Aseptic Processing and Sterilization


Aseptic Processing - Introduction

Basic Microbiology

Lesson Code: PST-600. Introduces microorganisms and the impact they have on pharmaceutical products.

Isolators

Lesson Code: PST-320. Introduces isolators and discusses the components and functions of different types of isolators.

Aseptic Processing - Cleanroom GMP

Aseptic Processing – Concepts and Controls

Lesson Code: ASP-1001 (PREMIUM LESSON). Explains why aseptic processing is used by providing an overview of microbial contamination and its effects on products. It describes how this contamination can be prevented by using controls and procedures that minimize bioburden in the manufacturing environment such as cleanrooms, gowning, appropriate behavior of personnel, and environmental monitoring.

Aseptic Processing - Cleanrooms and Control Technologies

Lesson Code: ASP-1002 (PREMIUM LESSON). Describes how cleanrooms are designed, constructed and operated to prevent contamination of products. This includes descriptions of HVAC and HEPA filters, unidirectional airflow, air locks, cleanroom architecture, pressure cascades and location of key equipment.

Aseptic Processing - Gowning

Lesson Code: ASP-1003 (PREMIUM LESSON). Describes the different gowning requirements typically used in aseptic manufacturing facilities to prevent contamination of products. It emphasizes the criticality of following correct gowning procedures for different cleanroom classes using ISO 5/6, ISO 7 and ISO 8 as examples.

Aseptic Processing – Contamination Control

Lesson Code: ASP-1004 (PREMIUM LESSON). Describes the main microbiological contamination threats found in an aseptic processing environment and how they can be contained using personnel gowning, appropriate cleanroom behavior, personal hygiene, and good cleaning and sanitization techniques, as well as microbial monitoring regimes.

Aseptic Processing – Decontamination and Sterilization Technologies

Lesson Code: ASP-1005 (PREMIUM LESSON). Describes methods typically used to decontaminate and sterilize equipment, consumables, containers and closures, and products before they are used or brought together in aseptic processing. Includes moist heat, dry-heat, VHP, and sterile filtration.

Sterilization

Sterilization and Prevacuum Autoclaving

Lesson Code: BPU-760. Describes steam sterilization, different autoclave types and the steam sterilization process including critical parameters, sterilization cycle, process monitoring and safety precautions.

Dry Heat Sterilization

Lesson Code: PST-392. Describes Dry Heat Sterilization and the products that can be sterilized by this process. Also covers the equipment and procedures used and the critical sterilization parameters.

Sterile Filtration

Lesson Code: PST-693. Describes Sterile Filtration and the products that can be sterilized by this process. Also covers the equipment and procedures used and the critical sterilization parameters.

Radiation Sterilization

Lesson Code: PST-394. Describes Radiation Sterilization and the products that can be sterilized by this process. Also covers the equipment and procedures used and the critical sterilization parameters.

Gas Sterilization

Lesson Code: PST-395. Describes Gas Sterilization and the products that can be sterilized by this process. Also covers the equipment and procedures used and the critical sterilization parameters.