Ecolab Contamination Control, a worldwide provider of leading products and services for the control of microbial contamination in the cleanroom environment, has launched a unique product that will revolutionise the process of transfer disinfection within the pharmaceutical industry.
Klercide Sporicidal Alcohol has all the positive features of an alcohol-based disinfectant, including a low surface tension which improves product contact. It also has a ‘flash off’ time of just two minutes and minimal residues, which combined with sporicidal properties, significantly enhances its efficacy.
Critically, Klercide Sporicidal Alcohol will minimise the risk of introducing spores to the manufacturing process during transfer disinfection; a process which has long posed a significant challenge to hospital pharmacies and pharmaceutical manufacturers alike.
It is exactly what the pharmaceutical industry and hospitals have been waiting for and has been specifically developed to address a long standing need to provide a sterile sporicidal product with the key characteristics of alcohol for the transfer disinfection process.
This is in line with recent regulatory guidelines, including GMP Annex 1 and PIC/S P1007-6 which states that ‘Sporicidal agents should be used wherever possible but particularly for spraying in components and equipment in aseptic areas.’
In the past, water based sporicides have been used which cause significant wetting, a feature not recommended for transfer disinfection. This can also increase the risk of inadequate product contact, leading to poor practical performance. It can also increase process time or require transfer to take place while the items are still wet. Water based sporicides also result in pooling which can significantly reduce material compatibility and increase the likelihood of residue build-up.
The consequences of inadequate transfer disinfection where spores evade the disinfection process are extremely serious.
This is a view supported by Good Manufacturing Practice (GMP), which states: ‘Transfer of materials into and out of the cleanroom is one of the greatest potential sources of contamination,’ (GMP Annex 1).
Klercide Sporicidal Alcohol is manufactured in Ecolab Contamination Control’s own purpose built cleanroom and is supported by the firm’s Process Match assurance mark to highlight that the manufacturing processes match those of its customers. It is also fitted with the patented SteriShield Delivery System (SDS), the only fully validated trigger spray system on the market, which ensures the integrity of the product is protected throughout its entire use.
By using Klercide Sporicidal Alcohol customers will improve their processes and deliver contamination control without compromise.
For more information please call +44 2920 854 390 or email infocc@ecolab.com.