Microbiology

Eurofins CRL Research Labs is a leading microbiology testing lab serving the cosmetic, personal care, and pharmaceutical industries. Our GCP-compliant facilities and FDA-recognised expertise make sure your products meet global standards of safety, quality, and compliance.

We support R&D scientists, product formulators, and quality teams with reliable data, from validating new preservative systems to running antimicrobial efficacy tests for NDA submissions.

1.GCP-Compliant Topical Antimicrobial Expertise

Our specialised lab in Texas focuses on the topical antimicrobial market. We deliver the antimicrobial effectiveness test and cosmetic microbiological tests required for OTC and pharmaceutical products. All testing follows GCP standards, giving you trusted results for regulatory submissions.

2.Global Regulatory Partnership

We act as your regulatory partner, guiding you through FDA requirements (including MoCRA), Health Canada, and the European Commission. With services like preservative efficacy testing and USP for preservative efficacy compliance, we help you achieve faster approval and global market access.

3.Comprehensive QC Solutions

We provide a full suite of quality control services at every stage of your product’s lifecycle. From preservative efficacy testing and raw material checks to final batch release, our solutions ensure product safety, stability, and consistency.

4.Custom Method Development

Our scientific team develops and validates custom testing methods for unique formulations. Whether you need specialised Preservative Efficacy Testing, antimicrobial efficacy test protocols, or advanced antimicrobial effectiveness test data, we design methods that deliver accurate, reliable results.

Understanding Microbiological Testing: Why It's Essential for Your Product

Microbiological testing is the scientific analysis of raw materials, in-process samples, and finished products for the presence and quantity of microorganisms such as bacteria, yeast, and mould. For the cosmetic, personal care, and pharmaceutical sectors, this testing is not merely a quality control measure; it is a fundamental requirement for commercial success and consumer safety. A robust microbiological testing program is built on four essential pillars that directly impact your product's viability in the market.

1. Ensuring Consumer Safety

The main goal of cosmetic microbiological testing is to keep consumers safe. Harmful microbes such as Staphylococcus aureus, Pseudomonas aeruginosa, or Escherichia coli can cause skin infections, allergic reactions, and serious health problems. Under FDA rules, any product contaminated with these organisms is considered adulterated. Rigorous antimicrobial efficacy tests confirm that your product is free from dangerous microbes before it reaches the market.

2. Guaranteeing Product Stability & Shelf-Life

Uncontrolled microbial growth can spoil products, changing their colour, smell, and texture, and breaking down active ingredients. This makes products ineffective and unsafe. Preservative Efficacy Testing (PET), also called a preservative challenge test, proves that your preservative system protects the formula throughout its shelf-life and use period. Following the USP for preservative efficacy standards helps prevent costly product recalls while ensuring long-term stability.

3. Substantiating Marketing Claims

In today’s competitive market, strong claims need solid proof. Studies like antimicrobial effectiveness tests and Time-Kill studies provide quantitative data to support statements such as “kills 99.9% of germs in 15 seconds.” This kind of evidence not only builds consumer trust but also sets your product apart from competitors.

4. Achieving Global Regulatory Compliance

Microbiological testing is essential for regulatory approval worldwide. In the European Union, for example, preservative efficacy testing results are required in the Cosmetic Product Safety Report (CPSR) under Regulation (EC) No 1223/2009. In the United States, the Modernisation of Cosmetics Regulation Act (MoCRA) requires compliance with Good Manufacturing Practices (GMP), where cosmetic microbiological testing and quality control are critical. Meeting these standards ensures smoother access to global markets.

A Full Spectrum of Microbiology Testing Services

Eurofins CRL provides a comprehensive portfolio of microbiology testing services, from foundational quality control assays to highly specialised efficacy studies. Our capabilities are structured to support your product from initial formulation through to post-market surveillance, ensuring quality and compliance at every step.

Specialised Topical Antimicrobial Efficacy Testing

Our core area of specialisation lies in the efficacy testing of topical antimicrobial products. Operating from a dedicated, GCP-compliant facility, we provide the highest quality data to support regulatory submissions for over-the-counter (OTC) drugs and pharmaceutical products. Our services are designed to validate the effectiveness of healthcare personnel's hand washes, surgical scrubs, hand sanitisers, and other antiseptic formulations for global markets.

Learn More About Our Topical Antimicrobial Testing Services

Classical Microbiology for Quality Control & Batch Release

These foundational services are the bedrock of a robust Good Manufacturing Practice (GMP) quality program. We perform essential tests required for the routine quality control of cosmetic, personal care, and non-sterile pharmaceutical products. This includes preservative efficacy testing or antimicrobial effectiveness test (PET/AET) to ensure product stability, Microbial Limits Testing (MLT) to confirm batch quality before release, and Time-Kill studies to substantiate germicidal claims.

Explore Our Classical & QC Testing Capabilities

Tailored Microbiology Solutions for Your Industry

We understand that each industry faces unique microbiological challenges and regulatory landscapes. Our services are tailored to address the specific needs of the cosmetic, pharmaceutical, and OTC sectors, providing expert guidance and compliant testing solutions.

Cosmetic & Personal Care Testing

The cosmetic industry is currently navigating the "clean beauty" movement, which presents a significant challenge for formulators: creating products that are both safe and align with consumer demand for "natural" ingredients and shorter ingredient lists. This trend often restricts the use of traditional, highly effective preservatives, making robust preservative efficacy tests more critical than ever.

We partner with formulators to validate alternative preservative systems, "hurdle technology" approaches, and multifunctional ingredients, ensuring products are effectively protected against microbial contamination while meeting market expectations.

Our expertise extends to ensuring compliance with key global regulations, including the FDA's Modernisation of Cosmetics Regulation Act (MoCRA), the EU's Regulation (EC) 1223/2009.

Pharmaceutical & OTC Microbiology

The pharmaceutical and OTC sectors operate under the most stringent regulatory requirements. Our services are performed in compliance with current Good Manufacturing Practices (GMP) to ensure the highest level of data integrity. We specialise in providing the critical data needed for regulatory submissions, including New Drug Applications (NDA).

Our expertise includes sterility assurance testing and the rigorous process of method validation, which is essential to demonstrate that a testing procedure is suitable for a specific product matrix, a fundamental requirement for regulatory bodies.

Global Regulatory Microbiology Requirements at a Glance

Navigating the complex and varied requirements of international markets is a primary challenge for brands seeking global distribution.

This table provides a high-level comparison of the microbiological safety frameworks in the United States, Canada, and the European Union, reinforcing our position as your expert partner for achieving multi-market compliance.

Quality Assurance & Validation: The Foundation of Reliable Data

In the highly regulated industries we serve, the quality and reliability of testing data are paramount. Our unwavering commitment to quality assurance is embedded in every aspect of our operations—covering our facilities, highly trained personnel, validated methodologies, and accurate reporting. This ensures that the data you receive is accurate, reproducible, and defensible before regulatory authorities.

Our laboratories are ISO 17025 accredited, meeting the global standard for the technical competence of testing and calibration laboratories. We strictly follow Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines, ensuring compliance for pharmaceutical, cosmetic, and OTC regulatory submissions.

A critical component of our quality system is the performance of method suitability testing (also known as the preparatory test). Before routine analysis begins, we validate that the test method is suitable for your specific product formulation. This is especially important for cosmetic microbiological tests, as many cosmetic and pharmaceutical ingredients have inherent antimicrobial properties. These can interfere with testing, potentially masking contaminants and leading to false negative results.

To address this, our suitability testing protocols are carefully designed to neutralise inhibitory effects, ensuring that any microorganisms present in your product are accurately recovered and enumerated. This validation step is required by regulatory authorities and is essential for generating reliable data.

Whether you need an antimicrobial efficacy test, antimicrobial effectiveness test, or preservative efficacy testing in alignment with USP for preservative efficacy, our expertise ensures your results are precise, compliant, and trusted across the industry.

We perform all tests in accordance with the latest versions of internationally recognised compendial methods. Our expertise spans a wide range of standards, demonstrating our comprehensive capability to meet diverse client and regulatory needs. These include methods from:

• United States Pharmacopoeia (USP)
• European Pharmacopoeia (EP)
• International Organization for Standardization (ISO)
• ASTM International
• AOAC International
• Personal Care Products Council (PCPC)

FAQs

What is microbiology testing, and why is it important?

Microbiology testing identifies and quantifies microorganisms (such as bacteria, yeast, and mould) in products to ensure safety, efficacy, and regulatory compliance. For cosmetics, personal care products, and pharmaceuticals, this microbiological testing is essential to prevent contamination, verify preservative effectiveness, and substantiate antimicrobial claims.

It helps protect consumers and maintain brand reputation by confirming the product's safety and effectiveness. This process is particularly critical for preservative efficacy testing to ensure the longevity and safety of the product throughout its shelf life.

What testing methods do you use?

We utilise a comprehensive range of standard methodologies from global standards bodies, including USP for preservative efficacy, ISO, ASTM, and European Norms (EN). Our services include specialised protocols such as ASTM E1174 for Healthcare Personnel Hand Wash, EN 1499/1500 for European compliance, and USP for preservative efficacy testing.

We also develop and validate custom methods to address specific product requirements and innovative formulations, ensuring that each product undergoes the correct microbiological testing for its target market.

How do I select the right microbiology test for my product?

The appropriate microbiological test depends on several factors, including your product type (e.g., cosmetic, OTC drug), its formulation (e.g., water-based, anhydrous), its intended use (e.g., topical, eye-area), your target markets (e.g., USA, EU), and any specific marketing claims you wish to make. For example, a hand sanitiser intended for sale in both the U.S. and Europe would require data from both ASTM E2755 and EN 1500 studies.

Our experts can provide a consultation to help you design a testing strategy that meets your specific product and business objectives, ensuring compliance with all regulatory requirements.

What regulations require microbiology testing?

Most major global regulations mandate microbiological quality and safety. The U.S. FDA's MoCRA requires adherence to Good Manufacturing Practices (GMP), which includes microbiological control. The European Union's Regulation (EC) 1223/2009 explicitly requires a cosmetic microbiological test as part of the mandatory Cosmetic Product Safety Report (CPSR).

Health Canada's Food and Drugs Act requires that cosmetics be manufactured under sanitary conditions to prevent contamination, ensuring preservative efficacy testing is done properly for market approval.

How do I interpret microbiology test results?

Test results are typically reported in terms of Colony-Forming Units per gram or millilitre (CFU/g or CFU/ml) or as a log reduction. For Microbial Limits Testing (USP), the CFU count is compared to established acceptance criteria for that product category. For Preservative Efficacy Testing (USP) or antimicrobial efficacy studies (ASTM E1174), results are often expressed as a log reduction, which represents the change in the microbial population on a logarithmic scale.

A 1-log reduction equals a 90% reduction, a 2-log reduction is a 99% reduction, and a 3-log reduction is a 99.9% reduction. These values are compared against the specific "pass/fail" criteria outlined in the relevant standard, ensuring accurate interpretation of the preservative efficacy and antimicrobial effectiveness of your product.

Partner with a Leader in Microbiology Testing

Ensure your product's safety, efficacy, and compliance. Contact our experts today to discuss your testing needs or request a quote. Our team is ready to provide the technical guidance and reliable data you need to bring your products to market with confidence.