Caltorque Medical Products Announces Addition of ISO 7 Cleanroom Facility

Caltorque Medical Products has announced the complete installation and ISO 7 certification of its production cleanroom facility. The HEPA-filtered cleanroom, certified by an independent outside agency, is used to manufacture single procedure torque limiting, ratcheting, and procedural package surgical kits for global orthopedic implant OEMs. Recently, the company added the cost advantaged Reusable Torque and Ratcheting product lines—also cleanroom manufactured.
 
The cleanroom was designed and installed to offer the best available capacity in the single use/single procedure manufacturing industry. The CMP cleanroom is the most comprehensive facility used in the manufacture of the company’s market specific product line.
 
“It is superior to any ‘clean space’ manufacturing currently in our competitive niche,” said President Brian Cutler. “Our total commitment to providing exceptional products manufactured in state of the art manufacturing facilities delivers on our commitment to cleanliness, validations, process control, and cost responsible products.”
 
Total quality systems and process controlled manufacturing implemented with state of the art HEPA filtration, gasket sealed ceilings, positive pressure air changes, epoxy sealed flooring and walls, full air wash anterooms, and materials transfer chambers provides for the strictest adherence to medical device manufacturing standards and particulate control while being completely ISO 7 certified and ISO 13485 certified. Full procedural and process training is required for all production personnel.
 
“Our customers demand validated production processes and facilities. As such, we also perform biological burden surveys for surface, air, and production product routinely. Many of our products are terminally sterilized and therefore require a strict control of cleanroom bio-burden to properly validate sterilization modalities and assure continuous sterilization integrity for EtO, Gamma, Electron Beam, Plasma, and others,” confirmed Doug Slomski, VP of sales and market development.
 
To further ensure that products are free of contaminants all components and sub assemblies are lot-traceable, and staged in the cleanroom facility.