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GMP Authentication Service for Cartridges-Dong guan kinda Filtration Equipment CO.,Ltd
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GMP Authentication Service for Cartridges
Kinda fully understands requirements and items that need to be confirmed and verified for sterilization filters in particular processing conditions specified in the new version of GMP and develops verification solutions to non-terminally sterilized products and terminally sterilized products which take the GMP guidelines, filter performance, and production processing conditions into consideration, with a purpose of getting approval from GMP experts with respect to the compatibility of the filters.
 
GMP Authentication Service for Cartridges
 
Bacterial viability test

Many drugs have antibacterial capability. This test is used to confirm viability of pseudomonas defects (ATCC 19146) in drug liquids which are under processing conditions, in order to select a proper cleaning solution and determine a bacterial challenge solution.
 
Integrity test
This test is performed in specified conditions to measure forward flow, pressure holding capability, or bubble point limit of filters that are wetted by fluids through specific processes, in order to check whether the integrity of the filters meets related indexes.
 
Chemical compatibility evaluation
Check appearance, physical properties, bubble point, and diffusion flow of filters for change before and after fluids experience specific processing, so as to check the cross reaction between the filters and the fluids.
 
Bacterial challenge research
Select pseudomonas defects and simulate specific processing conditions that are created based on the ASTM F-838 standards to check whether filters’ (3 batches) bacterial interception feature satisfies concentration requirement of 1×10 challenge level per cm2effective filter area, and whether the log reduction value of microorganisms is 7 at least.
 
Solute analysis and detection
Test the chemical substances of filters that are transferred to products while the filters are put in harsh conditions. Generally, solutes cannot be directly detected from the products. We use "simulation solvent" to perform qualitative and quantitative analysis and measurement.
 
Adsorbent and precipitate evaluation
Test impact of filters on quality of products that have undergone specific processing conditions, so as to select proper filters and determine proper processing, minimizing product adsorption and loss.
 
Verification test on filters after repeated use
Test the filters that have passed integrity test and experience repeated use for their bacterial interception feature.




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