Two-Day Virtual Course: Aseptic Processing in Pharmaceutical and Biotech Manufacturing – June 23-24, 2022 –

DUBLIN–(BUSINESS WIRE)–The “Aseptic processing in the manufacture of pharmaceutical and biotechnology products” training has been added to from offer.

Aseptic processing in the manufacture of pharmaceutical and biotechnology products The objective of the course is to explore the role of aseptic filling in ensuring that the manufactured product will maintain the level of sterility assurance prescribed by GMP

Sterile products can be classified into two main categories based on how they are produced — those that are terminally sterilized after the container has been filled and sealed, and those that are aseptically sterilized, i.e. filter sterilized as a bulk product, filled and then sealed.

Aseptic processing plays an essential role with large molecules that cannot be terminally sterilized. Verification of the sterile product production process is assessed by demonstrating various media filling process simulations which will vary in both number and size of containers as well as volumes filled over a defined time period.

Aseptic processing involves continuous risk assessment due to the inherent risks due to the consequences of management and process failure and the challenges of detecting, isolating, controlling and managing product contamination. In the context of aseptic processing, the severity of the consequences of a failure can be serious for the end user, while detection by sterility testing remains rather limited due to the small number of finished products tested.

The FDA and EMA require that any product that can be terminally sterilized be handled in this manner. However, almost all large molecules and some small molecules can only be sterilized by aseptic processes, i.e. membrane filtration.

With membrane filtration, establishing acceptable levels of microbiological contamination is essential to ensure both product safety and compliance. Responding to sterility complaints for Stage 1, 2, 3 and commercial products quickly and efficiently is important to avoid costly delays. Additionally, since aseptic processes are associated with the control of endotoxins, this must also be managed to acceptable levels.

Various variables can impact sterility assurance and the level of endotoxin that accompanies it. These include personnel, process, equipment, components, sterilization, depyrogenation, and facilities and utilities that impact the handling and processing of end products. Issues that need to be considered include monitoring environmental areas and personnel, water sources, media and media fills, property and sanitation.

Products that have always been filled aseptically have relied on the use of USP sterility testing to demonstrate sterility. However, since no more than 20 containers are tested per rack (TSB and FTM) regardless of production lot size, the use of sterility testing does not provide a high degree of sterility assurance (SAL). ). Thus, medium fills are now used to simulate actual fills and to demonstrate at least a 10-3 sterility assurance level without contamination. If the facility uses RABS or isolators to meet its filling needs, an SAL of 10-5 to 10-6 is possible because interactions with staff and the environment decrease markedly.

Media fills are required when commissioning an aseptic operation in a new facility, when a new container configuration (volume or neck size), or other unique activities associated with aseptic filling occur. Following the continued performance of a new aseptic filling line, requalification is required every six months.

He will review the issues of media preparation and setting up the “filtration train”, environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned), and cleaning of the room. and its equipment. Equipment used to monitor equipment and personnel will also be reviewed as well as clothing issues that periodically arise. The seminar will also discuss media failures and how to “overcome” them.

Due to the sensitivity and importance of media fillings, this live interactive training seminar is a MUST for anyone in your organization involved with aseptic filling in general and media fillings in particular. Please plan to attend as part of an interactive group project.

Learning objectives

  • Gain an understanding of the fundamentals and skills necessary to perform aseptic processing of sterile pharmaceuticals with minimal risk

  • Analyze issues impacting aseptic processing to include environment, personnel, clothing and disinfection

  • Acquire the skills necessary to master the process environment

  • Minimize media fill failures to enable production throughput

  • Determine how to develop support fill simulations to include “worst case” scenarios

  • Learn best practices for determining media padding sizes

  • Understand the “critical factors” required to maintain compliance

  • Decrease inspection observations

  • Avoid warning letters and consent decrees

Main topics covered:

Join the conversation from 7:45 a.m. to 8:00 a.m. EST

Beginning of the seminar at 8:00 a.m.

  • Aseptic Processing – Introduction

  • The sterile dosage form

    • Maintenance and control of critical environments

    • Development of operating procedures, calibration, preventive maintenance, CAPA, etc.

    • Operator training to include dressing

    • Documentation and evaluation of changes

Break 9:45 a.m. – 10:00 a.m.

  • Sources of contamination in aseptic manufacturing

    • Particle content checks, cross-contamination risks

  • Cleaning processes and agents for sterile production

Questions 11:15

End of the Seminar 11:30 a.m.

Day 2

Join the conversation from 7:45 a.m. to 8:00 a.m.

Beginning of the seminar at 8:00 a.m.

  • Development of support filling requirements in an aseptic environment

  • FDA Form 483s

  • Installation of equipment

  • Sterilization process

Break 9:45 a.m. – 10:00 a.m.

  • Media fills

  • Smoke studies and their importance in aseptic production (ISO class 5 facilities)

  • Sources of endotoxins

Questions 11:15

End of the Seminar 11:30 a.m.

For more information on this training, visit

Comments are closed.