Sofrigam’s guides to cold chain documentation

Rueil-Malmaison, France: – Pharmaceutical cold chain specialist Sofrigam SA has harnessed its expertise in temperature-controlled logistics to launch a series of guides on regulations and standards shaping the sector.

The Sofrigam guidance, which appears on its website, focuses on the various types of reference document that determine qualification of temperature-controlled pharmaceutical packaging solutions.

“It is difficult to know where to begin with all of the different reference documents that qualify pharmaceutical cold chain equipment,” says Sofrigam.

This multiplicity is because the regulations and standards that define acceptable levels of quality and security for temperature-sensitive medicines, drugs and vaccines originate from a number of organisations in different countries.

Regulations vs. standards

“Some reference documents come from standardization bodies authorized by states and have the status of norm,” says Sofrigam. “Others are written by industrial associations and groups and have the status of standards or guides. In both cases, these documents are established by a consensus of those directly involved.”

The distinction is important since application of a reference document is optional unless regulations make it compulsory.

Four types

Distribution of medicines via the temperature-controlled healthcare products cold chain is governed by four principal types of supplementary reference documents:

• Regulations: These are a set of instructions and rules governing an activity. Regulations are written by competent administrations and their application is compulsory
• Norms: A norm is a reference document describing a method for qualifying a temperature-controlled container, formalized by an independent body authorized for this purpose by a national or international authority (ISO, AFNOR, DIN, ASTM, BSI, NBN, JSA, etc.)
• Standards: A standard is a document similar to a norm but formalized by a group (consortium) of users and product or service providers. It seeks to ensure compatibility of products and services from different sources
• Guides and recommendations: A guide is a document, grouping together information on a topic, which serves as a benchmark. Recommendations are advice on good practice. For example, WHO has a guide on protocols for thermal efficiency testing: WHO/IVB/05.23

Pioneering guide

“The system is only as strong as its weakest link,” says Sofrigam, pointing out that it is vital to be able to identify the most relevant guideline or standard from the mass of potential documentation.

With this maxim in mind, the French-based company initiated production of a first practical guide for cold chain medicines, ‘Guide pratique: Chaîne du froid du médicaments’ jointly published in 2008 by the Société Française des Sciences et Techniques Pharmaceutique (SFSTP) sand the Association Française du Froid (AFF).

Sofrigam’s cold chain experts, as members of various technical committees within the AFF-SFSTP associations, contributed extensively to the production of this guide with other industrial refrigeration professionals, in the pharmaceutical and pharmacy sectors.

This practical guide on the medicine cold chain was one of the first quality reference documents to secure the distribution network of healthcare products via the cold chain (+2/+8°C) for all professionals involved in the medicine logistics chain: pharmaceutical laboratories, distributors and pharmacists. It aims to guarantee better security of the medicine delivered in line with regulatory constraints while optimizing operation costs using concrete examples to assist professionals in their various processes: writing specifications, validation of transport, implementation of controls, etc.

Sofrigam will call on much of the information contained in the French-language guide, updated for subsequent regulation and publications.

Combating complexity

“Year after year, the French Board of Pharmacists published its recommendations for maintaining the cold chain of healthcare products at the pharmacy (receipt, storage, preparation of medicines, patient recommendations). Where they are still valid, these reference documents have witnessed other initiatives to combat the complexity of the subject of refrigeration for healthcare products, such as the creation of a committee dedicated to the last mile within the AFF,” says Sofrigam.

“There are many reference documents encompassing the qualification protocols for cold chain packaging solutions and going through them can be confusing. In our next article we will look at the different parameters considered in the qualification protocols for insulated packaging solutions. This will compare the efficiency of the various packaging solutions available on the market,” says Sofrigam.

A subsequent Sofrigam article will provide a comparative summary of the different protocols for qualifying packaging solutions.

About Sofrigam

French-based Sofrigam S.A. designs and manufactures cool chain pharmaceutical shipping solutions and insulated boxes for the life sciences industries as well as for distribution and logistics companies.

The company was founded in 1979 by an industrial pharmacist and initially developed eutectic painkillers before specializing in the design and manufacture of insulated and refrigerated packaging, including pre-qualified insulated shipping and temperature management solutions. The company is headquartered in Ile-de-France with a production site at Arras.

Sofrigam offer solutions for the cold chain logistic problems experienced by the pharmaceutical industry. It offers a range of standard and made-to-measure thermal packaging products as well as customized services designed to achieve secure, cost effective and ecological cold chain logistics.

Sofrigam has become one of Europe’s leading cold chain specialists, sharing its expertise via seminars, publications and R&D collaborations. It also offers customized products and services designed to achieve cold logistics that are secure, cost-effective and comprehensively compliant.

Sofrigam partners with Ater Métrologie, a French-based ISTA and ISO 9001 certified laboratory that specializes in testing, validating and pre-qualifying temperature-controlled packaging and cooling systems. The laboratory carries out some 2,000 tests each year.