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PROCESS VALIDATION

As many different solutions as there are customers.

VALIDATION

PTA offers a full process validation protocol.

REPORT

Our customers receive a formal process characterization report.

FULLY CUSTOMIZABLE

Our complete validation protocol is fully customizable to fit our customers needs and their requirements.

PTA offers full process validation following an IQ, OQ, PQ protocol.

Dimensions, CTF/CTQs and proposed datam structures are determined after early customer communication and a formal print review. Once an IQ report is drafted and the PFMEA, control plan and process flow are in place, our customers receive a formal process characterization report that highlights all of the scientific methods used to determine the nominal process, as well as the parameters used to challenge the process (DOE).

No validation: Prototype tools
ISO 9001 Standard: Non-medical customers, included in quote cost
ISO 9001 Custom: Non-medical customers, included once scope is understood
ISO 13485 Standard: All medical customers, included in quote cost
ISO 13485 Custom: All medical customers, included once scope is understood

3-PIECE FAIR
Once the process is established, a 3-piece FAIR of all print dimensions and a 30-piece capability study for all pre-determined CTF’s and CTQ’s is provided and reviewed with our customers.
ADJUSTMENTS
Mold changes or print adjustments are made and requalified prior to proceeding into the OQ run, where another capability study and FAIR are provided to validate any changes.

CAPABILITY STUDY
Upon being released to production, a final capability study is performed during the PQ run. Our complete validation protocol is fully customizable to fit our customers needs and their requirements.

PTA PLASTICS   |   CONNECTICUT

148 CHRISTIAN STREET

OXFORD, CT 06478

(203) 888-0585

PTA PLASTICS   |   COLORADO

7350 DRY CREEK PARKWAY

LONGMONT, CO 80503

(303) 652-2500

CONNECT

ISO 9001:2015 CERTIFIED

ISO 13485:2016 CERTIFIED