iSpeak Blog

Inside the EASE Training Center: Where Hands-On Learning Meets Industry Excellence

Jean-François Duliere
EASE Training Center

For several years, ISPE has steadfastly organized hands-on training sessions to enrich classroom learning. Despite the challenges posed by the pandemic, we have successfully developed a program that integrates practical, experiential learning, leveraging ISPE's comprehensive training materials. We are thrilled to announce our partnership with the European Aseptic and Sterile Environment (EASE) to host our in-person instructor led training at their state-of-the-art facility in Strasbourg, France, providing participants with an exceptional hands-on learning environment.

What is EASE?

EASE is a training center strategically positioned near the prestigious Pharmaceutical University in Illkirch, a mere stone's throw from the magnificent city of Strasbourg. The EASE Training Center offers hands-on opportunities to engage with facilities, equipment, and staff members within an industrial environment purposefully constructed for training professionals in the pharmaceutical industry.

EASE Training Center

The Ground floor is dedicated to:
  • Locker rooms for entering clean areas.
  • Rooms designated for gowning training,
    • Several stations for simultaneous staff training.
    • Each company can conduct these trainings using their own gowning materials.
  • Four classrooms with easily adjustable setups depending on instructional needs
  • Technical areas, including:
  • Clean steam production and distribution
  • HPW reverse osmosis
  • Compressed Air
The First floor is dedicated to production areas:
  • Bioprocessing Upstream
    • Single use and permanent equipment
    • 1L to 200L bioreactors and stainless steel for bacteria growth
    • Ball Room setup with connection from the ceiling for mobile equipment
  • Bioprocessing downstream
    • TTF + Chromatography
    • Glass bio fermenters and stainless steel
  • OSD
    • For non-toxic API:
      • Direct compression
      • Wet granulation mixer granulator, fluid bed dryer, Sifter bulk mixer
      • Capsule filling
      • Tableting coating
      • Blistering
  • • Aseptic Processing
    • Grade C loading area for vials and introduction of stoppers in the grade B area
      • through a pass box if ready to use
      • through an autoclave if sterilization is needed
    • Access to Grade B through an airlock with windows to review the application of gowning procedures
    • A tunnel for depyrogenation between preparation room and filling area
    • Filling lines are based on RABS technology (Grade A and B)
The second floor is dedicated to HVAC:
  • Six HVAC systems dedicated to each operational area
  • AHU with observation windows to understand the construction and design
  • Some AHUs are equipped with an H202 decontamination system

This state-of-the-art facility is a groundbreaking training resource that ISPE has collaborated with to advance hands-on training, meeting the specific needs of our esteemed members and companies seeking to enhance staff training.

In 2023, ISPE successfully launched two pilot training events at EASE.

March 2023

  • A total of four – two-day courses were concurrently held, encompassing:
    • ATMP’s manufacturing
    • HVAC
    • Clean Utilities
    • Commissioning Qualification using documentation from this facility.

June 2023

  • An extensive two-day course centered on Aseptic processing and Annex 1
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Feedback From Instructors and Students

We received excellent feedback from instructors who were elated by the opportunity to deliver their trainings in a more practical manner at this facility. In addition, participants requested additional time in the hands-on training. To accommodate this request and offer attendees extended exposure to clean rooms, some training content for future events will be adjusted and distributed as pre-reading materials before the training sessions.

The ability to explain how to take air flow measurements in actual clean areas has proven to be incredibly beneficial. In the technical courses, exercises involving HVAC and clean utilities moved several times in clean rooms. The availability of having real clean areas received high appreciation from both instructors and students who had the opportunity to take real measurements.

Student feedback regarding the ATMP training has been very positive. Despite the session hosting only 14 students, a substantial five-hour duration was spent in the clean rooms, exceeding expectations.

The most recent training session at EASE focused on Annex 1 and aseptic processes, and instructors were thoroughly impressed with the facility's ability to support the course in its classrooms. During the training, we spent six hours in clean areas, with one part dedicated to manipulating connectors and operating tube welding machines. This hands-on experience allowed us to gain practical skills in this area. Additionally, time was spent in front of the biosafety cabinet, as the aseptic processes are equally applicable to ATMP, which involves manual work. We quickly realized that organizing work under a biosafety cabinet to avoid mistakes and prevent contamination is not as easy as it seems. This knowledge is also valuable for designing isolators for various operations, ensuring the equipment and gloves are located optimally. Furthermore, we spent two hours exploring an aseptic filling line in RABS, A/B. This gave us the opportunity to learn how to set up the machine, including the proper placement of needles and gloves. We also witnessed the different methods of supplying the machine with stoppers – either washed in the facility, sterilized at the entrance of the clean room, or using a pass-through for ready-to-use stoppers. Lastly, we were shown the washing machine for vials and the depyrogenation tunnel, further enhancing our understanding of the aseptic processes involved.

All these activities directly aligned with the course content. Additionally, students provided positive feedback, indicating a need for improvement in the machine-focused session f, with a smaller group of participants.

The City of Strasbourg

Strasbourg, situated along the border with Germany, is within close proximity to Basel, Switzerland, and a quick 2-hour journey from Frankfurt. The old city features a magnificent cathedral as its centerpiece. Travelers can conveniently access Strasbourg by a 2-hour train ride from Paris or a 1-hour flight from Amsterdam. Those interested in French cuisine will find the food in this area to be exceptional.

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