Detail Mold & Manufacturing operates an ISO 14644-1:2015 Class 8, ISO 13485:2016-certified cleanroom for contamination-controlled injection molding and assembly for medical device manufacturers and other regulated industries. The room runs under continuous particulate and environmental monitoring, with gowning protocols and material handling procedures documented at every entry point, so the controls that keep the environment compliant are enforced on every run.
Our ISO Class 8 environment supports precision components across regulated production, from diagnostic hardware to drug delivery devices.
Every cleanroom molding run is governed by documented quality controls from incoming material inspection through final part release. ISO 9001:2015 and ISO 13485:2016 certification cover the full process, and the audit trail follows every part from raw resin to finished output.
Every part that enters our cleanroom moves through a documented process. Material handling, gowning, and equipment setup follow the same procedure on every run, and the facility’s SPC and SQC-driven process controls catch variation before it becomes a nonconformance. Assembly happens in the same controlled environment as molding, so a part never leaves the room mid-process and picks up contamination risk crossing between facilities. That consistency is what supports pellet-to-part traceability and gives regulated programs an audit-ready record.
Medical device manufacturing is the primary application for Detail Mold & Manufacturing’s cleanroom injection molding capability. The same engineering team that builds the mold manages how it runs in the cleanroom, carrying RJG process monitoring and IQ/OQ/PQ validation capability directly into cleanroom production rather than treating it as a separate operation. Detail Mold & Manufacturing operates under its customers’ quality management systems and FDA frameworks rather than carrying direct FDA authorization.
See how our cleanroom, certifications, and validation services support medical device production.
Yes. Cleanroom assembly is available alongside cleanroom molding, so parts move from first shot through assembly without leaving the controlled environment. Secondary operations are available within the same facility as well.
Yes. Cleanroom injection molding programs at Detail Mold & Manufacturing can use existing tooling, molds built elsewhere, or molds built in-house. For programs transitioning from another supplier, the process includes mold validation and first article inspection before cleanroom production begins.
The cleanroom is the controlled production environment. IQ, OQ, and PQ are the qualification protocols that certify the equipment, process, and output within that environment for regulated production. We can run cleanroom programs that qualify through formal IQ, OQ, and PQ validation for medical device and other regulated applications.
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