A little over a year ago we took advantage of the opportunity to purchase a small cleanroom molding facility thinking “How hard could it be? We already build and sample molds for our medical customers, surely we can run production.” Well, let me tell you, it has proven to be more challenging than we anticipated but at the same time a challenge that has helped us improve our company overall and led to new opportunities to add customers.
Maintaining the integrity of our Class 8 cleanroom is our top priority to ensure we are producing and shipping the highest quality parts possible to our customers. The easiest way to maintain that integrity is to adhere to the philosophy of “If it doesn’t need to be in the cleanroom, don’t take it in the cleanroom.” Whether a piece of equipment is clean or not is irrelevant, anything that is introduced into the cleanroom creates the opportunity for contamination, so minimizing what goes in the cleanroom greatly decreases the chance of increased particulate counts.
Keeping a cleanroom “clean” begins as soon as you walk in the building and wipe your feet on the rug inside the door. Decreasing the amount of dirt and debris the tacky mats must collect as you enter the staging and production areas plays an important role in keeping that area as clean as possible. The next most important steps are the gowns, hair nets, beard covers, gloves, and shoe covers that must be worn inside the cleanroom. The number of particles shed from each individual is what contributes the most to elevated particulate levels inside the cleanroom and is where we focus the core of our training for employees.
In addition to the standard yearly certification testing the cleanroom undergoes, we will be adding monthly monitoring to our process via a handheld particulate counter. This allows us to be able to have an ongoing snapshot of where possible problem spots may lie within the cleanroom and the ability to address those issues immediately if any are found. Providing that extra level of monitoring and safety will provide our customers with the confidence we are taking every measure available in providing them with safe and ethically produced parts for their customers and patients.