CPC Biopharma Change Notice: New Facility and Redundant Cleanroom Manufacturing Space

 

Description of Change

CPC is building a new facility in Roseville, Minn. This facility will contain a redundant ISO Class 7 manufacturing cleanroom for biopharma product lines. This facility also will become the new shipping location for all CPC products, which will be reflected on future Letters of Certification.

Affected Products

All CPC biopharma product lines. See Appendix A for affected products.

Reason for Change

To accommodate CPC’s continued growth and to provide redundant cleanroom manufacturing.

Implementation Date

The new facility is expected to be completed Q3 2020. The redundant manufacturing cleanroom is expected to be operational Q4 2020.

Additional Information

As noted above, the new cleanroom will provide redundant manufacturing. CPC’s current biopharma cleanroom facility will continue to operate without change. This will ensure supply of product while the new cleanroom is being built and commissioned. There will be no interruptions of supply while the new facility is being qualified. After the new cleanroom is fully operational, the two cleanrooms will continue to operate simultaneously, which provides continued assurance of supply and capacity to grow in the future.

CPC will continue with quality system certifications to ISO 9001:2015 and ISO 13485:2016. All new manufacturing equipment qualified in the new cleanroom will go through CPC’s IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) validation process. The new ISO 7 cleanroom will be certified to ISO 14644 and 14698 standards. Following certification CPC will undergo a third party audit in alignment with the BPOG/RX360 single use joint audit program.

For additional information or questions, please email CPC at nick.johnson@cpcworldwide.com.

Appendix A