PolymerExpert designs custom specialty polymers for its customers. Whether in the medical, cosmetic or industrial fields, our productions are subject to batch release to ensure product conformity and quality. This requirement allows us to guarantee to the customer the conformity of the product to the required specifications and allows a traceability. Quentin Monange, operational quality expert explains the process.

Batch release, a continuity of the production process

Over the years, PolymerExpert has seen its activity as a polymer research and development laboratory evolve. Indeed, by moving from a strategy of off-the-shelf specialty polymers to a strategy of custom production with an increase in scale, the company had to implement a strict process to ensure the quality of its productions.

Historically focused on the medical sector, PolymerExpert has diversified to become a major player in the cosmetics and industrial sectors. The possibility of having several production lines allows the company to respond to numerous requests from industrialists in all sectors.  At the end of the production process, all the productions are subjected to the same requirement: the release of the batch.

This step of batch release is essential to guarantee the conformity of the synthesized materials to the customer’s standards, and thus guarantee his satisfaction.

This strict process, which is based on both our internal requirements and normative requirements, is described as follows

  • Documentary control of production documents: the versions and references of the working documents used, the presence of all the required information, the rules of drafting in accordance with Good Manufacturing Practices (GMP)
  • Control of the conformity of purchased raw materials: although a release process dedicated to raw materials already takes place before production, a new control is carried out afterwards to ensure the conformity of the product to our internal specifications.
  • Control of the conformity of the finished product: throughout the production process, analyses, carried out by our experts in analysis and with the help of our state-of-the-art analytical equipment, are carried out on the product to guarantee its conformity to the desired specifications. These results are summarized in a Certificate of Analysis (CoA).
  • Control of the final batch file: this file gathers all the evidence of the above-mentioned controls, allows us to control the coherence of all the information that can be found there and to establish the internal traceability of the products. This is the last step at the end of which a batch release certificate is issued.
La libération des lots : une garantie de conformité et de qualité des produits

Beyond customer satisfaction, it is essential to provide a product that complies with the requirements mentioned in the specifications, and of course, without defect and without danger. This is why PolymerExpert has adopted this rigorous and systematic internal control strategy leading to the release of each of its different products.

Since 2004, the company has been ISO 9001  certified. This certification not only reassures the customer about the quality policy and the constant improvement dynamics. In addition to ISO 9001 certification, PolymerExpert is also ISO 13485 certified, which refers to quality in the medical device sector. These two normative requirements allow us to control each stage of production and to objectively measure quality. In fact, in sectors where the health and safety of patients are at stake, compliance with the standards allows us to minimize the risks to human health by combining increased rigor in the production and quality teams.

These requirements concern absolutely all stages of the product manufacturing chain, from the release of raw materials, to the production stages, including control of the environment and cross-contamination, to packaging and traceability.

It is therefore with this objective of zero defects that methods and means have been put in place to harmonize all productions (cosmetics, industrial, and others) on these requirements and this rigorous model specific to the medical field.

However, it happens that products are found to be non-compliant after one of the above-mentioned controls and that deviations are observed. Specific procedures are then triggered. These problem-solving methods call on our technical experts, from our various departments: production, analytical, expertise, R&D, to investigate the origin of the problem. In a quality and transparency approach, the customer is systematically involved in these steps, both from an informative and safety point of view.

During the process, the products concerned must respect our internal procedures. This includes clear identification and isolation of the products. After a thorough investigation and after obtaining the customer’s agreement, the products can be put back into a classical cycle leading to the final release under waiver or, if the investigation does not allow to accept a deviation, they are then scrapped.

The quality indicators, analyzed internally on a regular basis, show the efficiency of the system in place and testify to customer satisfaction.

 

You want to design custom polymers?

For any request for support or information, please contact Quentin Monange or one of our experts by phone at 05.56.04.02.00 . We can also be reached by email : contact@polymerexpert.fr or via our contact form.

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Quentin Monange,
Operational Quality Engineer