MICROBIOLOGICAL

Microbiological testing for assessing the microbiological characteristics of finished devices, manufacturing process and manufacturing environment can help eliminate or minimize the risk of microbial contamination, hence the risk of infection to patients, users or third parties.

STC offers a comprehensive scope of microbiological test to assist medical device manufacturers in meeting the microbiological and sterilization safety requirements for regulatory approval.

Testing Capabilities

  • Bioburden test
  • Endotoxin determination
  • Sterility test
  • Package integrity test
  • Shelf life / Life cycle validation
  • Microbial identification
  • Compendial testing
  • Antimicrobial challenge
  • Cleaning validation
  • Customized microbial assessments
  • Microbiological limits test
  • Water sampling and testing for Sterility and Microbiological safety