With more than 15 years' experience of high-quality clean room manufacture, abiding by the principles of current good manufacturing practice (cGMP), Ecolab Contamination Control has an extensive knowledge of the rigorous regulatory standards, giving it unrivalled insight into the requirements of a sterile product range. This extends to ensuring that its manufacturing processes match those of its customers.
Ecolab Contamination Control is so confident that its Klercide range of contamination control products is produced under conditions which match those of its customers, that it has introduced a process match assurance mark.
The fully validated sterile product range for use in the clean room environment is manufactured in the company's purpose-built clean room in South Wales and produced to the requirements of cGMP.
The accredited facility sets a new standard in sterile disinfectant manufacture, with the potential to expand to meet future global demands and develop in line with the ever increasing regulatory requirements of the industry.
It extends to 5,000m² and incorporates five grade B and grade C clean rooms, with grade A laminar air flow at point of fill. Other innovative features such as interlocking hatches and an advanced intercom system minimise contamination risks and improve quality. Customers are actively encouraged to visit the site and carry out an independent audit.
Accreditations include ISO 9001 and ISO 13485 and Medical Device Directive 93/42/EEC for the manufacture and distribution of sterile and non-sterile clean room products.
The Ecolab Contamination Control facility manufactures a range of products, including alcohol and biocide sprays which feature the patented SteriShield Delivery System (SDS), the only validated trigger spray system on the market.
This creates a fully closed system, preventing 'suck back' and ensures the integrity of the product is completely protected throughout its entire use and not simply at the manufacturing stage.
Research has proven that conventional trigger sprays used with clean room disinfectants 'suck back' air, meaning the contents of the bottle can be contaminated from the first moment of use, leading to a spread of contamination around the clean room.
Ecolab Contamination Control's SDS operates as a closed system due to the vacuum created in use, with the dip tube providing the only point of exit from the bag of sterile liquid, which protects the sterility of the contents indefinitely, with a recommended best practice in-use shelf life of three months.
In addition to an innovative product range, Ecolab Contamination Control also offers SiteCheck as part of its commitment to best practice for all aspects of contamination control. This provides an impartial review of cleaning and disinfection processes, designed to give an independent perspective on compliance procedures. This can save time and internal management resources and prevent costly regulatory issues in the future.
SiteCheck is carried out by fully qualified microbiologists and quality experts and the results are summarised in a detailed report, designed to help prioritise and focus on the process-optimisation and cost-saving opportunities available. This service is provided free of charge and without obligation.