Plastikos Medical Accelerates Phase II Expansion Plans

Plastikos Medical expansion slated for March 2021 is expected double the size of the current ISO-7 cleanroom, and fit 15 additional medical injection molding machines. 


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Plastikos whiteroom.

Plastikos whiteroom. All photo credit: Plastikos

Plastikos Medical (Erie, Pennsylvania) opened its doors for business back in September 2019—just down the street from Plastikos’ headquarters—to focus on manufacturing precision-molded product for class II and class III medical devices. During the development phase of the project, the owners strategically separated the facilities growth plans into two phases. Phase II is slated to begin March 2021.

Phase I of Plastikos Medical consists of today’s current structure, which was completed in 2019: a 25,000-square-foot facility with 12,000 square feet dedicated to an ISO-7 cleanroom molding floor and accommodating 10 brand new (Arburg) medical injection molding machines. Five of those machines arrived onsite and were installed shortly after the buildings completed construction. The next five machines were added throughout 2020, and all 10 machines were fully operational as of October 2020.

According to Plastikos, construction of Phase II of Plastikos Medical will more than double the size of the current ISO-7 cleanroom. The added cleanroom space is also being strategically used to fit an additional 15 medical injection molding machines as the need for additional cleanroom molding capacity arises in support of Plastikos/Plastikos Medical’s global Medical Device customer base. Ultimately, this will bring Plastikos Medical’s total fleet to 25 cleanroom medical machines. Originally, this phase was part of the company’s five-year strategic plan. Due to exceptional growth from the medical sector of its business, this strategic plan is being fast-tracked to match the need for additional cleanroom capacity.

Plastikos notes that industry-leading automation will also be at the forefront of this expansion, along with the continued heavy utilization of Industry 4.0 principles and technologies. These upgrades, the company says, will subsequently reduce risk and afford a higher level of quality assurance and production efficiency for its medical customers.

Plastikos Phase 1

Plastikos Medical, phase I

“The success of Phase I was enabled by 10 years of previous cleanroom experience with strategic medical customers, extensive R&D and testing on the latest machine, mold and support technologies to meet our customers production demands and quality expectations,” says Robert Cooney manufacturing manager of Plastikos. “Looking ahead toward the Phase II plans, it is exciting to take these advances to another level in what we have collectively learned since Phase I has been operational.” 

As Plastikos Medical moves forward with its plans for expansion, Plastikos is simultaneously undergoing a medical-driven internal renovation. Currently, Plastikos operates with 27 whiteroom machines, plus another 10 ISO 7 cleanroom machines, totaling 37 molding machines. Renovations plans are underway to convert eight whiteroom machines into its own stand-alone ISO-8 cleanroom environment to further fulfill customer growth in the cleanroom medical space. Once completed, the space will fall under Plastikos’ current ISO 13485 certification and ISO 14698 compliance. This conversion is being done to offer additional support to medical OEMs with growing portfolios that require a higher level of stringent production and quality requirements.

Once completed, Plastikos’ new facility layout will include an ISO-8 cleanroom with eight medical molding machines, an ISO-7 cleanroom with 10 medical molding machines, and two whiterooms with 19 machines, respectively.

Philip Katen, president and general manager of Plastikos says, “The Plastikos, Plastikos Medical and Micro Mold team is proud to play a key role in the growth and success of all of our customers, and we consider ourselves as an extended member of their companies and their team. These two major medical, cleanroom construction projects reflect the proactive investment that we make into our facilities, our equipment, and our team to stay one to one-and-a-half steps ahead of our customers’ production needs. We are excited for this next chapter in our history as we look ahead in 2021 and beyond!”

Considering the unprecedented hardships experienced throughout 2020, the Plastikos, Plastikos Medical and Micro Mold team are honored to be a continued integral part of the essential workforce. The company says its medical growth is a direct reflection of the dedication medical OEM customers have towards continued medical product support and enhancing the quality of life to patients throughout the U.S. and globally.