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Sterile API

Aseptic API is the basis and source of pharmaceutical preparation enterprises, and the quality assurance level of its production is directly related to drug safety. The chemical compatibility of the filter element is strictly required by the material and liquid filtration in the production process and most of the solvents involved, especially the corrosive solvent filtration. INFINI combined with its laboratory process verification services to provide pharmaceutical companies with filtration products that meet the predetermined process standards and quality characteristics.


China is a major producer of API. In each link of the pharmaceutical industry chain, China plays a role in the processing and manufacturing of basic pharmaceutical raw materials, including fermentation, chemical synthesis, and animal and plant extraction. The filtration process provides a guarantee that the process operating within the predetermined parameters can continuously and effectively produce drugs that meet the predetermined specifications and quality standards.
Take semisubstance (semi-chemically synthesized antibiotics) as an example
Fermentation is also one of the important methods for the production of API. In particular, antibiotics API, such as penicillin and cephalosporin, are usually obtained by semi-synthesis combining fermentation with chemical synthesis.
Main filter points and applications:
1. Filter/material of main solvent: acetone, ethyl acetate, ethanol, triethylamine. Recommended for final filter: stainless steel shell +PTFE 0.22 m filter element. Prefilter/stainless steel housing +PTFE or PP material with different precision as required.
2, cefoic acid and cefosalt filtration/main materials: cefoic acid, cefosalt, final filter recommended: according to the needs of pre-filter/stainless steel shell +PTFE or PP material with different precision
3. Inorganic salt filter/Main materials: sodium acetate, sodium iso-octanoate, final filter recommended: stainless steel shell +PTFE0.22 m or PES0.22 m filter core.
4, activated carbon decolorization/main materials: inorganic salt, cefoic acid. Filter remove activated carbon, filter recommended: titanium rod, deep filter reactor.
5. Respirator filter (respirator) : Recommended configuration: stainless steel housing +PTFE0.22 m filter element
6. Gas filtration: nitrogen, compressed air, stainless steel shell +PTFE0.22 m filter element is recommended; Choose to fold 1-3 microns with or without stainless steel case +PP depending on the specific situation.

Note: For detailed technical solutions, please contact your sales engineer.

Process examples:

 

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