Technical Services

Technical Services

Serial number Project Standard
Medical Device Performance Testing
1 Testing of physical properties such as rigidity, toughness, strength, puncture resistance, flow rate, and tensile strength. GB/T18457-2015
2 Chemical testing for pH, heavy metals, and other parameters GB/T14233.1-2008
3 Ethylene Oxide Residue Testing GB/T 16886.7-2015
4 Sterility testing 2020 Edition of the Chinese Pharmacopoeia
5 Bacterial Endotoxin Test GB/T 14233.2-2005, Chinese Pharmacopoeia, 2020 Edition
Cleanroom Testing
1 Suspended particles GB/T 16292-2010, GB/T 25915.1-2010
2 Settling bacteria GB/T 16294-2010
3 Air change rate GB/T 25915.3-2010
4 Static pressure difference GB/T 25915.3-2010
5 Temperature GB/T 25915.3-2010; GB/T 25915.3-2010
6 Relative humidity GB/T 25915.3-2010; GB/T 25915.3-2010
Process Water Testing
1 pH, nitrite, ammonia, electrical conductivity, oxidizable substances, non-volatile matter, heavy metals 2020 Edition of the Chinese Pharmacopoeia
2 Microbial Limit Tests and Bacterial Endotoxin Assays 2020 Edition of the Chinese Pharmacopoeia