Microbiology in the Pharmaceutical Industry
Microbiology is an important part of the pharmaceutical industry, ensuring patient safety among other things. Dephamon has many years of experience in this field and offers a full range of consulting services, from environmental monitoring and gowning to setting up aseptic work processes and product analysis.
As an expert, I strive to provide the highest level of service to my clients. Contact me today to learn more about how I can help you meet your microbiological needs.
Environmental Monitoring
Environmental monitoring is an essential part of quality control in pharmaceutical manufacturing. To ensure that products are of the highest quality, cleanrooms must be maintained that meet stringent bacterial count standards. Environmental monitoring contributes to this by providing a continuous record of cleanroom conditions. This data can then be used to identify potential problems and take corrective action. By maintaining a clean and well-monitored environment, pharmaceutical manufacturers can ensure that their products meet the highest quality and safety standards.
Gowning
The reduction of the total germ count in the cleanroom is achieved, among other things, by a well thought-out room design with checkrooms and airlocks. Since personnel are one of the main sources of contamination in the cleanroom, consistent adherence to hygiene measures such as hand washing and wearing cleanroom clothing is of utmost importance.
I am happy to offer my support in the creation of a risk-based gowning concept tailored to your operation.
Aseptic Work and Aseptic Processes
A good understanding of the transmission pathways of microorganisms and their natural habitat is the basis for establishing aseptic processes. Samples for analysis must also be taken carefully and in compliance with strict hygiene rules in order to avoid secondary contamination by personnel, the environment or equipment.
Microbiology expertise is at the heart of every aseptic process.
A cross-departmental and cross-process Contamination Control Strategy (CCS) identifies, adequately addresses and minimizes contamination risks in the aseptic process. The contamination control strategy must be created in a complex process and reviewed regularly. I will gladly take over the creation of your CCS including a concept for the regular revision for you.
Product Analytics
Microbiological product analysis shows the condition of the product at the time of analysis. Microorganisms, however, are living organisms that reproduce or die depending on the conditions (presence of nutrients, temperatures, etc.). During their life phases they produce, among other things, metabolic products which can negatively affect the product or the patient. In order to obtain a holistic picture, the entire manufacturing process from raw material to in-process controls to the final product must be sampled and analyzed accordingly. I can advise you on the sampling concept for your manufacturing process.
The final product analysis serves as the last confirmation of the required quality, e.g. by means of the methods Sterility, Endotoxin, Microbial Enumeration test & Specified microorganisms.
Equipment qualification
No analytical result can be regarded as “valid” unless the analytical instrument is qualified or the operators are trained. Planning and execution of Installation Qualification (IQ) and Operational Qualification (OQ), as well as writing of the qualification report and planning of re-qualifications of analytical instruments are also part of my competences.
