Prepco Medical Device Manufacturing

About Prepco

Prepco has 20 years of experience of plastics manufacturing and 12 years of medical device manufacturing specializing in producing minimally invasive, disposable surgical devices. These devices include epidural catheters, wound drainage tubes, autologous blood reinfusion devices, dilators, and more.

What makes us stand out?
We focus carefully on each aspect of manufacturing, from design concept discussions to final product testing. Our exceptional product quality and success at solving difficult design issues lead the industry.

Our Personnel
Prepco maintains high standards, both for our products and personnel. We have a low staff turnover. Each of our highly qualified staff members has passed rigorous training and testing programs. This results in quicker completion cycles and precision products.

Our Work Environment
We follow clean-room procedures to the letter, from entryway tacky mat floor coverings, to garments, to positive-pressure clean work areas. These work areas, unlike ordinary work areas, are maintained with the strictest adherence to proper cleanliness standards. The work table surfaces and floors are wiped daily with isopropyl alcohol. The rooms are accessible only through two airtight doors. All personnel working in these areas are required to wear hair nets, lab smocks, shoe coverings, and gloves.

We conduct viable particulate air sampling with our SAS-sampling equipment and prepare written reports upon customer request.

Our Certificates and Authorizations

Prepco is registered with the FDA and strictly adheres to FDA Quality System Regulations. Products are manufactured according to CFR 820 regulations

(Code
of Federal Regulations, 21 CFR Ch. 1, part 820, Good Manufacturing Practice for Medical Devices, Subpart A-J.

Prepco also meets ISO 9002 requirements and specifications.

Our Documentation and Quality Assurance Testing
The presence and indentification of each component can be traced by its controlled lot number during the manufacturing process and in any and all shipments of completed devices. Prepco maintains Device Master and Device History Records, available for inspection at any time.

Our quality assurance is serious business. All components and material inspections are conducted within HEPA-filtered laminar flow units meeting all federal standards which maintain clean room quality from manufacturing through testing.