The Challenges of Adopting Single-Use Technology - Insights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach. - BioPharm

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The Challenges of Adopting Single-Use Technology
Insights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach.


BioPharm International Supplements
Volume 25, Issue 11, pp. s4-s8

IMPLEMENTATION CASE HISTORIES

Vivalis has worked with SUT since 2006, and the company has gained experience in implementing and deploying SUS via a wide range of products. The experience includes:

  • Maintaining a structured and lifecycle appropriate approach to implementation
  • Starting the supplier qualification process as early as possible via technical diligence
  • Ensuring an open and transparent relationship with SUS suppliers and vendors
  • Maintaining a careful stakeholder management policy to ensure no technology overlap
  • Testing a SUS product before it's purchased to ensure compatibility
  • Approaching self-made SUS assemblies with care
  • Ensuring that impact and compatibility are assessed at all levels.

The last two points are illustrated below.

Self-made assemblies

A self-made assembly is a SUS designed, prepared, and controlled on the end-user's site. These are often process transfer manifolds, used for connecting equipment to allow fluid transfer. On-site preparation can lead to significant quality standard discrepancies compared with external sourcing. The lesson learned over several years was the importance of applying the same quality principles as those employed by an external supplier. Self-made assemblies must have specifications, appropriate documentation including batch process records, operator training and stability studies if appropriate, as well as be qualified (this includes sterility) and subject to change control process.

Assessing impact and compatibility at all levels

The example cited here is for an indirect impact situation. A rig for the sampling of condensates was used as part of the quality control process for the company's clean steam distribution system (sampling tubing, connectors and a bioprocess bag for sample collection). No previous validation or verification of the rig was carried out. During routine sampling, analysis of the condensates returned a non-conform test result, having very high levels of total organic carbon (TOC).Initial suspicion was directed at the clean steam distribution system and some unidentified contamination or some anomaly at the external testing organization. It was only after extensive investigation that the bioprocess bag was identified as the source of the high TOC results due to extractables and leachables in the bag. No prior evaluation of the compatibility of the SUS had been made. There is now a rigorous process in place for verification of SUS used for direct or indirect impact systems.

STEPHEN BROWN, PHD, is Chief Technical Officer at Vivalis, 6 rue Alain Bombard, 44800 Saint Herblain, France, Tel. +33.228.07.37.10,


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Source: BioPharm International Supplements,
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