Frontage has the complete core services, latest technologies, and robust processes to support your microbiological testing needs for pharmaceutical product development and CMC operations. Microbiological testing is a critical component for ensuring the quality and safety of pharmaceutical products. In addition to robust manufacturing processes and controls, an appropriate QC testing strategy can provide assurance that products are free of contaminants and are suitable for their intended use.
Our experienced team at Frontage understands that these factors that contribute to method sensitivity and variability are important in generating consistent results and allowing meaningful data evaluation.
Microbiological Testing Services at Frontage
- Microbial Limits Testing (Bioburden): Minimize potential risk to process and product and ensure product stability by employing this widely performed testing on nonsterile raw materials, APIs, and finished products. USP <61> and USP <62> will quantify your contaminant levels
- Sterility Tests – USP <71>: Demonstrate that your manufacturing process and controls yield a sterile finished product by conducting tests capable of detecting both aerobic and anaerobic bacteria, along with yeasts and mold.
- Bacterial Endotoxins Test – USP <85>: Ensure the safest final product by detecting the levels of endotoxins that may be present in a product or raw materials used in manufacturing the final product.
- Antimicrobial Effectiveness Testing – USP <51>: Assess your preservative efficacy early in the formulation development process by evaluating the ability of your product in reducing the levels of contaminants that may be introduced during or subsequent to manufacturing.
Validation of Methods
All Frontage microbiological testing methods are compliant with validated compendial tests, but the suitability of test parameters is demonstrated for each individual product formulation. Suitability testing establishes the test conditions under which the product does not interfere with the test.
- Suitability Testing: MLT and AET
- Inhibition/Enhancement Testing: BET
- Bacteriostasis/Fungistasis Testing: Sterility
Frontage offers the right experience and insight into investigations for your product testing
Choose Frontage – Choose Success
The drug development and manufacturing sponsor is the ultimate owner of the quality and safety of the product. Choosing a service provider like Frontage can set you up for success.
- Expertise: We are knowledgeable in the concepts, requirements, and interpretations of microbiological testing
- Transparency: We collaborate transparently with our sponsors to make the best decisions and provide the highest quality services.
- Technology: Frontage Laboratories has state-of-art laboratory facilities in Exton, PA, a suburb of Philadelphia to support your microbiological testing needs.