Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Level Prescribed by GMPs

Live, Interactive Training Webinar

Date: Tuesday February 12, 2019
Time: 1:30pm - 3:30pm ET (New York Time)
Instructor: Barry A. Friedman Ph.D. Biography>>>

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Sterile products may be broadly classified into two main categories based on their production mode -- those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled and then sealed. Aseptic processes play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated by the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period of time.

Products that have historically been aseptically filled have relied upon the use of USP <71> Sterility Tests to demonstrate sterility. However, since no more than 40 containers are tested regardless of the production lot size, the use of sterility tests does not provide a high degree of sterility assurance (SAL). Thus, media fills are now utilized to simulate the actual fills and to demonstrate at least a 10-3 sterility assurance level of no contamination. If the facility uses RABS or isolators, a SAL of 10-5 to 10-6 is even possible since the interactions with personnel and the environment decrease markedly.

Media fills are required during the commissioning of an aseptic operation within a new facility, when a new container configuration (volume or neck size) or other unique activities associated with aseptic filling occurs. Following the on-going performance of a new aseptic filling line, a requalification is required at six month intervals.

The objective of this live training webinar is to explore the role of media fills in assuring that manufactured product will retain the sterility assurance level prescribed by GMPs. It will review the issues regarding preparing media and setting up the “filtration train”, environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned) and the cleaning of the room and its equipment. Equipment used to monitor the equipment and personnel will also be reviewed along with gowning issues that periodically arise. The webinar will also discuss media failures and how to “work through” them. Because of the sensitivity and importance of media fills, this live training webinar is a MUST for anyone in your organization that is involved in aseptic filling in general and media fills in particular.

Learning Benefits:
-Review aseptic processing media simulations to include the theory behind the concept .
-Review the scientific knowledge and risk management concepts involved in developing a media fill and the interpretation of the results.
-Review aseptic processing media simulations to include various process variations to include lyophilization.
-Examine why planned and unplanned media fill interruptions are a critical component of any simulation.
-Explain why environmental monitoring is an important element of process simulations.
-Review the issues of growth promotion testing and the necessity of having qualified personnel read the media fills.
-Learn how to “work through” media fill failures.
-The role of microbial identification in media fill failures.
-Case studies of Warning Letters involving media fills.
-How to gain the most information possible from each aseptic processing media simulation.

Webinar outline and time breakdown:

Time*
1:15 PM Log In Period
1:30 PM Introduction
1:40 PM Definitions,
Exploration of concept behind aseptic processing media simulations,
Looking at scientific analyses and risk management behind media simulations,
Consideration of the elements in developing a media fill; developing the necessary paperwork,
2:30 PM Break
2:40 PM Reading the results – having qualified personnel,
How to “work through” media failures and identification of microorganisms,
Warning Letters –Examples using aseptic processing media simulations,
3:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Validation
  • Product Development
  • Project Management
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Incoming Materials and Receiving

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Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>

 

 

Course Number: 231

This live training webinar is a MUST for anyone in your organization that is involved in aseptic filling in general and media fills in particular. A thorough training on the role of media fills in assuring that manufactured product will retain the sterility assurance level prescribed by GMPs, the issues regarding preparing media and setting up the “filtration train”, environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned), the cleaning of the room and its equipment, review of the equipment used to monitor the equipment and personnel.

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Client Testimonials:

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