Quality
At J-PAC we understand that stringent product and packaging certifications are not only required for regulatory reasons, but also for creating trust with our valued clients. As a result, we offer our clients peace of mind with certified and <15% RH controlled clean room environments as full FDA and ISO certifications.
In addition to customized room environments, we offer
- ISO 13485:2003 certification
- Certified ISO Class 7 & 8 Clean Rooms (formerly known as Class 10,000 and 100,000 respectively)
- FDA Registered - QSR/GMP Compliance
- Certified ISO Class 7 <15% RH Dry Rooms
- Sterilization Validation Assistance
Through each step of the manufacturing and packaging process, J-PAC's team follows stringent accountability guidelines that provide clients with Real Time Job Tracking and Process Performance Evaluations. With each service performed, J-PAC continually monitors and reports on project efficiency and validation.
J-PAC prides itself on our ability to work with our clients to develop consistent quality measures throughout the entire manufacturing and packaging process. These include elements of Supply Chain Management in order to ensure that our clients are provided with products of the highest quality on time and on budget.
Today's medical device market demands execution of projects that meet FDA and ISO certification standards. J-PAC understands the role a good device manufacturer and packager plays in its clients quality process and does everything, in the corporations ability, to support its clients efforts.
J-PAC's Quality System is the foundation of our business and a substantial reason why our clients place their medical device business in our capable hands. Our Quality System drives effective project management process affirming J-PAC's ability to produce acceptable product at fair price that meets or exceeds our clients specifications.