IS Med Specialties offers a range of contract services including packaging and subassembly handling within a Class 100,000 cleanroom environment. Subassemblies can be built and packaged to fit customer requirements. IS Med Specialties repackages medical filtration and component products without introducing additional particulate matter or bioburden to the products. The firm’s repackaging capabilities include volume reduction from a large quantity bag to smaller bags and multipart kitting into a single bag. Custom labelling services are also offered. Certified to ISO 9001:2008, the company is a subsidiary of Industrial Specialties Manufacturing, which specializes in making plastic and metal miniature components.
■ IS Med Specialties
Custom Packaging Development
An outsourcing partner developing customized product systems to meet specified design requirements of clients in the medical device and diagnostic industry, J-Pac Medical supports all phases of the product life cycle, including development, manufacturing, packaging, and logistics and supply-chain management. The company is FDA-registered as a medical device manufacturer and device labeler-relabeler, and its quality management is certified to ISO 13485 standards. The contractor offers custom tooling capabilities and takes an integrated approach to projects that considers materials, tooling, processes, and automation in a customized plan. Applying its expertise in the thermal manipulation of polymers, it designs and develops custom-shaped implantable medical devices and also surgical instrumentation for the cardiovascular, orthopedic, and soft-tissue repair markets.
■ J-Pac Medical
Life Science Outsourcing operates a packaging division that is an ISTA-certified packaging test lab. The division is devoted to the validation, testing, and design of packaging for medical device manufacturers and other life science companies. Equipment used in its Class 10,000 cleanroom area includes a variety of tray and pouch sealers. Its testing and validation services are based on ISO 11607-1:2006 and are designed to assure compliance with FDA, ISO, EN, and CE Mark requirements. Shown here is the dye penetration testing offered by the firm, which is used to check for seal leaks in medical packaging such as pouches, trays, and blisters.
■ Life Science Outsourcing Inc.
Custom Packaging Development
Providing an array of medical device packaging services, CleanCut Technologies operates Class 10,000 and Class 100,000 cleanrooms in its ISO 13485–certified facility. The company manufactures clipless dispensers, and HDPE pouch cards are made in a Class 8 cleanroom and then transported into a Class 7 cleanroom for additional assembly, cleaning, inspection, double polybagging, and labeling. The company is certified to ISO 13485 and registered with the FDA. The company also has developed clipless catheter and guidewire dispensers designed to address international packaging and waste reduction standards. The dispenser is smooth and rigid, eliminating puncture and pouch failures. CleanCut is on more than 450 companies’ approved supplier lists internationally.
■ CleanCut Technologies