As a leading contract developer and manufacturer in the biopharmaceutical industry (CDMO) our client has become a European Center of Excellence for CDMO plasmid DNA. Thanks to the company's 40 years of experience in microbial fermentation, it now offers comprehensive support services for microbial APIs, plasmid materials, starting material for in-vitro transcribed mRNA vaccines and raw material for adeno-associated vectors and lentiviral vectors.
Hygiene, an elementary component of GMP, plays an essential role in the production of high-quality medicinal products or microbial APIs.
The aim of ensuring hygiene in the pharmaceutical industry is to avoid contamination of all kinds of medicinal products. The focus of many hygiene measures is on protection against microbiological contamination.
For this reason, rantronik was commissioned to act as our customer's hygiene officer and to gain an overview of the existing hygiene standards.
In this function, the storage and use of cleaning agents and disinfectants were inspected, the cleanroom clothing and gowning were assessed against current standards and sources of contamination were identified.
Furthermore, the importance of microorganisms in industrial hygiene was explained and the characteristics and identification possibilities of microorganisms were presented.
Another focus of the tasks was the creation of a detailed action plan with preventive measures for the internal value chain, starting with materials management and storage, through the entire production lines to API filling and shipment documentation.
rantronik was able to convey to our customer's employees the understanding that each individual must contribute to a high level of hygiene in pharmaceutical production in order to manufacture a high-quality drug or microbial active ingredient.
The employees were made aware of the risks that can arise for the products due to poor hygiene and how they can reduce these risks through their own hygienic behavior.
Do you also have questions or issues relating to hygiene in the pharmaceutical industry or even an acute need for action? Get in touch with us. We will be happy to support you.