RSSL's GMP compliant microbiology laboratory supports pharmaceutical, biopharmaceutical, medical device and biotech manufacturers with routine testing, method development and specialist consultancy at every stage of the product lifecycle.
Fully qualified to support batch release and regulatory submissions
Our services cover every product stage, from raw materials to finished product
+40 years' experience in Ph. Eur. United states & Japanese Pharmacopeias
All testing under one roof, reducing coordination complexity
Our scientists do more than generate data. They help you interpret & defend it.
Whether you need routine quality control, support with method development or help resolving an
unexpected microbiological challenge, our team can support you across the six key areas below.
We provide the batch release data you need to demonstrate compliance and support QP decisions.
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We verify your products meet regulatory acceptance criteria for microbial limits and specified organisms.
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We help you demonstrate that your manufacturing environment remains under microbiological control.
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Disinfectant efficacy & validation
We deliver the identification data you need for contamination trending, root cause analysis and corrective action.
We confirm your preservative system and disinfection regime remain effective throughout shelf life
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Online and in-person training to strengthen your team's understanding of microbiological control across pharmaceutical manufacture.
RSSL offers routine quality control for both sterile and non-sterile products, support with facility environmental monitoring programmes, microbial identification using biochemical and molecular methods and antimicrobial testing. Where standard pharmacopoeial methods require adaptation for your specific product matrix, we provide method development, validation and verification services to ensure your testing programme is fit for purpose.
We also provide consultancy and troubleshooting support, whether for continuous improvement of your contamination control strategy or in response to a specific incident such as an out-of-specification result or environmental excursion.
We test pharmaceutical products (sterile and non-sterile), biopharmaceuticals, medical devices, combination products, raw materials, excipients, and water systems. Our services support products across all routes of administration.
Our microbiology laboratory tests to European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP), and Japanese Pharmacopoeia (JP) requirements. Where your product is registered in multiple markets, we can advise on harmonised testing strategies.
Yes. Where standard compendial methods are not suitable for your specific product matrix (for example, products with inherent antimicrobial activity) we provide method development, validation, and verification to establish a testing approach that is both scientifically sound and regulatory defensible.
Yes. Our consultancy team supports out-of-specification investigations, environmental excursion root cause analysis, and contamination trending. We combine identification data with process understanding to help you identify the source and implement effective corrective actions.
