How Personnel are monitored
Personnel in critical areas may be monitored for microbial contamination utilizing contact plates. The contact plates monitor areas of the body that may interact with the sterile field or product exposure areas. These may include gloved hands, forearms, or other areas. Personnel monitoring is a good indication of how well personnel are gowning when they enter the clean room. Many companies utilize this testing for proficiency based training programs for clean room personnel.
Environmental organisms recovered from manufacturing areas should be identified to show what organisms are present, and what may be contaminating the product. Knowing will provide the company with important information in monitoring and preventing potential future contamination pitfalls. Microbial identification is another service which E/M Associates, Inc offers. It is important that proper disinfectants are used on a routine basis to keep the level of house organisms in check. A disinfectant study should be implemented to demonstrate the effectiveness of the sanitizers used against "house organisms." This effectiveness study exhibits to regulatory agencies that the company is using the correct sanitizer at appropriate dilutions and contact times to combat potential contamination.
There are many factors one should consider when determining what locations in a clean room to sample. These factors include potential product exposure areas, processing parameters, HEPA locations, equipment design and validation criteria. Frequency of monitoring depends on product and quality requirements. Sampling frequency may be subject to change depending on trending analysis and changes in equipment, processing or number of personnel. A sampling plan describing procedures and identifying sample sites, sampling numbers and sample frequency should be developed and properly documented in order to demonstrate that there is a constant level of control over the environment within the clean room facilities.
Alert and Action levels should be implemented based on your products, the intended use of the clean room and the classification of the clean room. There are three classifications for clean room facilities and each has it’s own Alert and action levels. The three classifications are ISO 5 (Grade A), ISO 7 (Grade C) and ISO 8 (Grade D). ISO 5, having the lowest Alert and Action levels of environmental contaminants and ISO 8 having the highest. An Alert is an indication that the level of microbial growth may me reaching an undesirable level. If an Action Level occurs, sanitation of the area should begin immediately as well as an assessment of what caused the Action level to be reached. Monitoring should be increased until microbial counts return to a desired level.
A well developed Environmental Monitoring Program is a proactive way to assure the cleanliness of the manufacturing facility is maintained.
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