Medical cGMP plastic injection molding
High quality plastic injection molding is the lifeblood of our 20+ year business. All of our client’s parts are carefully molded to our high standards. Medical device parts are held to a higher industry standard, and we meet or exceed this standard for molding medical devices. The USA and Canada, among others, have developed a standard of current Good Manufacturing Practices, or GMP as the standard name is abbreviated.
The Good Manufacturing Practices (GMP) are regularly updated with new developments. Manufacturers who keep current use the cGMP designation. Permian Plastics is cGMP, verifying that our procedures and techniques are constantly improved to stay at the forefront of medical device and medical parts manufacturing. Adhering to these standards allows Permian to produce parts with exceptionally low defect levels and provide lot traceability that is accurate and rapid. Permian is a FDA Registered, ISO 9000 registered company, UL certified molder that regularly trains production staff:
- Permian Plastics, LLC achieved its initial ISO 9000 certification (Certificate No. COO-984) 2000 and was recently recertified under ISO 9001:2008 (Certificate No. C2010-00572).
- Permian Plastics, LLC achieved FDA registration in 2004 (FDA registration No. 3004594387) and operates with full medical GMP compliance
- Permian Plastics, LLC. has been an Underwriter’s Laboratories (UL) certified molder (designation B-1675) since 1998
- Training and retraining of employees
- Preventive maintenance for primary and secondary equipment as well as production tooling
- Internal quality audits
- LEAN teams
- Documented root cause process
Hygiene and controlled conditions are important to maintain the integrity of a product. You need a facility and materials that you can count on for consistent output and clean production. We offer Class 100,000 clean room capability.
Defined manufacturing processes are not only a GMP, but also an important way to manage your own process to ensure that you are achieving your desired results, including timeline needs and streamlined, cost-effective methods. Permian’s document process encompasses and exceeds the FDA and ISO minimum standards. This level of record keeping detail allows medical device manufacturers to confidently design parts and operation manuals with the assurance that Permian molded parts will conform as specified.
Medical cGMPs are overseen by the US Food and Drug Administration (FDA) and change over time. Be sure to select a plastic injection molder who stays current. Call Permian Plastics at 636-978-4655 to learn how the company adheres to these regulatory requirements.