industrie dispositif médical ACM Pharma

Bioburden

Development, validation, transfer, method applicability and microbial load control of medical devices intended to be sterilized.

Tailor-made support

ACM Pharma adapts to each need

This test is selected for determining a quantitative estimation of the number of viable microorganisms (aerobic / anaerobic) associated with medical products, raw materials or tissue samples. Suitability of the processing methods should be validated. Bioburden testing is typically conducted to help select a material for a device or to help establish a sterilization method.  This tests are carried out according to standard NF EN ISO 11737-1 with development of the germ recovery method, characterization of the microbial load (aerobic and anaerobic), evaluation of the inhibitory effect and physical stress.

Business process

Our approach

1

People above all

A team of engineers and pharmacists specializing in microbiology.

2

Material and methods

Latest generation equipment and our proactivity in integrating rapid / alternative methods and disruptive innovation technologies.

3

Web portal

A customer portal for monitoring tests and analyzing trends.

approche ACM Pharma

Listening to you, we identify your needs and implement our expertise for a tailored, efficient and tailored service.

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