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 clean rooms and production locations
- LAL endotoxine testing
- Challenge testing
- Anti-bacterial testing
- Microbiological testing according Ph. Eur.
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Facility & process validation
Packaging validation
Validation studies
Sterility testing
Product validation & lot release
Microbiological analysis
Passion for excellence
Quality excellence on microbiological validations and related microbiological services.
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.
Exceed Customer Expectations
Providing exceptional value and incomparable service to our customers.
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.
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