Due to stringent regulations, most pharmaceutical and life sciences products must be produced in clean room conditions – and a clean room door is the first step in ensuring a safe and clean environment. But choosing the right door for this highly specialized environment can be challenging.
That’s where a high-performance clean room door can help. These specially designed doors ensure the highest levels of purity and quality in your clean room to support regulatory compliance and product quality.
Advantages of high-performance doors
Regulatory compliance. A high-performance clean room door must meet Current Good Manufacturing Practices (cGMP) regulations, as well as any applicable USDA, FDA, NSF and ISO standards.
Proper humidity levels. High humidity levels can cause many problems in a clean room, such as bacteria growth, product degradation or damage, as well as corrosion. It can also lead to static electricity, which can interfere with the movement of particles inside the clean room. Fluctuating humidity levels can also make clean room employees uncomfortable, which could lead to costly mistakes or production delays.
Standard clean room guidelines state that Relative Humidity (RH) levels in clean rooms should remain between 30-40% RH year-round. A high-performance door can help you easily maintain these humidity levels in your clean room.
Controlled temperatures. Even small fluctuations in clean room temperatures can cause issues for people and products. When cleaning staff or technicians shiver or sweat, they release more particles into the air, which could contaminate the environment and compromise production standards.
In general, the temperature of a clean room should be maintained at 69.8°F (21°C). A high-performance door helps regulate this temperature to keep employees comfortable and maintain product integrity.
Quality seals. Good sealing performance can maintain the cleanliness level, ensuring high-quality production. Look for a high-performance door that includes a full-size seal to keep contaminants out.
Fast open and close rates. High-performance doors open and close quickly to minimize air incursion and contaminant ingress.
Pressure differential control. A high-performance door helps maintain the correct pressurization within a clean room to prevent cross-contamination between environments and block contaminants from entering production areas from adjacent areas.
Cleanability. High-performance doors come in a variety of materials designed for easy cleaning. For example, a stainless-steel door allows complete wash-down to virtually eliminate potential sites for bacteria manifestation.
Rytec offers door models that meet all stages of guidelines and a variety of compliance needs. Whether for basic full sealing capabilities, full wash-down to ensure cleanliness or strict USDA/FDA or cGMP guidelines adherence, there’s a Rytec door for your specific application.
Contact us today to discuss your clean room door needs.
