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

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

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

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

Quality Standards based on type of Lab

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.

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.

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

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

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

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)?

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

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.

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

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

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

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

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

        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  

  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 1 2 3 4 5 6 TIME

Threshold Indicator -

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.

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

A Cumulative Time Temperature Indicator (TTI)

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

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

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

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

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)

Cold Chain Monitoring Facility Monitoring Monitoring Single location Monitoring Multiple locations

Cold Chain Monitoring Facility Monitoring

Cold Chain Monitoring Transport Monitoring Innovative

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

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

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

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

Cold Chain Maintaining With active cooling system Innovative

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

Cold Chain Maintaining With passive cooling system

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

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

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