Comprehensive Services
We offer a unique and broad array of consulting and professional services to simplify your experience.
Applications Engineering
Since 2012, we have been integrating our Pico-Cylinders into medical and pharmaceutical devices with customers around the world. Our objective is simple: to ensure that you will be successful with implementing Pico-Cylinders to fully optimize the unique advantages that gas-powered delivery systems can provide. Since we are focused on medical devices, we understand the reliability and robustness requirements for life-critical devices over their lifetime. Our Application Engineers help customers save time and money by leveraging our proven experience to integrate our Pico-Cylinders into their medical devices, or other specialty high-quality designs. From regulatory requirements to safety standards, your communications with our Application Engineers are seamless – We speak your language.
Device Development
Does your drug or implantable need a delivery device? Picocyl creates a custom solutions using our gas-powered Pico-Cylinder technology. Since we have designed, developed and brought to market many medical devices that exploit the many benefits of our cylinders, we are in the best position to optimize our cylinders to meet your device requirements. From a blank sheet of paper to full product release and everything in between, Picocyl will shorten your development lead time and reduce risk.
Environmental Sustainability & Waste Management
At Picocyl, we adhere to strict, ecofriendly waste management protocols, in order to uphold our responsibilities to our customers, and in order to be good stewards to our planet. For every device we help develop, and for all components we manufacture, we gladly offer the option to receive the unused or used material as part of our Sustainable Waste Management System. Additionally, we ensure that our people and waste management partners are protected from any health hazards relevant to the handling of devices and components.
Contract Manufacturing
Manufacturing excellence is at the core of Picocyl. Our manufacturing facility and quality system were meticulously designed from the ground up with a focus on the exacting standards of medical device manufacturing. From our ISO 13485:2016 certified quality system, to our Class 8 clean room, we have created a culture of quality that extends to every person we hire and process we create. This started with our world class automated Pico-Cylinder manufacturing lines that have produced millions of leak-free Pico-Cylinders. The same attention to detail has continued with every manufacturing line that we have created or transferred to our facility, always maintaining the highest standards of reliability in the products we produce. Picocyl provides turn-key solutions for manufacturing sub-assemblies through to fully assembled and packaged devices.
Customization
As innovators and creators, we are inspired when customers provide us with opportunities to design a custom solution for their application. Identifying the right Pico-cylinder size, gas type, and fill masses, are challenges we solve on a regular basis. We also have great insight into other special cases such as some pharmaceutical applications where the gas comes in contact with the drug. We understand that these cases may require special levels of cleanliness, and we work directly with you to develop procedures that ensure your device meets the necessary ISO or customer provided standards. Whatever the challenge is, we are open and excited to work together on creating a solution that suits your needs.
Process Methodologies
Picocyl engineers can evaluate and provide design support for all of the elements of your pico-cylinder integration:
- Cylinder/pin mounting
- Actuation methods
- Activation analysis
- Gas selection/optimization
- Gas volume optimization
- Power delivery optimization
- Dead volume utilization/optimization
- Pressure vessel analysis
- Thermal analysis
- Shelf life analysis
- Cleanliness analysis
We ensure that the finished gas system is reliable, robust, manufacturable, cost-effective over the full life of the device. We also design, build prototypes and manufacture actuation mechanisms that can be integrated into your device to accelerate your time to market by letting you focus on your core application expertise while we focus on our core expertise of developing and providing complete gas systems.
Our products are the most reliable gas cylinders in the world, which is why many customers have chosen to replace their industrial-version gas cylinder with our Pico-Cylinders. We provide customers with a full analysis of their current device to produce a turn-key solution for integrating our cylinder.
Manufacturing starts during the design process. All of our Pico-Cylinders and Opener Pins go through an intensive design for manufacturing process where designers and suppliers collaborate to create parts that are functional and highly reproducible. By focusing on consistent manufacturing methods such as injection molding and deep drawing, we ensure quality is designed into our products the beginning.
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 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.