Two-Day Online Course: Aseptic Processing in Pharmaceutical and Biotech Manufacturing

ByMike V. Cooper

Dec 24, 2021

DUBLIN, December 24, 2021 / PRNewswire / – “Aseptic Processing in Pharmaceutical and Biotech Manufacturing” training has been added to ResearchAndMarkets.com offer.

The objective of the Aseptic Processing in Pharmaceutical and Biotechnology Product Manufacturing 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 broad categories according to their mode of production: those which are terminally sterilized after filling and sealing the container and those which are aseptically sterilized, i.e. sterilized. by filter as a bulk product, filled and then sealed. Aseptic processing plays a vital role with large molecules that cannot be terminally sterilized. The verification of the production process of sterile products is assessed by demonstrating various simulations of the media filling process which will vary both in number and size of containers as well as filled volumes over a defined period of time.

Aseptic processing involves risk assessment on an ongoing basis due to the inherent risks due to the consequences of management and process failure and the challenges of detection, isolation, control and management of contamination. some products. In aseptic processing, the severity of the consequences of failure can be severe for the end user, while detection by sterility testing remains rather limited due to the small number of end 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 methods, that is, by membrane filtration.

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

Various variables can impact the assurance of sterility and the level of endotoxin that accompanies it. These include personnel, process, equipment, components, sterilization, depyrogenation as well as tools and utilities that impact the management and handling of end products. Issues that need to be considered include monitoring of environmental areas and personnel, water sources, racks and media fillings, dressing and disinfection.

Products that have historically been aseptically filled have relied on the use of USP sterility testing <_1> to demonstrate sterility. However, since no more than 20 containers are tested per medium (TSB and FTM) regardless of the size of the production lot, the use of sterility testing does not provide a high degree of sterility assurance (SAL). .

Thus, media fillings are now used to simulate actual fillings and to demonstrate at least a 10-3 sterility assurance level of freedom from contamination. If the facility uses RABS or isolators to meet their filling needs, a SAL of 10-5 to 10-6 is possible as interactions with personnel and the environment decrease dramatically.

Media fillings 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.

It will review the issues of media preparation and installation of 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 examined as well as clothing issues that arise periodically. The seminar will also discuss media failures and how to “overcome” them.

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

Seminar participants will learn the following:

  • Acquire an understanding of the fundamentals and skills necessary to perform aseptic processing of sterile pharmaceuticals with minimum risk
  • Analyze issues affecting 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 media infill simulations to include “worst case” scenarios
  • Learn the best techniques for determining media infill sizes
  • Understand the “critical factors” required to maintain compliance
  • Reduce inspection observations
  • Avoid warning letters and consent decrees

Agenda

Day 1

Join the conversation 7.45 a.m. – 8.00 a.m.

Start the seminar 8h00

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 dress code
  • Documentation and evaluation of changes

To break 9.45 a.m. – 10.00 a.m.

Sources of Contamination in Aseptic Manufacturing

  • Particle content checks, risk of cross contamination
  • Cleaning processes and agents for sterile production

Question 11:15

End of the Seminar 11:30 AM

Day 2

Join the conversation 7.45 a.m. – 8.00 a.m.

Start the seminar 8h00

Development of media filling requirements in an aseptic environment

  • FDA Form 483
  • Equipment set up
  • Sterilization process

To break 9.45 a.m. – 10.00 a.m.

Media filling

  • Smoke studies and their focus in aseptic production (ISO class 5 facilities)
  • Sources of endotoxins

Question 11:15

End of the Seminar 11:30 AM

For more information on this training, visit https://www.researchandmarkets.com/r/d63zvq

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SOURCE Research and Markets

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