Single-Use Disposables - What you need to know - Live Online Training
Tuesday, 20 February 2024 9 .00 - 17.15 h
Course No. 20911
Speakers
Dr Simone Biel
Merck
Dr. Daniel Müller
GMP Inspector
Prof Dr Regine Eibl-Schindler
Zürcher University of Applied Science
Nicola Rutigliani
Merck
All times mentioned are CET.
Objectives
This online training course gives an overview on available Single-Use Technology and how this technology can be implemented in the GMP manufacturing Environment.
Background
The use of Single-Use Technology increases in many biotechnological processes as well as in sterile filling processes. There are different reasons for this development, i.e.
Avoiding cleaning and cleaning Validation
Reducing time to market by omitted construction activities
Simplified scale-up procedures
High flexibility
On the other side – especially in comparison to stainless steel – new questions arise like
How to qualify and validate the technology?
What are the consequences at the GMP-Level?
How much responsibility can be transferred to the SU supplier?
How should Leachable&Extractable Data be evaluated?
These and other questions will be discussed and answered during the course by experts from university, pharmaceutical Industry and GMP authorities.
Target Group
The course is directed at staff from pharmaceutical industry and suppliers from
Production
Engineering
Research & Development
Quality Assurance
who want to learn how Singe-Use Equipment can be implemented in Biotech and Sterile Operations in a GMP-compliant way.
Technical Requirements
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Programme
Single-Use Technology in Biopharmaceutical Production: An Overview from USP to Fill&Finish Technologies
Categorisation of available single-use Systems
Disposables in Upstream-Processing
Media preparation
Cell expansion and Fermentation
Disposables in Downstream-Processing
Filtration and chromatography
Buffer preparation and storage
Disposables in formulation and filling
Freeze Technology
Hybrid/closed technology platforms
Single-Use Systems – GMP Inspector’s View
Overview and evaluation of latest regulatory documents
Official guidelines, pharmacopoeias & other papers
Recent developments
Selected Highlights
Single-use systems versus multi-product Equipment
Important requirements for GMP-compliance
Regulatory view on both types of Systems
Managing suppliers of single-use Systems
Requirements for supplier qualification
GMP inspections
Typical issues and deficiencies
Quality Approach in Manufacturing of Single-Use Systems – How to assure Performance, Robustness, and Sterility of Single-Use Systems
Single-use assembly Validation
Qualification of components
Sterilization qualification
Manufacturing processes
Quality Control
Release testing
Certification
Risk mitigation practices
Process particulate Control
Operator Training
Leachables & Extractables
Patient safety evaluation, study design
Support by the supplier
The Role of Extractables/Leachables in the Adoption of Single-Use Systems The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy. This presentation will focus on:
The approach to adopt the BioPhorum (BPOG) extractables protocol as a baseline testing strategy
How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds
Important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used
Case Study Merck: Single-Use Technology in Aseptic Drug Product Manufacturing
Reasons for using SUT
Process: pooling, filtration, filling
Project: facility and equipment pre-requisites, qualification and implementation of SUS
Risk identification when using SUT and Mitigation strategy (e.g. integrity assurance)
Lessons learned and best practice when moving from traditional filling to SUT
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