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These tips can help you reduce false failures and improve robustness and reliability
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
Bacterial endotoxin is the lipopolysaccharide component of the cell wall of Gram-negative bacteria
PUPSIT is required by regulation. The first regulatory prescription came from EMA in 1997 with the first version of Annex 1
The Need for Risk Assessment
Hydrophobic Filter Cartridge Integrity Testing
filtration systems are an essential part of the production process.
Serum Filtration – A challenge – SFS provides solution:
General Information
Facing the Challenges of Drug Product Manufacturing”
Even people in early civilizations filtered liquids, usually by using woven materials like cloth to strain water