Cleanroom Manufacturing
Overview
Our facility was built from the ground up to manufacture components and devices for the medical and pharmaceutical industries. Picocyl is an ISO 13485:2016 certified company and manufactures our products in a certified Class 8 cleanroom in our start-of-the-art facility in Golden, Colorado.
All of our proprietary manufacturing processes are designed and validated to meet current Good Manufacturing Processes (GMP). Our experience, technologies, capabilities, validated proprietary manufacturing processes, and strategic partnerships are unmatched in the medical gas-filled cylinder industry.
Starting with the leadership of our company and branching throughout our organization, we are experienced medical professionals that are intimately familiar with high standards necessary to design and manufacture medical devices.
From our state-of-the-art automated gas filling and sealing, to our precision measurement equipment, to our proprietary gas analytics, to statistical process controls, we are constantly monitoring our performance and continuously improving.
Our customers confidently use our Pico-cylinders and accessories in their delivery devices, saving and improving patients’ lives every day around the globe.
Features
- Automation for gas filling and sealing
- Robust Proprietary Leak Detection Equipment and Processes
- Failure Mode & Effects Analysis (dFMEA and pFMEA)
- Laser marking for lot traceability and customized QR code customer information
- Full Design Control with maintenance for Design History Files (DHF) and Technical Files
- Statistical Process Control
- Test Method Validations
- Automated Inspection Processes and equipment for critical dimensions
- Performance Tracking of Overall Equipment Effectiveness (OEE)
- Contract manufacturing services for device subassembly and final assembly
ADDITIONAL FEATURES
Certified gas provided by approved suppliers
On-site bulk gas storage tanks
Custom gas mix ratios, gas types and grades
Validated gas blending system with analytics
High purity gas distribution systems
World class automated gas filling and welding machines
Mass spectrometry for air content testing
Gas chromatography to determine potential impurities in gases
3D printing
Model shop for quick-turn prototyping
QUALITY
State of the art precision measurement equipment
Failure modes and effects analysis (dFMEAs and pFMEAs)
Software validations
Process validations
Periodic re-validations
Lot traceability
Supply chain management
INSPECTION
100% In-process gas mass verification
100% elevated temperature testing to ensure cylinder sealing integrity
100% Empty Cylinder Detection System
Laser marking verification systems
High speed counting and weight measurement system
Proprietary burst pressure and puncture force test systems
Optical Comparator and precision measurement equipment
Quick Tour
Take a glimpse into our state-of-the art facility…
Areas of Excellence
Our comprehensive proprietary manufacturing and quality processes and skilled team members are holistically aligned for medical-grade quality, performance, reliability, efficacy, compliance and for optimal product manufacturability.
Manufacturing starts during the design process. All of our Pico-Cylinders, Pico-Pins and Actuators go through an intensive design for manufacturing process where designers and supply chain partners collaborate to create parts that are functional and reproducible from both low to high volumes. Through focusing on our competencies and our partnerships’ core competencies, such as injection molding, deep drawing and progressive die stamping, we ensure quality is designed into our products from design to production.
During the design phase, our application engineering team has experience with injection plastic molding to support enhanced integration and packing of our components. We have design capabilities for Dynamic Analysis , Design of Experiments, mold flow analysis, 3D tolerance analysis, Finite Element Analysis and Computational Fluid Analysis.
The care we take with our Gas Filling & Welding process can be felt throughout every facet of our organization. We utilize a fully validated proprietary state-of-the-art in-house gas blending system with process monitoring analytics. Our system is capable of handling custom mix ratios, gas types, and grades. This allows us to fully customize the gas that is put in your cylinder to meet the needs of your application. By only using the best certified gas – provided by approved suppliers – and keeping it in on-site bulk gas storage tanks, we can ensure 100% quality. Additionally, we have in-house gas chromatography equipment to determine potential impurities in gas content.
Our high purity distribution systems transfer the gas to our world class proprietary automated gas filling and welding machines, fully operated and maintained by our experienced manufacturing and automation staff. Every step of the process is meticulously documented, iterated upon and improved, to provide the most consistent and best possible end product. Pico-Cylinders are precisely filled with high-purity gases to custom volume and pressure specifications and then contained in the cylinder using our proprietary gas-filling and welding technology. To ensure component integrity, each Pico-Cylinder is 100% verified for fill weight, and laser marked for identification & traceability.
The core of Picocyl’s business is filling Pico-Cylinders with gas and welding the cylinders closed to create a leak-free Pico-Cylinder. To this end, a tremendous amount of effort has been invested into world class facilities, equipment, automation, processes, supply chain partnerships, and quality controls. We hold ourselves to the highest standards, created multi-stage checks throughout our manufacturing line and more, all to ensure that our Pico-cylinders are leak-free. With our leak-free proprietary processes we can meet your shelf-life requirements.
Our 5-Step Process for 100% Reliability:
1 – FILL WEIGHT VERIFICATION
We ensure that each Pico-Cylinder meets the correct gas-fill specifications during the automated gas-filling and welding process through proprietary weight verification systems.
2 – GROSS MASS AND PART IDENTIFICATION
Each Pico-cylinder is permanently laser-marked with its gross mass for downstream quality checks. Custom QR codes are laser-marked on each cylinder for component lifecycle traceability.
3 – HEAT CONDITIONING
Next we heat condition each Pico-Cylinder to increase the cylinder’s internal pressure. This accelerates any potential leaks, ensures welding integrity at higher temperatures, and prepares the component for step #4 – Leak-free verification.
4 – LEAK-FREE VERIFICATION
We then ensure that each Pico-Cylinder will meet gas specifications at the end of its shelf life to provide you the confidence you need for your medical device operation. Our customized gas analyzers are validated to detect gas leakage. Through our proprietary technology Pico-Cylinders are measured for possible leakage, ensuring that the Pico-Cylinder retains adequate gas-fill levels throughout its intended lifecycle.
5 – EMPTY CANISTER DETECTION SYSTEM
A final quality inspection step, prior to packaging & shipping, is performed through an automated proprietary ECDS process for ensuring product integrity.
At Picocyl quality is built into everything we do. From our state-of-the-art precision measurement equipment, to statistical process controls, we are constantly monitoring our performance and improving it. Automated inspection processes and equipment help us to efficiently manage our manufacturing lines; while our focus on quality tools – like failure modes and effects analysis (dFMEA and pFMEA) we perform – help us to identify and prevent problems before they happen. We have a fully ISO 13485:2016 certified quality system for maintaining design history files, documenting test method validations, and keeping track of when periodic re-validations need to occur. We have successfully completed an FDA inspection, multiple pharmaceutical, and medical device company audits.
All components are manufactured in a state-of-the-art ISO Class 8 cleanroom. Our manufacturing environment ensures a clean, safe and contaminant-free Pico-Cylinder.
We use state of the art inspection equipment in our receiving departments, in process inspections, and final inspection processes. For our Pico-Cylinders we employ high speed counting, weighing, and proprietary burst pressure and puncture force test systems.