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Zhongyue Industrial (Shanghai) Co., Ltd. has built a laboratory for filter element verification, which can provide comprehensive testing and verification services for pharmaceutical, food, beverage and filter manufacturers, as well as accurate filtration scheme and documents conforming to regulatory requirements.
The specific verification contents are as follows:
Validation project | Verification scheme 1 | Verification scheme 3 |
1 batch of product and 1 batch of filter | 1 batch of products and 3 batches of filters | |
Bacterial viability | √ | √ |
Integrity of product wetting | √ | √√√ |
Bacterial challenge experiment | √ | √√√ |
chemical compatibility | √ | √ |
Dissolved matter | √ | √√ |
Precipitation and adsorbate experiment | assessment | assessment |
Note: √ indicates that the number of validation items is selected according to the drug production management standard (revised in 2010)
Filter performance verification service items:
1. Viability of bacteria
To confirm the survival of challenge microorganisms in the drug under process conditions, so as to determine the reasonable bacterial challenge method. It includes non bactericidal products, neutral bactericidal products and bactericidal products.
2. Product wetting integrity
Determine the forward flow, pressure holding test and bubble point test values of a specific product after wetting at a specified temperature.
3. Bacterial challenge test
According to the standard of ASTM f838, the membrane or filter was challenged with the bacterial liquid with an effective filtration area of not less than 107 CFU / cm2 to verify the microbial retention capacity of the membrane or filter under specific conditions. Different kinds of bacteria were selected for different pore sizes to challenge.
4. Chemical compatibility
Under specific process conditions, the changes of appearance and physical properties, bubble point and diffusion flow of the filter were tested to verify the cross change between filter and process fluid.
5. Dissolved matter
The dissolved matter, extract or extract is directly expressed as the quantitative and qualitative analysis of "nonvolatile residue (NVR)".
