Contact Us: +606-7947 606

Email Us: info@sanichem.com.my

 
 

OUR SERVICES

Ethylene Oxide Residuals

Ethylene Oxide Residuals Analysis is to determine the amount of ethylene oxide (EtO), Ethylene Chlorohydrin (ECH) and Ethylene Glycol (EG) still remaining in the medical device which has undergone EO sterilization. The total amount of EtO and ECH present at the time of testing is compared with allowable limit as stated under ISO 10993-7 guideline. Sanichem is the only accredited laboratory which offer EtO residual analysis for medical devices in Malaysia.

Microbiology Tests for

Medical Devices

Microbiology testing of medical device include bioburden and sterility test.  Bioburden test is to determine the number of viable microorganism present in the product for routine QA/QC and sterilization dose determination. Sterility test is to verify that the products are sterile after undergoing sterilization process.  Sanichem assist medical devices manufacturers and contract sterilizers for their sterilization validation requirement.

Water Analysis

Water analyses are very important to ensure safe use of water and control of water pollution. Several regulatory standards have been drawn up and enforce by various authorities. Department of Environment regulate the release of industrial effluents and monitor raw water quality. Health department regulate the quality of drinking water consume by general public. Sanichem offer testing for compliance to these regulatory standards.

Other Tests

We also other analytical services including:

  • Biocompatibility testing 

  • Chemical and microbiological Environmental Monitoring

  • Food Chemistry, Food Microbiology and Food Quality testing

  • Training (Method Validation, Measurement Uncertainty, Internal Audit) 

 

 OUR CLIENTS