Description
This book addresses a long felt need in the industry for coherent information on “contamination control, cleanrooms and biosafety” and offers insights, guidance and assistance to ensure that facilities, practices and procedures are in step with current norms.
The highlight of the book is its focus on the environmental expectations and testing for continued compliance as laid down in :
- ISO 14644 Standards for Cleanrooms and Qualification
- ISO 14698 Final Draft International Standards for Biological Monitoring and Control
- MCA Orange Guide December 2002, just released
- USFDA Draft Guidelines for Sterile Drug Products by Aseptic Processing as released on September 27, 2002
- The WHO Guidelines for Sterile Pharmaceutical Preparations
By explaining the Whys, Hows and Whats, it helps clear myths and misconceptions that abound in the industry, and presents a composite, holistic approach to understanding, analyzing and synthesizing cleanroom systems and practices. Starting from basics the book takes the reader progressively to advanced concepts and techniques that a layman as well as the expert can appreciate and apply the emphasis is centered around real life problems throughout the books.
Whether you belong to Aerospace or Zoonosis, if contamination Biosafety is your concern, this book is for you.
About the Authors:
K. Moorthy is a graduate in Electrical Engineering from the Indian Institute of Technology, Bombay, with postgraduate qualifications in Marketing Studies from The Institute of Marketing London.
He is actively involved as Technical Expert assisting several upcoming labs and facilities around the country and acts as consultant to major Pharmaceutical and Biotech Companies.
His 30 years of experience have been in applications engineering in the fields of medicare (patient care and diagnostics) and microcontamination control (cleanrooms and laminar airflow technologies). He conducts inplant training as well as public workshops on Microcontamination Control, Biosafety and Good Aseptic Practices, which has drawn participants from industrial sectors. He facilitates at special workshops on the subject convened from time to time by DRDO, BARC and SSPL.
His intimate knowledge of the subject, and his ability to present complex concepts and insights, to both laymen as well as professionals and management, in a manner that is easy to understand and apply has won him acclaim all round.
He conducts regular inplant training as well as public workshop on Microcontamination Control, Biosafety and Good Aseptic Practices, which has attracted participants from different industrial sectors. He acts as facilators at special workshops conducted by Defence Research and Development Organization (DRDO), Bhabha Atomic Research Centre (BARC) and many advanced research labs.
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