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IVT Brief Points

This document provides an overview of the organization, training, and process flow for sanitizing an aseptic facility. It discusses setting up the proper organization structure, providing basic training to personnel on microbiology and cleanroom behavior, and outlining the sanitization process. The sanitization process involves classifying cleanroom areas, material movement procedures, monitoring the cleanroom, cleaning versus disinfection methods, and sanitizing the facility, equipment, and air systems. It aims to prevent microbial contamination and comply with international standards through proper sanitization procedures.

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40 views2 pages

IVT Brief Points

This document provides an overview of the organization, training, and process flow for sanitizing an aseptic facility. It discusses setting up the proper organization structure, providing basic training to personnel on microbiology and cleanroom behavior, and outlining the sanitization process. The sanitization process involves classifying cleanroom areas, material movement procedures, monitoring the cleanroom, cleaning versus disinfection methods, and sanitizing the facility, equipment, and air systems. It aims to prevent microbial contamination and comply with international standards through proper sanitization procedures.

Uploaded by

Masthan GM
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Brief Introduction On Organization, Training and Process flow for Sanitization of an

Aseptic Facility

Speaker Details : Amjad Ganma


MSc in Pharmaceutical Validation (London)
Quality Unit Manager
Tabuk Pharmaceutical Manufacturing Company
Tabuk, Kingdom of Saudi Arabia

Introduction:
This training enlightens an insight view of aseptic manufacturing facility and its features that
focus on possible measures to gain the advantages to execute all the measures to comply
with international standards and overcome pons-and-cons in the aspect of Sanitization. The
regulation tightens and pays vigorous attention in dealing with Aseptic Facility; therefore, the
Organization plays a major role to conduct training on appropriate technical personnel on
process flow of sanitization of an Aseptic Facility.

In a nutshell: Aseptic manufacturing is complex working procedure, which consists of


several consecutive and necessary working steps, each of them contributing its part towards
the aim of manufacturing an aseptic product (prevention of microbial contamination) with
strict compliance to the international regulation and standards, which can be achieved only
by having proper sanitization established procedures.

Part One: Organization Set-up

 General Design Criteria


 Lay Out Considerations
 Room Function
 Surface Finishes and Materials of Construction
 GMP Requirements for Electrical Systems

Part Two: Basic Training

 Microbiology for the non microbiologist


 Gowning training
 Cleanroom behavior
 Understand Disinfectors and Disinfection Procedures
 Sources of Contamination
 Microbiological Controlled Environments

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Brief Introduction On Organization, Training and Process flow for Sanitization of an
Aseptic Facility

Part Three: Process Flow

 Classifications for Airborne Environmental Cleanliness Requirements.


 Area Classification for Typical Process Stages.
 Material movement.
 Personal attention and movement during process.

Part Four: Sanitization

 Clear Room Monitoring during aseptic operations.


 Cleaning Versus Disinfection.
 Disinfectant and Antiseptics.
 Mechanism of Disinfectant Activity.
 Equipment Considerations
 Sanitization Methods
o Automated Cleaning Systems
o Steam Sterilization and Sanitization
o Chemical sterilization and Sanitization (Vapor and Gaseous)
o Air System Cleaning and Sanitization
 Cleaning and Disinfectant Materials
 Facility Sanitization.

Part Five: Interactive Exercise

 Aseptic Processing Issues.


 Case-study
 Warning Letters

Part Six: Bonus Material

 Validation Plan for Aseptic HVAC System.


 Qualification Protocol for Disinfectant

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