CPC opens additional cleanroom

CPC opened a new production facility and global headquarters in June 2020 in Roseville, Minn., to accommodate significant growth and the need for expanded manufacturing and office space. Product from the Roseville facility’s Class 7 cleanroom begins shipping October 21, 2020. The company continues to operate its existing cleanroom facility with shipments also moving through the Roseville facility.

Validation and ISO Certifications

CPC has completed rigorous quality validation processes and obtained new or updated relevant ISO certifications for the Roseville facility, its new cleanroom manufacturing space, and the company’s existing cleanroom operations. CPC continues with quality system certifications to ISO9001:2015 and ISO13485:2016. All new manufacturing equipment qualified in the new cleanroom went through CPC’s Installation Qualification (IQ ), Operational Qualification (OQ) and Performance Qualification (PQ) validation processes and the cleanroom has met the certification standards of ISO14644 and ISO14698.

Joint Audit Program for Single-use Systems – BPOG and Rx-360

CPC’s cleanroom operations in August were audited at biopharma single-use industry standards by Rx-360, an independent firm whose mission is to offer a joint-audit model to ease the burden and cost of customers conducting their own onsite audits. The protocol for this two-day audit was determined following a pilot project with BPOG (Biophorum Operations Group) that showed the success of using a joint-audit model in conjunction with biopharma single-use systems. Further, it accommodates the concerns and difficulties of suppliers, and customers and their auditors during the pandemic. CPC’s audit was sponsored by multiple customers.

CPC customers may license the report through Rx-360 and receive the full audit document package, including audit plan, auditor qualifications, final report, CAPA documentation (if applicable), and closure documentation.

Learn more about Rx-360.

Read the Rx-360 letter announcing its audit of CPC cleanroom operations and contact information for licensing the report.

With its validation processes confirmed and the audits complete, CPC has provided customers a final notice that it will begin shipping on October 21, 2020, products it has produced in the new cleanroom.


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