Drug delivery innovators, designers and manufacturers across the globe begin the shift to Pico-Cylinders as the preferred power source for next-gen therapies; Picocyl responds to deliver on growing demand.
GOLDEN, Colo., Sept. 12, 2023 /PRNewswire/ — Picocyl LLC (Picocyl), a designer, developer and manufacturer of next-generation drug delivery solutions, today announced that they have expanded their United States-based manufacturing facility by over sixty percent due to increased demand for their flagship Breakaway Septum Pico-Cylinder product (Breakaway Septum). Subminiature, medical-grade cylinders are quickly becoming the preferred power source for an entire generation of drug delivery innovations as new therapies present too many complex challenges for legacy power sources (springs, batteries).
For Picocyl, the industry leader in medical-grade, micro gas-powered cylinders, the build-out for the additional manufacturing capacity was completed rapidly, within a six-month timeline. Beyond standard manufacturing facilities, medical-grade Pico-Cylinders require a cleanroom manufacturing capability, with ISO 13485 certification. Additionally, the company’s proprietary manufacturing processes are designed and validated to meet current Good Manufacturing Processes (GMP). The build-out required strong leadership from Picocyl’s executives, and full engagement from the company’s engineering, quality, production and operations teams. As part of the initiative, the company added a state-of-art, fully-automated production line which enables multiple products, each with unique variations, to be manufactured on the same line.
Picocyl also announced the promotion of Kassandra Smith to Operations Manager. Ms. Smith assumes the responsibilities for day-to-day management and oversight of all manufacturing facilities, manufacturing operations and production delivery. These facilities (located in Golden, Colorado) and all quality systems have been meticulously designed to the exacting standards of medical device manufacturing and feature an ISO 13485:2016 certified quality system and a Class 8 clean room. The world-class automated Pico-Cylinder manufacturing lines produce millions of leak-free Pico-Cylinders, along with the other products which are part of the Pico-System.
“The demand curve for the Pico-Cylinder has been incredible,” says Ms. Smith. “But our key indicators forecasted the impending increase in orders and our Leadership reacted quickly with additional investment to bolster our facilities, manufacturing operations and team members. I am extremely proud of our team. Building-out the new space and getting it online in a condensed timeframe was a significant challenge, yet we banded together and made it happen.”
New drug therapies require an improved power source, which can be tuned to delivery requirements, has the capability to drive highly viscous materials, high dose volumes, has consistently high performance, superior quality, is easy to use, and helps create a pleasant patient experience. Compressed gas Pico-Cylinders meets and exceeds these requirements.
“We couldn’t be more excited, says Bob Barron, CEO at Picocyl. “The Pico-Cylinder is a game-changer for drug companies, medical device designers and for patients. The Pico-Cylinder makes it possible to bring a host of new, innovative, life-changing therapies to market, and Picocyl is honored to play our part to enable improved patient outcomes. As such, we have a duty to support this movement and deliver on increased demand.”
Picocyl enables the future of drug delivery and other special applications through innovative device design and gas-powered solutions for the medical and pharmaceutical markets. Every product, application and solution we deliver is built from the ground up in our USA-based, state-of-the-art, cleanroom manufacturing facilities (ISO Class 8). A pioneer in developing unique energy sources for drug delivery, the Company’s flagship Pico-Cylinders have become the industry standard for single use, gas-powered devices.
Picocyl is ISO 13485:2016 certified, FDA registered and has been audited and approved by numerous medical device and pharmaceutical firms, and has been FDA Inspected.
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SOURCE Picocyl LLC