Microbiology Testing

Infinity Laboratories offers robust microbiological testing for every stage of your pharmaceutical drug product and medical devices’ lifecycle to eliminate the risk of microbial contamination. Powered by our national network of state-of-the-art, Good Manufacturing Practice (GMP) compliant laboratories, our team can work with you to uncover and conduct the optimal assays to safely deliver your product to the market.

Maintaining Sterility From Development Through Execution

Microbial contamination can pose serious risks to patients using nonsterile or injectable pharmaceutical drug products and implantable medical devices. Microbiological testing is vital to assure the lack of microorganisms such as specific pathogens, bacteria, yeast, and molds.

There is the risk of microbiological contamination at many stages during a product’s journey to the patient. Infinity provides robust method development, method validation, and testing for potential contamination sources throughout the product lifecycle. Types of microbiological testing, include:

  • Bioburden testing
  • Biosafety testing
  • Media fills
  • Microbial culture media preparation
  • Mycoplasma testing
  • Pyrogen testing
  • Sterility testing
  • Cleaning validation
  • Air monitoring
  • Water testing

Microbiological Testing Method Development & Validation

Infinity has the experience and technology needed to conduct method development and validation for the entire product lifecycle. Learn how we support our clients’ avoidance of microbial contamination from pre-clinical to commercial production with comprehensive analytical testing procedures.

Comprehensive Microbiology Testing & Study Services

Infinity has the technology and staff to support a wide range of microbiology testing. Our team acts as an extension of yours to determine the assays suited to your pharmaceutical or medical device product. All tests are conducted in our GMP-compliant laboratories and under standards set by the United States Pharmacopeia (USP).


Antimicrobial Effectiveness

Standard: USP <51>

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

Bacterial Filter Retention

Standard: ASTM F838-83(1993)

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

Container Closure Testing/Microbial Ingress

Standard: USP <1207>

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

Endotoxin Testing

Standard: USP <85>

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

Media Fill

Standard: Client Specific

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.

Method Suitability (B&F)

Standard: USP <71>

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.

Microbial Examination

Standard: USP <61>, USP <62>

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

Microbial Identification

Standard: Vitek®, MicroSEQ

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

Microbial Limits

Standard: USP <61>, USP <62>

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. 

Sterility Testing

Standard: USP <71>

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 Testing, Rapid (5 Day)

Standard: Milliflex ®, BacTAlert

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.

Cleaning Validation Studies

Standard:  AAMI TIR30:2011 (R2016), ISO 11737-1:2018

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

Disinfectant Studies

Standard: USP <1072>

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

Product Inoculation Studies

Standard: ANSI/AAMI/ISO 11135, ISO 17665

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

Get in Touch

Want to learn more about our microbiology testing services? Connect with one of our team members today.