Facilities
J-PAC moved into its current 60,000 square-foot state-of-the-art facility in 2001. J-PACs facility was constructed to facilitate the rapid construction and start-up of additional clean rooms. These rooms can be custom built to meet our client's product / production needs as well as corporate confidentiality needs.
J-PAC manufactures and assembles medical devices in
- 6 individual ISO Class 7 clean rooms, including one Dry Room and one Alcohol cleaning room
- 2 ISO Class 8 rooms for the manufacture of thermoformed trays and Form/Fill/Seal operations
ISO Class 7 Clean Rooms
J-PAC utilizes cellular manufacturing modalities and as such has a number of customized ISO Class 7 Clean Rooms specifically designed to accommodate the manufacturing lines that are housed within them.
These rooms are validated to ISO Class 7 standards and are monitored constantly for particulate count, Relative Humidity (RH) and temperature.
The humidity controlled room allows J-PAC to work on moisture sensitive, materials that need to be packaged in a relatively dry environment. The room is maintained at <30% RH and is equipped with Nitrogen Storage Chambers, Nitrogen-flush, Vacuum Packaging capabilities and equipment supporting headspace analysis.
The facility is ideal for the processing of PGA or Lactide/Glycolide products, as well as thermoplastic products targeted for gamma sterilization.
Solvent Cleaning Room
The solvent cleaning room, is equipped with an explosion proof electrical system and fume management system. It is designed specifically to support solvent scouring operations required to remove processing residuals from implantable medical devices.
J-PAC currently processes both permanent and absorbable orthopedic implants in this room.
Additional parts cleaning processes, via de-ionized air wash, are available at J-PAC to reduce loose particulate loads on super critical components.
ISO Class 8 Clean Rooms
The ISO Class 8 Suites house some of our Form/Fill/Seal Machines, Thermoforming Machines and a variety of de-ionized air wash cleaning stations.
These rooms are validated to ISO Class 8 standards and are monitored constantly for particulate count, Relative Humidity (RH) and temperature.
Tool Shop
J-PAC has strong in house tool room capabilities staffed by several tool room associates averaging over 20 years of experience.
Associate expertise and the fact that J-PAC fabricates its own molds, custom fixtures and automation allows its clients to bring new products to market faster and within budget.
The facility houses equipment such as computer generated CNC machines, Bridgeports, and lathes.