Ecolab Contamination Control (Ecolab) has launched a unique product, which will revolutionise the process of transfer disinfection in the pharmaceutical industry.
Ecolab is a worldwide provider of leading products and services for the control of microbial contamination in cleanroom environments. Its 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 enhance its efficacy.
Critically, Klercide Sporicidal Alcohol will minimise the risk of introducing spores to the manufacturing process during transfer disinfection. This process has long posed a significant challenge to pharmaceutical manufacturers and hospital pharmacies and alike.
According to Ecolab, it 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: ‘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 grow the risk of inadequate product contact, leading to poor practical performance. Process time may also be increased or it may 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) guidelines. GMP Annex 1 reads: ‘the transfer of materials into and out of the cleanroom is one of the greatest potential sources of contamination’.
Klercide Sporicidal Alcohol is manufactured in Ecolab’s own purpose built cleanroom and is supported by the firm’s process match assurance mark. This highlights that the manufacturing processes match those of its customers. It is also fitted with the patented SteriShield delivery system, which is the only fully validated trigger spray system on the market. This 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.