What Is Pharmaceutical Testing?
Pharmaceutical microbiology testing evaluates the microbiological quality of pharmaceutical ingredients, formulations and finished products. It helps identify microbial contamination, assess product quality and support compliance with applicable specifications and regulatory requirements.
Testing can be performed throughout the product lifecycle, from raw materials and manufacturing environments to finished products. Depending on the application, this may include microbial limits testing, sterility testing, bioburden testing, preservative efficacy testing and environmental monitoring.
These assessments help pharmaceutical manufacturers identify potential microbial risks, maintain quality throughout production and generate reliable data to support quality control and regulatory requirements.
Why Pharmaceutical Companies Choose Accugen
Accugen Laboratories is an FDA-registered lab that provides high-quality USP and cGMP-compliant microbiological testing for pharmaceutical manufacturers, drug product formulators and developers, and raw material suppliers. Our team is made up of qualified, experienced professionals who perform all tests in accordance with strict regulatory guidelines and laboratory conditions.
Tested and certified by experts
With decades of specialized experience and qualifications, our team of microbiologists ensures that every product receives the highest standard of testing.
Costs that make sense for your business
With a commitment to delivering world-class pharmaceutical testing, we ensure your products meet the highest standards at the best prices.
Accurate results, delivered on time
Our streamlined processes and rigorous methodology ensure your products are tested precisely, and your time-to-market is never compromised.
Pharmaceutical Testing Services
Accugen Laboratories offers pharmaceutical microbiology testing services that ensure product stability, regulatory compliance, and reliable manufacturing performance through precise laboratory analysis. These tests include:
USP 60 Microbiological Examination of Non-Sterile Products: Tests for Burkholderia cepacia Complex
Screens pharmaceutical water systems for Burkholderia cepacia complex (BCC), an objectionable organism known to survive and proliferate in low-nutrient aqueous environments.
USP 61 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests
Includes total aerobic microbial count (TAMC) and total combined yeast and mold count (TYMC).
USP 62 Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms
Detects the following microorganisms:
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Escherichia coli
- Bile-tolerant Gram-negative bacteria
- Clostridia species
- Salmonella species
- Candida albicans
USP 51- Antimicrobial Effectiveness Testing (AET) Or Antimicrobial Preservative Effectiveness Testing
This test is used to determine the presence of the following microorganisms:
- Escherichia Coli
- Staphylococcus Aureus
- Pseudomonas aeruginosa
- Candida albicans
- Nocardia brasiliensis
Sterility Test USP 71
These include:
- Direct inoculation
- Direct immersion
- Membrane filtration
LAL Bacterial Endotoxin Test
A test done to detect endotoxins and other pyrogens in drugs and medical devices.
Minimum Inhibitory Concentration Test (MIC/MLC)
The test determines the lowest concentration of an antibiotic or antimicrobial agent that prevents the growth of bacteria or fungi in vitro to help identify the most effective treatment.
Microbial Identification
This analysis is performed to detect and identify bacteria, yeast, fungus, and molds in pharmaceutical products.
Pharmaceutical Sectors We Support
✓ Biotechnology
✓ Innovative and Brand-Name Pharmaceuticals
✓ Generic Pharmaceuticals
✓ Active Pharmaceutical Ingredients (API)
How to Submit a Sample
Order a test kit
Collect your sample
Ship to the lab
Receive your results
What Our Clients Say
Accugen performs routine microbiological testing for our cosmetic and OTC products. They have a very friendly and attentive staff. All reports are sent to us in a timely manner. Very happy with their service and will continue to use them for the foreseeable future.
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I rate very highly of Accugen Laboratories Inc. and its personnel, who performs microbiological testing on our products. Very professional, knowledgeable, friendly and helpful. Their turnaround time exceeded our expectations. Stayed in contact before and after analysis. We will continue to use them for our testing.
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Highly professional, provide quality data and detailed reports. Great customer service. They really care about providing excellent services.Accugen is the best microbiology testing lab and we highly recommend it.