Respiratory
METERED-DOSE INHALERS
NEBULIZERS
PORTABLE OXYGEN CONCENTRATORS
SUPPORTING EVERY BREATH IN
CRITICAL RESPIRATORY CARE
We partner with leading respiratory device manufacturers to mold critical components for metered dose inhalers, respirators, nebulizers, and portable oxygen systems, to name a few. Our experience spans complex dose counters, valve housings, and flow-control features that require sub-0.002″ tolerances, when the application demands it. We routinely scale these programs into high-cavitation, fully automated cells running on one of our white room molding floors, as well as within our ISO 7 and ISO 8 cleanrooms to support volumes in the tens-of-millions of parts annually.
Our customers turn to Plastikos, as we deeply understand that even minuscule changes in geometry can affect dose accuracy, spray pattern, and airflow resistance. For portable oxygen, dimensional drift in valves or seals can mean leaks, false alarms, or inconsistent delivery.
We continue to invest in cavity pressure monitoring and automated cavity separation, giving our customers cavity-level traceability for each shot. Combined with advanced metrology, including CT scanning for complex internal geometries, this approach reduces risk and supports stable, repeatable production for millions of respiratory components per year.
HOW WE DELIVER FOR
CRITICAL RESPIRATORY DEVICES
ADVANCED PROCESS MONITORING
Process Engineers are trained at Multiple RJG Master Molder Levels through their rigorous standards. Also, we routinely utilize cavity pressure sensors with process monitoring technology to achieve 100% monitoring and traceability on patient-critical-applications.
INTEGRATED ROBOTICS
Each medical molding machine is equipped with its own multi-axis robotics system. Part handling and cavity separation are achieved utilizing integrated robotics. These systems are also tied into our process monitoring system to discard product that may drift outside our molding parameters, which are established during our rigorous mold validation.
RISK MITIGATION
Multiple manufacturing sites and mold storage vaults allow for segregated tool storage in crisis situations (fire, flood, etc.). Also, standardized molding machines and a machine replacement plan reduce machine downtime and virtually eliminate delays due to equipment issues.
CUSTOMER SPOTLIGHT
METERED DOSE INDICATORS
Our customer is a global respiratory device manufacturer focused on metered dose inhalers (MDIs) and nebulizer-based drug delivery. Their portfolio includes high-volume, patient-critical components where every dose must be delivered consistently over the full life of the device.
As our customer prepared for expanded market demand and product updates across their respiratory platform, they needed a strategic molding partner that could qualify a large family of tools, manage both new tool builds and legacy tool transfers, and ramp cleanroom production to millions of parts annually without compromising quality or timelines.
Our partnership began with a multi-tool program for critical MDI components and quickly expanded to include a significant transfer of existing nebulizer tooling. Together, we aligned on a Design–Build–Run approach that leveraged Plastikos, Micro Mold, and select external tool shops to deliver what our customer’s regulatory and commercial teams required.
The Initial Challenge:
- Qualify 5 new multi-cavity tools for MDI components, ranging from 8 to 32 cavities per mold.
- Equip all new tools with cavity pressure sensors tied into eDART systems for cavity-level monitoring and traceability.
- Support millions of parts per year across multiple respiratory SKUs, with tight, repeatable dimensional control on critical features.
- Absorb and re-qualify a large set of existing nebulizer tools being transferred from another supplier.
OUR APPROACH (DESIGN-BUILD-RUN & TRANSFER)
1) Program & Tooling Strategy
- Implemented an integrated Design–Build–Run plan that combined Micro Mold’s in-house tooling expertise with select external tool shops to keep overall lead times practical while preserving Plastikos’ design standards.
- Specified cavity pressure sensors on every tool and tied them into eDART-equipped molding machines to enable real-time process monitoring and cavity-level genealogy.
2) New Tool Build and Qualification for MDI Components
- Collaborated with our customer’s engineering team on DFM, focusing on gate locations, wall thickness, and venting around features.
- Utilized advanced metrology (vision systems and, where appropriate, CT scanning) to confirm dimensional capability across 8–32 cavity layouts before moving into formal IQ/OQ/PQ validation.
3) Tool Transfer and Requalification for Nebulizer Components
- Conducted a structured incoming audit on each transferred nebulizer tool, assessing steel condition, cooling, venting, etc.
- Refurbished, retrofitted, or reconfigured tools as needed to align them with Plastikos’ tooling standards.
- Re-established optimal molding processes, then executed full IQ/OQ/PQ protocols to demonstrate capability under our customer’s quality system.
4) Full-Scale Production and Ongoing Monitoring
- Brought more than 20 tools—a mix of new MDI molds and transferred nebulizer molds—through qualification into sustained production.
- Leveraged cavity pressure monitoring and automated cavity separation to maintain lot-level traceability.
- Standardized process documentation and mold maintenance plans across tool families, ensuring that production could be supported long-term across Plastikos and Plastikos Medical.
PIONEERING THE FUTURE OF MEDICAL DEVICE MANUFACTURING WITH PRECISION, CARE, AND INNOVATION
If you’re ready to elevate your project with top-tier injection molding services, contact us today.
