Measures the effectiveness of antimicrobial preservatives that are added to prevent microbiological growth in pharmaceutical nonsterile dosage forms and cosmetics.

Ensures the quality of pharmaceutical drug products by validating their sterile filtration systems’ capabilities.

Confirms that medical devices will not allow microorganisms into patients through any point of entry by validating container closure systems.

Detects bacterial endotoxins on medical devices or pharmaceutical injectables using Limulus amebocyte lysate (LAL), which have been prepared for use as an LAL reagent.

Process simulation that assesses the performance of an aseptic manufacturing procedure by replacing the pharmaceutical product with a sterile culture media. Regularly conducted to confirm that mixing and handling techniques are adequate and consistent.

Validation of sterility testing method to confirm that it is suitable for your pharmaceutical or medical device product under USP 71 pharmacopeia standards and GMP microbiology standards.

Conducted to measure the quantity of microorganisms or detect the presence or absence of specific microorganisms in a nonsterile pharmaceutical drug product.

Detects the presence of microorganisms in a pharmaceutical drug product using either the Vitek® or MicroSEQ Rapid Microbial ID Systems.

Quantifies how many microorganisms are present in a nonsterile pharmaceutical drug product by adding a product sample to a cell medium for three to five days. 

Method development and testing of the sterility of the final pharmaceutical or medical device product under USP 71 pharmacopeia standards and GMP microbiology standards. Membrane Filtration tests and direct inoculation methods are conducted.

Sterility test to detect microbial contamination in a finished drug product with a reduced timeline of just five days using either the Milliflex ® Rapid Microbiology Detection System or the 7-day BacTAlert 3D Microbial Identification System.

Documented verification of adequate cleaning and sterilization of equipment and facilities for manufacturing pharmaceutical and medical device products.

Validates disinfectant substances used in cleanrooms for pharmaceutical drug products and medical devices.

Evaluates a cleaning processes’ ability to fully sterilize a medical device by exposing pre-inoculated devices to controlled microorganisms and then conducting sterilization.