DESINFEKTION
A proactive approach to transfer disinfection Summary by Jennie von Fielitz, Miclev AB Appropriate care is vital but even that can fail if the sligh test errors are made during the manufacture, preparation and supply of intravenous drugs and nutrition for vul nerable patients.
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t is well documented that the biggest threat to the integrity of intravenous drug delivery is the introduction of products and equipment to the cleanroom, the most vulnerable area of which is around the transfer hatch.
Incidents and guidance 1. For example, in 1994 ‘The Manchester Incident’ occurred. Two children died following the administration of contaminated total parenteral nutrition (TPN). This led to the publication of the Farwell Report to give guidance on aseptic preparation and dispensing in UK pharmacy units. 2. In 2012 the New England Compounding Center (NECC), was responsible for issuing a steroid (MPA) with fungal contamination to the market place, resulting in the death of 64 patients. “As alleged in the indictment, these employees knew they were producing their medication in an unsafe manner and in insanitary conditions, and authorized it to be shipped out anyway, with fatal results.”
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3. The Drug Quality and Security Act was passed in 2013 to grant the FDA more authority to regulate and monitor the manufacturing of compounding drugs. Recent research has shown that the incidence of spores in a cleanroom environment can be as high as 10% in C/D and 13% in A/B areas, showing that a sporicide is required at both the first and second stage of transfer into the C/D and A/B areas to reduce the risk.
40% of consumables are contaminated A study has shown that around 40% of consumables being transferred are contaminated with bacterial spores. The same study also identified that if the transfer disinfection procedure employed was spraying with alcohol, only 27.6% of the spores would be removed. Various authorities and governing bodies have issued guidelines or requirements for sporicidal transfer disinfection in recent months. Example – PIC/S “Sporicidal agents should be used wherever possible but particularly for ‘spraying in’ components and equipment in aseptic areas.” Example – EU Annexe1 “The transfer of materials into
and out of the unit is one of the greatest potential sources of contamination.”
Example - MHRA “...evidence suggests that the majority of contaminants within Grade A processing zones arise from the transfer of items. Before transfer to the manufacturing room, a sanitisation step using a spray and wipe technique including a sporicidal agent designed to inactivate bacterial and fungal spores must be carried out.” Example – TGA (Health Safety Regulation) “The Therapeutic Goods (Manufacturing Principles) Determination No 1 (2013) specifies that medicinal products supplied in Australia have to meet the PIC/S Guide to Good Manufacturing Practice (GMP) - 15 January 2009, PE 009-8, except for its