Extractable & leachable Certificate
Published on by sanjay k, CEO at Chirag Technoproducts And consultants in Business
Anybody please elaborate about this. Also, do every filter mfg. possess this kind of certification?
Taxonomy
- Pharmaceuticals Waste
- Filters
- Filtration Solutions
- Product Certification
- Pharmaceutical Chemicals
- Pharmaceuticals
- Water Filtration
- LEEDS Certification
- Certification
- Pharma Other
2 Answers
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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.
1 Comment
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Dear Bill Goodwin,
Thank you for your reply.
The Cartiridge Filters comes from Small mfg. Industry. They don`t go for any testing or certification. Even big players does not provide any such certificate. They provide self certified data sheet only after request.
On customer end the Audit person demands such certification which sometimes not feasible commercially.
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I use wound filters in cartridges for purifying water, they are made from plastic materials - the winding and the body. None of this material is compostable so is pure plastic waste or material for recycling - if such a process is available. Is this your situation?
The partial solution is to change for back washing perforated steel filters which will work down to 50 micron and take some load off your wound filters and give longer life.
1 Comment
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Dear gavin maclellan,
Thank you for your reply.
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