Microbiological Testing

masthead-innerpage-graphics
Petri dish with yellow and green microbial growth

Microbiological Testing Services

Perritt Labs stands as a distinguished leader in the pharmaceutical industry, providing comprehensive microbiological testing services for non-sterile drugs. With decades of experience since our founding in 1973, our reputation for precision, reliability, scientific excellence, and quality is unmatched. We are a cGMP,  FDA-registered and inspected, and A2LA-accredited laboratory dedicated to upholding the highest standards of quality and regulatory compliance to meet your needs.

Overview of Microbiological Testing Services

Our microbiological testing services encompass a wide range of analyses as well as method development. Our goal is to help clients detect and identify microorganisms that have the potential to impact product quality and a user’s well-being. Our microbial testing is advantageous for preventing the spread of objectionable microorganisms, verifying a product’s shelf-life and stability, discovering sources of contamination, and protecting your brand’s reputation.

Our professionals deliver personalized service that fosters long-term client partnerships. When critical decisions hinge on accurate microbiological testing, know that Perritt Labs is here to help you.

industry-mobile industry-bg

Why Microbiological Testing Services Are Important for Safety and Protecting Consumers

In the non-sterile pharmaceutical, cosmetic, and healthcare product sectors, microbiological testing is a regulatory requirement. Contaminated products pose significant risks, but our rigorous microbial testing protocols are designed to detect potential microbial contamination, ensuring that every consumer product reaching the market is safe, stable, and meets the desired specifications.

Partnering with Perritt Labs demonstrates your commitment to consumer protection and mitigates the risk of product recalls, regulatory actions, and reputational damage. We help you navigate the complexities of FDA microbiological testing with confidence, providing data you can trust.

Contact Us

Products We Test

Perritt Labs offers specialized microbiological testing for non-sterile products across several industries:

  • Oral products: tablets, capsules, powders, syrups 
  • Topical products: creams, ointments, gels, lotions
  • Non-sterile liquids: suspensions, solutions for oral or topical use
  • Inhalation powders (not sterile, unlike many nebulizer solutions)

Skin care, hair care, makeup, and other personal care items.

Household and cleaning products that require microbial control.

Ensure premium quality regarding lotions, sanitizers, and related goods.

Types of Testing We Conduct

Our cGMP microbiological testing services are designed to meet global pharmacopeial and regulatory requirements. Explore your testing options available from Perritt Labs below:

  • Microbiological examination of non-sterile products and microbial limits:
    • USP <60>, <61>, <62>
    • Ph. Eur 2.6.12 and 2.6.13
    • JP 4.05 sections I and II
  • Antimicrobial/preservative effectiveness testing:
    • USP <51> antimicrobial effectiveness test
    • Ph. Eur. <5.1.3> efficacy of antimicrobial preservation
    • Japanese pharmacopoeia, JP <19> preservative effectiveness tests
  • Bioburden testing: This is critical for assessing microbial loads in raw materials, samples, and finished products.
  • Microbial content testing: Helps determine the level and identity of viable microorganisms present in a pharmaceutical drug substance or drug product or in-process materials.
  • DEA schedule I, II, III, IV, and V drugs: We provide specialized testing for controlled substances.
A microbiologist using a microscope for analysis and adjusting the focus

Environmental Monitoring Assistance

Perritt Labs provides expert assistance with environmental monitoring programs, including:

  • Water systems: Test for microbial quality in purified water and compendial waters.
  • Air: Benefit from airborne microbial and viable particulate monitoring.
  • Surfaces: Evaluate the cleanliness and effectiveness of disinfection processes.
  • Compressed air: Assess the air quality used in manufacturing processes.
  • Cleaning validation: Identify shortcomings in your cleaning and sanitization procedures.

Microbial Method Development

We specialize in method development and validation services, leveraging established compendial, ASTM and AOAC methodologies to ensure the accuracy, reliability, and regulatory acceptance of your testing protocols. Our skilled scientists develop testing solutions tailored to your unique product and regulatory landscape.

Contact Perritt Labs for Microbiological Testing Services

Elevate your product safety and regulatory compliance with Perritt Labs. Our commitment to scientific excellence, personalized service, and accuracy makes us the preferred choice of B2B decision-makers. We are ready to discuss your testing needs.

Contact Us
Focus on the speciment area of a microscope that has a round object on it that a scientist is about to apply some liquid to with a pipette full-width-cta-pattern-1