|Title:||Sterilisation of Pharmaceuticals in Sterilising Service Departments and Operating / Procedural Rooms|
|Document ID:||Operational Directive OD 0517/14|
|Date of issue:||Thursday, 3 April 2014|
|Description:||Additional processing of pharmaceuticals after manufacture to provide a Ďsterileí product by hospital sterilising services is an unacceptable patient safety risk as further sterilisation processes may result in changes or deterioration in the quality of the pharmaceutical and is not to occur in WA HCFs.|
|Applicable to:||All Medical and Nursing Staff, Sterilisation Services Staff|
|Framework:||Public Health Policy Framework|
|Period of effect:||from 1 April 2014 to 1 April 2019|
|Review date:||1 April 2019|
|Authorised by:||Professor Bryant Stokes, A/DIRECTOR GENERAL, Department of Health WA, 28-Mar-2014|
|Print version:||View print version|
Sterilisation of Pharmaceuticals in Sterilising Service Departments and Operating / Procedural Rooms
Compliance with this Operational Directive is mandatory for all public hospitals and those private healthcare facilities, including satellite haemodialysis units, contracted to provide services to public patients.
This Operational Directive describes the requirements in relation to the preparation and use of sterile pharmaceutical products in Western Australian (WA) healthcare facilities (HCFs).
Pharmaceutical: also referred to as medicine, medication or medicament can be defined as any chemical substance intended for use in the medical diagnosis, cure, treatment or prevention of disease.
The manufacture of sterile pharmaceutical products is subject to regulated requirements in order to minimise risks of microbiological, particulate and pyrogen contamination. These stringent requirements are detailed in the Therapeutic Goods Administration publication Australian Code of Good Manufacturing Practice (GMP) – August 2002 and further enhanced by the adoption of the amended GMP Guide for Medicines as a Manufacturing Principle – January 2009 and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) international standards – October 2008.
The holder of a manufacturing authorisation must manufacture sterile pharmaceutical products so as to ensure they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy.
Additional processing of pharmaceuticals after manufacture to provide a ‘sterile’ product by hospital sterilising services is an unacceptable patient safety risk as further sterilisation processes may result in changes or deterioration in the quality of the pharmaceutical. In addition, the use of alcoholic, antiseptic or disinfectant solutions to wipe or soak external surfaces of vials, ampoules or bottles does not achieve surface sterilisation and products processed in this manner are unsuitable for use in a sterile procedure.
Pharmaceuticals shall not be sterilised in hospital sterilising service departments or in operating / procedural rooms.
All pharmaceuticals required to be sterilised for use shall be purchased by the hospital pharmacy or supply department directly from a manufacturer licensed to provide sterile pharmaceuticals. These pharmaceuticals must have been sterilised by the manufacturer prior to supply.
Executive Directors of public and licensed private hospitals contracted to provide care for public patients are responsible for ensuring compliance with this Operational Directive.
1. Therapeutic Goods Administration. The Australian code of good manufacturing practice (GMP) – for medicinal products. Accessed October 4th 2011 at: http://tga.gov.au/industry/manuf-medicines-cgmp.htm.
2. Guide to Good Practices for the Preparation of Medicinal Products for Healthcare Establishments. PE 010-3. Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme. (PIC/S). Accessed December 9th 2013 at: http://www.picscheme.org/publication.php
Professor Bryant Stokes
This circular last updated: Thursday, 3 April 2014 at 10:33am