Lenge Purification Equipment Co., Ltd. and Jiangnan University established the Institute of materials and technology, and the graduate-student workstation. With advanced imported test equipment, standard test procedures and testing proposals, we can provide customers with various test and validation services, such as chemical compatibility, extractables, adsorption, bacterial challenge, bacterial viability, integrity, recycle use, etc.
For different customers, we simulate the produce process under the most disadvantage conditions, and make qualitative and quantitative estimation of dissolution by imported infrared spectrometer, ultraviolet spectrophotometer, HPLC and other equipment, thus make the quantitative analysis of the product absorbed on the membrane.
Sterilized filter should be discarded after each batch use. However, if you want to reuse it in the next batch, then you need to verify the maximum batches it could be re-used.
Principle and method selection
Verification is necessary when reuse liquid sterilizing grade filter to produce medicine. It include but not limited to: repeated technology and methods, simulating actual reuse under the worst condition to get the validation parameters, which include repeat sterilization, flux, pressure differences and thus doing the integrity test base on the parameters.