Aseptic Processing and Sterilization

Aseptic Processing - Introduction

Basic Microbiology

Lesson Code: PST-1200. Introduces microorganisms and the impact they have on pharmaceutical products.

Isolators

Lesson Code: PST-1220. Introduces isolators and discusses the components and functions of different types of isolators.

Lesson Code: PST-1210. This Lesson is aimed at personnel who require an overview of how HVAC systems are used in cleanroom environments to regulate airflow, pressure, temperature, and humidity, and how HEPA filters regulate air quality.

Cleanrooms - Rules, Control Parameters, and Testing

Lesson Code: PST-1265. This e-Lesson is aimed at personnel who require an overview of general cleanroom rules and the cleanroom parameters that are controlled, monitored, and tested in pharmaceutical and biologics facilities.

Aseptic Processing - Cleanroom GMP

Aseptic Processing – Concepts and Controls

Lesson Code: ASP-1101 (PREMIUM LESSON). This e-Lesson is for personnel in regulated industries who require an overview of Aseptic Processing, including technologies and techniques for contamination control and prevention, and procedures used to minimize bioburden

Aseptic Processing - Cleanrooms and Control Technologies

Lesson Code: ASP-1102 (PREMIUM LESSON). This e-Lesson is aimed at personnel in regulated industries who require an overview of how cleanrooms are used in Aseptic Processing, how cleanrooms are designed and operated, and the role of associated contamination control technologies such as HVAC systems, HEPA filters, pressure cascades, and airlocks.

Aseptic Processing - Gowning

Lesson Code: ASP-1103 (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-1104 (PREMIUM LESSON). This e-Lesson is aimed at personnel in regulated industries who require an overview of the contamination prevention measures, procedures, and practices that are typically implemented in aseptic processing including the use of cleanrooms, cleanroom gowning, cleanroom cleaning procedures, microbial testing, correct cleanroom behavior, and appropriate personal hygiene.

Aseptic Processing – Decontamination and Sterilization Technologies

Lesson Code: ASP-1105 (PREMIUM LESSON). This e-Lesson is aimed at personnel in regulated industries who require an overview of methods typically used to decontaminate and sterilize equipment, consumables, containers/closures, and products as part of Aseptic Processing. Methods covered include moist heat, dry heat, hydrogen peroxide vapor, and filtration.

Sterilization

Sterile Filtration

Lesson Code: PST-1293. 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.

Gas Sterilization

Lesson Code: PST-1295. This e-Lesson is aimed at personnel who require an overview of the use of ethylene oxide (ETO) in gas sterilization, the products that can be sterilized by this process, the equipment and procedures used, and the critical sterilization parameters.

Moist Heat Sterilization - Autoclaves

Lesson Code: PST-1291. This e-Lesson is aimed at personnel who require an overview of moist heat (steam) sterilization via autoclaving, including equipment used, critical process parameters, and the different stages of a sterilization cycle.