Microbiology laboratory
Accredited ISO 17025 microbiological and analytical testing to support pharmaceutical and medical device manufacturing, sterility assurance and product release.
Scientific expertise. Geographic proximity. Digital convenience.
Our team of microbiologists provides specialist support throughout the device manufacturing quality control process – from selecting the right testing methods to guiding you through execution and results interpretation.
We take an individualized approach to every project, ensuring your specific product requirements are fully understood and supported.
Our online platform enables seamless access to test results, making your experience efficient, transparent, and easy to manage. By simplifying workflows and reducing administrative burden, we help you focus on what matters most: bringing safe and ISO 17025-compliant products to the market.
Closer labs, faster results
Located within Ensera’s European facility in Wrocław, Poland, our ISO 17025 accredited microbiology lab offers a clear logistical advantage for customers across Central Europe.
Berlin and Dresden are under three hours’ drive away, while strong transport links also provide efficient access from Czechia and Slovakia. This proximity enables faster sample transportation and more responsive project support, helping you keep your device production and release timelines on track.
Our testing services
Discover our comprehensive range of microbiological and analytical tests, designed to speed up and support your manufacturing controls, sterility assurance requirements and product release.
Bioburden
Any sterilization process can eliminate only a limited number of microorganisms, making it crucial to measure and characterize the viable microbes present on devices, materials, or packaging. We develop and execute bioburden methods specifically tailored to your needs. Our accredited bioburden testing supports dose calculations, monitors production, and provides detailed aerobic counts.
Sterility
Our accredited product sterility test verifies that a sterilized device has undergone an effective sterilization process during validation and routine release, including the use of biological indicators. To ensure accuracy and prevent contamination, our microbiologists perform all testing within ISO‑classified cleanroom environments, including ISO 5 laminar flow cabinets inside an ISO 6 cleanroom under continuous particulate and microbial monitoring.
Bacterial endotoxins (LAL)
Endotoxins are toxins released from gram‑negative bacteria, and our accredited LAL test detects their presence. This ensures that medical devices, injectable products, water systems, and materials are free from harmful endotoxins, confirming whether a product or substance meets applicable requirements.
Microbial environmental monitoring of cleanrooms
Microbial environmental monitoring provides valuable data on the microbiological quality of cleanrooms and controlled environments. The results of our accredited test determine the level of microbiological purity of the air, buildings, equipment, surfaces, clothes, and personnel which define sampling points and the frequency of checks.
Water
This accredited test analyses the water which plays a role in cleaning equipment and components during medical device and pharmaceutical production. Because water quality directly impacts the manufacturing process, maintaining strict microbiological control is essential.
Subvisible particle testing
The latest addition to our accredited testing methods scope, subvisible particle analytical testing helps detect and quantify particles that are too small to be seen with the naked eye but may still affect product quality and patient safety. This method is particularly relevant for parenteral products, where control of particulate contamination is a critical quality requirement.
Microbial identification
We can detect and provide basic identification of bacteria or fungi by using selective agar and controlled incubation conditions, followed by microscopy and staining tests on any colonies that grow. When needed, advanced identification can be outsourced using MALDI‑TOF.
Get in touch about our testing services
We’re always happy to hear about your specific testing and analysis requirements. From routine tests to more complex investigations, our dedicated laboratory team will work closely will you to find the right microbiological or analytical testing approach for your medical device or pharmaceutical program.
With a deep understanding of regulatory expectations and real-world applications, our priority is to delivery reliable, fast and robust results.
