I never thought I’d end up inspecting medical clean rooms. Honestly, I thought I’d be working in a lab making groundbreaking discoveries, or at least wearing a fancy white coat. But life has a funny way of leading you down unexpected paths. It all started when I accidentally walked into a clean room on my first day at work—without realising I needed to be suited up. Safe to say, my colleagues weren’t impressed with me contaminating the space! Fast forward a few years, and here I am, a seasoned clean room quality inspector at AMT Pte Ltd, ensuring that everything in our medical clean room assembly process meets the highest standards. The irony still makes me chuckle.
Setting up a medical clean room for device assembly is a serious business. It’s not just about cleanliness; it’s about creating a highly controlled environment where even the smallest particle could impact the quality and safety of the medical devices being manufactured. Here are the key considerations you should take into account when setting up a medical clean room for device assembly.
1. Understanding Clean Room Classifications
Before diving into the nitty-gritty, you need to determine the clean room classification you require. Clean rooms are classified based on the number of particles permitted per cubic metre of air. In medical clean room assembly, the most common standards to follow are ISO 7 or ISO 8. ISO 7, for example, allows a maximum of 352,000 particles per cubic metre, while ISO 8 allows more—up to 3.5 million particles.
It’s important to understand these classifications early in the planning process, as they dictate the types of filters, airflow systems, and protective measures you’ll need. At AMT Pte Ltd, we adhere strictly to these classifications to ensure we produce medical devices that are both safe and compliant with regulatory requirements.
2. Airflow and Filtration Systems
One of the most crucial aspects of a medical clean room is its airflow and filtration systems. Proper airflow is essential for maintaining the clean environment necessary for medical clean room assembly. High-Efficiency Particulate Air (HEPA) filters are commonly used to remove 99.97% of particles as small as 0.3 microns.
Ensure your clean room has laminar airflow, meaning that air flows in parallel streams to reduce turbulence, which can dislodge particles from surfaces and contaminate products. A tip here is to check your air filter systems regularly—if they’re not working at peak efficiency, you’ll find your clean room quickly becomes more like a regular room, which is bad news for medical device manufacturing!
3. Temperature and Humidity Control
Controlling temperature and humidity is critical for two reasons: first, to maintain the integrity of sensitive medical devices, and second, to ensure that employees are working in comfortable conditions. High humidity can cause condensation, which is disastrous for medical device components, especially electronics. On the flip side, low humidity can cause static build-up, which can interfere with delicate manufacturing processes.
At AMT Pte Ltd, we maintain strict control over temperature and humidity levels to ensure that every aspect of our medical clean room assembly process is optimised for quality. Automated monitoring systems can be a great investment to keep an eye on these environmental factors without the need for manual checks.
4. Proper Gowning and Staff Training
This brings me back to my early days—proper gowning is essential to avoid contamination in the clean room. Every person who enters a clean room must wear specialised garments, such as coveralls, gloves, masks, and goggles. At AMT Pte Ltd, we take gowning procedures very seriously. It’s not just about donning the gear, but also about putting it on in the correct order, ensuring no skin is exposed.
Equally important is training. Everyone working in the clean room must be trained on best practices, from moving around to handling materials. Even the smallest lapse in protocol can introduce contaminants.
5. Regular Monitoring and Maintenance
Once your clean room is up and running, it’s not a “set it and forget it” situation. Regular monitoring is essential to ensure that the room continues to meet the necessary standards. This includes particle counts, pressure differential checks, and air change rates.
Make sure you schedule regular cleaning and maintenance of your equipment and environment. Even small issues like a clogged air filter or improper gowning practices can significantly impact the integrity of the clean room. At AMT Pte Ltd, we have a rigorous inspection schedule in place to catch potential issues before they become major problems.
Conclusion
Setting up a medical clean room for device assembly is a meticulous process that requires careful attention to detail. From understanding clean room classifications and airflow systems to ensuring proper gowning and continuous monitoring, every aspect of the environment plays a crucial role in maintaining the quality and safety of medical devices.
At AMT Pte Ltd, we pride ourselves on our state-of-the-art clean room facilities and the stringent standards we uphold throughout the medical clean room assembly process. With the right planning, training, and equipment, your clean room will be well-equipped to handle the complexities of medical device manufacturing—just remember not to walk in un-suited like I did on day one!
