Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. It is a major determinant in ensuring the quality of a pharma product. Control of the following is crucial to protect the product from contamination:
- Airborne particulate
- Differential pressure
- Air velocity
If these have to be controlled and the quality and safety of the pharmaceutical product are to be assured, it is necessary to design, monitor and validate a clean room HVAC system. It is also necessary to get a proper understanding and testing of the clean room environment according to international regulatory standards from a compliance perspective.
A webinar on giving full understanding of cleanrooms
A complete understanding of all these aspects of a cleanroom will be the content of a highly educative webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this webinar, Roger Cowan, who is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing, will be the speaker.
Roger’s areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.
Please visit http://bit.ly/2xQeo8o to enroll for this webinar.
Cleanroom from all perspectives
It is important that a clean room’s HVAC system is fully understood, properly designed and 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. At this webinar, Roger will explain the various US and international regulatory requirements for various clean room classifications. He will offer an understanding of Environmental Control vs. Environmental Monitoring.
Roger will then offer a comprehensive overview of the mechanics of cleanroom HVAC, at which elements such as engineering diagrams and schematics, HVAC equipment components, the automated control systems that are available, cleanroom design considerations, the proper building construction and layout necessary for achieving both optimum efficiency of the system and optimum cleaning and sanitization of the clean room, are included.
Principles of HEPA filtration
In addition to the physical aspects of a cleanroom, Roger will also delve into the principles of HEPA filtration. Other issues such as the desired clean room airflow patterns and how to achieve them, proper procedures for HEPA filter leak testing, differential pressure, air velocity, flow rates, air pressure balancing, and temperature and relative humidity controls and specifications are also detailed.
And then, Roger will take up comprehensive procedures for cleaning and sanitization of the clean room environment, where he will review the best disinfectants currently available along with their respective advantages and disadvantages. He will then detail clean room contamination due to personnel, at which both gowning technique and aseptic practices are discussed.
HVAC systems validation and monitoring
Finally, Roger will also detail the full set of requirements for HVAC system validation and ongoing monitoring of the clean room environment with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.
This webinar provides high value to personnel in areas such as Quality Assurance, Environmental Monitoring, Microbiology, Manufacturing, Validation, Engineering, and Maintenance.