validation starts with chemical compatibility
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Chemical compatibility testis used to evaluate the chemical impact of the medium to be filtered on the filtration device under specific process conditions to avoid potential filter damage or alteration and to avoid contamination of the feed liquid by leachables or particulates.in a broad sense., on the one hand, we should consider the influence of the filter medium on the performance of the filter, on the other hand, we should also consider whether the filter will pollute the product, such as extract, particulate matter, etc. Extracts are usually examined and identified in the "Extractable & Extract Evaluation and Validation,pharmaceutical process generally examines the effect of the filter medium on the performance of the filter., or "chemical compatibility" as discussed herein ".
Because there may be many chemical interactions between the filter device components and the medium to be filtered, the filter manufacturer providesGeneral Chemical Compatibility Datacan often be used as a basis and basis for further testing. The filter user shouldComplementary research based on process. Common chemical compatibility tests may include integrity, tensile strength, NVR, extractables, particulate matter, flow rate, optical or scanning electron microscopy (SEM), burst pressure, and film/O-ring thickness. It is recommended to use multiple methods to combine tests, because a single test may not detect subtle incompatibilities.
but at the same time, it should also be noted that,many of the items in the above test methods do not have acceptable standards that have been verified, compatibility testing is usually only used as a basic auxiliary judgment for verification items., whether the filter is suitable for specific product and process conditions should also be evaluated and confirmed in combination with other verification items.
it is worth noting that,filter membrane itself does not represent the integrity of the filter., the seams between the filter membranes and the welding and sealing parts of the filter membrane and the hardware connection also affect the integrity of the filter; at the same time, other parts of the filter, such as the support layer, the housing and the O-ring, may also have compatibility problems with the to-be-filtered medium. ThereforeUsually the chemical compatibility test should cover the entire filter unit, not just the filter membrane..
In addition, in orderSufficient response worst condition, the parameter setting of compatibility verification should be in principle.above process temperature,time longer than contact time(the contact time contains the actual filtering time and possible commissioning time).
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