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Environmental Monitoring and Disinfectant Efficacy Testing

Honeyman Group Ltd

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Course Description: In today?s society hygiene has become increasingly important, and it is essential that manufacturers produce safe products through the control of hygiene and ultimately biocontamination control. Biocontamination control largely used to be dependent upon anti-microbial agents, however now that the use of these agents have been reduced, or even forbidden in some countries, manufacturers need alternative biocontamination control measures. Environmental monitoring is a method of biocontamination control, which does not directly interfere with the product or manufacturing process. Environmental monitoring of controlled environments represents a critical process control step in the manufacture of pharmaceutical products with a high emphasis placed on products manufactured within the controlled environment of a clean room. However, given the variety of environments, sampling equipment and methods there is no definitive standard or regulatory document which defines the requirements for every scenario or environment as this would be impossible to implement. Environmental monitoring allows pharmaceutical manufacturers to continually monitor the effectiveness of control measures and also allows any threats to the product being manufactured to be identified. A formal system of biocontamination control should be established, implemented and maintained within cleanrooms and the associated environments. A poorly designed or badly managed programme may result in misleading data in relation to the manufacture or assessment of products. Environmental monitoring represents a high percentage of the microbial analysis performed in an average production plant and as such, must be designed and managed with great care. The programme should involve monitoring of air and personnel as well as surfaces. It is important that through your environmental monitoring programme the focus is placed on product safety rather than on demonstrating that the perfect sterile environment exists. Disinfection forms a fundamental part of the maintenance schedule for any manufacturing facility. Recently, there has been an increasing amount of interest in disinfection practices, as inadequate disinfection can have a direct impact on product quality and therefore risk to the patient. Therefore, the use of disinfectant falls under the remit of cGMP and should be controlled as such. The aim of this two day course is to deliver a thorough understanding of the many different considerations that must be made when devising and executing an environmental monitoring programme in both sterile and non-sterile manufacturing environments, an introduction to effective cleaning procedures and disinfectant regimes, the development of effective cleaning and disinfectant agents and the validation and control of these procedures. 'Excellent/interactive/extremely useful - thank you!' Quality Director, Pharmapak (UK) Ltd, Wirral, UK Seminar Programme: Regulatory Requirements and Recommendations - Especially BS EN ISO 14698 (?Cleanrooms & Associated Control Environments - Biocontamination Control?) and ISO 14644 (?Cleanrooms & Associated Control Environments - Air Cleanliness?). Specific Standards Relating to the Clean Room Environment and the Environmental Controls and Measures which are Required to be In Place, Classification of Air Cleanliness. How to Choose Representative Sites in the Critical Zone as well as the Surrounding Areas. Viable (Microbiological) and Non-Viable Monitoring. Methods and Techniques Available i.e. the Use of Contact Plates for the Monitoring of Surfaces, Settle Plates to Enable Air Quality Monitoring and Swabs for the Sampling of Irregularly Shaped Articles and ?Hard to Reach? Areas. Selection of Monitoring Locations and Frequencies Including Clean Rooms, Changing Rooms, Manufacturing Areas. Interpretation of Results. Trend Analysis and Review of Data. What to do With the Data Generated? How ?Action? and ?Alert? Levels are Defined as Indicated in T

Course Description: In today?s society hygiene has become increasingly important, and it is essential that manufacturers produce safe products through the control of hygiene and ultimately biocontamination control. Biocontamination control largely used to be dependent upon anti-microbial agents, however now that the use of these agents have been reduced, or even forbidden in some countries,...

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