Within engineering and manufacturing processes, cleanroom capabilities are often crucial for medical devices, especially for Class II and Class III devices, due to strict regulatory standard requirements. Medical device manufacturers remain competitive through the quality, safety and effectiveness of their devices. One of the basic principles is that devices must be kept free of contamination and manufactured within a bioburden controlled environment. Cleanroom Manufacturing – A different skill set Cleanroom manufacturing requires a different labor skill set. Every product manufactured in a cleanroom has a custom process developed. A cleanroom operation can be very manually intensive, with 20 people, or more, in the cleanroom assembling products. Some products need a higher level of automation to support reliability and placement precision of components within the products. It really depends on the product, and often it’s a combination of higher labor content and automation usage coupled with skilled technical craftspeople overseeing the entire process. For example, if we look at a complex surgical system used in minimally invasive surgery, the system is composed of three different subsystems: the console for the imaging, the cart system and the hand piece, which includes a single-use-device. The single-use-device is manufactured within a cleanroom environment. The process involves three six-axis robots for the electronic assembly – picking, placing and inserting electronic components. Once a skilled technician and quality engineer program the automation solution, these robots require zero traditional touch labor and are involved in important steps, including laser welding, soldering, adhesive gluing and UV lithography. Followed by a variety of tests, including hipot tests, continuity tests, flow tests and other functional tests following several protocols and parameters used to ensure reliability of the product. There are also visual inspections done by the robots, using different reference points, during assembly to ensure the proper rotation, placement and insertion of the parts. Finally, there is sterile barrier packaging. Overcoming challenges Medical devices are becoming more sophisticated, sensitive and complex – often having the potential to become damaged or degraded by conventional sterilization processes. The manner in which device manufacturers control and protect their manufacturing environment, including how they maintain and develop appropriate ‘cleanroom’ processes – is becoming more challenging. Typically, issues arise within the supply chain as product tolerances continue to tighten. It’s critical to have a very robust inspection process to examine incoming components before they become value-added parts of a finished product. It’s an easy rule: If you’re starting off with bad components, naturally, your end product won’t be able to fulfil all the performance and reliability requirements. Another typical issue often occurs during critical processes, such as ultrasonic welding or laser welding, as well as the breach of sterile packaging, which could mean a recall of the product. On paper, these processes might seem easy, but if neglected can lead to very serious consequences. Operating a cleanroom can be a challenge, particularly to ensure each product’s specific regulatory requirements are met. There are strict hygiene requirements and fitness-to-work requirements to ensure there is control of the materials and people entering the room. This includes, for example, the installation of a filtration system and HEPA filters for cleaning the air and filtering compressed air, gowning procedures (i.e. shoe covers, hairnets and hand washing procedures) as well as strict rules on how to enter and operate in a cleanroom environment. Often, the more people you have within the assembly process, the greater the chance of contamination. There can also be microbiological contamination or bioburden risks, so cleaning solutions have to be changed at regular intervals to make it impossible for the microbial to become resistant to certain cleaning procedures. Relying on an experienced partner A cleanroom that is not fully controlled can have significant consequences, for example, a product being recalled or put on hold, because quality control found a hair in the packaged device. Precision and execution are vital to your product’s success. It makes sense to trust a partner with longstanding expertise in cleanroom manufacturing – one who can guarantee the quality of your product. Overall, relying on a single, trusted partner ensures the highest quality product and greatest transparency for the customer.