IQ/OQ/PQ validation

Aprios Custom MFG (formerly Diversified Plastics) is an employee-owned custom manufacturing company with over 48 years of experience, specializing in injection molding and additive manufacturing for mission-critical B2B devices. The company operates two facilities in Minneapolis, MN, and Vista, CA, and is ISO 9001, ISO 13485, ITAR, UL Blue, and FDA Registered.

additive manufacturingassemblyCarbon DLS 3D printingclean room manufacturingfinishingFirst article inspectioninjection moldinginsert moldinglabelingmicro moldingovermoldingpackagingprototypingQuality Managementtooling

Detail Mold & Manufacturing is an ISO-certified precision mold builder and manufacturer founded in Georgetown, Texas in 1990. The family-owned company designs and builds injection molds to Class 101 standards and runs injection molding and production machining in-house, serving clients nationwide in aerospace & defense, medical, and telecom industries. It holds ISO 9001:2015 and ISO 13485:2016 certifications.

3, 4, and 5-axis CNC millingcleanroom injection moldingCNC lathe turningCNC machininghole pop EDMinjection moldinglaser engravinglaser weldingmold design & engineeringmold repair & maintenancesinker EDMsurface grindingwire EDM

Fedegari is an industrial partner that provides turnkey solutions for sterile pharmaceutical production, from design to validation. Founded in 1953, the group began as a manufacturer of autoclaves and sterilizers and now offers process flow design, machine selection consulting, in-house manufacturing, installation, start-up, and IQ/OQ/PQ validation, with service support in over 100 countries.

autoclave manufacturingGMP compliance verificationin-house manufacturing of critical componentsinstallationprocess automationprocess flow designstart-upsterilizer manufacturingwasher-sterilizer design

Inteprod LLC is a contract manufacturer based in Eagleville, PA, specializing in private-label finished product manufacturing for medical, diagnostics, food safety, and industrial technology markets. Founded in 2004, it is ISO 13485:2016 certified and FDA registered, and guides products from engineering transfer through alpha, beta, pilot, and full-scale production builds.

alpha/beta/pilot buildscleanroom assemblycontract manufacturingengineering transferprocess documentationproduct refurbishmentsterile packagingsupply chain coordinationtraceability and labeling