ISPE Hands-On Aseptic Processing & Pharmaceutical Water Systems and HVAC for Pharma Facilities Training

4-Day Training Event at the European Aseptic and Sterile Environment

13 - 16 MAY 2024 | (EASE) Facility Strasbourg, France


What to Expect?

Overview of EASE Facility

Strasbourg, France


Training

HVAC for Pharma Facilities Overview - Days 1 and 2


Ensure control of critical environments within your facility and maintain GMP inspection readiness through improvements to your air, HVAC, and contamination controls. Topics include control system alarm management, common system construction deficiencies, GMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.

  • Implement global GMPs for HVAC and Environmental Control
  • Control and monitor HVAC system-critical parameters 
  • Utilize pharmaceutical cleanroom air classifications 
  • Improve product protection through efficient HVAC operation 
  • Select HVAC system designs appropriate for each production phase
  • GMPs for Environmental Control and HVAC
  • Control of Contaminants and Cross-Contamination in Critical Environments
  • The Design to Qualification Process (The Design Continuum)
  • Cleanroom Design Considerations
  • Cleanroom Design Techniques
  • Typical Systems
  • Documentation, Maintenance and Inspection
  • Other References
  • Final Exam, Exercises

Global Governance Critical Utilities
Boehringer Ingelheim GmbH

Stephan Neumann an M.Sc. in Utility Engineering and an M.Sc. in Pharmaceutical Microbiology. With a tenure at Boehringer Ingelheim since 2002, he has held various roles in local engineering and Corporate Quality and currently serving as the Global Head of HVAV & Critical Utilities in the global engineering organization. His experiences include designing, commissioning, and validating HVAC and Critical Utilities systems, as well as providing support and maintaining technical engineering standards for pharmaceutical water systems and HVAC systems across the global production sites.

He did contribute to the ISPE Handbook "Production of Water for Injection without Distillation", which describes multiple ways to produce WFI acc. to European regulations. He also was a chapter lead for the ISPE Good Practice Guide on  "Membrane Based WFI systems", ISPE Good Practice Guide on "Maintenance" and was co-chairing the revision of the ISPE Good Practice Guide on "Process Gases".

Stephan is also one of two technical experts of the EDQM Water Group. This group is responsible for the water monographies in the European Union.

Pharmaceutical Water Systems Overview - Days 3 and 4


Pharmaceutical Water is, perhaps, the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for delivering pharmacopoeial Purified Water (PW) Water for Injections (WFI), and Highly Purified Water (HPW).

This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.

Upon completing days 1 and 2 of this event, you will be able to examine methods for proper water quality selection and receive detailed guidance regarding the choice and use of appropriate construction materials and instrumentation. Particular attention will be paid to

  • System and component sanitisation procedures and microbial control 
  • Guidance regarding appropriate monitoring programmes during ongoing operation as well as during initial system qualification.
  • Regulatory
  • Planning and Programming
  • Basic Water Chemistry and Microbiology
  • Pretreatment and Purification Processes
  • Choice of Systems and Processes
  • Basic Chemistry and Microbiology
  • Storage and Distribution Configurations
  • Storage and Distribution Design
  • Rogue, Stainless Steel and Passivation
  • Tradition, Risk and Science Based Water System
  • System Sampling
  • Pre-Course work materials
    • This course includes access to course content that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
    • The course will also cover regulatory requirements including USP, EP, and JP Monographs, the USFDA Guide to Inspections of High Purity Water Systems, current FDA views, and current Good Manufacturing Practice (cGMP) requirements. Common water system myths will also be explored and a variety of practical system designs will be evaluated for EP, EMA, USP and FDA compliance, as well as their advantages and disadvantages. Particular attention will be paid to system and component sanitization procedures and microbial control.
  • Interactive exercises
  • Utilities Tour of a HPW/WFI system + Pure Steam generator at the EASE facility
  • Learning assessments
  • Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
  • Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases

Global Governance Critical Utilities
Boehringer Ingelheim GmbH

Stephan Neumann an M.Sc. in Utility Engineering and an M.Sc. in Pharmaceutical Microbiology. With a tenure at Boehringer Ingelheim since 2002, he has held various roles in local engineering and Corporate Quality and currently serving as the Global Head of HVAV & Critical Utilities in the global engineering organization. His experiences include designing, commissioning, and validating HVAC and Critical Utilities systems, as well as providing support and maintaining technical engineering standards for pharmaceutical water systems and HVAC systems across the global production sites.

He did contribute to the ISPE Handbook "Production of Water for Injection without Distillation", which describes multiple ways to produce WFI acc. to European regulations. He also was a chapter lead for the ISPE Good Practice Guide on  "Membrane Based WFI systems", ISPE Good Practice Guide on "Maintenance" and was co-chairing the revision of the ISPE Good Practice Guide on "Process Gases".

Stephan is also one of two technical experts of the EDQM Water Group. This group is responsible for the water monographies in the European Union.


Who should attend this 4-Day hands-on training event?

  • Production operators, quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management having assigned ATMP-focused roles/responsibilities
  • Managers of production and quality assurance
  • Process engineers
  • Engineers responsible for infrastructure and maintenance
  • Quality managers
  • Shop floor supervisors
  • Suppliers for equipment and infrastructure of aseptic manufacturing plants
  • A/E consultants in facility design
  • Project/manufacturing engineering resources engaged in ATMP project execution
  • Personnel who need an in-depth understanding of the potential risks around ATMP manufacturing
  • Service organizations, suppliers, and vendors who serve pharmaceutical industry clients focused on ATMP manufacturing
  • Academic Institutions engaged in ATMP development/manufacturing
  • Vendors and suppliers of equipment/systems focused on the global ATMP “launch”
  • Scale
  • Closed systems & single-use
  • Patient-specific therapies

Register Now!


Pricing

  Early Registration *Ends 31 Dec 2023 Regular Registration
Member $3,200.00 $3,500.00
Non Member $3,500.00 $3,800.00
Government $1,600.00 $1,600.00
Student $1,000.00 $1,000.00

EASE Training Facility

  • EASE, Campus d’ILLKIRCH 80 route du Rhin 67400 ILLKIRCH, France EU

    EASE, Campus d’ILLKIRCH 80 route du Rhin 67400 ILLKIRCH, France EU

  • Upstream

    Production & QC area upstream

  • Upstream 2

    Production & QC area upstream 2

  • Production area for sterile liquids

    Production area for sterile liquids

  • Production area for dry forms

    Production area for dry forms

  • Air treatment system

    Air treatment system