key Points
The central portion of the indicator is the reactive portion.
It is light at the start and progressively and irreversibly darkens
The color change is faster at higher temperatures and slower at low temperatures.
End point is reached when the color of the central area is equal to the reference ring color.

23.      A Cumulative Time Temperature Indicator (TTI) T E M P (°C)25 20 15 10 5 -5  T E M P
(°C)   
TIME

24. A Cumulative Time Temperature Indicator (TTI)

25. Cold Chain Monitoring Facility Monitoring
Dataloggers for storage rooms, facilities
Chart recorders –
Strip
circular
Wired dataloggers –
Stand Alone
Multichannel
Wireless dataloggers
Single location
Multiple locations

26. Conventional Cold Chain Monitoring Facility Monitoring
Dataloggers for storage rooms, facilities
Chart recorders –
Sensor is connected to chart recorder
With ink or thermal print readings are recorded
Normal or thermal paper is used for recording.
Out put is in graphical format.
Requires battery , chart paper, ink pen as consumable.
Life of pen is short.
Mechanical device needs maintenance
Chances of errors in loading the paper
Need to keep the papers as record
Conventional

27. Conventional Cold Chain Monitoring Facility Monitoring
Dataloggers for storage rooms, facilities
Wired dataloggers –
Widely used system for Datalogging
Gives digital output.
System involves a junction box connected to single or multiple channels linked to sensors.
Junction box are linked to each sensor by wires.
System is connected to PC or electronic recorder
Data available in numerical and graphical format.
Alerts are generated
Remote access may be possible.
Conventional

28. Innovative Cold Chain Monitoring Facility Monitoring
Dataloggers for storage rooms, facilities
Wireless dataloggers
Advanced Datalogging system
Data transfer is through Radio frequency.
System involves a Radio Modules connected to sensors and Radio Receiver connected to PC .
No need of junction box, wires. .
System is very flexible and expandable
Data available in numerical and graphical format.
Alerts are generated
Remote access is possible.
Use of internet, LAN/WAN network for multiple sites.
Innovative

29. Integrated wireless facility and transport monitoring solution
Cold Chain Monitoring
Cold Chain Monitoring
Facility Monitoring
Facility Monitoring
Integrated wireless facility and transport monitoring solution
Cobalt radio Modules with sensor
Cobalt Radio Receiver
and Repeater
Thermo software ( server/ client based)

30. Cold Chain Monitoring Facility Monitoring
Monitoring Single location
Monitoring Multiple locations

31. Cold Chain Monitoring
Facility Monitoring

32. Cold Chain Monitoring
Transport Monitoring
Innovative

33. Shipment & transportation Monitoring
Cold Chain Monitoring
Shipment & transportation Monitoring
Dataloggers for Transportation
Electronic Indicators–
Indicates the temperature excursions in view of threshold limits
Does not provide graphs and tabular data.
Does not need any reader or PC for checking data
Conventional

34. Shipment & transportation Monitoring
Cold Chain Monitoring
Shipment & transportation Monitoring
Dataloggers for Transportation
Electronic dataloggers –
Records temperature as per intervals
Provides graphs and tabular data.
Just require PC to download the data.
Also indicates alerts

35. Innovative Cold Chain Monitoring Shipment Monitoring
Single use pre programmed PDF Temperature recorders
Multiple use programmable PDF Temperature recorders

36. 7 Questions to ask before selecting temperature monitoring device -
What you want to monitor ? Product or facility
Why you want to monitor ? For protection or projection
When you want to monitor ? During storage or transportation
Where you want to monitor? Single or multiple locations
How extensive you intend to monitor? Single user or many users
What is the value of monitoring for the product? Moderate or high
How much you want to spend

37. Cold Chain Maintaining With active cooling system
Innovative

38. Cold Chain Maintaining With active cooling system
An Innovative active cooling system
which works on 12V DC supply.
Cool cargo consist of
An insulated container ranging
from 70 liters to 200 liters
An active cooling system with
high performance linear motor
CFC free cooling mechanism.
Available in two types
Cool cargo Refrigerated – 70 to 200 liters
Cool cargo FZ – Freezer type 100 liters

39. Cold Chain Maintaining With passive cooling system

40. Innovative With passive cooling system Cold Chain Maintaining
For Cryo storage & shipments
Innovative
For Long Time Passive Storage
For dry ice shipments
For long term shipments
Up to 10 days 2-8⁰C storage
For at 2-8⁰Cshipments

41. Conclusion
Laboratory services handles Temperature of sensitive products
GLP demands to monitor the temperature exposure so as to Protect products from deterioration during Storage and transportation.
Use of innovative COLD CHAIN solutions brings the ease, flexibility and expandability of the technologies while meeting the demands of GOOD LABORSTRY PREACTICES

42. Thank You For more details - www. lisalineasia. com info@lisalineasia
Thank You For more details -