BIO-PROCESSING
MICROFLUIDIC & GAS PUMPS
STERILE CONNECTORS
UNPARALLELED CLEANROOM MANUFACTURING
FOR BIO-PROCESSING DEVICES
Plastikos & Plastikos Medical brings deep experience supporting our bio-processing customers that rely on precise, contamination-sensitive plastic components—from microfluidic pumps and flow-control cartridges to sterile fluid-path connectors. All molding for these devices is performed in ISO 7 and ISO 8 cleanrooms, helping our customers maintain low bioburden levels all the way through their assembly process.
Our quality system is ISO 13485 certified and aligned with ISO 14698 biocontamination control, so each micro-scale channel, seal interface, and connection point is produced under a rigorously validated, fully traceable process. This same infrastructure has been proven across drug delivery systems and microfluidic diagnostic applications, giving bio-processing and pharma teams confidence that critical fluid-handling components will meet their dimensional, cleanliness, and regulatory requirements from development through commercialization.
HOW WE DELIVER FOR
CRITICAL BIO-PROCESSING DEVICES
ISO 7 CLEANROOMS
Two separate, state-of-the-art facilities with more than 50,000 square feet of combined cleanroom infrastructure with press tonnages ranging from 66T to 350T. All cleanroom machines are equipped with 3-Axis robotics to enable part handling and cavity separation.
ISO 8 CLEANROOM
One stand-alone cleanroom with 8 medical molding machines ranging from 88T – 220T. Each ISO 8 cleanroom machine is equipped with its own 3-axis robot.
ISO 13485 Certified
As an ISO 13485 certified facility, we continue to deliver the internationally recognized quality standard for the manufacture of Medical Devices. We are also ISO 14698 compliant and conduct routine bio-burden testing throughout the facilities.
CUSTOMER SPOTLIGHT
MICROFLUIDIC PUMPS
When a previous supplier abruptly shut down, our customer—a global medical device manufacturer—faced an immediate risk to a family of microfluidic and gas transfer components that supported complex diagnostic and fluid transfer equipment. They needed a new molding partner who could step in quickly, protect continuity of supply, and manage a sizable portfolio of existing tools without disrupting day-to-day production.
Our customer selected Plastikos based on precision micro-molding expertise, and proven track record in microfluidic and other fluid-path applications. Together, we aligned on a fast, structured transfer plan that would keep patient-critical components flowing while we assessed, stabilized, and upgraded the transfer tools for long-term performance.
The Initial Challenge:
- 34 existing injection molds had to be moved and re-qualified.
- Nearly 100 active part numbers were tied to these tools, many in continuous production.
- The entire transfer window was less than sixteen weeks from initial notice to full-volume production.
- The molds arrived without steel prints, maintenance histories, or spare component inventories.
- Many tools required engineering rework before they could safely run in production.
OUR APPROACH (DESIGN-BUILD-RUN)
1) Rapid Transfer Planning & Risk Assessment
- Plastikos created a dedicated cross-functional transfer team spanning tooling, process engineering, quality, and production planning. Each mold was prioritized based on shipment frequency and inventory coverage so that the highest-risk tools were evaluated and qualified first, protecting our customer's production schedule.
2) Tool Inspection, Refurbishment & Documentation
- On arrival, all 34 molds went through a structured teardown and inspection.
Whereby, our team: - Mapped each tool, component by component, to rebuild missing documentation.
- Identified worn components, steel conditions, and maintenance gaps.
- Implemented targeted repairs and engineering changes to stabilize performance and reduce unplanned downtime.
3) Process Qualification & Production Ramp
- Once tools were mechanically stabilized, Plastikos established robust molding processes for each part number using scientific molding principles.
4) Lifecycle Mold Management & Continuous Improvement
- With in-house mold maintenance and detailed records now in place, ongoing life-extension strategies were implemented across the tool set. Preventive maintenance schedules, component tracking, and performance monitoring were used to prevent failures and incrementally improve part performance over time.
STRATEGIC SUPPLIER PERFORMANCE
- TO-DATE, OUR TOOL MAINTENANCE STRATEGIES WERE ABLE TO EXTEND THE MOLD LIFE AN ADDITIONAL 1,000,000 CYCLES (AND COUNTING) ON THE CUSTOMER'S HIGHEST RUNNING APPLICATIONS.
- AS A RESULT OF OUR SUPPLIER PERFORMANCE, WE ALSO BEGAN WORKING WITH SEVERAL OTHER DIVISIONAL LOCATIONS WITH THIS ACCOUNT AND CONTINUE TO GROW STRATEGICALLY.
- WE CONSISTENTLY MAINTAIN OVER A 95% ON-TIME DELIVERY RATING WHILE MANAGING OUR CUSTOMER'S JUST-IN TIME INVENTORY STRATEGY.
Customer Response
“Plastikos has set the standard that we use for packaging and delivery with other suppliers. Within our instability of demand, Plastikos has maintained a culture of stability. Plastikos, without fail, responds quickly and efficiently to our changing requests. A true partnership.”
— Kim C., Materials Manager
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.
