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Medical Grade Injection Molding Service with ISO 9001 Certified Quality and Biocompatible Materials for Process Validation
| Place of Origin | Xiamen, China |
|---|---|
| Brand Name | KDET |
| Certification | ISO 9001:2015, IATF 16949 |
| Model Number | KD-MG-MD016 |
| Minimum Order Quantity | 500 pieces |
| Price | Based on complexity and volume |
| Packaging Details | Custom PE bags + export cartons + pallets |
| Delivery Time | 15-30 days mold; 7-15 days production |
| Payment Terms | T/T, L/C, PayPal |
| Supply Ability | 5,000,000 pieces per year |
Product Details
| Cleanroom Class | ISO Class 8 (Class 100,000) | Medical Materials | Medical-grade PC, ABS, PP, PE, PSU, PPSU, PEI, PEEK, LSR |
|---|---|---|---|
| Biocompatibility | USP Class VI, ISO 10993 | Sterilization | EtO, Gamma, E-beam, Autoclave Compatible |
| Process Validation | IQ/OQ/PQ Per GMP | Documentation | Batch Records, Traceability, Calibration, Environmental Monitoring |
| Certification | ISO 9001:2015 | ||
| Highlight | ISO 9001 Certified Injection Molding Service,Biocompatible Materials Medical Grade Injection Molding,Process Validation Cleanroom Injection Molding |
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Product Description
KDET provides medical-grade injection molding services for medical device, diagnostic, and life science applications requiring cleanroom production, biocompatible materials, and rigorous process validation. Our ISO Class 8 (Class 100,000) cleanroom molding facility operates under GMP guidelines with HEPA filtration, positive pressure, temperature and humidity control, and documented personnel hygiene protocols. Since 2007, we have manufactured millions of medical components for leading device OEMs, supporting their FDA 510(k), CE marking, and ISO 13485 compliance requirements.
Company Strength: 18 years of injection molding excellence since 2007 | ISO 9001:2015 & IATF 16949 certified | 40-50 skilled professionals | 80%-90% export to 30+ countries | 5,000,000+ pieces annual capacity | Full in-house tooling, molding, QC, and global logistics from Xiamen, China.
Product Solutions
KDET delivers world-class medical grade solutions engineered to meet the demanding requirements of global OEM manufacturers. With 18 years of industry experience, ISO 9001:2015 and IATF 16949 certifications, and a fully integrated manufacturing facility, we provide comprehensive solutions from initial engineering consultation through tooling, production, quality assurance, and international logistics. Our structured project management methodology ensures transparent milestones, clear communication, and documented quality verification at every stage.
Key Features- ISO Class 8 Cleanroom Production: Our dedicated medical molding cleanroom features HEPA filtration (99.97% at 0.3μm), positive pressure differential, temperature control at 22±2°C, humidity control at 45±10% RH, and documented cleaning and monitoring protocols — meeting ISO 14644-1 Class 8 standards.
- Medical-Grade Materials: We process a comprehensive range of medical-grade polymers including USP Class VI certified materials, ISO 10993 biocompatible grades, and FDA-compliant resins — all with full material traceability and certifications of conformance.
- Process Validation (IQ/OQ/PQ): Every medical molding process undergoes formal Installation Qualification, Operational Qualification, and Performance Qualification protocols with documented evidence that the process consistently produces product meeting predetermined specifications.
- GMP-Compliant Documentation: Our medical production operations are documented per Good Manufacturing Practice (GMP) guidelines including batch records, material traceability, equipment calibration logs, environmental monitoring records, and personnel training documentation.
- Dedicated Medical Production Cells: Medical components are manufactured on dedicated production cells with physical segregation from industrial production areas, dedicated material handling equipment, and separate tool storage to prevent cross-contamination.
- Sterilization Compatibility: Our medical components are designed and manufactured for compatibility with common sterilization methods including EtO (Ethylene Oxide), Gamma radiation, E-beam, and autoclave — with material selection and process validation supporting your chosen sterilization method.
| Parameter | Specification |
|---|---|
| Cleanroom Classification | ISO Class 8 (Class 100,000) per ISO 14644-1 |
| Environmental Control | Temperature 22±2°C, Humidity 45±10% RH, HEPA filtration, Positive pressure |
| Medical Materials | Medical-grade PC, ABS, PP, PE, PSU, PPSU, PEI (Ultem), PEEK, LSR |
| Biocompatibility | USP Class VI, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation/Sensitization) |
| Sterilization Compatibility | EtO, Gamma (25-50 kGy), E-beam, Autoclave (121°C/134°C) |
| Process Validation | IQ/OQ/PQ per GMP guidelines; 50-shot capability study with Cpk ≥ 1.67 |
| Documentation | Batch records, Material traceability, Calibration logs, Environmental monitoring, Training records, CoC/CoA |
| Injection Machines | All-electric 50T – 250T for precision control and clean operation |
| Part Weight Range | 0.05g (microfluidic features) to 250g (device housings) |
- Drug Delivery Devices: Insulin pen components, inhaler actuators and dose counters, auto-injector housings and mechanisms, and pre-filled syringe components requiring precision molding and biocompatibility.
- Diagnostic Equipment: Point-of-care test cartridge housings, microfluidic chip substrates, reagent reservoir components, and laboratory consumables (pipette tips, specimen containers, petri dishes).
- Surgical Instruments: Disposable surgical tool handles and bodies, trocar housings, stapler components, and electrosurgical device housings with electrical insulation requirements.
- Implantable Device Components: Non-implantable external components of implantable systems including programmer housings, charger cases, and patient communication devices.
- Medical Packaging: Sterile barrier tray systems, surgical kit organizers, and device protection components manufactured under Class 8 cleanroom conditions.
Industry Success Case: A European medical device company developing a next-generation auto-injector required a manufacturing partner capable of producing 8 precision-molded components with biocompatible PC/ABS in an ISO Class 8 cleanroom. We validated 8 molding processes with full IQ/OQ/PQ protocols, achieved Cpk ≥ 1.67 on all 42 critical dimensions, and established documented batch manufacturing with full material traceability. The client received CE marking and FDA 510(k) clearance using components manufactured on our production line. Annual production volume is 2.4 million units with zero biocompatibility-related field complaints.
Production Cycle
- Engineering Review & DFM: 2-5 working days — Design analysis, simulation, and feasibility report
- Mold Design & Approval: 3-7 working days — Full 3D mold design for client sign-off
- Mold Manufacturing: 15-30 working days — Precision machining, EDM, heat treatment, assembly
- Mold Trial & Samples: 2-3 working days — T0 samples with dimensional inspection report
- Production & QC: 7-15 working days — Full production with SPC and in-line inspection
- Packaging & Shipment: 2-5 working days — Professional export packaging with documentation
| Parameter | Details |
|---|---|
| Minimum Order Quantity | 500-5,000 pieces depending on part size and complexity |
| Mold Lead Time | 15-30 working days |
| Sample Lead Time | 3-5 days with existing molds; 5-15 days with new tooling |
| Production Lead Time | 7-15 working days after sample approval |
| Payment Terms | T/T 30% deposit, 70% before shipment; L/C at sight available |
| Shipping Methods | Sea freight (15-40 days), Air freight (3-7 days), Express (3-5 days) |
| Packaging | Custom PE bags + export cartons + fumigated pallets |
Q: Are you ISO 13485 certified for medical device manufacturing?
A: While we operate under ISO 9001:2015 and follow GMP guidelines for medical device components, our facility is not directly ISO 13485 certified. However, our quality systems, cleanroom operations, process validation protocols, and documentation practices are designed to support our customers' ISO 13485 compliance requirements. Many of our medical device customers include our facility in their supplier audits as part of their own ISO 13485 quality system.
Q: Do you provide material biocompatibility documentation?
A: We provide material supplier certificates for USP Class VI, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation and sensitization) testing where applicable. We maintain full material traceability from resin lot through finished product batch. For new applications, we can coordinate biocompatibility testing through certified third-party laboratories at the customer's direction and expense.
Q: What process validation documentation do you provide?
A: We provide complete IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) documentation per GMP guidelines. This includes equipment specification verification, process parameter development studies, 50-shot capability studies with Cpk analysis, and ongoing process monitoring plans. All validation documentation is maintained in our quality records for the life of the program.
Q: How do you prevent cross-contamination between medical and industrial production?
A: Medical components are produced on dedicated all-electric machines in a physically segregated ISO Class 8 cleanroom with separate HVAC, entrance, and personnel protocols. Medical tooling is stored in a dedicated clean storage area. Material handling, work-in-progress, and finished goods for medical products are segregated from industrial production throughout the facility. Personnel working in the cleanroom follow documented gowning and hygiene procedures.
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