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ICG A3P Single Use Systems

Single-use systems (SUS: single-use systems) grow considerably to meet the industry requirements: ease and speed of implementation, indirect response to cleaning validation issues, flexibility, costs reduced infrastructure ...

The development of the adoption of these systems still poses more questions on various topics:

  • Quality: extractable / relarguables, interactions containment, systems integrity, quality control of materials, process validation using such solutions ...
  • Technologies: disposable sensors, interfacing and interconnections with conventional equipment, physical limitations of the SUS (flow, pressure, ...), control / monitoring systems (proprietary or not), implementation (use validation) new single-use technologies entering the market.
  • Environment: How do these systems can be integrated into sustainable development programs and minimization of environmental impacts ...?
  • Supply: how to ensure security of supply throughout the product chain, from the raw material for manufacturing polymers to delivery to the end customer SUS? Is it possible to develop standards in order to set up double sourcing? ...
  • Life Cycle Management: User-supplier partnership in the management of SUS product life cycle
  • Economic Comparison of installation and operating costs of SUS versus conventional systems, control cost trends, ...
  • Regulatory changes, particularly on the initial validation and continuous of these technologies.


A3P decided to create an ICG on this issue so as to allow the various industries concerned to discuss these issues and arrive on common consensus to facilitate the implementation and use of these technologies.

The objectives of the ICM will :

  • Establish a guide of recommendations for industry on deployment, use and maintenance (Life Cycle Management) of single-use solutions;
  • Make a point about the regulations and the association guides internationally applicable;
  • Achieving an overview of key issues SUS: validation, environmental impact, integrity testing, extractables / relarguables ...
  • Providing space technology watch & innovation through scientific articles and briefs for members via some existing media (The Wave website A3P ...) or build (newsletter ...)
  • Develop a collaborative platform between users and providers, in order to anticipate changes and work jointly on shared standards
  • Foresee the possibilities of communication of the results for different subjects.

The results of the different topics will be presented at next A3P events in which participants could be invited to comment, possibly interactively, on certain principles and certain orientations emerged.

Call for applications
We are looking to build this GIC maximum 20 experienced professionals.
The deadline for nominations is attached to the deposit of 31 March 2017.
To apply you must complete the online form below and motivate your application (CV, define your motivations in a few lines ...).
A3P select the selected profiles and a first physical meeting in our offices (Lyon) will be held on 06 April 2017.

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Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

More info on video (Versiongb here )


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letter   newsletter A3P
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    You can not load Article (ID: 2149) into Itself

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    Creating a GIC A3P Barrier Technology

    Appendix 1 under review should strongly recommend the absence of direct human intervention in the critical area during the aseptic manufacture of sterile therapeutic products and therefore the use of barrier technology. It is likely that this will be the first step towards the prohibition of direct human presence for new aseptic manufacturing units in the next revision of Annex 1 unless strongly justified exception.

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    Following the application entry in the 1er October 2015 15 of the new Annex "Qualification and Validation" Good Practices for Manufacturing of health products for human and veterinary use, many of you rework the specific part of the subchapter dedicated 10 the Cleaning Validation. Indeed, this Section now has 15 subparagraphs, when the previous version dated 2001 there were only 7. This regulatory strengthening highlights major changes on this subject: Acceptance criteria based on the CRP approach, very marked distinction between manual cleaning receipts and automated ones, need for very precise rational and well argued as to choice of (these) product (s) Worst case, in the choice of areas to be sampled.

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