In case you missed it, C&J Industries is undergoing a significant facility expansion, which includes the addition of a new cleanroom. This expansion is set to nearly double our Class 8 Cleanroom medical injection molding capacity, in addition to the cleanroom molding we perform cleanroom assembly operations. This will enhance our capabilities in molding and assembling high-quality medical devices and other critical components.
To ensure top-notch cleanroom protocols and training, we recently sent Cameron Costner, Regulatory Affairs Administrator, to the Institute of Environmental Sciences & Technology’s ESTECH Conference in Las Vegas, Nevada. ESTECH is the leading conference for professionals in the fields of contamination control, cleanrooms, controlled environments, product reliability, environmental testing, and nanotechnology. Cameron shared his experiences and insights from the conference, shedding light on the importance of maintaining and improving cleanroom standards.
A Dive into ESTECH 2024
Cameron described his attendance at ESTECH 2024 as “extremely valuable.” The conference, filled with experts ranging from microbiologists to cleanroom designers, provided a rich learning environment. Cameron participated in various sessions, including a boot camp-style training that covered the design, build, and testing of cleanrooms.
“The first few days were geared around the design, build, and testing for the cleanroom—kind of like the ins and outs of how you should design it. As far as where you should have your diffusers, your air returns, and how you determine particle count locations,” Cameron explained. This foundational knowledge is crucial for ensuring compliance with the ISO 14644 standard, which governs cleanroom classifications and air cleanliness levels.
Another significant aspect of the training was the emphasis on cleaning protocols. “The second big class that I attended was around cleaning and the importance of ensuring the cleanroom areas and workstations are clean. Not just visibly clean, but making sure we’re eliminating the bacteria,” Cameron highlighted. Understanding best practices for cleaning frequencies and the appropriate garments to wear in the cleanroom are vital for maintaining a contamination-free environment.
Integration into C&J Industries
Cameron reassured that the new cleanroom will be seamlessly integrated into C&J’s existing processes. “We’re working to integrate the new cleanroom into our current training regimen,” he said. This involves updating documentation and forms specific to the new cleanroom while maintaining existing standards.
In order to keep up with ISO & FDA standards, cleanroom training at C&J is ever-evolving. Cameron believes his experience at ESTECH will help inform C&J’s training efforts in the new cleanroom. “At ESTECH, I was able to reaffirm that what we’re doing in the C&J cleanrooms is in compliance with those standards, but I also gained a better understanding of the cleanrooms themselves and how best to train our cleanroom teams,” Cameron elaborated. “It’s important that we cross-train everyone so they all understand the protocols and can run every job.” This approach ensures that employees are versatile and capable of operating in different environments, whether it’s a cleanroom or a less controlled white room.
Rigorous Testing and Quality Assurance
Ensuring that the new cleanroom meets all standards involves several testing phases. This thorough testing ensures that the cleanroom functions correctly under various conditions and maintains the necessary air quality and particle count standards.
C&J Industries is also responsible for monitoring the cleanrooms’ particle counts and air change rate. “We do an annual qualification to ensure the cleanrooms meet the criteria for ISO classification,” Cameron explained. “And as part of our continuous monitoring program we take a particle count at set locations and daily air pressure checks to ensure that we meet the ISO requirements.”
Looking Ahead: The Future of Cleanrooms at C&J
Progress continues to be made on the expansion, including the cleanroom and a tunnel to connect our two facilities. Cameron emphasized the long-standing expertise of C&J in cleanroom work.
“C&J has been doing cleanroom work for a long time. Luckily for me, when I came into this position, we’d been doing cleanrooms for 20-plus years already, so I inherited a great system,” Cameron said. “I’m just trying to continue to learn and improve our cleanrooms and our processes and ensure that we’re doing it right, being compliant, and making great products for our customers.”
Cameron’s attendance at ESTECH 2024 and the ongoing efforts at C&J highlight the company’s commitment to excellence in cleanroom standards and operations. As C&J Industries continues to expand and innovate, our dedication to maintaining high-quality cleanroom environments in the field of medical device manufacturing will remain unwavering.
Follow our journey as we expand and enhance our cleanroom capabilities. Discover how our commitment to top-notch standards in medical device manufacturing can benefit you. Connect with us.