Microbiological quality control maintains product integrity.
Microbial contamination of drug products is a serious issue in the pharmaceutical industry. The presence of microbes can contaminate sterile environments and cause severe illness, particularly with parenteral drugs that are administered directly into the circulatory system.
To protect public health and comply with regulatory requirements, testing for the presence of potentially harmful micro-organisms is crucial. Exova SL Pharma offers comprehensive microbiological development and quality control testing services, as well as support during all phases of product and process development.
Our microbiology development and testing services include:
- Sterility test method development and validation
- Microbial examination test method development and validation
- Bacterial endotoxin test method validation and testing
- Antimicrobial preservative efficacy testing
- Particulate matter testing
- Container and closure integrity testing
- Sterilization cycle development and validation
- Batch release and stability testing (both development and commercial batches)
- Filter validation bacterial retention studies
- Microbiological assays
- Special research studies
- Technology transfer
Exova SL Pharma’s highly qualified and experienced technical staff use state-of-the-art equipment and apply advanced techniques in testing. We operate under current Good Manufacturing Practices (cGMPs) and are regularly inspected by the Food and Drug Administration (FDA).
Our extensive expertise in microbiological development, together with a robust quality control program, help you ensure product quality and patient safety.