For biocidal and chemicals companies, today’s environment is defined by a critical tension: accelerating innovation while navigating increasingly stringent regulatory expectations, data scrutiny, and global compliance demands.
The challenge is no longer just generating data - it is generating trusted, regulatory‑ready evidence that stands up to the highest standards, across markets, without slowing your path forward.
At Eurofins BioPharma Product Testing, we operate at the intersection of science, regulation, and strategy - transforming complexity into clarity.
With more than 40 years of expertise in cGMP and GLP environments, we deliver data that is not only compliant, but decision‑enabling.
Our operations, accredited under GLP, GMP, ISO, and VAH, and aligned with CEN, ISO, ASTM, and OECD standards, ensure global acceptance and uncompromising integrity.
From our European center of excellence - 16,000+ sqm of advanced laboratory capacity powered by over 500 specialists - we support projects of any scale with precision, agility, and consistency.
We partner with our clients to not only meet requirements, but to anticipate them - turning regulatory complexity into a source of confidence and competitive advantage.
Because today, certainty is not operational. It is strategic.
Complex formulations, evolving regulations, and increasing scrutiny on data quality make biocidal development more demanding than ever.
The challenge is clear: generate precise, regulatory‑ready data without slowing progress.
At Eurofins BPT, we deliver targeted analytical expertise, combining robust methods, trusted data, and clear scientific guidance to de‑risk development and strengthen submissions.
Fully aligned with your formulation and regulatory pathway, we ensure the right insight, exactly when it matters.
Analytical Method Services
Product Testing & Quality Control
Stability Studies
Safety & Compliance Testing
Regulatory Support
Demonstrating the true efficacy of biocidal products means navigating complex microbiological requirements, evolving global standards, and increasing scrutiny on performance claims.
The challenge is not only to test - but to generate robust, defensible data that validates real‑world effectiveness and withstands regulatory review.
At Eurofins BPT, we combine deep microbiological expertise with internationally aligned methodologies to deliver clear, reliable results that strengthen your claims and support approvals across Europe and the U.S.
Working as an extension of your team, we provide the insight and precision you need - exactly when it matters.
Microbiology & Disinfectant Validation
Efficacy Testing
Application‑Specific Efficacy Testing
Preservative Effectiveness
Assessing environmental impact today means navigating evolving regulations, diverse global requirements, and increasing scrutiny on sustainability and safety.
The challenge is to generate reliable, regulatory‑accepted data that clearly demonstrates environmental compliance without delaying market access.
At Eurofins BPT, we deliver high‑quality ecotoxicological insight to support confident decision‑making - combining scientific rigor with full alignment to OECD, ISO, and UBA standards.
Our studies provide the robustness, relevance, and global acceptance required to validate your product’s environmental profile and support approvals across markets.
Aquatic Toxicity Testing
Biodegradability Testing
Specialised & Application‑Specific Testing
Eurofins BioPharma Product Testing network of laboratories offers a broad spectrum genetic and alternative toxicology models to evaluate the safety of substances chemical mixtures as required by international regulations such as REACH Regulations (1907/2006) and CLP (1272/2008) and according to the EU Biocides Regulation No. 528/2012.
With more than 30 years of experience and state-of-the-art equipment, we deliver project specific solutions in the fields of genetic and alternative toxicology. As a leader in safety testing, Eurofins BioPharma Product Testing is committed to the advancement of animal welfare and concern for animals as a core aspect of corporate social responsibility. We also offer several methods to replace the use of in vivo methods to evaluate eye irritancy, local tolerance, performance testing and others.
Our toxicology offering includes:
Sterile filtration of drug products is one of the common methods of (cold) sterilisation considered in biopharmaceutical industries worldwide for heat sensitive formulations. It is a critical step in ensuring product sterility and drug safety for patients.
Filter qualification and filtration process validations are essential in order to meet safety and regulatory requirements for sterile drugs. Due to the rising demand for biological products, the importance of new filtration systems is increasing, from large apparatus to small single-use filters. Further, the current difficulties in the global supply chain are triggering new opportunities for membranes and filter cartridges from local manufacturers. As a consequence, the need for process-specific up-to-date procedures to properly qualify new filters is becoming more and more critical.
The guidelines currently available, such as PDA TR 26 “Sterilising Filtration of Liquids”, establish high-level requirements and do not specify test protocols, which are left to the manufacturers’ and testing laboratories’ knowledge and experience. Worst-case conditions with respect to product characteristics and process parameters need to be assessed for each filter validation test. The experimental design should be evaluated and justified on a case-by-case basis, depending on the type of filter membrane, product features, and process conditions. Failing can lead to costly delays in getting your product to market.
Successful filter validation requires a partner with experience in properly evaluating and documenting each element of filter validation.
Whether you are in early-stage development or looking for a partner to take your sterile product into GMP manufacturing, let our expertise help you succeed.
Our services include:
Our filter validation testing services provide documented evidence of the functionality of the filter, under the same conditions in which it will be used during the pharmaceutical manufacturing process.
Our multidisciplinary approach and state-of-the-art laboratories, as well as the close collaboration with filter manufacturers, provides the necessary expertise and robust testing solutions required by the evolution of new products and filtration processes, along with the robust expectations from the regulatory agencies.
Your reliable testing partner