Environmental monitoring (EM) of cleanrooms is the responsibility of the microbiologist and requires many decisions, para. B example how often to monitor, where to monitor, which samples to take, which culture medium to use, how long to incubate, how to interpret the data and what identifications to make. It suggests that certain conditions may require microaerophilic monitoring, for example when.B using certain gases or when the sterility test with anaerobic media fails. Independent consultant Julie Roberts (J. Roberts Associates) examined how to manage the identification (ID) of non-sterile MS, discussed, for example, which colonies to identify, and decided how far the analysis should go. Before emerging markets can begin, environmental control should first be addressed, Roberts said. “Think about how the cleaning process, operators and material transfer are controlled.” The chapter deals with established monitoring methods, i.e. for surfaces, it talks about the use of swabs and contact plates; for air (space and housing), it examines active air samples and deposit plates; and to watch people, he talks about finger swabs and clothes plates. There are also useful tips for studying trends.

He discusses what to look for when obvious trends occur, for example, .B suggests looking at HVAC maintenance, disinfectant practice, unusual events or activities in the cleanroom, physical temperature fluctuations, and employee training. Environmental monitoring (EM) was one of the topics discussed at Pharmig`s recent two-day meeting in Oxford. Changes to emerging markets guidelines, guidance on EM strategies and their limitations were discussed. Susan Birks points out some of the key points that the USP reminds microbiologists that all monitoring methods are flawed and that one method cannot detect all types of contamination, Sandle said. For example, air samples are said to be particularly low, surface methods have low recovery rates, and all methods of recovering damaged or stressed microorganisms are poor. Therefore, numerical targets in the UFC should not be used as limits, but as targets – and low or no counts are not in themselves guarantees of microbial control. “Are you waiting for an action limit to fail, or are you doing something at the alarm limit, or are you interested in everything on that plate because it`s from a Class A area? Would you change your strategy if you had an Environmental Monitoring Performance Qualification (EFM) with a significant change to a plant? And if you do a media fill, are you going to move to another level of identification? The chapter stresses that an em program should not be created and implemented until airflow mapping and heating, ventilation and air conditioning (HVAC) technology dynamics have been optimized. It also emphasizes particle control and practical monitoring and acknowledges that there will be occasional fluctuations of particles, especially for UDAFs in clean rooms, and says there will be fluctuations with insulators, so control here should be more important. However, to more accurately determine which microbes are exact, FOCUS laboratories will perform microbial identifications using biochemical or genetic methods. Risk assessment allows the microbiologist to make better decisions about where to look and how to determine what`s there – but there`s still no guarantee of success. However, EM finds microbes, and after incubation, decisions must be made about which colonies to identify and study on the plates. “Should you look at each colony on a single plaque or decide that some look the same, so look at each of them that look different?” Roberts asked.

. It is important to know how many microbes are in the facility, but also what kind of microbes. FOCUS Laboratories characterizes each colony from a surface or air plate into groups such as Gram-negative rods, staphylococci, etc., so that the customer has an idea of the origin of the contamination and the risk. CLICK HERE to learn more about microbial identification. In any case, the levels of action and alert should be rational and justified and should be continuously reassessed and improved. FOCUS laboratories can help determine rational alarm and action levels based on past historical trends. FOCUS Laboratories uses either a histogram approach or a standard deviation approach. Contact us for more information. After the initial clean-up, several days of MS are required to demonstrate that the plant has been properly cleaned and that the environment is no longer polluted Annex 1 of the European Union: Manufacture of sterile medicines Due to the limitations of the quantification technology, the lowest number of PDUs that can be accurately reported is five. Therefore, this suggests that if the number is less than 15cfu and the trend is good, this is not a problem.

However, if the number is greater than 15, an examination is required. This is in relative contradiction to current EU regulatory expectations, where measures for outcomes above 4-10CFU would be expected, Sandle said. Sampling frequencies are also less stringent than in THE EU-GMP, and the document states that sampling points should be based on careful observation of the clean room, with the most likely route of contamination being in the air. Laboratories with larger budgets may be able to purchase one of the many instruments that enable phenotypic or genotypic identification of species. All these identification methods (visual, photographic, phenotypic or genotypic) can be acceptable provided that they are well rationalized and justified by the company. Those working in non-sterile processes are unlikely to need PCR IDs, while those performing sterile filling operations need the ability to regularly specify organisms and perform PCR IDs when sterility errors or media filling errors occur,” she said. USP : Recommended initial recovery rates for contamination. Roberts then discussed EMPQ procedures. When moving walls or installing new equipment or filling line, the area must be requalified. The first step is to review the emerging markets risk assessment and determine where the samples are best located.

then look at how the microflora of this area has changed; also find out which plates will be examined. USP strongly supports the use of rapid microbiological methods in MS, but does not specify how they could be used. All references to validation have since been removed from the chapter. This chapter does not refer to the condition of the “dormant” cleanroom as used in other guidelines. The USP chapter refers to the fact that everything is “working.” As regards the guidelines for air change rates (AC), the 20 conventional AC/h used in EU GMPs have been abolished and the USP recommends different air levels for different classes of clean rooms (see Table 1). Keen reminded delegates that a European Championship programme is not a static thing; whenever something changes in the production area, that is…