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ECA - Barrier Systems
Barrier Systems (25 March 2020)
This is why you will benefit from attending this conference:
- Case studies from various pharmaceutical companies will deal with the implementation, qualification and operation of Isolator and RABS systems.
- You will discuss the current state of the art and new technological developments in Barrier Systems technology.
- You will get to know first hand the new EU-GMP Annex 1 draft requirements on Barrier Systems
- Experts from pharmaceutical companies will share their knowledge regarding operational experience
The protection against microbial contamination is the most important point for drugs produced by aseptic processes. Today the regulators require a more strict separation between operators and product in the form of an access barrier.
Two systems are on the market – RABS (Restricted Access Barrier System) and Isolators. But only isolators are referred to by the US FDA as advanced aseptic technology.
This conference will focus on current questions of barrier systems coming from FDA regulations as well as from the revised EU-GMP Annex 1, and it will specifically address the subject from the perspectives of pharmaceutical operators, planners and engineers.
Didier Meyer, DMCompliance
This event is directed at decision-makers from pharmaceutical production, development and quality assurance/control. It also addresses engineers and planners who need to be well informed about current developments in the field of barrier systems.
Case Study AbbVie: The new Biologics Site in Singapore
Dr. Rolf Ratke, Abbvie
Ronan Mc Garvey, Abbvie Singapore
- The Site strategy
- Products, processes & equipment
- Cooperation with EMA, blueprint to prepare for the successful pre-approval-inspection
- From start- up to realization until approval
Handling and processing of large containers in aseptic isolators – best practice example
- Initial situation / basic conditions
- Requirements concerning isolator technology
- Loading and unloading of large containers – decontamination
- Specific requirements vaccine production
Aseptic processing and filling of a viral vector for gene and cell therapy
Leslie Southam, Oxford Biomedica
- An integrated solution of a state of the art small batch filler in a barrier system, designed to fit a biological production process: Freeze/thaw and time restrictions of the product lead to a special line layout where formulation and filling are combined in one barrier system
- Application of No-touch-transfer (NTT): An alternative methodology to introduce pre-sterilized product containers into the Grade A environment without in process disinfection steps
- Aseptic Containment Approach: Requirements on containment driven by cross contamination control are combined with requirements for aseptic filling and viral containment
Barrier Systems and Annex 1: GMP inspectors’s point of view
Dr. Daniel Müller, Local GMP Authority of Baden-Württemberg
- Most important changes of Annex 1 – an update
- Regulatory comparison of Annex 1 version 2018 and new / intended Annex 1
- GMP inspector’s comments on new / intended requirements for barriers
New-Designed Isolator for Aseptic Filling
Quentin Majeau, Hydro-Fill
- Isolators : Overview
- Disposable Isolator to a Virtual-wall Isolator
- Virtual wall Isolator : containment or Class A operation
- Virtual wall Isolator : Integration on a disposable filling line
Writing User Requirement Specifications (URS) for Isolator projects
Dr. Timo Krebsbach, HHAC Labor Dr. Heusler
- The URS should define clearly and precisely, what the user wants the equipment to do in terms of performance characteristics, product quality metrics, and production yields. It should also define any nonfunctional requirements, constraints, and deliverables that need to be supplied with the system.
- The presentation shows the lesson learned from the view of a customer.
- In the future topics like automation and digitalization need more attention from the very beginning