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Out of specification microbiology results in aseptic services

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Topics: Aseptic services

A pair of short videos about dealing with out of specification (OOS) microbiology results in aseptic services.

This article forms part of a series
  1. Quality assurance for aseptic services videos
    1. Best practice aseptic processing in technical services
    2. Supervising cleanrooms in aseptic services
    3. Developing standard operating procedures in aseptic services
    4. Designing worksheets for aseptic services
    5. Change management in aseptic services
    6. Deviation management in aseptic services
    7. Investigating deviations in aseptic services
    8. Out of specification microbiology results in aseptic services
    9. Objectionable microorganisms in aseptic services
    10. Corrective and Preventive Action in aseptic services
    11. Management review and KPIs in aseptic services
    12. Self-inspection (internal audit) of aseptic services
    13. Chemical and physical stability evaluation in aseptic services

Contents

  1. Using our best practice videos
  2. Dealing with OOS microbiology results videos
    1. Part 1
    2. Part 2
  4. Update history

Using our best practice videos

Our video topics are based on emerging themes and problem areas identified at aseptic preparation audits and from queries from Trusts. We provide them here so they can be viewed at any time.

These videos were created by the SPS QA team and have been periodically used during the SPS QA lunchtime webinar sessions.

You remain professionally responsible and accountable for your own actions when using our advice and guidance.

Dealing with OOS microbiology results videos

This pair of videos explores the fundamentals of a specific type of deviation: managing out of specification microbiology environmental monitoring results in pharmacy aseptic units.

Part 1 is a 35-minute video discussing the effective triaging and trending of out of specification results and assessing the need for further investigation.

Part 2 is a 42-minute video taking a deeper dive into the process of investigating and responding to out of specification microbiology monitoring results within your service.

Part 1

Part 2

Update history

  1. Published
  2. Video moved to a series of article, no change to video content