As a leader in worldwide quality assurance, Silliker understands the rigor and challenges of quality in the highly regulated manufacturing environments of the pharmaceutical, complimentary medicine and medical devices industries. To be successful in these industries where stringent codes of Good Manufacturing Practice (GMP), Regulations and Regulatory Audits drive strong commitments to quality, technical knowledge and scientific data is no small feat. As your partner in quality, Silliker can help you choose the right solutions. With our accredited labs and experienced experts on your side, you can rest assured your product will always meet and exceed your consumers’ expectations
Medical Devices
Guidance papers for the medical device industry concerning sterilization validation, bioburden validation, testing and program maintenance and inclusion of new medical devices into existing sterilization processes can be obtained by request from Silliker Australia Sales.
Our services include:
Microbiological:
Cleanroom services:
Audits
Baseline studies
Cleaning validation
Monitoring
Process water testing
Product Testing:
Antiseptics and surgical scrubs - in vivo efficacy studies
Antiseptics, disinfectants and antimicrobial preparations – efficacy evaluation
Bacterial endotoxin testing (LAL) and test method validation
Bioburden determinations
Bioburden recovery validation
Microbial limits testing
Preservative efficacy testing (PET)
Raw materials and finished product testing to TGA, BP, USP, EP and Harmonised testing requirements;
Test for Sterility (Sterility Testing - compendial)
Test of Sterility (used in the validation of a sterilization process)
Chemical:
Cleaning validation testing
Ethylene oxide residues
Preservative level verification testing – by application
Finished product testing to TGA, BP, USP, EP and Harmonised testing requirements – by application
Sunscreen actives testing
Consulting:
Bioburden program set-up and maintenance
Cleanroom consultancy services:
Audits
Baseline studies
Cleaning validation
Cleaning validation
Preservative systems - development and evaluation
Product family and master device set-up and maintenance
Regulatory assistance – laboratory testing and sterility assurance
Staff training – targeted and specialized
Sterilisation process validation:
Electron beam
Ethylene oxide;
Gamma irradiation;
Heat
Test methods - development and validation
Troubleshooting
Contact Us to learn more about our Therapeutic and Medical Device Testing
