Sterility Assurance - Concept and fundamentals

Sterilization is an essential stage in the processing of any product destined for parenteral administration, or for contact with broken skin, mucosal surfaces, or internal organs, where the threat of infection exists. In addition, the sterilization of microbiological materials, soiled dressings and other contaminated items is necessary to minimize the health hazard associated with these articles.
Sterilization processes involve the application of a biocidal agent or physical microbial removal process to a product or preparation with the object of killing or removing all microorganisms. These processes may involve elevated temperature, reactive gas, irradiation or filtration through a microorganism-proof filter. The success of the process depends upon a suitable choice of treatment conditions, e.g. temperature and duration of exposure. It must be remembered, however, that with all articles to be sterilized there is a potential risk of
product damage, which for a pharmaceutical preparation may result in reduced therapeutic efficacy, stability or patient acceptability. Thus, there is a need to achieve a balance between the maximum acceptable risk of failing to achieve sterility and the maximum level of product damage that is acceptable.
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
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[@manikumar-kw7kc]

Neat n simple explanation... Thank you

[@TheMaheshLawate]

Can you clarify this from EU Volume 4 annex 1 as I am confused how to include load dryness by visual inspection in SOP or part of line clearance?
8.56 The items to be sterilised, other than products in sealed containers, should be dry, packaged in a
protective barrier system which allows removal of air and penetration of steam and prevents
recontamination after sterilisation. All loaded items should be dry upon removal from the steriliser.
Load dryness should be confirmed by visual inspection as a part of the sterilisation process
acceptance.

[@ravinderreddy2676]

sir please explain about Risk assessment on new facility creation