When we said we were committed to continually fulfilling customer requirements and improving our quality management system, we took this promise to heart. To us, continuous improvement isn’t merely an industry buzz phrase – it’s our reality, as evidenced by the latest advancement in our production process: a new ISO 14644 cleanroom.
Our new cleanroom is an initiative led by Quality Assurance Manager Scott Tyson. The idea spawned from customer requests and enhanced expectations for medical device manufacturing cleanliness and excellence. Having previous experience using a cleanroom, Scott was the ideal candidate to steer the ship, collaborating with local cleanroom experts at Atmos-Tech Industries in Ocean Township, NJ.
“After extensive research and consideration, we selected a cleanroom solution to provide our customers with the cleanest product possible,” said Scott. “It’s now an extension of our manufacturing process, taking us to the next level in our ability to provide clean parts, which is very critical in the medical device industry.”
Our communications team recently caught up with Scott to learn more about our new cleanroom. But first, let’s cover the basics by answering this common question: what is a cleanroom?
Per ISO 14644-1, cleanrooms are defined as follows:
A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room.
Next, discover what makes our cleanroom unique.
Located in the Quality Control (QC) area of our facility, the 12-1/2’w x 6’d x 7’h cleanroom sits adjacent to a large wash tank for wires and tubes, functioning as the final stage of cleaning and packaging.
Scott identified the following noteworthy features of our new cleanroom:
1. ISO 14644 Compliant
2. Two 99.99% HEPA fan filters to keep the airborne particles at bay
3. Two sealed LED paneled light fixtures to protect against particle formation
4. Easily cleanable vinyl curtains and vinyl-coated sheetrock
5. Specialized cleanroom-friendly ceiling tiles
In the next section, discover how our cleanroom works – and how we know it’s working.
Our new cleanroom is designed to follow a three-step process:
Step 1: High-efficiency HEPA air filters supply air from above
Step 2: The air flows in a downward direction
Step 3: The air leaves the cleanroom under the vinyl curtains, moving any airborne particulate down and out of the room.
Scott says that we know the cleanroom is clean because we use a particulate counter to sample air and measure the quantity and size of the particles in the room. While we take samples more frequently to establish a baseline, our protocol will eventually dictate a minimum sampling of once per month.
Only trained, qualified, and properly dressed personnel are allowed inside the new cleanroom to prevent contamination. Before entering, our team wears proper gowning, including hair and beard covers, lab coats, and gloves. In addition, Scott has instructed everyone to follow strict hand-washing protocols. No one can bring prohibited items into the space, including jewelry, food, tissues, cell phones, reading materials, purses, wallets, or dirty bins. Cleaning and packaging materials, clean bins, and products slotted for cleaning and packaging are the only items allowed inside the cleanroom.
Our strict hygienic standards also include a thorough cleaning regimen:
• Wiping work surfaces between jobs
• Cleaning the interior walls and ceilings once per week
• Mopping the floors frequently with a clean pad
• Using trusted brands of window-type cleaners
So, what does our new cleanroom mean for you? Continue to the final section of our article below to find out.
Investing in an ISO 14644 cleanroom isn’t just the right move in our ongoing quest for excellence – but it also adds value by eliminating a cleaning step downstream.
“Our new cleanroom reduces the need for our customers to do additional cleaning of the components coming from our facility, saving them time and money,” Scott added. “It has truly expanded our capacity and enhanced our standard procedures in a valuable way.”
To learn more about our new ISO 14644 cleanroom or our medical device component manufacturing capabilities, contact our team online or call 215-383-9996.
Overall, precision CNC machining provides abroad range of production capabilities for parts and finishing in various industries, including manufacturing. Depending on the application environment, needed material, volume, lead time, budget, and desired features, there is always an optimum method that will deliver the desired result. Please don't hesitate to contact us if you have questions about what CNC machining method will best suit your desired features. Our team will be more than glad to review your print and provide timely feedback and input on the specific elements in your design.