Facilities, Utilities & Cleanroom Qualification for Pharmaceuticals and Biologics

De: Ben O'Shea

Narrado por: Virtual Voice

This book integrates the fundamentals of facility design for clean rooms, adjacent zones and clean utilities. There is extensive resources available that address these topics, however, they are often taken in isolation with a focus on one particular subject. This publication by Modular MedTech pulls the core knowledge across facility design, HVAC, cleanroom classification and clean utilities into one consolidated title. The book is presented in large 7.5inches x 9 inches with colour illustrations included where necessary.
After reading this book the reader should be confident in understanding how requirements for facilities are defined and how requirements are assessed through design qualification and verified in qualification and validation.
Introduction to Commissioning, Qualification And Validation
Regulatory Requirements
EU GMP V Annex
Validation and product lifecycle
Cleanroom Qualification
Cleanroom Environment
Cleanroom Zoning and Classification
Types of Contamination
Cleanroom Classification Table
Zone Classification
HVAC Particulate Control
Total Airflow Volumes & Recovery Rates
Unidirectional flow
Temperature
Relative Humidity (RH)
Control and Spread of Smoke
Cleaning
HVAC System Design
ISO Standards for Cleanrooms
Temperature
Air Handling Units
Filtration
course/ PRE- Filtration
Fine / SECONDARY Filtration
Compliance Tests for GMP Zones
Clean Room Design Considerations
Utility Gases & Water
CLEAN STEAM
RO Water, DI water and Water for Injection
Water Systems
High Purity Water System Design
Water for Injection
WFI generation, storage and distribution
Microbial Limits
Purified Water Systems
Compressed Air- Generation, storage and distribution
Introduction
Compressed Air Design Requirements
Design Element: Inlet Air filters
Design Requirements
Design Qualification
DQ Evaluation
Clean steam
Facilities Monitoring
Gase Systems
Argon Gas
CARBON DIXOIDE
oxygen
Steam Sterilization
Sterilization and Disinfection
Parametric Approach
Risk and Sterility
Spaulding’s classification
Cleaning
Clean-in-Place (CIP)
PIC/S Guidance on Limits
Antimicrobial Techniques
Pasteurization
Sterilisation Processes
FDA Categorisation of Established Sterilization Processes
Steam Sterilizer (Moist Heat) - Development of Sterilization Processes
The Sterilizer as Equipment
The Sterilization Process
Validation of Steam Sterilizers
Requalification
Industry Standards relevant to Sterilization
Principle of Operation
Alternatives to Steam Sterilization
Ethylene Oxide (EO)
Oxidizing and Non Oxidizing Disinfectants
Sodium hypochlorite
Depyrogenation
Pyrogens
Bacterial Toxin
Pyrogen Assay - Limulus Amoebocyte Lysate
Endotoxins and Depyrogenation
Biological Indicators for Dry Heat
Control of Materials
Contamination Considerations
Start-up Condition
Failure of Depyrogenation
Depyrogenation -Performance Qualification (PQ)
Aseptic Processing
Design Considerations for Isolator Systems
Definition of Aseptic Processing
Regulations and Standards
Technical Comparison of Terminal Sterilization and Aseptic Processing
Isolator and Glove Access
Isolator Design Requirements
Materials of Construction
Isolator Access
Isolator Decontamination
Isolator Barrier Systems
Isolator Interfaces
Isolator Decontamination
Facility Layout for Aseptic Processing
Air Classifications
Filling Operations
Aseptic Process Simulation
Sterile Barrier Packaging Systems
Material Compatibility
Factors in Design and Development
Performance of Packaging System
Stability of Packaging
Lifecycle approach to Sterile Barrier Systems
Factors in Sterile Barrier Validation
(c) 2024, Modular MedTech