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Aseptic Handling

  • Chapter
Practical Pharmaceutics

Abstract

Aseptic handling is the process to enable sterile products to be made ready to administer, using closed systems. The starting materials are sterile and must be kept sterile during the process. This chapter describes the conditions to do so (sterility assurance). The most important points are trained staff wearing special clothes and sterile gloves, working ‘non touch in a Grade A zone (LAF cabinet, safety cabinet or isolator) and using materials and equipment with a low bioburden.

If antineoplastics (cytostatics) are involved requirements are not only to protect the product against contamination of micro-organisms, but also to protect the operator and the environment from these hazardous medicines.

Microbiological checks are carried out firstly to see if staff are sufficiently skilled in aseptic activities, secondly to determine the microbial risk from the environment and thirdly to validate the aseptic procedures.

This chapter does not cover the situation where medicines that cannot be sterilised in their final container are sterilised by aseptic filtration.

Based upon the chapter 25 Aseptisch Werken by Frits Boom, Hans van Doorne and Marco Prins in the 2009 edition of Recepteerkunde.

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Author information

Authors and Affiliations

  1. Zaans Medisch Centrum, Koningin Julianaplein 58, 1502 DV, Zaandam, The Netherlands

    Frits Boom

  2. Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne, UK

    Alison Beaney

Authors
  1. Frits Boom
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  2. Alison Beaney
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Corresponding author

Correspondence to Frits Boom .

Editor information

Editors and Affiliations

  1. Laboratory of Dutch Pharmacists, Royal Dutch Pharmacists Association KNMP, The Hague, The Netherlands

    Yvonne Bouwman-Boer

  2. Former Quality Control Pharmacist to the Welsh Hospitals, Cardiff, United Kingdom

    V'Iain Fenton-May

  3. The Hague Hospital Pharmacy, The Hague, The Netherlands

    Paul Le Brun

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Boom, F., Beaney, A. (2015). Aseptic Handling. In: Bouwman-Boer, Y., Fenton-May, V., Le Brun, P. (eds) Practical Pharmaceutics. Springer, Cham. https://doi.org/10.1007/978-3-319-15814-3_31

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  • DOI: https://doi.org/10.1007/978-3-319-15814-3_31

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-15813-6

  • Online ISBN: 978-3-319-15814-3

  • eBook Packages: MedicineMedicine (R0)

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