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Insulated packaging solutions conforming to ISO 9001 and ISO 14001 Standards

07 April 2014

Sofrigam manufactures insulated and temperature controlled packaging solutions suitable for use by health professionals, pharmaceutical laboratories and logisticians. We apply a quality policy throughout the entire manufacturing process in order to satisfy the requirements of ISO 9001 and 14001 certifications.

The manufacturing process of Sofrigam insulated boxes meets the requirements of ISO 9001 Standards.

ISO 9001: continuous improvement at the core of the manufacturing process

A number of points are evaluated in the context of certification to ISO 9001: organisation, control of non-conformities, satisfaction monitoring, etc. This Standard concerns the general aspects of quality management.

For example, in terms of organisation, we follow the FIFO (First In, First Out) principle for the rational stock control of raw materials. The earliest entries into stock are the first to be used. The traceability system for insulated containers, their components and gel packs ensures very precise monitoring at every level of the production phase, for each packaging solution.

In conjunction with our policy of continuous improvement, our company is audited at regular intervals by the pharmaceutical laboratories with whom we work.

ISO 14001: reducing negative impacts on the environment

Certification to ISO 14001, obtained in January 2001, recommends conducting an environmental analysis. Its purpose is to categorise potential risks on the basis of their hazardous nature and their impact on the various activities of the establishment. The objective is to identify any significant environmental aspects in order to conduct ‘clean-up’ operations.

In our manufacturing process, we do not discharge any fluids outside the factory. Waste products resulting from scrap and dust particles from polyurethane insulation and cardboard are controlled on a consistent basis. We have also applied strict procedures regarding the presence of harmful organisms in order to safeguard the cooling devices.

The Quality and Environment Manager ensures compliance with ISO 9001 and ISO 14001 standards in the manufacturing process of temperature controlled packaging.

The design phases of an insulated shipping system and the role of the Quality Department

The manufacture of a made-to-measure solution involves several stages:

  • Our engineers specialising in the cold chain analyse the client’s logistical network (temperature ranges and profiles, volume of products to be dispatched, ratio of payload volume to external volume, preparation procedures, etc.)
  • They produce a 3D drawing of the packaging solution.
  • The files are then processed by production machinery.

The manufacturing process is highly flexible, due to the different sizes of the polyurethane sheets. In this way, the packaging solution is constructed around the product, so as to limit the number of voids in the containers.

The Quality Department applies a series of checks, mainly dimensional, on the insulated packaging solutions. A quality inspector systematically checks the raw materials and the finished products.

Baptiste Lebrun, the Quality and Environment Manager, ensures that the products conform to ISO 9001 and 14001 Standards. “On average, we inspect 50,000 units per month. We also control product non-conformities, internally or externally, and initiate remedial action” he explains.

Finally, the Quality, Health, Safety and Environment Manager assumes responsibility for the Quality Department and he participates in production development projects in France and internationally.

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