Cleanrooms and other controlled environments must be qualified prior to use. This is more than just making sure the particles (non-viable) are within limits of the classification to be established, according to ISO 14644-1. Classification is just one part of the overall program that needs to go into qualifying cleanroom for use. One of the first steps should be the establishment of a Master Plan. This would include, at least, a discussion as to why the room is needed, a risk analysis and management plan, the processes to take place in the room and all the necessary equipment. Also, references to the standards to be followed for the qualification in addition to ISO 14644-1, should be listed and process flows (personnel, product, waste) should be mapped.
Qualification takes place in different phases and occupancy states of the cleanroom. Installation qualification happens in the “As Built state”, after the initial construction of the cleanroom. This is to make sure the cleanroom functions as it was designed. Items typically tested during IQ are particles (classification of the cleanroom), air flow, air pressure, air exchanges, and initial (baseline) recovery of microorganisms. Also, all documents, drawings, and auxiliary systems are reviewed and deemed appropriate.
The Operational Qualification (OQ) which is performed while the cleanroom is “At Rest”. This means that all equipment and supplies are in the area and the equipment is functioning properly. Personnel are not utilized in this phase. This qualification makes sure that all the equipment and the facility are installed correctly and are working together to maintain a clean process and area. Testing is again performed for particles to ensure that the introduction of equipment has not affected the classification of the room. Air flow is demonstrated, usually with visual smoke studies. Microbial monitoring is performed to ensure that the equipment is not negatively contributing to the environment and that cleaning processes are adequate.
When the cleanroom is in the Operational state, the Performance Qualification takes place. This is when people are in the room and all processes are taking place. It is best to include the maximum number of people to be expected in the room. Monitoring for particles and microorganisms again takes place. All critical process parameters are checked to make sure they stay within pre-established limits. Also, all training for personnel working in the area should be completed and cleaning and maintenance procedures finalized. Compilation of the data from these successful tests will demonstrate that the facility is functioning properly and that that everything is ready for actual production.
Though environmental monitoring includes monitoring for temperature, humidity, light, particles, microorganisms and other possible contaminates to processes or products, it generally means testing for microorganisms (bacteria and mold). This is done by taking samples from the air and surfaces. It could also include water and compressed air testing. Environmental monitoring is performed throughout all stages of cleanroom qualification. Typically, the number of sites is determined based on the number of sites used for the particle testing. It also continues routinely on a daily, weekly, monthly or other schedule, based on a risk assessment, and at less sites, but includes critical control points. LexaMed can provide the sampling plates and the equipment to keep you in compliance.
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