Saint Gobain Change Notice: Extruded Platinum Cured Tubing – ID, OD and/or Wall measurement equipment change

 

Scope of Change:

Product names and item numbers will not change. The affected parts number are: SG Beaverton Part# All SG Beaverton Platinum Cured extruded finished goods and all finished goods containing Platinum Cured extruded product that are 0.9” diameter OD or smaller are within scope of this change.

Not in Scope:

Any platinum cured tubing that is 0.9” larger in diameter will not be in scope in this change.

Change Description:

Saint-Gobain Beaverton (SGB) is in the process of revising how the ID, OD and/or Wall of extruded platinum cured tubing is measured. Currently, the ID, OD and/or Wall measurements within the Extrusion and Packaging departments are measured using Optical Comparators. Keyence IM-7020 measurement devices will replace the existing Optical Comparators.

Change Impact / Risk Assessment:

Risk is low:

  •  There is no potential impact on the validated state of ID, OD and/or Wall measurements.
  • There is no potential impact on regulatory filings.
  • There is no potential impact on production or product quality.
  • There is no potential impact to environmental, health and safety. Implementation Date: SGB is proposing to implement the Keyence IM-7020 measurement devices to replace the existing Optical Comparators in the Extrusion and Packaging departments by the end of Q3-2020.

Next Steps:

Please take this opportunity to contact the Customer Service Team or your Saint-Gobain District Sales Manager should you have any questions / concerns.

John A. Steichen Quality Engineer Saint-Gobain, Beaverton, MI

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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

 

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