Скачать или смотреть HPHV Cycle , Sterilization Controls, Steam Quality and Validation aspects

The provided source is an article from Pharmaceutical Resource & Education Services that analyses the High Pressure High Vacuum (HPHV) cycle in steam sterilizers, drawing on extensive validation experience. It offers guidance intended to assist personnel involved in validation testing, acting as a training tool or refresher concerning steam sterilization principles. The text details the various stages of the sterilization cycle (t1 through t6), defines key terms such as equilibration time and holding time, and specifies acceptance criteria for critical parameters like temperature and pressure during the plateau period. Furthermore, the source outlines the necessary steam quality tests—including dryness, superheat, and non-condensable gases—and recommends the use of biological indicators for cycle validation, referencing standards like BS EN 285:2015.

This Video Presented By:
Palash Chandra Das, M.Pharm (Pharmaceutical Chemistry)

About Myself:
I have completed my B.Pharm and M.Pharm in Pharmaceutical medicinal chemistry from WBUT. In the year 2010, I started my journey in the Pharmaceutical Industry. In my career I worked with the F & D, Production and Quality Assurance department etc. I have a good exposure in several Sterile Green field and Brown field projects. Involved in various regulatory audit like CDSCO, WHO, USFDA,TGA,MHRA, GERMAN, UKRAINE, ANVISA-Brazil, INVIMA-Colombia, RUSSIA, IRAN, PMDA-Japan, South Korea etc.
Core Technical Skill:
Sterile Injectable dosages form (SVP and LVP ) with liquid and lyophilized form
Qualification & Validation , Computer System Validation, Sterility Assurance, Quality Management System, Risk Management, cGMP training, Failure Investigation , Auditing

Follow me,
Read my blog Pharmaceutical resource and educational services at: https://pres.net.in/blog/
Follow me at LinkedIn :   / palashchandradas  
Follow me at Twitter :  / palash_das  
Follow me at Instagram:   / pharmacistpalash  

Join Me,
Admin and Member of "Global Federation of Pharmaceutical Industrial Association"
Free joining link :   / onlinepharma  

Share your queries and concern at [email protected]