Clean Room Injection Molding
ISO 13485 clean room injection molding with ISO Class 5–8 cleanrooms for molding, inspection, assembly, and packaging.
- ISO 13485–certified clean room production
- ISO Class 5–8 cleanrooms for critical processes
- In-cleanroom inspection, assembly, and packaging
- Full lot traceability and inspection reports
Cleanroom Injection Molding Services
Clean room injection molding is used when particulate control matters.
At Kemal, molding, in-process inspection, assembly, and packaging can all be performed inside ISO Class 5–8 cleanrooms. We follow ISO 13485–aligned controls and provide documented traceability and inspection records to support consistent quality.
Cleanroom Injection Molding Capabilities
| Capabilities | Details |
|---|---|
|
Cleanroom Classes |
ISO Class 5, 7, and 8 cleanrooms. Injection molding, in-process inspection, assembly, and packaging are performed inside the cleanroom based on part cleanliness requirements. |
|
Processes in Cleanroom |
Injection molding, insert molding, and selected overmolding operations are conducted inside or directly connected to the cleanroom environment, supported by in-house mold design and build. |
|
Typical Part |
Small to medium-sized components with contamination-sensitive or fit-critical features, including diagnostic housings, microfluidic parts, connectors, covers, and caps. |
|
Supported Materials |
Medical-grade and cleanroom-compatible thermoplastics (e.g., PC, PC/ABS, PP, PE, PA6/PA66, PBT, PMMA, PVC). Material documentation is available to support regulatory and quality submissions. |
|
Quality System & Traceability |
ISO 9001 and ISO 13485 certified. IQC / IPQC / OQC controls, CTQ-based inspection planning, full lot traceability, and dimensional inspection records available (e.g., FAI or CMM reports as required). |
|
Post-Molding Operations |
Cleanroom or controlled-environment inspection, assembly, testing, kitting, sealing, labeling, and integration with validated packaging processes to protect cleanliness through shipment. |
Typical Cleanroom Molding Parts We Support
Sealing Components & Leak-Critical Parts
Parts with O-ring grooves, valve seats, or fluid-tight interfaces where particle control impacts sealing performance.
Microfluidic & Fluid-Path Components
Flow channels and fluid-contact parts where small defects or contamination can affect function and validation.
Diagnostic & IVD Housings
Enclosures and covers that require controlled handling, repeatable assembly fit, and inspection-based release.
Connector Housings & Electrical Interfaces
Precision housings for terminals, sensors, or mating features where particulate control supports reliable interfaces.
Optical / Sensor Covers & Clean Surfaces
Cosmetic or functional surfaces that are sensitive to particles, scratches, or handling marks.
Packaging-Ready Medical Components
Parts that must move from molding to controlled packaging steps to maintain cleanliness through shipment.
Why Choose Kemal for Cleanroom Injection Molding
ISO Class 5/7/8 Cleanrooms
ISO Class 5, 7, and 8 cleanrooms support molding programs that require particulate control. Cleanroom classification and monitoring records can be provided upon request.
ISO 13485 Quality System
We support cleanroom programs under an ISO 13485–aligned quality system. Lot traceability, inspection release criteria, and audit-ready record samples are available upon request.
DFM Feedback Before Tooling
Get DFM feedback before cutting steel. We review gating, wall thickness, shrink/warpage risk, and CTQ features, then recommend changes to reduce rework and tooling loops.
Predictable Lead Times
Tooling, trials, and cleanroom production are managed in-house to reduce schedule uncertainty. We share milestone updates from DFM to T0/T1 sampling and approval.
Cleanroom Assembly & Packaging
Cleanroom or controlled-environment pack-out helps protect cleanliness after molding. When required, we support labeling, lot traceability, and inspection documentation for shipment release.
Change Control & Revision Traceability
We manage design, tooling, and process updates through a documented ECN/ECR workflow. Revision history can be linked to samples and production lots, with records available upon request.
Design & DFM Support for Cleanroom Molded Parts
Submit your CAD and drawings to receive DFM feedback focused on cleanliness risk, CTQ features, and downstream validation.
- Gate location and vestige control near fluid paths, sealing surfaces, or cosmetic areas
- Wall thickness, ribs, and draft to reduce sink, flash, and particle-generating rework
- Material selection for sterilization methods (EtO, gamma, autoclave) and chemical exposure
- Weld/knit line positioning relative to high-stress regions and critical sealing interfaces
- Tool design features for cleanability (vents, shutoffs, and geometry that avoids dirt-trap dead zones)