PenJet® Corporation manufactures out of a 50,000-sq-ft facility, about 35 miles east of Los Angeles.
The facility features a 10,000 square foot molding clean room certified to Class 100,000, as well as a 500 square foot clean room, certified to Class 10,000, for assembly and secondary operations such as ultrasonic welding, annealing, pad printing and hot stamping. It also offers molding in a certified Class 1,000 environment using an internally developed Clean Conveyor technology.
It has the following practices in place: Registered FDA manufacturer, Good Manufacturing Practices (GMP's), Standard Operating Procedures (SOP's), real time SPC/SQC, clean room operating standards, in-process and final inspection systems and self-audit procedures. Along with all these systems, it adheres to IS0-9002 standards.
PenJet® is currently tooled and set up for low volume manufacturing
production, much of which is for extensive clinical trials. It's
manufacturing facility will be able to produce about 50 million
PenJets® annually. Because of PenJets® modular manufacturing
design, other facilities, either independent or within pharmaceutical
companies, can be rapidly ramped up for additional production.