Guidebook on Pharmaceutical Cleanroom Monitoring System | February 9, 2016 10:00 AM - February 9, 2016 1:00 PM |

Guidebook on Pharmaceutical Cleanroom Monitoring System

Event Summary

February 9, 2016
February 9, 2016 10:00 AM
February 9, 2016 1:00 PM
Online Compliance Panel
[email protected]
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This webinar details and explains the various US and international regulatory requirements for various cleanroom classifications. Environmental control of pharmaceutical cleanroom is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the cleanroom environment according to international regulatory standards is important from a compliance perspective.

Objectives of the Presentation
GMP Compliance of Cleanroom Environment
Regulatory Cleanroom Classification and Requirements
HVAC System Components
Cleanroom Design and Layout
HEPA Filtration
Differential Pressure and Air Pressure Balancing Considerations
Temperature and Humidity Controls
Cleaning and Disinfection
Non-Viable Particulate Monitoring Systems
Microbial Monitoring Systems
Personnel Gowning and Aseptic Practices in Cleanroom
HVAC System Validation

Why Should you Attend
It is important that a Cleanroom's HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.

The webinar provides a comprehensive overview of the mechanics of cleanroom HVAC. This includes engineering diagrams and schematics. HVAC equipment components are detailed as well as the automated control systems that are available. Cleanroom design considerations are included. Proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the Cleanroom.

The principles of HEPA filtration are described along with desired Cleanroom airflow patterns and how to achieve them. Proper procedures for HEPA filter leak testing is included. The webinar then provides valuable information on differential pressure, air velocity, flow rates, and air pressure balancing. Temperature and relative humidity controls and specifications are also detailed.

All current air monitoring systems for non-viable particulate and microorganism measurement are fully reviewed. Comprehensive procedures for cleaning and sanitization of the Cleanroom environment are presented along with a review of the best disinfectants currently available along with their respective advantages and disadvantages.

The subject of Cleanroom contamination due to personnel is discussed. This includes both gowning technique and aseptic practices. Finally, a full set of requirements for HVAC system validation is detailed. Ongoing monitoring of the Cleanroom environment is discussed with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.

Who can Benefit
This webinar will provide valuable assistance to all personnel in:
Quality Assurance
Environmental Monitoring

Note: Use Promo code SMMSE and get 10% off on registration (Valid till March 31st)


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