Extractable & leachable Certificate

Question

One of our customer from Pharma Industry is asking for- Extractable & leachable Certificate for spun Cartridge filters.
Anybody please elaborate about this. Also, do every filter mfg. possess this kind of certification?

Bill Goodwin · Accepted Answer

Sanjay, E&L testing and qualification is common in food- and drug-related industries, and is typically regulated by national agency (e.g. FDA in US, CDSCO in India (Central Drugs Standard Control Organization), perhaps European Medicines Agency in Europe.  Another potential resource is the ICH (International Council for Harmonization.)   If you are new to this, perhaps best to network a bit and find a 3rd-party laboratory in your area that performs this type of evaluation - and learn from there.  There are often many regulatory documents and guidelines to become familiar with, and as well, the specific application of your product from one customer to another may demand different levels of scrutiny and evaluation of risk concerns.   Hope that helps.

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