Sofrigam pharmaceutical insulated packaging solutions: quality first!

The quality of Sofrigam insulated packaging solutions is linked to our expertise in engineering of the cold chain and a manufacturing process which requires precision and know-how. Sofrigam has implemented a well-established quality process before, during and after production. Interview with Anne de Wispelaere, Quality, Health, Safety and Environment Manager.

What does the quality process consist of 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. 

Our ISO 14001 certification demonstrates our commitment to reduce the environmental impact of our activity by controlling our energy expenditure. 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

 

What actions are implemented before, during and after the production of our 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.

More specifically, this process involves the following: 

  • Selection of our suppliers and control of raw materials before production of our insulated packaging solutions,
  • Quality controls carried out by a full-time quality controller on the semi-finished products,
  • Verification of recordings attesting to the controls prior to batch release. 

 

Do Sofrigam insulated packaging solutions 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.

Our insulated packaging solutions are qualified in accordance with standards and regulatory reference documents specific to cold chain packaging solutions (NF S99-700 standard, ISTA 7D and 7E standards, etc.). 

Some of our products are Certicold Pharma certified by the Cemafroid centre of technical expertise. Certicold Pharma is a European certification label specific to equipment for the healthcare product cold chain. It requires the observance of precise specifications which guarantees the quality of the insulated solution, its conformity with Good Distribution Practice of healthcare products (GDP) and a fair price. A genuine guarantee of performance and quality for cold chain solutions, especially since the certification audit is done on a yearly basis. 

 

Sofrigam works with large pharmaceutical laboratories which have very strict quality processes. How do they carry out quality controls on the 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. 

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. 

 

What do these audits focus on?

All 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.

 

Do you have any questions concerning Sofrigam’s quality process or would you like to know more about how we work? Contact us!

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