Microbiological Testing

This includes:

• Microbial Limit Testing USP <60>
• Sterility Testing USP <71>
• Bacterial Endotoxin Testing, BET USP <85>
• Antimicrobial Effectiveness Testing (AET) USP <51>
• Microbial Identification USP <1113>

AET evaluates a product’s ability to reduce microbial populations over time when challenged with specific organisms. Testing can be performed on a range of products, including injections, parenterals, topicals, orals, antacids, and transdermals, and may include facility resident organisms. A neutralization study confirms that the selected diluent effectively neutralizes antimicrobial components.

Formats include:

• AET Individual Organism – USP <51>, CTFA M3/M4, EUPh 2.1.1,
• ISO 11930:2012
• AET Mixed Organisms – CTFA M3/M4
• AET Product Neutralization – CTFA/USP

Testing applies to product samples, water samples, and recovery tests when method manipulation is required.

Method validation requires three product lots. Special considerations apply to samples that are opaque, highly colored, outside pH 6–8, contain polypropylene or cells, or are packaged in polypropylene. Low endotoxin vials are available for purchase for sample submission.

B&F Testing verifies that products requiring USP <71> Sterility Testing do not inhibit microbial growth, ensuring accurate sterility test results and preventing false negatives.

Performed after manufacturing and before sterilization, this testing determines the microbial load and helps assess the sterility assurance level the appropriate sterilization cycle parameters needed to obtain the required sterility assurance level.

Our testing follows ANSI/AAMI/ISO Guideline 11737-1, Sterilization of Medical Devices – Microbiological Methods, Part 1: Determination of a Population of Microorganisms on Products, and includes:

• Bioburden Validation Testing – Exhaustive Recovery Method
• Bioburden Validation Testing – Product Inoculation Method
• Bioburden Validation Testing – Bacteriostasis and Fungistasis Testing

BIs are used to monitor the effectiveness of sterilization and decontamination processes.

Our capabilities include:

• Population Reduction – Log Reduction Analysis
• Population Reduction – Positive/Negative (Go/No-Go)
• Direct Transfer – Strips, carriers, and ampoules
• Population Verification

Aseptic media fill studies are essential for validating aseptic manufacturing processes, and requirements can vary across global markets. Gillson Sciences tests aseptic media fill samples in accordance with a range of compendial guidelines, providing sterility confirmation and growth promotion testing to ensure your processes meet regulatory standards.

U.S. Pharmacopeia standards require documented proof that facility disinfectants are effective. This includes demonstrating that cleaning agents work on the hard surfaces within your facility and against resident microorganisms. Gillson Sciences provides microbial cleaning validation services to help you meet these stringent regulatory requirements with confidence.

Microbial content testing, also known as microbial limit or bioburden testing,evaluates cosmetic products for microbial contamination. Preparatory testing is performed to ensure results are valid and reliable. Testing for drug products and raw materials follows USP <61> and USP <62>, while medical devices are assessed according to AAMI bioburden testing guidelines. Sterile drug products are tested per USP <71>.

We perform:

• CTFA M1 – Quantitative testing to determine total microbial plate count
• CTFA M2 – Qualitative testing for specified organisms, with evaluation of any recovered organisms for potential safety or product stability concerns.

Accurate microbial identification is crucial for controlling contamination, ensuring product quality, and meeting regulatory compliance requirements. Gillson Sciences offers advanced techniques to meet a wide range of testing needs.

MALDI-TOF Mass Spectrometry – state-of-the-art technology that analyzes the unique protein “fingerprints” of microorganisms, providing highly accurate species-level identifications within minutes. This rapid, reliable method supports GMP, ISO, and FDA-regulated environments.
Benefits: Same-day turnaround, industry-leading accuracy, cost savings over biochemical assays.

Applications:

• Environmental monitoring isolates, raw materials and in-process testing, sterility investigations, product release testing, contamination events.

Also known as microbial content or bioburden testing, microbial limit testing evaluates non-sterile pharmaceutical products, nutritional supplements, and dietary supplements for microbial content. Sterile products are tested separately under USP <71> Sterility Test guidelines.

Preparatory testing is performed to ensure the accuracy and reliability of results.
USP <61> and USP <2021> – Quantitative tests to determine total aerobic microbial count and total combined yeast/mold count.
USP <62> and USP <2022> – Qualitative tests for specified organisms that may be present. Any organisms recovered should be assessed for potential impact on user safety and product stability.
Clients may refer to USP <1111> or USP <2023> for guidance in selecting the appropriate tests for their product.

We prepare and store USP reference microorganisms and facility-resident flora for use in required manufacturing studies. Our capabilities include producing frozen microbial cultures to support drug product testing and validation.

Tests include:

• Water Systems
• Environmental Monitoring
• Autoclave Qualifications & Biological Indicator Analysis
• Aseptic Media Fill
• Cleaning Validation/Verification
• Calibration Services
• Qualification Services

Sterility testing is performed on substances, preparations, or articles that must be sterile.

Common methods include:

• Direct Transfer – Product immersion or direct inoculation
• Flush Method
• Filtration (preferred method)
• Bacteriostasis and Fungistasis (B&F Testing)

Water is a critical raw material and ingredient in product manufacturing, used in both processing and formulation.

Gillson Sciences offers water testing services in compliance with USP, EUPh, CTFA, and JP requirements, including:

• Total Organic Carbon Testing (TOC) – USP <643>, JP, EUPh
• Bacterial Endotoxin Testing (BET) – USP <85>
• Hemodialysis Water Testing
• Heterotrophic Plate Count
• Screening for Fluorescent Pseudomonas Group and Coliforms
• Nitrate Testing – EUPh
• Conductivity – USP <645> Stage I, II, III
• Resistivity
• pH
• Recovery Efficiency Testing is performed on the first microbial sample.

Water testing supplies are available from Gillson Sciences.