About the product
IRT supports its partners in the medical device industry with a broad range of services.
Image result for medical device testing labs in indiaWe perform hygienic qualification of production facilities, microbiological tests on products before and after sterilisation, and screen for possible residual contaminants from the sterilisation process (endotoxins, ethylene oxide). We can also conduct studies for migration of substances from packaging material (leachables).
Our Medical Device Testing Services include:
Determination of bioburden before sterilisation
Sterility testing according to USP and EP of products and biological indicators
Method development and validation
Package expiration dating studies
Endotoxin testing
Gel clot, kinetic, and chromogenic
Residual ethylene oxide testing according to EN ISO 10993-7
Environmental monitoring of production zones
Viable and nonviable particulate analysis
RODAC and swab analysis of surfaces
Cytotoxicity bioassay
Polymer identification
FTIR, TGA, DSC
Container Closure Permeation
Dye and microbial ingress studies
Test for leachable substances according to EN ISO 10993-173
Contact SGS today to learn how we can help with quality control testing for your medical devices.
Email us: [email protected]
Image result for medical device testing labs in indiaWe perform hygienic qualification of production facilities, microbiological tests on products before and after sterilisation, and screen for possible residual contaminants from the sterilisation process (endotoxins, ethylene oxide). We can also conduct studies for migration of substances from packaging material (leachables).
Our Medical Device Testing Services include:
Determination of bioburden before sterilisation
Sterility testing according to USP and EP of products and biological indicators
Method development and validation
Package expiration dating studies
Endotoxin testing
Gel clot, kinetic, and chromogenic
Residual ethylene oxide testing according to EN ISO 10993-7
Environmental monitoring of production zones
Viable and nonviable particulate analysis
RODAC and swab analysis of surfaces
Cytotoxicity bioassay
Polymer identification
FTIR, TGA, DSC
Container Closure Permeation
Dye and microbial ingress studies
Test for leachable substances according to EN ISO 10993-173
Contact SGS today to learn how we can help with quality control testing for your medical devices.
Email us: [email protected]
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