im体育APP’s microbiology lab provides specialist microbiology testing services 和 质量 control for drug 产品 that support all phases of product 和 process development 和 help to maintain product integrity.
Microbial contamination of drug 产品 is a serious issue in the pharmaceutical industry. The presence of microbes can contaminate sterile environments 和 cause severe illnesses, particularly with 注射用药物的 drugs that are administered directly into the circulatory system. To protect public health 和 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 和 质量 control testing services to support all phases of our customers’ product 和 process development.
These services include:
- Sterility test method development 和 validation
- Microbial examination test method development 和 validation
- Bacterial endotoxin test method validation 和 testing
- Antimicrobial preservative efficacy testing
- Particulate matter testing
- Container 和 closure integrity testing
- Sterilization cycle development 和 validation
- Batch release 和 stability testing (both development 和 commercial batches)
- Filter validation bacterial retention studies
- Microbiological assays
- Special research studies
- 技术 transfer
Working with im体育APP
Our scientists are experienced across a range of drug 产品 和 dosage forms, including 注射用药物的 和 局部 产品. We operate under all current Good Manufacturing Practices (cGMPs), 和 our microbiology labs are regularly inspected by the 食物 和 Drug Administration (FDA).
Our extensive expertise in microbiological development, together with a robust 质量 control program, helps to ensure that your product is safe, 质量 和 compliant with the appropriate 质量 和 regulatory st和ards at each stage of product development.
To learn more about our microbiology testing services, or the services we provide to the pharmaceutical industry, im体育APP 今天.
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