Independent microbiological laboratory

Micro-Serve laboratory is an independent ISO 13485 certified microbiological laboratory, focussed on tests of Medical Devices in relation to sterilization validation. Flexible and cost-effective service, serving clients from all over the world.

Micro-Serve microbiological laboratory has many years of experience in the field of (gamma-)sterilization and microbiological testing of Medical Devices.

We offer a high level of knowledge of the applicable standards like ISO 11137, ISO 11737 and TIR 33. Our deep knowledge and process flexibility makes us your right partner concerning a validation protocol, perform laboratory tests and reporting all results.

The business concept of Micro-Serve laboratory is to supply a total range of microbiological tests, validations and related services. Our services are specifically for the CE-mark sterile medical devices, designed to specific client requirements and meet the respective ISO standards.

Validation studies according to ISO 11137 a. Method 1 b. Method 2 c. Method VDmax25 d. Method VDmax15 e. Method TIR 33
Routine tests Routine Bioburden testing Routine Sterility testing
Accelerated aging and real time aging studies
Monitoring of cleanrooms and production locations
LAL endotoxine testing
Challenge testing
Anti-bacterial testing
Microbiological testing according Ph. Eur.

Micro-Serve Laboratory ISO 13485:2003 certificate

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Facility & process validation

Packaging validation

Validation studies

Sterility testing

Product validation & lot release

Microbiological analysis

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Passion for excellence

Quality excellence on microbiological validations and related microbiological services.

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Knowledge

Professional Quality Lab Services with a high level of knowledge of the applicable standards like ISO 13485, ISO 11137, ISO 11737 and TIR 33.

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Exceed Customer Expectations

Providing exceptional value and incomparable service to our customers.

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Commitment

Creating solid and enduring relationships with our customers through our continuous commitment to meet and exceed their expectations.

Communication

We communicate information in a constructive, timely and clear manner.

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Integrity and ethics

We adhere to the highest standards of integrity in our relationships with customers and suppliers.

If you have any questions about our services please feel free to contact us