Clean Room Operations

Value-Added Services:

Additional Qualifications:

PCIs Clean Room injection molding areas consist of Class 7 (10,000) & Class 8 (100,000) certified environments, giving us the flexibility to provide customers with true turnkey operations at any pre-qualified press.

Our commitment to quality ensures that our processes will comply with the most stringent regulatory requirements. Polymer's strict Quality Management System, registered to ISO 13485:2003 & ISO 9001:2008, contains detailed standard operating procedures for gowning, processing techniques, product handling and associated auxiliary documentation for equipment, supplies, etc.

PCI operates within the quality system regulations (QSR) for FDA 21 CFR Part 820 Medical Devices and Current Good Manufacturing Practices (CGMP) and is compliant with all relevant ISO requirements.

Process Qualification Options

Every product PCI manufactures is qualified prior to production. We offer both standard qualification services as well as extended qualification
options encompassing all phases of your product development from design through manufacturing.

Standard Qualification Includes:

Process Capability / Qualification Study

Our standard qualification procedures include process capability and qualification studies. As part of the process capability study, we will identify your critical process parameters and define acceptable specification ranges. Key product characteristics will be analyzed to quantify how well the process can meet your precise manufacturing needs.

As part of the process qualification phase, we will sample and test your products at various stages of the manufacturing process, with no "extra"
or "special" processing performed, to validate that your product specifications are met.

"FAIR" First Article Inspections

PCI will perform first article inspections on production indicative parts to verify that the parts meet your customer specifications, required tolerances and quality control requirements.

Sample Submissions

Maintaining quality and ensuring customer satisfaction are top priorities. Once a sample submission is approved by a customer, PCI maintains the "customer approved" product samples for the lifetime of your product to ensure repeatability between production batches and that your requirements for quality are maintained.

5732 Big Tree Road
Orchard Park, NY 14127-4196
Phone: (716) 662-8550
Fax: (716) 662-8555

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