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Original research
Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part B: risk control
  1. Frits A Boom1,
  2. Judith M Ris1,
  3. Tjitske Veenbaas2,
  4. Paul P H Le Brun3,
  5. Daan Touw4,5
  1. 1 Zaans Medical Centre, Zaandam, Noord-Holland 1502 DV, The Netherlands
  2. 2 Albert Schweitzer Ziekenhuis, Dordrecht, Zuid-Holland 3318 AT, The Netherlands
  3. 3 Department of Clinical Pharmacy and Toxicology, Leiden University Medical Centre, Leiden, The Netherlands
  4. 4 Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, Groningen, The Netherlands
  5. 5 Pharmacokinetics Targeting and Toxicology, University of Groningen, Groningen, The Netherlands
  1. Correspondence to Mr Frits A Boom, Zaans Medical Centre, Zaandam, Noord-Holland, The Netherlands; fritsboom70{at}gmail.com

Abstract

Objectives To determine prospectively the risk reducing measures of non-sterility during aseptic handling and to develop a method for prioritising these measures.

Methods In the first part of this series of articles, we identified all sources of risk which could contaminate a product during aseptic handling, and calculated the remaining risks of non-sterility using a risk assessment (RA) model. We concluded that additional research of some risk sources was needed before risk control (RC) could be executed on all risk sources.

The chances of technical problems with a laminar airflow cabinet or safety cabinet (LAF/SC) were collected from 10 hospital pharmacies using a questionnaire. The chances of blocking first air were examined by airflow visualisation (smoke studies). For checking the way of working during aseptic handling, a checklist for an audit was developed.

Risk control was executed by a multidisciplinary team of (hospital) pharmacists and technicians, a consultant experienced in aseptic processing and an independent facilitator. They determined the risk reducing measures for each source of risk and the influence of these measures on the remaining risk (expressed as risk prioritisation number).

Results The chances of defects of the LAF/SC were low. Airflow visualisation is a sensible method to find the correct location of materials and equipment inside the LAF/SC and to detect a way of working without blocking first air on critical spots. Audits will provide valuable information about the way aseptic handling is executed and the remaining risks as a consequence. The risk of non-sterility caused by needle or spike contact with critical spots of vials and ampoules (stopper or ampoule neck), blocking first air under downflow and touching critical spots cannot be eliminated completely.

Conclusion The RA/RC model shows the impact of risk reducing measures on the probability of non-sterility during aseptic handling. The calculated risk prioritisation numbers are helpful in prioritising these measures. Audits result in risk reduction for nearly all sources of risk.

  • aseptic preparation
  • audit, self-inspection
  • compounding (individualised preparation)
  • disinfection
  • good manufacturing practice (GMP)
  • laminar flow technology
  • manufacturing, small scale
  • protocols & guidelines
  • reconstitution
  • risk management
  • safety cabinets
  • validation preparation process

Data availability statement

Data are available upon reasonable request. An Excel file with the data for figures 2, 3 and 4, and supplementary files 4 and 5, is available.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/ejhpharm-2019-002179

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    Data availability statement

    Data are available upon reasonable request. An Excel file with the data for figures 2, 3 and 4, and supplementary files 4 and 5, is available.

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