2019 ISPE Aseptic Conference

Next Steps in Future of Aseptic Processing: Containment, Multi-Product Facilities, & Robotics

The 2019 ISPE Aseptic Conference focuses on the future of aseptic processing, including containment, multi-product facilities, and the increasing use of robotics. Now in its 28th year, join us for the Aseptic Conference to discover more about these aspects of Aseptic Processing:

Emerging/Trending Technology

The pharmaceutical industry must identify and drive emerging trends in new technology. We’re looking for case studies about technologies such as “lights-out” processing, gloveless isolators, closed-system processing, advanced on-line monitoring, rapid-microbiological monitoring, and pulsed-light decontamination.  We’re also looking for companies the use automated, clean-in-place isolators to enable multi-product flexibility for toxic/ high-potency materials.  

Single Use

Single-use systems in the pharmaceutical industry offer a lot of advantages: no material prep and sterilization on site, off-the-shelf solutions, and reduced capital investment. At the same time, per batch cost of goods increases, and maintaining reliable supply with vendors and their changes can be challenging. Leachables and extractables, particles, leaks, and integrity can also become bigger issues. Submit a case study/presentation sharing your knowledge and experience implementing single-use systems.  

Flexible and Multi-Product Facilities

Building flexibility into new facilities is key to optimal operational usage. Submit a case study/presentation where flexibility was included early in the design phase, allowing for seamless transitions for evolving requirements. The best flexible lines include provisions to run different products in different presentations on the same line. To achieve this, quick change-over procedures, including measures to avoid cross-contamination, need to be in place. We’re looking for examples of facilities where this strategy has been successfully implemented and approved by regulatory authorities.  

Aging Facilities and Upgrades/Renovations

The Survey on Aging Facilities conducted by ISPE in 2018 showed that many facilities are falling behind in upgrading to current aseptic standards and regulatory expectations. Upgrades and renovations, while keeping the facilities in operation are possible. Submit a case study of a successfully executed upgrade. Examples of such upgrades may include retrofit of a conventional filling line to a RABS filling line. We’re also looking for the regulatory filing aspects of these upgrades.

Robotics

Inspired by the advancement of robotics in other industries, the pharma industry is beginning to challenge the traditional aseptic model with an ideal goal of zero operator intervention in the aseptic filling/stoppering process. Robots can be used to minimize manual glove port manipulations and reduce both the amount and the complexity of equipment. They offer full flexibility for various packaging types with rapid format change and ensure accurate and clean container handling. Above all, robotic systems can be adapted to meet evolving pharma industry requirements. We’re looking for case studies of successfully implemented robotic technology to reduce human intervention.

Small Batches/Personal Medicine/ Modular Technology

Many drivers in the pharmaceutical industry are pushing manufacturing operations toward smaller batches, including personalized/ individualized/ stratified medicine, including cell and gene therapies. Beginning now and growing in the future, one batch may be one vial/ bag for one patient. This strong trend raises questions and brings new challenges: how to test and release a “batch” of one container? How to validate a “batch” of one container? Sterility assurance? Supply chain? Submit your real-world case studies in this evolving area.  

Containment and Sterility, Cleaning and Cross Contamination Prevention

By the year 2025, every second new Biopharmaceutical product will be considered highly potent and/or toxic with the oncology sector driving the growth. New combination products like ADC`s “Antibody Drug Conjugates”, Gene and Cell Therapy create more stringent requirements for cleaning in multi-product facilities to prevent cross-contamination and provide occupational safety for the operators. Share your experience with multi-product facilities with potent/toxic products.


Who Should Attend?

  • Sterile products processing Community of Practice participants
  • Engineering system owners or project managers responsible for aseptic processing equipment
  • Validation personnel responsible for aseptic processing equipment qualification
  • Quality assurance personnel responsible for maintaining the integrity of aseptic systems
  • Equipment manufacturers and suppliers providing state-of-the-art aseptic technology including robotics
  • Aseptic manufacturing subject matter experts and management
  • Aseptic processing consultants and regulatory specialists
  • Manufacturers of design, facilities, building, commissioning, and validation
  • Plant managers
  • Quality systems/assurance and quality control (QA/QC)
  • Engineering sterility assurance
  • Small-scale facilities and compounding pharmacies

Learning Objectives:

  • Manage the complexities of a high potent fill-finish process
  • Implement the newest technology in aseptic filling
  • Effectively manage leachables and extractables
  • Standardization of single-use equipment for fermentation, purification, and fill-finish
  • Barrier technology management
  • Small-scale manufacturing and clinical supply
  • Contribution of robotics to sterility assurance in aseptic

Program Committee

NAME
Jörg Zimmermann
Vice President
Bereichsleiter Vetter Development Service
Vetter Pharma-Fertigung GmbH & Co. KG, Germany
NAME
Hite Baker
Principal Process Engineer
DME, USA
NAME
Richard Denk
Director Sales Containment
SKAN AG
NAME
Klaus Ullherr
Senior Product Manager
Robert Bosch Packaging Technology GmbH
NAME
Christa Meyers
Senior Pharmaceutical Engineering Specialist
CRB
NAME
Michael Faia
Associate Director
Project Management, Jazz Pharmaceuticals, Inc.
NAME
Matthew VonEsch
AVP
Xeno and Regenerative Medicine Operations, United Therapeutics Corp.
NAME
Walt Senour
Principal Process Engineer
Retired