Recommendation of the Quality Task Group (125): Comparison of sterile barrier systems

Recommendation of the Quality Task Group (125):
Comparison of sterile barrier systems


Authors: T. Appel, S. Bungardt, D. Diedrich, A. Forster, K. Gehrmann, A. Hartwig, A. Jones, J. Metzing, A. van Waveren; e-mail: qualitaet@dgsv-ev.de

Introduction

The introduction of a new STERILE BARRIER SYSTEM (SBS) constitutes a significant change to the instrumentation circuit. This change may impact the process and outcome quality, logistics, storage and, ultimately, the entire cost structure of the reprocessing process.
Therefore, all important aspects and potential effects should be considered and investigated beforehand. This Recommendation is designed to support that undertaking.

Business administration assessment

In principle it is important to ensure that as few different varieties of SBS as possible are used. REDUCING THE VARIETIES has many benefits:

  • Routine work practices save time and reduce mistakes
  • Validation of the packaging process pursuant to DIN EN ISO 11607-2 is less labour intensive (each type of packaging requires separate validation)
  • Less intensive training needed
  • Standardization of transport and storage
  • Less administrative effort (e.g. article numbers, orders, product data sheets)

Before contemplating changing the SBS, the COST FACTORS of the existing and the new systems should be compared:

  • Investment costs (e.g. containers or transport baskets for soft packaging)
  • Costs for consumables (e.g. non-wovens (fleece), paper film packaging, labels, adhesive tapes, filters, absorbent non-wovens, edge and tip protectors, protective packaging, etc.)
  • Maintenance and repair costs (e.g. for containers/transport baskets)
  • Reprocessing costs (e.g. for containers/transport baskets)
  • Time investment for the actual packaging process, handling (e.g. orders, transport, etc.) and/or for the reprocessing process required
  • Disposal costs
    • Transportation of contaminated supplies
    • Waste
  • Costs for adapting the storage/transport system to the requirements of the new packaging materia

 

++ For further information please download the full recommendation here ++

 

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