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)
Early DFM reduces tool-change loops and shortens validation time for cleanroom production.
Related Services for Cleanroom Injection Molding
Tool design support for cleanroom molding, including gating strategy, venting layout, shutoff integrity, and parting-line control. Design deliverables and revision history are available as required.
In-house mold manufacturing for cleanroom programs, with shutoff control, venting strategy, and surface finish planning built into the tool.
rototype-to-production injection molding with process controls and inspection checkpoints for repeatable quality. Cleanroom support available as required.
Finish options for parts with cosmetic or cleanliness-sensitive surfaces. We consider texture, polish level, and post-processing steps to help reduce cosmetic defects and handling risk.
Quality controls for cleanroom molding programs, including IQC/IPQC/OQC, CTQ-based inspection, and documented lot traceability. Audit-ready inspection records are available upon request.
Cleanroom Assembly & Packaging
Controlled-environment assembly and pack-out to protect cleanliness after molding. Share packaging format, labeling, and traceability requirements during quoting.
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FAQ's
What ISO cleanroom classes do you support?
We support ISO Class 5, 7, and 8 cleanroom environments. The appropriate class depends on your part’s contamination risk and which steps must remain controlled (molding, inspection, assembly, or packaging).
Which steps can be performed inside the cleanroom?
Based on project requirements, we can perform injection molding, in-process inspection, secondary assembly, and packaging/pack-out inside the cleanroom environment. Tell us which steps must remain controlled so we can align the workflow and documentation.
What documentation and inspection records can you provide?
We can provide lot traceability and inspection documentation aligned to your program requirements. Common deliverables include dimensional inspection reports (FAI and/or CMM reports as required), material documentation (e.g., CoC/certifications as required), and audit-ready record samples upon request.
Can you support ISO 13485 requirements?
Yes. We support cleanroom programs under ISO 13485–aligned quality controls, including defined inspection checkpoints, documented lot traceability, and audit-ready records as required. Share your validation and documentation expectations in the RFQ so we can match deliverables to your program.
What materials do you commonly mold for cleanroom programs?
We commonly mold medical-grade and cleanroom-compatible thermoplastics such as PC, PC/ABS, PP, PE, PA6/PA66 (nylon), PBT, PMMA, and PVC. Final material selection is confirmed during quoting/DFM based on functional requirements, sterilization method (if applicable), and documentation needs.
Can you support sterilization methods (EtO, gamma, autoclave)?
Yes. We can support programs that use EtO, gamma, or autoclave sterilization, as long as the selected material and part design are compatible. Share your sterilization method and exposure conditions during quoting/DFM so we can confirm material suitability and any design or process considerations.
Do you support insert molding or overmolding for cleanroom parts?
Yes. We support insert molding and selected overmolding operations for cleanroom parts, based on insert type, geometry, and cleanliness requirements. Share the insert details (material, dimensions, retention features) and any CTQ interfaces in your RFQ so we can confirm feasibility, control points, and inspection needs.
What should I include in my RFQ for cleanroom molding?
Include the items below so we can confirm the correct cleanroom class, process steps, and documentation package:
CAD + drawing (STEP/IGES + PDF) and any CTQ features called out
Material (or acceptable alternates) and any color/additive requirements
Quantity & timing: prototype / pilot / production volumes and target dates
Cleanroom requirements: desired ISO class (if known) and which steps must be controlled (molding, inspection, assembly, packaging/pack-out)
Sterilization method (EtO, gamma, autoclave) and exposure conditions, if applicable
Insert/overmolding details (insert type, tolerances, retention features), if applicable
Documentation needs: lot traceability, CoC/material certs, FAI/CMM reports, change control expectations
Packaging/labeling requirements: bagging/sealing format, labels, and any shipment release criteria
