Competence in Containment Technology
for Safe Processing of OSD-Forms (Pharma)!

December 15, 2022

Introduction

Our digital, interactive, and live workshop #8! Giving you practical insights from the comfort of your home-office or workplace.

Information

WHY SHOULD I PARTICIPATE?

More and more of the new OSD drugs comprise of highly active components, where just milligrams of API are required for one daily medical dose.
Thus, the pharmaceutical industry is facing increasing demand from regulatory authorities to achieve lower limits with regards to cross contamination.
On the other side, rising HSE requirements come up, in order to avoid negative health effects to the personnel producing those medicines. PDE,
OEL, or OEB are the major key words related to that topic. 

How much containment is actually required? How do I work with products with an OEL less than 1 μg/m3? How clean is clean? How do I achieve the
required cleanliness of my equipment? What is the regulatory authorities view on containment and highly active API? All these questions will be
discussed and answered in our workshop.

The course covers standard and sophisticated containment technologies for the relevant solid dose manufacturing of drying, granulation, agglomeration,
and beyond, by combining theory, hands-on training, and demonstrations.

At the end, the attendees will take with them an enhanced knowledge and also some practical rules to be able to improve their daily work-tasks.
All chapters will be recorded, the presentation material will be made available electronically.

WHO IS THE WORKSHOP DESIGNED FOR

If you are working with highly active pharmaceutical products for OSD forms, or your company intends to work with them, you will take great advantage
in participating in this seminar. Practical examples and demonstrations will illustrate appropriate solutions to engineers, pharmacists, and operators
working in or for the pharmaceutical industries. Hence, the workshop is perfectly suitable for those who are looking for a detailed overview on
the appropriate approach to economical containment solutions in a short period of time.

Speakers & Host

The Technology Training Center is proud and honored to host these experts for the live workshop:

Host

Andreas Gottschalk
Head of Technology Training Center (Binzen DE)
LinkedIn

 

Speakers

Dr. Andreas Flückiger
Consultant, Occupational Toxicology and Containment for the Pharmaceutical Industry
(Pratteln BL, Switzerland)
LinkedIn

Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG (Allschwil BL, Switzerland)
LinkedIn

Dr. Axel Schiffmann
Head Pilot Plant & Systems
Pharmaceutical R&D
F.Hoffmann La Roche Ltd.
(Basel BS, Switzerland)
LinkedIn

Dr. Ramona Labatzke
Occupational Hygienist
Praevena AG
(Rheinfelden AG, Switzerland)
LinkedIn (Dr. Ramona Labatzke)

Silke Büchl
Occupational Hygienist
Praevena AG
(Rheinfelden AG, Switzerland)
LinkedIn (Silke Büchl)

Michael Maintok
Business Development Key Technologies (Containment)
Glatt GmbH (Binzen BW, Germany)
LinkedIn

 

Pricing

COST

EUR 300,– excl. VAT

The fee includes online participation, streaming of the recording, and accompanying workshop notes.

Students/Academia: Free (copy of ID and of a valid registration at an educational institution is required)

University confirmation form

Live program

Live Program for Session A | – Times are listed in Central Europe Summer Time (Berlin, CEST).

07:00 | 14:30 Login & Online Registration

07:30 | 15:00 Andreas Gottschalk
Welcome, House-Keeping, Introduction to the Technology Training Center (TTC), the Glatt Group, and to the topic of today.

07:45 | 15:15 Michael Maintok
Containment In OSD Production.
When it comes to the production of oral solid dosage forms containment is a big issue. But is for each process step from the micronized active powder to the coated tablet the same containment requirement? Is there a difference even when in each process step the same API is handled? And how must highly active pharmaceutical ingredients be handled that it is done safely? This lecture gives an overview on the actual industrial standard.

08:30 | 16:00 Richard Denk
ISPE DACH Containment Manual.
Back in 2015 the ISPE DACH Containment Expert Group published the first edition of the Containment Manual and in 2021 the second Edition. With more than 1200 sold books globally it is one of the most successful documents of the ISPE. The intention of the Containment Manual is to provide support in the designing or retrofitting of high potent facilities with practical information and illustrations. During the presentation the different topics from fundamentals of containment, technical solutions, how to measure containment and cleanliness will be explained.

09:15 | 16:45 Break / Yoga Session

09:30 | 17:00 Andreas Flueckiger
Containment: Benefits for Worker Health Protection, Good Manufacturing Practices and Finances – A Win-Win Situation
Containment, once perceived by many as a cumbersome obsession of the occupational health specialists, has developed into a discipline with well-recognized benefits in GMP. Investments often have a rapid payback. This presentation explains how to select adequate solutions for process containment. The decision must be based on the potency of the material to be handled and on data on the containment capability of the equipment. Finally, the presentation sheds light on the roles of primary and secondary containment.

10:15 | 17:45 Ramona Labatzke | Silke Buechl
Challenges during performing APCPPE (former SMEPAC)
Insights into performing exposure measurements at a tabletting machine or a fluidized bed dryer (FBD) according to the APCPPE protocol.

10:45 | 18:15 Axel Schiffmann
Effective WIP/CIP for OSD Processing Equipment

11:30 | 19:00 Andreas Gottschalk
Closing remarks.
Summary, Questionnaire, Preview on next workshops, Contact information.

11:35 | 19:05 End