Sofrigam reveals details of its Quality Assurance program

Rueil-Malmaison, France: – Temperature-controlled logistics and pharmaceutical cold chain specialist Sofrigam SA has implemented a rigorous quality assurance (QA) process to cover every stage of its production of insulated packaging.

Sofrigam’s Quality, Health, Safety and Environment (QHSE) Manager Anne de Wispelaere has been explaining how the QA program is based on expertise in cold chain engineering and a manufacturing process demanding precision and know-how at ever y stage of production.

ISO 9001 and ISO 14001 certified

Anne de Wispelaere is interviewed in a recent article posed on the company’s blog page. She was first asked to explain the basic quality process at Sofrigam.

“Sofrigam is ISO 9001 and ISO 14001 certified. ISO 9001 guides us in implementing a system of continuous improvement in our organisation, in managing non-conformities and the follow-up of customer satisfaction, while ISO 14001 certification demonstrates our commitment to reduce the environmental impact of our activity by controlling our energy expenditure,” Ms. de Wispelaere explains.

“The eco-design of our products, recycling and development of reusable insulated packaging solutions are an integral part of this process. These certifications and their criteria provide us with a regulatory framework to conduct a pertinent and effective quality process,” she adds.

Production process

Ms. de Wispelaere described the actions that Sofrigam implements before, during and after the production of insulated packaging solutions.

“Sofrigam remains faithful to its values of quality, innovation, technical expertise and reactivity. Our quality policy and our action plan of continuous improvement are based on these values,” she said.

Specifically, this process involves careful selection of suppliers and control of raw materials pre-production, quality controls carried out by a full-time quality controller on the semi-finished products and verification of recordings attesting to the controls prior to batch release.

Standards & regulations

Sofrigam insulated packaging solutions must respond to specific quality standards/regulations/certifications.

“All of our insulated packaging solutions are tested and qualified in the thermal testing laboratory. We systematically provide our clients with thermal efficiency test graphs, proof of performance and reliability of the packaging solutions maintaining the required temperature conditions,” said Anne de Wispelaere.

Sofrigam insulated packaging solutions are qualified in accordance with standards and regulatory reference documents specific to cold chain packaging solutions, such as NF S99-700, ISTA 7D and 7E standards.

Certicold certification

Some Sofrigam products are certified by the Cemafroid center of technical expertise with the Certicold Pharma label, which is a European certification specific to cold chain equipment for healthcare products. It requires the observance of precise specifications that guarantees the quality of the insulated solution, conformity with Good Distribution Practice (GDP) of healthcare products and fair price.

“This forms a genuine guarantee of performance and quality for cold chain solutions, especially since certification audit must take place annually,” said Anne de Wispelaere.

Laboratory standards

Sofrigam works with large pharmaceutical laboratories that have very strict quality processes. Ms. de Wispelaere explained how these integrate with Sofrigam’s own quality controls on insulated packaging solutions.

“Sofrigam does indeed work with large global pharmaceutical groups. Our insulated or refrigerated packaging solutions are intended to transport, in the case of the largest ones, thousands of euros of vaccines, insulins and other heat-sensitive medicines. Quality is therefore a major challenge: the integrity of the products is at stake, as well as the health of the patients,” she said.

Quality auditing

“The responsibility of the pharmaceutical companies is to ensure that the shipping conditions guarantee the quality of the transported products. This is why we are regularly audited by our clients to verify that Sofrigam continues to comply with the strict standards of the pharmaceutical industry with regard to heat-sensitive packaging solutions,” said Anne de Wispelaere.

“All Sofrigam company processes can be subject to audit: from the HR department to logistics. However, auditors of pharmaceutical laboratories focus primarily on activities with a direct impact on the quality of the delivered insulated packaging solution such as production, quality control, logistics, staff training, maintenance or even the thermal testing laboratory,” she explained.

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.