Medical Device

Pharmaceutic Testing

Medical Device – Testing

Your products contribute to save life every day and we want to help you in that mission. Producing safe products is a core goal in medical device industry and quality assurance is a key component in achieving that goal. Because of the important role of your products, the medical device industry is heavily regulated. Regulatory bodies requires that the manufacturing and sterilization process be validated and these validations typically require laboratory analysis. As part of Natec group of companies, we are particularly involved in your field of activity and who better than us can understand your challenges. We stand behind the quality of our results and the strength of our customer partnerships.

Standards and regulations covering this fields of activity

The use of appropriate controlled manufacturing processes that establish a consistent product bio-burden prior to the sterilization process (e.g., use of clean rooms and/or controlled environments)
Validation and control of the primary packaging process to assure the integrity of the sterile pack
The validation and control of the sterilization process.

We perform hygenic qualification of production facilities, microbiological tests on products before and after sterilization. Our Medical Device/ Pharmaceutical Testing Services include:

Determination of bioburden before sterilization
Sterility testing according to USP and EP of products and biological indicators
Method development and validation
Endotoxin testing
Environmental monitoring of production zones
Package expiration dating studies (aging studies)Container Closure Permeation
-Viable and nonviable particulate analysis -Contact plate and swab analysis of surfaces
Dye and microbial ingress studies