Element’s microbiology lab provides specialist microbiology testing services and quality control for drug products that support all phases of product and process development and help to maintain 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 illnesses, 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 therefore crucial.
Our microbiology lab offers a comprehensive range of microbiological development and quality control testing services to support all phases of our customers’ product and process development.
These 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
Working with Element
Our scientists are experienced across a range of drug products and dosage forms, including parenteral and topical products. We operate under all current Good Manufacturing Practices (cGMPs), and our microbiology labs are regularly inspected by the Food and Drug Administration (FDA).
Our extensive expertise in microbiological development, together with a robust quality control program, helps to ensure that your product is safe, quality and compliant with the appropriate quality and regulatory standards at each stage of product development.
To learn more about our microbiology testing services, or the services we provide to the pharmaceutical industry, contact us today.
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