Case Study: Swissfillon’s Approach To Single-Use Formulation & Filling

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In 2019 Swissfillon were inspected and approved by the FDA to supply drug products into the USA, following on from EU approval in 2018. This young fill finish CMO was started in Switzerland in 2013 and built a state-of-the-art cGMP production facility from the ground up.

 

Swissfillon recognized early on that single-use systems met their requirements for multi-product manufacturing and would help their clients get their drugs to market faster.

During this case-study webinar, participants will learn:

  1. How working in partnership with a supplier can be part of a QbD approach to minimize risk
  2. Strategies & design improvements for single-use systems to reduce risk in the process
  3. How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple
 

Duration: 2 hours

 

 

Moderator

Helene Pora

 

VP Technical Communication & Regulatory Strategy

 

 

Hélène has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 35 years of experience working for the biopharmaceutical industry, the last 30 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interest groups with a strong focus on BPOG, and BPSA.

 

Presenters

Rainer Glöckler

 

Swissfillon AG
Chief Technical Officer

 


The CTO of Swissfillon AG, Rainer Glöckler is responsible for the perfect process in the production of the filling line. He has acquired the necessary skills in over 20 years of professional experience in pharmaceutical production. After completing his studies in biotechnology, he applied for a job at Lonza AG in Visp, where he held various positions, including production manager. Rainer Glöckler joined Swissfillon AG with relevant professional and management experience.

 

Kevin Thompson

 

Pall Corporation
Technical Director

 


Kevin is a Technical Director in the Pall Advanced System Solutions (PASS) team, delivering customer focused process engineering and project management for integrated solutions to the pharmaceutical industry. Kevin is located within the Pall Harbourgate offices in Portsmouth UK, where he manages a group of project managers, process engineeers and commissioning engineers that support global projects. Most recently his team has been dedicated to the Astra Zeneca / Oxford COVID-19 vaccine project where their involvement started in the early process development phase.

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October 2021

Integrity Assurance for Single-Use Systems An End-User’s Perspective

 

What should you consider when building an integrity control strategy for your single-use systems (SUS)? How do you overcome application challenges?

 

Join leading industry experts Charlotte Masy of GSK and Patrick Evrard from Pall Corporation to gain insights and answers in this webinar from BioPharma Asia on integrity Assurance for Single-Use Systems, an End-User’s Perspective. They will present several case studies to show how integrity concerns can be practically addressed for cGMP manufacturing applications and the results observed a few years on. 

 

Attendees will learn about:

 

  • The latest regulatory requirements for integrity assurance of SUS
  • The different technologies available to control integrity of SUS
  • Key parameters that affect integrity measurements

 

Register now for this webinar from industry experts on October 6.

 

Watch