Containment: The Devil is in the Detail

Wednesday 22 September - Thursday 23 September

Seminar Content Level: Intermediate

Seminar Leaders: Richard Denk, Hecht Technologie, Germany; Lisa Cardo; GSK, Italy

The devil is in the detail. There is no more appropriate expression in relation to containment. During this two-day seminar, we will review the critical points when planning a new containment facility or modernising an already existing manufacturing plant.

Topics covered during the seminar will include: maintenance of containment transfer systems, containment process systems, waste handling, and cross contamination and cleaning. Interfaces to other systems, such as filters and quick couplings such as Tri Clamps round off the programme. 

The seminar will also include a workshop allowing participants to discuss various topics in small groups. A specially-developed case study covering problems occurring frequently in industry will be used to focus the discussion. Afterwards, there will be a panel discussion with subject-matter experts. Participants can expect an interactive seminar with a comprehensive insight into the world of containment. This seminar will provide an overview of powder containment concepts as well as state of the art engineering solutions.

Take Back to Your Job:

  • Understand that different toxicology limits are set for worker, product, and environmental protection
  • Identify the critical areas for waste handling, maintenance, cleaning, and interfaces on containment transfer systems
  • Be aware of latest trends in containment
  • Describe how other industry professionals solve containment challenges
  • Understand the new technologies available and their impact on containment and cross-contamination

Who Should Attend:

Project, process or manufacturing engineers, environment and health and safety professionals, quality assurance, professionals from production or manufacturing operations, professionals from process development, owners or operators, consultants, CMOs

Related Technical Documents:

  • ISPE Baseline® Guide: Volume 1 – Active Pharmaceutical Ingredients
  • ISPE Baseline® Guide: Volume 2 – Oral Solid Dosage Forms
  • ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
  • ISPE Knowledge Briefs:
    • Risk-based Approaches to Cross-contamination
    • Containment Hierarchy of Controls
    • Dry-powder Sampling and the Containment of Hazardous
      Compounds

Communities of Practice (COPs):

API, Containment, Disposables, OSD, Product Process Development

 

Programme

Day 1 Wednesday 22 September

10.00 – 10.15 Welcome and Introduction
Lisa Cardo, GSK (Italy); Richard Denk, HECHT Technologie GmbH (Germany)

10.15 – 11.00 Keynote - Regulatory View on Containment Issues in Europe
Catherine Lefebvre Afssaps (France)
Stay tuned for updated session information.

11.00 – 11.45 High Containment for a Multipurpose OSD Production
Bernd Mümmler, Excella Pharma Source (Germany)

  • Process and equipment design
  • Product handling and operating procedures
  • Personal protective equipment

11.45 – 12.30 Production with Safe Handling of Highly Active Compounds (OEL 40ng/m3)
Friederike Hermann, Lonza (Switzerland)

  • How to develop a containment process in the laboratory
  • What it means to provide safe quality control in the laboratory
  • Surrogate testing and occupational hygiene monitoring

12.30 – 13.30 Lunch and Networking Break

13.30 – 14.30 Workshop on Two Case Studies Part I
Pam Davison, PJD Process (UK)

  • Case study 1 - API multi-product
  • Case study 2 - OSD multi-product
  • Delegates form initial views based on knowledge brought to seminar

14.30 – 15.15 Reduction of Airborne API, Decontamination of Protective Clothing, Reducing Crosscontamination
Martin Axon, Safebridge (UK)

  • The application of a fogging/misting shower in production operations
  • Differences between a fogging and a misting shower
  • The potential for operator exposure and cross contamination during protective clothing removal due to presence of API on clothing surface
  • The significant effects of the use of a fogging/ misting shower on airborne API and surface contamination associated with protective clothing

15.15 – 15.45 Break

15.45 – 16.30 Developing a Risk Based approach linked to a Banding System
Peter Marshall, AstraZeneca (UK)

16.30 – 17.15 Concept for Efficient Handling of Highly Potent APIs for the Manufacture of Solid Dosage Forms – Dedicated Area for Sex Hormones
Hubert Bensmann, Haupt Pharma Münster GmbH (Germany)

  • Consistent high/closed design from dispensing of API to coating of tablets
  • Challenge between investment volume and EHS/GMP requirements
  • Risk-based approach for selection of equipment
  • How to keep manufacturing costs under control

17.15 – 17.30 Questions and Answers, Close of Day 1
Lisa Cardo, GSK (Italy); Richard Denk, HECHT Technologie GmbH (Germany)

17.45 – 18.45 Exhibition Networking Reception

 

Day 2, Thursday 23 September

09.00 – 09.15 Review of Day 1, Introduction of Day 2
Lisa Cardo, GSK (Italy); Richard Denk, HECHT Technologie GmbH (Germany)

09.15 – 10.00 Case Study - A risk-based approach to a cost-effective containment design
Per Kronovall, Pharmadule (Sweden)

  • Selecting the appropriate containment technology for handling of potent compounds based on risk assessment to avoid over-designing a facility or operational procedures
  • Impact of facility design, capital cost, lead time, validation
  • Comparison between barrier and isolator technology
  • Case study of a filling operation
  • Regulatory view

10.00 – 10.45 Case Study – Philosophy and Rationale for a State-of-the-Art Tablet High Containment Facility
Lisa Cardo, GSK (Italy); Nicola-Maria Trivelli, GSK (Italy)

  • Philosophy and rationale for a state-of-the-art tablet high containment facility
  • Project planning and execution
  • Installation and validation
  • Challenges/decisions and lessons learned

10.45 – 11.15 Break

11.15 – 12.00 Case Study - Multiproduct Oral Solid Dosage High Containment Facility (OEL 1μg/m3)
David Swift, CH2MHill (Ireland); John O’Loughlin, Servier (Ireland)

  • Equipment design - dispensing, granulation, coating
  • Containment transfer - split cone technology
  • Facility design - architectural features and HVAC design

12.00 – 13.00 Round Table Discussions
Richard Denk, HECHT Technologie GmbH (Germany)

  • Waste handling
  • Product sampling
  • Cleaning
  • Containment transfer systems

13.00 – 14.00 Lunch and Networking Break

14.00 – 16.00 Workshop on Two Case Studies Part II
Pam Davison, Company (UK)

  • Case study 1 - API multiproduct
  • Case study 2 - OSD multiproduct
  • Delegates reach conclusions based on knowledge gained during the seminar
  • Presentation of conclusions in plenary session

16.00 – 16.15 Questions and Answers, Close of Seminar
Lisa Cardo, GSK (Italy); Richard Denk, HECHT Technologie GmbH (Germany)