Cold Chain Compliance

Overview

The term ‘pharmaceutical cold chain’ describes an interconnected process that maintains therapeutic products at a specified low temperature range during all the logistic and distribution steps from original manufacture to final use.

Unlike ‘cool chain’, which means preventing temperature-sensitive pharmaceutical and biotech products from overheating, cold chain involves actively keeping products chilled, using refrigerants or other media.

The term ‘chain’ is well chosen since it is an interdependent series of links, with failure of any one rendering the whole process invalid and therefore useless.

Sofrigam is expert in helping clients meet the demands of cold chain compliance; with a range of cold chain insulated packaging and cooling media solutions coupled with expert advice and consultancy services.

Cold chain standards

Cold chain standards are determined by a series of guidelines and regulations governing temperature control in storage and shipping. Compliance will be defined by gap analysis of the standards that apply to the products in the cold chain and the measures being taken to ensure temperature control during shipping and storage.

The main cold chain standards are defined by:

• US Food and Drug Administration (FDA: Guidelines for Wholesale Prescription Drug Distributors (CFR 205) and Current Good Manufacturing Practice for Finished Pharmaceuticals (CFR 211)
• International Conference on Harmonization (ICH): Stability Testing of New Drug Substances and Products: CPMP/ICH/2736/99
• United States Pharmacopoeia: Chapter 1077: Good Packaging Practices and Ch. 1079: Good Storage & Shipping Practices
• Parenteral Drug Association (PDA) Technical Reports: TR 39 and TR 52
• Health Distribution Management Association (HDMA): Guidelines for Managing Cold Chain & Temperature Sensitive Products (2009).
• International Safe Transit Association (ISTA) Test Procedures 5B and7D
• American Society for Testing and Material (ASTM) Standard Test Method: Thermal insulation quality of packages.
• International Air Transport Association (IATA): Perishable Cargo Regulations manual
• Cold Chain Committee: Guidelines for the development of insulated shipping containers.

Cold Chain Process Compliance

Compliance with cold chain standards for pharma and biotech transportation processes can be audited by asking a series of generic questions. These include:

• Is the packaging used formally qualified for the product being shipped?
• Is equipment or media used to control the temperature levels suitable or formally calibrated?
• Does the package used during transportation ensure temperature uniformity within the container?
• Is a temperature profile study required?

Cold Chain Qualified Packaging

Cold chain compliance requires the shipper to use Qualified Packaging Methods: insulated containers, conditioning materials or other methods that are proven to maintain internal temperature at the specified target range and compliant with the product specifications during the entire transportation and storage processes.

In order to be fully Qualified, packaging for drugs and other pharma/biotech products must fulfill the users’ specifications requirements and must also:

• Be designed thermally
• Have a specification that relates to target temperature profiles and Logistic history
• Be formally qualified thermally
• Be verified for specification and insulating effectiveness
• Be maintained or constructed to relevant Standards such as ISTA (5B, 7D, 7E, Standard 20 or PDA TR 39

Sofrigam Cold Chain Compliant Products and Services

Sofrigam designs, manufactures and qualifies packaging for cold chain storage and transport.

In addition to providing a wide range pre-qualified insulated packaging solutions for cold chain products, Sofrigam engineers can produce tailored thermal package designs and qualification. Sofrigam works with pharmaceutical, medical device, and biotech companies to design, manufacture, test and qualify thermal packaging for temperature sensitive pharmaceutical products required to maintain a specific temperature range throughout the cold chain shipping process.

Sofrigam can also provide expert services to include:

• Thermal Modeling and Simulation
• Package Performance Modeling and Testing
• Temperature Profile Study (TPS)
• Temperature Mapping
• Thermal Equipment Qualification

Sofrigam offers a portfolio of products and services to meet the growing demands placed upon the life science industry. Sofrigam is a complete cold chain packaging solution provider specializing in the field of temperature-controlled packaging. This product and service offering is meant to act as an “all in one” package of services to be a more economical option for pharmaceutical and medical device companies.

Sofrigam Cold Chain Qualifications

Sofrigam’s commitment to quality in cold chain packaging and logistics is proved by its numerous certifications. These include:

Quality :ISO 9001:2008 certification delivered by the SGS organisation confirms that Sofrigam has an ongoing internal improvement system in place . This regularly assesses and improves issues such as organisation, processing of non-conformities and client satisfaction.

Environment :ISO 14001:2004 certification is based on an environment management system focusing on environmental impact, environmental performance and energy expenditure. ISO 14001 certification confirms that Sofrigam has put in place an ongoing improvement approach designed to reduce the impact we make on the environment in the short, medium and long term.

Sofrigam’s partner laboratory Ater Métrologie is ISO 9001 certified and has obtained ISTA certification of its expertise and competence. This certification confirms that Ater Metrologie is qualified and equipped to test the performance of our insulated and refrigerated packaging products in accordance with ISTA procedures.

Resources

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Supplier Information
Supplier: Sofrigam SA
Address: 212 avenue Paul Doumer, 92508 Rueil Malmaison, Cedex, France
Tel: +33 (1) 46 69 85 00
Fax: +33 (1) 47 25 98 44
Website: www.sofrigam.com