Infrastructure Planning for Cleanroom Manufacturing

Plastikos’ journey into cleanroom molding started with just one press and a vision for expansion to support the medical molding industry even before we had a customer that required the space. “If you build it, they will come.”

THE JOURNEY FROM ONE CLEANROOM PRESS TO A THRIVING OPERATION

In 2009-2010 we created a temporary cleanroom at Plastikos, equipped with Arburg’s clean air module that covers the clamping area of the machine, sealed conveyors and a small packaging room that launched our medical injection molding operation. Soon after, we secured our first cleanroom medical customer and expanded to three cleanroom presses. We saw an opportunity to enter that niche at a relatively low cost and we recognized the potential to leverage our technical molding expertise and toolmaking capabilities at Micro Mold to start marketing Plastikos as a capable cleanroom molder.

We quickly outgrew this initial cleanroom space and started plans to design our first addition at Plastikos, an ISO 7 cleanroom with 10 machines in 2014. However, we anticipated reaching capacity quickly and in late 2015, we acquired additional property located a quarter mile away from our existing facility to meet the demands of new business ramping up. We broke ground on the Plastikos Medical building in 2019 (our second ISO 7, 10 machine cleanroom), which took about a year to complete.

Amid the expansion in 2020, we had a new customer approach us with a large transfer opportunity but at that time, we lacked cleanroom capacity. We needed to derive another plan to handle the production demand and win the business. Over the course of the next six months, Plastikos converted a previous white room area of 8 machines to accommodate the customer’s project. ISO 8 (vs ISO 7 in our two prior new build cleanrooms) was an efficient choice to meet the customer’s requirements in the time we had. We were quickly operating with an all-new wall panel system, ceiling grid, lighting and air handling enhancements in support of our new medical customer, producing essential medical devices to combat COVID-19. This adaptability fueled further growth and new business opportunities.

GROWTH FORMULA

Our Company stays true to our core values, despite our rapid growth. Looking at our roots, back to our Founders, Tim Katen and Dave Mead, Micro Mold set the foundation as a technical, high-end mold maker, embracing the challenging parts regardless of what they were, starting with connector tooling in the late 1970’s. Micro Mold’s experience and expertise in building medical molds for OEMs laid the groundwork for Plastikos’ and Plastikos Medical’s journey and success today. We had a solid equation for success when you added the two together before branching off into cleanroom medical molding: Plastikos’ scientific molding capabilities, running challenging materials in the electronic connector market and Micro Mold, as a competent mold builder.

The foundation of building the tool is crucial as it provides the know-how to encompass long-term production and serviceability. Furthermore, Plastikos adds the right people and engineers to support and maintain the mold. Customers look for capable engineers whose work and feedback they can trust and consistently rely on, which is one reason why our Company stands out along with our worldclass facilities so close to one another and all the necessary resources (engineering, toolroom, maintenance, IT) to call upon when needed to support the highest levels of manufacturing and quality. Additionally, our close relationship with Penn State Behrend, a local college with one of just a handful of accredited four-year Plastics Engineering Technology programs across the nation, has helped us grow the molding side significantly over the last 15 years. We have stayed true to our specialty for decades through focusing on tight tolerance and challenging applications. We’ve established credibility through our precision molding abilities and trusted Engineering Team and customers are comfortable sourcing work here.

AUTOMATION

Automation has become a cornerstone of our operations over the last 10 years, particularly as our cleanroom volumes and production have increased. The automation notably supports volume efficiently while minimizing quality risk. Packaging becomes more challenging as volume increases and customers are looking for cavity separation, custom labeling and vision inspection. Our high mold-build standards include cavity sensors and end-of-arm tooling that enables efficient and high-quality production and capabilities to segregate suspect production, as needed. We’ve grown on what we started at Plastikos and took it to another level as we’ve advanced into supporting the medical industry through our cleanrooms at both molding locations and can confidently produce many millions of parts without worrying, “will our scrap rate increase because we don’t have the ability to scale efficiently without creating more quality risk?” We put a significant amount of focus and work into getting smarter with more integrated technology through mold design/build, process excellence and automation. Through these collective efforts, we’ve consistently shipped over a half billion parts to our customers in each of the last three years, greater than 300% growth from 10 years ago while also achieving record low external rejections.

KEY CONSIDERATIONS IN DESIGNING A NEW MEDICAL FACILITY

When we began planning the Plastikos Medical facility, we had the benefit of starting from scratch instead of moving into an existing facility. We endured a long planning process with many decisions to ultimately achieve exactly what we sought. Our prior technical molding experience at Plastikos and 20+ years of lessons learned, and continuous improvement helped pave the way for success in building the new medical cleanroom facility.

One key to laying out the design was to optimize access and below grade (basement) areas for utilities, raw materials and auxiliary equipment. In a traditional molding environment, these items are dropped in from overhead and placed on a molding floor adjacent to the molding machines. Various types of auxiliary equipment have fans which can stir particulates but when placed underground, as we did at Plastikos Medical, it eliminates the risk in a cleanroom molding environment. Also, many traditional molding machines include fan cooling inside electrical cabinets that we were able to strategically avoid by selecting a supplier that uses liquid cooling and thus, further mitigating a potential particulate concern inside a cleanroom. Additionally, ease of maintenance in a separate basement area is an added benefit to minimize risk of particulates.

Another key consideration in designing the new medical molding facility was optimizing the machine layout. This was twofold, to include airflow and spatial logistics. Machine layout is critical to ensure the air changes flow properly and that air dams are not created, which would otherwise impede the room’s self-sustaining abilities.

LESSONS LEARNED THROUGH A DECADE OF MULTIPLE EXPANSIONS

We are blessed and fortunate with how our medical molding expansions at Plastikos and then building Plastikos Medical have garnered success. It’s a testament to many years of hard work, continuous improvement and overcoming various challenges along the way. From the onset of Plastikos Medical, we envisioned running highly automated, high-volume, lights-out production. At the time, we were fortunate to have molds already running at Plastikos which were strategic candidates to run at Plastikos Medical with seamless integration since they virtually ran unattended, with no defects, molding issues, or unplanned tooling issues. Much of the time spent on planning and designing Plastikos Medical was to ensure that we had all the support infrastructure, material handling, auxiliary equipment and automation to safely and efficiently run the molds as we envisioned. Fast forward to the current day, new molds that are pre-determined and qualified to be a fit for Plastikos Medical have started in development there and eventually progress right into production (without the need to run at Plastikos initially before transferring).

Plastikos Medical was expanded in 2022 (Phase II) that added capacity for 16 additional machines following the initial construction in 2019 (Phase I building maxed out at 10 machines). As of today, 23 of the 26 machines are on-site and scheduled for production. One key improvement we made in Phase II was addressing packaging and labeling bottlenecks, determined through Phase I. Initially, while production was maximized overnight, all finished packaging was required during the day after employees arrived each morning and it took several hours to catch up instead of focusing on value-added activities, quality inspections and audits, etc. In the planning of Phase II, we implemented an autonomous mobile robot (AMR) to transport production to a centralized packaging room where packaging, labeling and storage into inventory are completed to streamline the process.

PARTNERING FOR SUCCESS

We largely stayed with the proven suppliers who we’ve been working with for many years for machines and auxiliary equipment at Plastikos Medical. We hired a general contractor who had many years of experience with large local and critical projects to partner for the Medical facility itself and with cleanroom design and controls. The combination of knowledge and expertise along with their engineering partners was ultimately a great fit and aligned well with our expectations and customer requirements.

A significant innovation at Plastikos Medical that we hadn’t done in the past was central material handling of our virgin, colorant resins feeding to the machines and collection of runner regrind coming from the machines. This required some additional research and planning to identify the best supplier and incorporate the processes into the facility design. To be successful with the lights-out production plan, it truly requires a deep level of integration from the material feed system, machine, mold, automation and all auxiliary equipment that need to be working in unison and communicating 100% of the time. Connecting these various pieces of equipment ensures efficiency and safety as various controls, precautions and alarms are needed. Having night shift support at Plastikos, just a quarter mile away, has been beneficial with rapid response to restart a machine, if needed with minimal downtime.

KEY CERTIFICATIONS

Plastikos was ISO 9001 certified before we entered the medical molding division and then we quickly attained our ISO 13485 certification. Two additional certifications were added later, including ISO 14644 (cleanroom compliance) and ISO 14698 (bioburden compliant).

While operating controls and air changes vary depending on cleanroom classification, we decided to begin with an ISO 7 (class 10,000) cleanroom in 2015. This provided an added level of security and built-in cushion (1/10th of particulate requirement of customers who required ISO 8, class 100,000). Plastikos Medical followed suit in 2019 and 2022 with an ISO 7 cleanroom.

STAYING TRUE TO OUR CORE PRINCIPLES

Our foundation is built upon designing molds for tight tolerance and specialized industries and producing finished parts in our worldclass, highly automated and efficient facilities. We prioritize strong partnerships with customers who understand and appreciate the collective value that our Companies provide through service, engineering excellence, unparalleled quality, and a relentless drive for continuous improvement.

Every day, we continue to build on our founders’ vision who had humble beginnings with a drive and knack for hard work, attention to detail and excellence that have propelled our Companies to where they are today. We are true to our roots as we invest in top-tier talent and cutting-edge innovation to create long-term career opportunities and drive the future of medical device manufacturing.

ABOUT THE AUTHOR

As Manufacturing Manager, Rob Cooney plans, schedules and manages many of the company’s advanced production processes and engineering — ensuring that products are made efficiently and adhere to strict company standards and customer expectations.

Rob has held various positions in the company dating back to 2002 as a Tooling Engineer and has been a critical asset to the company during its steady growth.

He holds a B.S. in Plastics Engineering Technology from The Pennsylvania State University, Behrend College. An avid hunter and swimmer, Rob recently accomplished a milestone of a lifetime on July 19, 2018, when he completed a 24.3-mile marathon swim across the open waters of Lake Erie.