Manufacturing & Quality
Medical device critical components demand medical manufacturing & quality
Medical Device Manufacturing Environment
Picocyl’s pico-cylinders are manufactured in the USA at our headquarters in Golden, Colorado.
Manufacturing and quality processes, plant layout, automated proprietary production equipment, and our highly skilled team are singularly purpose-driven to provide our customers with the most reliable gas cylinder solutions in the world.
Our customers confidently use our pico-cylinders in their devices, saving and improving patients’ lives every day.
Quality Management System and Class 8 Certified Cleanroom
Picocyl is an ISO 13485:2016 certified business, in compliance with FDA QSR 21 CFR part 820 and has 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.
Proprietary Gas-Filling & Welding Technology
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.
Our 5th-generation, proprietary automated gas-filling and welding equipment was custom designed for the medical industry with annual capacities from hundreds of thousands to tens of millions of units per year.
Leak-Free Verifications
At Picocyl, we consider our product to be a critical component of our customer’s devices.
For this reason, after the automated gas filling and welding process, each pico-cylinder undergoes three additional 100% leak-free verification process steps to confirm seal integrity and ensure performance over its entire shelf life.
“Picocyl has been a great partner in the development of our technology. The Picocyl Team is very knowledgeable and responsive, which helped our project team make timely decisions and execute more efficiently.”
—John F. Love, VP of Product Development & Operations, Enable Injections
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 pico-cylinders 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.