We have years of experience and processing knowledge in
cutting holes in tubes, bending tubes, molding connectors directly onto tubes,
printing, end forming, and welding. We produce wound drainage tubes, catheters
of all types and sizes, blood reinfusion devices, dilators, and obturators.
We have large volume production capabilities, quick turn
around, and minimal set-up charges.
Radio frequency (RF) induction end forming and welding of
extrusion to net shape for catheter construction. We excel by end forming
almost any engineering thermoplastic material to any size. We form extremely
clean, crisp, and clear tips. We can even complete a full edge radius on a tip
without any sharp edges, a process where experience shows.
We have perfected
the ability to produce long, tapered tips with very soft materials.
We have a unique ability to create smooth transition welds
between different extrusions. To weld two different durometer, multi-lumen
extrusions while keeping these lumens open is an accomplishment in our
Pad printing with clear, strong images. We can put
registration marks, graduations, indicators in bands or one to two side marks.
Prepco can print 30” images along an extrusion.
Over molding. We provide high quality, yet low cost,
hardened tool steel insert injection molds, particularly adept at specialty
connectors and manifolds. Prepco is capable of high volume production, with
single or multi-cavity molds. We can give you quotations within 24 hours.
Packaging and Shipping All products that are shipped in bulk
are placed in double polybags with cardboard shippers. Each bag is labeled with
product number, revision level, lot number, quantity, purchase order number and
description, and sterility condition.
Prepco supplies certificates of compliance and a packing
list with each shipment.
With 7200 ft² of manufacturing space that includes 3000 ft²
of ISO class 8 cleanrooms. The complex catheter and implant devices we
manufacture adhere to comprehensive traceability and strictly enforced written
procedures at each step of the manufacturing process.
The cleanrooms are fully equipped with injection molding machines,
packaging, and custom forming & cutting equipment to meet your diverse
Materials and quarantined items are stored in locked,
controlled access areas. Both truck dock and raised platform shipping is
available for receiving and shipping of small lots or large skids of product. We operate with dedicated work cells for each medical
device, combined with multi-use special operation areas for injection molding
and bulk packaging. Cross-training is routinely used to provide flexibility in
meeting quick delivery schedules.
Whether your product requires a work cell with one person
part-time or a crew, we have the space and infrastructure to meet your
production requirements. Options with flexible space in our building provide
the expansion possibilities to meet required production needs.
Our ISO 13485:2016 Certified Team of engineers, material experts, skilled technicians and Quality Assurance Specialists make Prepco, Inc. stand out from the rest. You can count on us to develop functional prototypes and scale up for manufacturing. Prepco, Inc. offers you a true, full prototyping & manufacturing partnership with the resources to get your project into the market.
There are many medical device component manufacturers in the world but Prepco offers decades of experience and a history of cost saving innovations. Molding parts as small as .1 cubic millimeter is achieved with refined equipment and processes.
Prepco offers a complete range of catheter manufacturing capabilities and the ability to create custom equipment allows us to produce complex, intricate devices to your specifications.
Our assemblers are experienced in very small medical device assembly often requiring processing and inspection under the microscope. We accept short run production testing as well as ongoing routine volume production shipped as desired.
Prepco has 30 years of contract medical component manufacturing specializing in minimally invasive, disposable surgical components.
We focus carefully on each aspect of manufacturing. Our exceptional product quality and success at solving complex manufacturing issues lead the industry.
What makes us stand out?
We focus carefully on each aspect of manufacturing, from concept discussions to final product testing. Our exceptional product quality and success at solving complex issues lead the industry.
Our Work Environment
We follow controlled work environment methods carefully, utilizing double door entry, entryway tacky mat floor coverings, protective garments and positive pressure HEPA filtered work areas. The work table surfaces are wiped daily with 70% isopropyl alcohol.
We conduct laser particulate air sampling and work surface viable particulate count.
Inspections of components and raw materials are conducted within HEPA filtered areas. Our Certificates and Authorizations
Prepco 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.
Our Documentation and Quality Assurance Testing
The presence and identification 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 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.