Inside the EASE Training Center: Where Hands-On Learning Meets Industry Excellence
Jean-François Duliere
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.
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
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.
Jean Francois Duliere is a Pharmacist by education. Jean Francois started his professional life 20 years in pharmaceutical industry Quality Control, Production in various positions...
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