Precision Injection Moulds for Medical Applications
Custom moulds for syringes, labware, drug delivery systems, diagnostic components, and confidential medical devices — with cleanroom-oriented validation and scientific dispatch standards.
Medical Injection Moulding — Built for Demanding Compliance
Medical injection moulds require exceptional precision, stringent validation, and manufacturing partners who understand the regulatory and quality standards of the medical device industry. MIR Moulds applies cleanroom-oriented validation protocols, comprehensive SIM analysis, and scientific process validation to deliver moulds that meet the highest medical quality requirements.
💉 Syringe & Needle Moulds
Syringes (all sizes), Luerlock connectors, auto-disable syringes, plunger tip moulds, barrel moulds, needle hub moulds, and safety syringe components.
🔬 Labware Moulds
Petri dishes, PCR tubes, pipette tips, blood collection tubes, urine containers, stool containers, centrifuge tubes, microplates, and culture dishes.
💊 Drug Delivery Moulds
Inhaler components, autoinjector housings, pen needle components, IV bag connectors, dosage caps, and specialty drug delivery device parts requiring ultra-tight tolerances.
📋 Diagnostic Components
Test strip holders, cassette moulds, reagent containers, microfluidic channel components, diagnostic card housings, and point-of-care device enclosures.
📈 High-Cavitation Medical Moulds
16, 24, 32, 48, 64, 96 and 128-cavity moulds for high-volume disposable medical components. Consistent fill, balanced cavities, validated across all positions.
📄 Confidential / NDA Projects
We work under NDA for confidential medical device developments. Secure project handling from brief through DFM, prototyping, validation, and production mould delivery.
Medical Products We Mould
Cleanroom-Oriented Validation Process
Every medical mould dispatched from MIR Moulds has undergone a comprehensive scientific validation process. We apply injection moulding science to document, verify, and prove the mould’s performance before it reaches your facility.
SIM Validation
Scientific Injection Moulding validation establishes robust processing windows, identifies critical parameters, and documents the mould’s performance envelope for manufacturing consistency.
DOE — Design of Experiments
Structured DOE protocols to identify optimal process conditions, assess variable interactions, and establish control limits for each cavity and parameter combination.
cpK Process Capability
Statistical process capability analysis (cpK ≥ 1.67 for critical dimensions) confirms the mould consistently produces parts within specification across all cavities.
Pressure Curve Analysis
In-mould pressure sensor data and fill analysis to verify balanced filling across all cavities, detect short shots, and confirm gate seal timing for every cavity.
Multi-Cavity Fill Analysis
Short shot studies, balance analysis, and sequential fill verification across all cavities to confirm uniform fill and consistent part quality throughout the mould.
Dimensional Reports
Full CMM dimensional inspection reports, first article inspection (FAI), and complete traceability documentation provided with every medical mould delivery.
Start Your Medical Tooling Project
Send your medical device drawing or product brief. We’ll provide a technical response within 24 hours.
Send Medical Tooling Brief
Tell us about your medical device or component. We respond within 24 hours.
Medical Moulds — FAQ
Do you manufacture ISO 13485-compatible moulds?
Our manufacturing and validation processes are designed to support ISO 13485 and FDA requirements. We provide full dimensional reports, validation documentation, and traceability records with every medical mould.
What cavitation levels can you achieve for medical moulds?
We manufacture medical moulds from single-cavity prototypes to 128-cavity high-volume production tools. Cavity balance, fill consistency, and cpK validation are performed on every mould regardless of cavitation.
Can you handle NDA projects?
Yes. We routinely work under NDA for confidential medical device developments. Contact us to arrange NDA execution before any technical exchange.
What materials do you mould for medical applications?
PP, PE, PS, ABS, PC, POM, PETG, COC/COP, PLA, TPE, and medical-grade specialty polymers. We provide material recommendations based on your regulatory requirements and application specifications.