The performance standards of clean rooms and clean room air purification systems are often an area of significant focus for those in the environmental health and safety industries. This is often in reference to decisions about the design of facilities, or standards and regulations when making decisions about what industries to service and what infrastructure this requires. However, when was the last time you thought about how your existing systems are performing? In industries where clean rooms are used, deploying a system for your intended level of service is not sufficient assurance unless you have also tested its configuration to meet your standard and conduct ongoing monitoring to confirm ongoing compliance. Without monitoring, it is impossible to know whether the system you are using is meeting the promised standard and if you are in continued compliance with a regulatory requirement or supplier agreement. Therefore, the environmental monitoring of clean rooms is an important consideration for Aeroex and those in the quality or health and safety industries.
Requirements for Environmental Monitoring
Some regulatory environments require ongoing environmental monitoring, meaning that irrespective of the benefits (see below) you will need to do it. You should be aware of your ongoing monitoring requirements at the outset when establishing a clean room.
In Canada, Annex 1 to the Good Manufacturing Practices Guide (GUI-0119) outlines how to do monitoring depending on the class of clean room you operate, with higher levels requiring constant monitoring and lower levels requiring more periodic monitoring. There is some flexibility in sample size when compared to the definitions in ISO 14644. In the United States, an independent standard was maintained until 2001 when the General Services Administration adopted ISO 14644 for internal use as the standard for environmental monitoring of clean rooms.
Benefits of Environmental Monitoring of Clean Rooms
Environmental monitoring of your clean room may seem like an added expense or undue workload when it is first considered. However, this proactive measure brings many benefits to the organization and the client. It can even help save you money or find opportunities. Some of the benefits include:
- Performance Guarantees. If you have a good supplier of air purification systems like Aeroex, your purchase agreement will likely include expectations about the minimum standard of performance under ideal operating conditions.
- Items Under Warranty You may also have purchased a limited or extended warranty. If you do not check the performance of your air purification system through clean room environmental monitoring, you may miss a malfunctioning part that could be easily replaced under your warranty. Take advantage of the warranty with monitoring for signs of any issues.
- Save Money on Filters Changes and Purification System Maintenance Even with Aeroex air purification systems that use large volumes of filter media to prolong filter changes and avoid clogging, all systems eventually require filter changes. Typically, manufacturers will provide approximate timelines between changes but how do you know when exactly to do so? Some environments with heavy contaminants require frequent changes to keep performance up to par while others may last longer than expected due to other beneficial sterilization measures taking place. If you do environmental monitoring, you can use the changes in conditions to correspond with a change in filter with clear justification. So long as you meet performance standards, you may be able to save money by waiting on a filter change.
- Clean Room Design Features. Air purification systems are one aspect of clean room design, and performance is impacted by other features like airlocks, doors and furnishings, appliances, garments, etc. If environmental monitoring shows a slide in performance and your air purification system is fully functional you may need to take a look at the other clean room inputs. Continued monitoring during retrofits can help to quantify the benefits of changes you make to your clean room operation or detect when a new process positively or adversely impacts your environment.
- Compliance. Environmental monitoring logs can help to easily demonstrate compliance with a regulatory requirement or supplier agreement, or even to prepare you for an ISO 14644 certification.
- Data. When you perform environmental monitoring, the data you get provides an immediate snapshot into the state of your clean room and air purification systems. However, the value of this data grows over time as it turns from a snapshot to a historical trend report. As you get more data, you will be able to see trends in how your clean room performs which can lead to inquiries that result in failure finding, root cause analysis, optimizations and savings, etc.
How to Conduct Environmental Monitoring
The aforementioned GUI-0119 provides practical advice on how to conduct environmental monitoring. Devices like portable particle counters can be used, provided that the tubing is not too long (which can cause condensation in the tubing while traveling to the sampler). The unidirectional airflow requirement of high-level clean rooms can pose additional sampling challenges, resulting in the need for isokinetic sample heads. A monitoring system could use multiple airborne sampling points, which could feed one or more particle counters. Typically, the system used depends on the expected particle sizes you will encounter and are trying to regulate. Some materials have greater risks, such as radiopharmaceuticals.
Once you have selected the equipment you wish to use, you will want to create a sampling plan including identifying the particle types you need to detect, designating your sample points, and establishing a baseline of background conditions. Once operational, continue monitoring while recording your sanitation practices as well as any issues you detect.
Your Clean Room Experts
At Aeroex we are advocates for environmental monitoring of clean rooms. We design our systems for a long life of high performance and know models like the Air-Fit will hold up to continued monitoring. We are partners committed to your success and appreciate any dialogue or observations that come out of your monitoring efforts. When selecting your clean room air purification system, we will keep environmental monitoring considerations front of mind and make recommendations about how best to achieve your targets. If you are seeking a partner committed to the long-term success of your clean rooms, contact Aeroex today.