2 Day Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers Course - September 8-9, 2021 - ResearchAndMarkets.com

The "Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers" training has been added to ResearchAndMarkets.com's offering.

This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection.

The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures),Gowning Controls, Personnel Training, Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy), Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program and the Basics of Sterilization Processes- Physical and Chemical Processes will also be discussed.

The various regulatory bodies' requirements such as 21 CFR Part 211 (mostly relevant 211.113 "Control of microbiological contamination", ISO 14644 (Various Parts), FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice") amongst others and the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products are important to the quality determination and release of the finished manufactured products.

Learning Objectives

• Discuss Cleanroom Classification, Regulations and Guidelines
• Summarize how to Perform Cleanroom Design, Validation/Qualification, Operation, Environmental Monitoring Program and ensuring a state of control
• Describe Aseptic Practices, Personnel Health Practices, Gowning and Trafficking Patterns in a Cleanroom
• Establish and describe the Requirements of Cleanroom Cleaning/Disinfection and Contamination Control Practices
• Summarize various Sterilization Processes, Advantages and Disadvantages - both Physical and Chemical
• Describe the Sterilization Processes and Controls

Key Topics Covered:

DAY 01 (9:00 AM TO 4:00 PM EDT)

9:00 AM - 10:00 AM: Module 1

• Cleanroom Guidelines, Regulations and Definitions
• Summary of Key Areas of Cleanroom Technology and Classifications
• Define the EU, ISO and USP Recommended Limits for Microbial Contamination
• Cleanroom Design and Initial Design Considerations
• Cleanroom Design Guidelines - Facility Layout, Airlocks or Anteroom, Windows and Speaking Diaphragms, Pass-through and Gowning Rooms
• Cleanroom Design Guidelines - Cleanroom Location, Make-up Air, Cleanroom Walls- Seamless, Non-porous Surface

10:00 AM - 10:15 AM: Break

10:15 AM - 11.00 AM: Module 2

• Review Cleanroom Design Guidelines (Material of Construction for Cleanroom Ceilings), Cleanroom Doors and Cleanroom Floors
• Discuss the Design Guidelines (HVAC & Filtration Systems) and the types of Cleanroom Airflow

11:00 AM - 12:00 PM: Lunch Break

12:00 PM - 01.30 PM: Module 2

• Summary of the principles and regulations guiding Cleanroom Validation (OQ/PQ) and Operation testing
• Performing Cleanroom Effectiveness Verification Tests and utilizing Cleanroom Cleaning Validation Data in a PQ Process
• Designing a Cleanroom Performance Qualification (PQ) Protocol and Report
• Applying the Fundamentals of Environmental Monitoring (EM) Program, Limits, Requirements, Excursion Investigation and Data Trending
• Perform a correlation between Contamination Control and Environmental Monitoring
• Understand the Causes of Adverse Trends

01:30 PM - 01:45 PM: Break

01:45 PM - 03.00 PM: Module 3

• How to Use the principles of Aseptic Practice regulation to set up an Aseptic Environment and for the manufacturing of a product
• Cleanroom Practices - Personnel Health and Cleanliness, Personnel Practices (Sterile Gloves, Sterile Gowns and Operator Technique)
• Step-wise approach in performing workstation and Equipment Cleaning and Disinfection
• Process flow/Trafficking Patterns for Equipment, Materials, Personnel, Supplies and Waste within a Cleanroom

03:00 PM - 04.00 PM: Question and Answers

DAY 02 (9:00 AM TO 4:00 PM EDT)

9:00 AM - 10.00 AM: Module 1

• Cleaning/Disinfection Program Guidance and Regulations
• The Basics of Microbiology and Contamination Control and Mitigation
• GMP Cleanroom Cleaning and Primary Cleanroom Contaminants
• Cleanroom Gowning Guide, Garment Recommendations, Gowning/Degowning and Requirements by ISO Classification

10:00 AM - 10:15 AM: Break

10:15 AM - 11.00 AM: Module 2

• Sterilization Processes and Methods (Physical and Chemical)
• Terminologies and factors influencing Thermal (Heat) Sterilization
• Examples of Dry Heat Sterilization (Hot air oven, Flaming (AKA Red Hot Sterilization), Incineration, Dry Heat Tunnels, Infra-red Radiation
• Moist Heat Sterilization and Examples - Pasteurization, Boiling, Tyndallization, Autoclave/Steam Sterilizer.

11:00 AM - 12:00 PM: Lunch Break

12:00 PM - 01.30 PM: Module 2

• Advantages and Disadvantages of various types of dry heat and moist heat sterilization processes
• How to Differentiate between Ionizing and non-ionizing Radiation including microwave Radiation, Ultraviolet Radiation, Gamma Rays/Gamma Sterilization
• Use and Disadvantages of Ionizing Radiation-Gamma Radiation
• Chemical Sterilization Methods using various types of liquid sterilants such as Phenolic, Hydrogen Peroxide, Halogens, Chlorine and Alcohols, Heavy Metals, Quatenary, Peroxygens and Aldehydes

01:30 PM - 01:45 PM: Break

01:45 PM - 02.45 PM: Module 3

• Chemical Sterilization using Gaseous Method such as Ethylene Oxide, Formaldehyde and Glutaraldehyde Sterilization
• Sterilization by Filtration and various types of Filters
• Monitoring of Sterilization Processes using Mechanical and internal chemical Indicators
• Routine Monitoring of Steam Sterilizers and Ethylene Oxide Sterilizers - Bowie Dick Type Tests and Test Results
• Installation & Repair Testing and Sterilization Process Monitors

02:45 PM - 03.45 PM: Review of case studies

03:45 PM - 04.00 PM: Question and Answers

For more information about this training visit https://www.researchandmarkets.com/r/4p27ke

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