ERIE, PA (March 3, 2021). Plastikos Medical officially opened its doors for business in September 2019 – 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 I of Plastikos Medical consists of today’s current structure that was completed in 2019; a 25,000 ft² facility with 12,000 ft² dedicated to an ISO-7 cleanroom molding floor and accommodating 10 brand new (Arburg) medical injection molding machines. Five of those machines arrived on-site and were installed shortly after the buildings completed construction. The next 5 machines were added throughout 2020, and all 10 machines were fully operational as of October 2020.
The construction of Phase II of Plastikos Medical is slated to begin in March of 2021, which will more than double the size of the current ISO-7 cleanroom. The added cleanroom space is being strategically utilized 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, that 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 Medical’s expansion also includes substantially more than just doubling the ISO-7 cleanroom space from 12,000 ft² to 24,000 ft². Industry-leading automation will also be at the forefront of this expansion, along with the continued heavy utilization of Industry 4.0 principles & technologies. These upgrades will subsequently reduce risk and afford an even higher level of quality assurance and production efficiency for our medical customers.
Robert Cooney (Manufacturing Manager of Plastikos) commented: “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. 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 + another 10 ISO 7 cleanroom machines, totaling 37 molding machines. Renovations plans are underway to convert 8 whiteroom machines into its own stand-alone ISO-8 cleanroom environment to further fulfil 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 8 medical molding machines, an ISO-7 cleanroom with 10 medical molding machines, and two whiterooms with 19 machines, respectively.
Philip Katen (President & General Manager of Plastikos) commented: “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 & Micro Mold team are honored to be a continued integral part of the essential workforce. The companies’ medical growth is a direct reflection of the dedication our Medical OEM customers have towards continued medical product support and enhancing the quality of life to patients throughout the U.S. (and world-wide).
About Plastikos, Inc. & Micro Mold Co., Inc.:
Based in Erie, Pa., Micro Mold & Plastikos specialize in precision mold design & fabrication as well as tight-tolerance injection molding. Plastikos Medical came online in 2019 and is 100% dedicated to supporting the Medical OEM customer-base. With over 100,000+ square-feet of combined mold design & fabrication, engineering, as well as cleanroom and white room manufacturing space, our primary fields of expertise relating to plastic manufacturing include; medication delivery systems, surgical eye care, microfluidic, and electronic connector, among others. Our medical molding rooms are controlled through two ISO 7 cleanrooms (class 10,000). The Lifetime Mold Warranty program that we offer to qualifying molds is a testament of our devotion towards manufacturing the highest quality products for our customers.
