Innovations – Quality Controlled Gas Management
Every product or solution begins with a dilemma, challenge, question or harebrained idea. Get to know the inspiration that drove our Team…
Challenge: Ensuring gas reliability, quality & compliance.
The care we take in developing Pico-Cylinder solutions, extends past the physical product and into the handling of each material component in the process. Selecting the best gas type for the application, and adhering the correct storage, filling, handling and measurement protocols, often marks the difference in quality and performance.
The care we take with our Gas Quality & Systems Management processes can be witnessed throughout every facet of our organization. With a fully validated, proprietary, in-house gas blending system, we are capable of handling custom mix ratios, gas types, and grades. This allows us to fully customize the gases that are put into your cylinders to meet the needs of any application. By only using the best certified gases – provided by approved suppliers – and storing it in on-site bulk gas storage tanks, we can ensure quality, functionality and reliability.
Our validated gas 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 engineering staff. Each step of the process is meticulously documented for control and lot traceability, 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. Utilizing in-house gas chromatography equipment we can verify that the purity of the contained gas meets the required specifications.
- Medical grade components
- Optimized gas content for your application
- High reliability
- Increased Shelf Life
- Component Traceability
- Regulatory compliance
Testing & Analysis
- Gas chromatography verification of gas content and purity
- Biocompatibility, cytotoxicity, intraocular irritation, sensitization, particulate, endotoxin, extractables/leachables, and pyrogen testing based on your medical device requirements
- Design failure mode and effects analysis (dFMEA) – full design evaluation to ensure cylinder integrity under all expected environmental and use conditions
- Process failure mode and effects analysis (pFMEA) – full material, manufacturing, and process analysis to ensure that the gas maintains the purity
- Aging and cleaning validations for cylinders
- Mass spectroscopy for Pico-cylinder extended shelf life
- Highly Accelerated Life Test (HALT)
- Highly Accelerated Stress Screening (HASS)
- Picocyl can synthesize specialty gasses specifically for your application. Customized mixtures can also be created on-site with validated process controls.
- Picocyl utilizes bulk liquefied gas storage to assure uninterrupted supply of high purity gas for system and process optimization.
- Each gas supplier is audited, vetted and approved, and each gas lot is certified and traceable.
- Our blending system is capable of handling custom mix ratios, gas types, and grades. This allows us to fully customize the gases that are put into your cylinders to meet the needs of your application.
- Helium can be mixed with Argon and Nitrogen as a tracer gas to ensure leak free integrity.
- Every step of the transfer process and equipment is designed and controlled to maintain gas purity. Proprietary filling processes are integrated into state of the art fully automated filling equipment that incorporates laser marking of cylinders for lifetime traceability and verification of fill mass.
- Gas is transferred from bulk storage to a Class 8 cleanroom environment where the Pico-cylinders are filled and welded.
- For extreme high purity applications, such as implantable ophthalmic gas, we developed a novel transfer system that evacuates the air from cylinders and backfills with the implant grade gas with no addition of air. Gas chromatography testing ensures that the purity specifications of the source gas are maintained.
- High temperature cycling of Pico-cylinders to ensure sterility of the delivered gas.