Description:

• Environmental regulation of pharmaceutical clean rooms is fundamental to the production of a quality item. The meaning of Environmental regulation and Ecological Monitoring is debated. Control of conditions like microorganisms, temperature, airborne particulate, moisture, differential weight, air velocity, airflow, and workforce is significant to shield the product from pollution.
• Therefore, the plan, approval and continuoussupervision of a clean room HVAC system is important to guarantee the quality and security of the pharmaceutical products.
• Likewise, an appropriate comprehension and testing the surroundings of the clean room in relation to international regulatory principles is critical from a compliance point of view.

Why should you attend ?

• It is vital that a spotless room's HVAC system is completely realized, appropriately designed and accurately approved. In the event that this is achieved, it will give the environmental control that is required to satisfy the regulatory particulate and microorganism levels needed to produce quality pharmaceutical product.
• The first thing this webinar is about is details and explanation of the diverse US and worldwide regulatory prerequisites for different clean room classifications.
• Afterward, the webinar gives a broadoverview of the technicalities of clean room HVAC. This incorporates engineering graphs and schematics. Components of HVAC equipment are definite and also the computerized control systems that are obtainable. The considerations of clean room design are included. Appropriate construction of buildings and blueprint is important to accomplish both ideal productivity of the system and ideal cleaning and purification of the clean room.
• The standards of HEPA filtration are portrayed alongside required cleanroom airflowmodels and how to accomplish them. Legitimate techniques for HEPA filter spill testing is incorporated.
• The webinar then gives worthwhileinformation on differential pressure, rates of flow, air speed and balancing ofair-pressure. Temperature and relative humidity management and conditions are likewisecomprehensive.
• Detailed methodsof cleaning and purification of the surroundings of theclean room are introduced alongside a survey of the best disinfectants that is presentlyobtainable alongside their individual benefits and hindrances.
• The subject of clean room infectionas a result of staff is discussed This involves both gowning procedure and aseptic practices.
• Lastly, a complete set of prerequisites for HVAC system approval is detailed. Current observing of the clean room surroundings is talked about according to schedule, details, and OOS (out-of-spec) activities that might be needed.

Area covered in the session:

• GMP Compliance of Clean Room surroundings
• Clean Room Design and Layout
• Regulatory Clean Room Classification and Requirements
• Temperature and Humidity Controls
• Differential Pressure and Air Pressure Balancing Considerations
• Personnel Gowning and Aseptic Practices in Clean Room
• Cleaning and Disinfection
• HVAC System Validation
• HEPA Filtration
• HVAC System Components

Who will benefit:

This webinar will give significant help to all staff in:

• Quality Assurance
• Validation
• Engineering
• Manufacturing
• Maintenance
• Environmental Monitoring
• Microbiology