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is the filter you use clean?

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filters, filter supporting hardware, filter installation and process may bring to the product.particulate pollutionrisks, so these materials and processes should be evaluated and confirmed for particulate control.

Usually the supplier will flush the filter and sample the washing fluid to detect particles smaller than 10 microns and larger than 25 microns, and the test results should bemeets pharmacopoeia. These criteria should also be used to confirm that the filter meetsinfinite dimensional shedding.

 

 
 
 
 
 

In addition to particulate matter, the filter may also beOther Pollutants, such as endotoxins, organic carbon, or oxidizable substances. Potential sources may include surfactants, wetting agents, additives in the manufacture of plastic components, debris from the production process, and component materials.

on the filterpre-flushing can reduce levels of particulate matter and contaminants, and may be performed as part of the wetting process prior to integrity testing. But at the same time should also pay attentionpre-flushing, such as the exclusion of hedge lotion, can not affect the concentration of the product and other quality parameters; in the case of pre-flushing before use after sterilization, the discharge collection of flushing fluid should also be considered, and the sterility of downstream systems should not be affected.flushing method shall be verified. During normal operation, the flushing volume shall not be less than the verified minimum flushing volume.

 

 

if useddisposable filtration systemPre-flushing is required before use. The following factors shall be additionally considered in the design: pressure resistance of upstream connecting pipeline, downstream sterility, and sufficient space (such as installation of sterile barrier filter or sterile bag of corresponding volume) for exhaust and drainage.

 

 

 

 

 

 

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