For over 40 years, Precision Engineered Products’ medical and surgical business units have been working hand-in-hand with leaders in the medical industry to bring innovation and world-class quality to the design and execution of medical disposables, surgical devices and medical assemblies.
PEP provides a broad spectrum of support services to optimize performance and reliability, and lower cost. Our medical assembly operations rely on in-house designed and standardized assembly equipment to provide complex automated, semi-automated and manual assembly. Cellular manufacturing operations provide quality output of stamped and molded components for further assembly into a broad array of medical and surgical devices.
Precision Engineered Products facilities are configured to work with your designers and engineers to provide whatever level of assembly services your operation requires.
Clean Room Assembly
Clean room assembly uses PEP-designed equipment to provide complex automated, semi-automated and manual assembly under highly controlled conditions. Our four Class 100,000 (ISO Class 8) clean assembly rooms are staffed by dedicated manufacturing engineers and GMP-trained assemblers. Assembly processes include staking, ultrasonic welding and adhesive bonding.
Our clean assembly areas are supported by our Class 10,000 (ISO Class 7) clean micro molding operation. Process capabilities include parts with features as small as 2 microns and part weights down to 0.0001 grams. In addition, we specialize in the design and supply of product-specific packaging programs. Precision Engineered Products capabilities include specification rigid blister/Tyvek®, pouch and bulk packaging. We can also provide assemblies sterilized through gamma radiation or ethylene oxide, supported by in-house protocol validation including kill rates to 106, accelerated aging and transit testing.
Our talented engineers can manage the development process from idea conception to volume production of the final product. From planning to execution, we are ready to completely satisfy your product needs.
Precision Engineered Products provides a wide array of engineering services to support new product design including part design and process control and validation. Our staff of engineers work in highly-skilled cross functional teams to create innovative product and tooling designs. The teams work to mistake-proof, optimize anticipated performance, reliability, and manufacturability, while driving out unnecessary cost. Fused Deposition Modeling, Finite Element Analysis (FEA), Moldflow® and other solid modeling tools are used throughout the design process to insure optimized process development and rapid movement to reliable full production. All of this is supported by our dedicated Process Improvement and Technical Service teams utilizing process excellence skills to enhance quality and accelerate cost reduction.
Planning for product quality occurs early in the development process. This enables our team to identify critical requirements and define all quality assurance methods for application throughout the entire medical and surgical manufacturing process. With a state-of-the-art metrology lab and quality system that is ISO 9001, ISO 13485 and FDA registered, Precision Engineered Products handles your most technically challenging medical and surgical designs with competence to satisfy all of your validation requirements.
Through the use of real-time process monitors, on-line vision systems, and statistical process control, we continuously monitor key process parameters as well as critical product attributes to assure that our processes are repeatable, providing our clients with defect-free products. In addition, regulatory compliance technicians and engineers ensure that FDA/GMP and ISO standards are maintained.
Precision Engineered Products metrology capabilities extend to some of the latest tools to validate complex multi-filleted or featured parts including laser scanning CMM, a process that results in a complete 3D point cloud. Laser scanning enables complete inspection and modeling of complex medical and surgical parts and assemblies.
Vertical integration – tool build and maintenance, stamping, insert molding, assembly and a dedicated prototype facility provide Precision Engineered Products with the means to deliver rapid prototypes of medical and surgical parts and devices.
PEP’s commitment to a dedicated prototype manufacturing capability is specifically designed to attend to the needs of our customers without having to rely on the equipment and personnel resources in our manufacturing areas. Our ability to complete rapid tool modifications in response to product design changes accelerates product development. This translates into delivery of prototype parts ranging from two days to two weeks. Proof of concept parts and assemblies or small quantity production runs are produced to your specifications backed up by our demonstrated capabilities in engineering, manufacturing and tooling. Ultimately, this up-front design and process qualification ensures out-of-the-box product quality and the delivery of robust products to your customers.
- Integrated injection molding and precision stamping
- Fourslide implant wire forming and surgical staple cartridges
- Specification rigid blister, pouch and bulk packaging
- Sterilization – gamma radiation or ethylene oxide
- Protocol validation – kill rate 106 accelerated aging, transit testing
- Automated vision inspection