The new room extenuates the security and accountability of the SEFAR PHARMA-Grade product line that includes fluid bed dryer bags, centrifuge liners, and nutsche filters.
The room adheres to Sefar’s cGMP guidelines for pharmaceutical fabrication, consistent with their two Class 10,000 cleanrooms ISO 7 (ISO 14644-1) that create parts used in medical applications.
The white room procedures follow ISO 8 (ISO 14644-1) standards.
All equipment is sanitized before each production run. The new room is equipped with sewing machines, used to fabricate products.
Sefar market manager Mike Branson told the Pharmaceutical Online that the company can control the quality level at all steps within the manufacturing product.