The last thing customers need in a cleanroom environment is doubt about the validity of products, or to compromise their procedures and protocols. Ecolab Contamination Control has introduced an assurance mark in support of its own manufacturing processes.
The company’s new brainchild, Process Match, highlights the processes used for its Klercide range of contamination control products which are exactly the same as those used by its customers.
James Tucker, marketing director of Ecolab Contamination Control says: ‘The Process Match assurance mark shows we are totally confident in our own manufacturing processes, which also take place in cleanrooms, and give our customers complete peace of mind.’
The fully validated sterile product range for use in the cleanroom environment is manufactured in a purpose-built cleanroom in South Wales, UK and produced to the requirements of cGMP. In South Africa, the product range is available from Ecolab’s local office.
The fully accredited facility is 5 000m2 in size and incorporates five Grade B and Grade C cleanrooms, with Grade A laminar air flow at point of fill. Other innovative features such as interlocking hatches and an advanced intercom systems minimise contamination risks and improve quality.
Products manufactured at the facility include alcohol and biocide sprays, which feature the patented SteriShield delivery system (SDS), which is said to be 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 total use and not simply at the manufacturing stage.
‘Research has proven that conventional trigger sprays used with cleanroom disinfectants ‘suck back’ air,’ says Tucker. ‘This means the contents of the bottle can be contaminated from the first moment of use, leading to a spread of contamination around the cleanroom. This actually happened in a hospital only eight hours after the first use of 70 per cent alcohol: Bacillus subtilis spores were found and survived inside the bottle.’
Ecolab’s fully validated protected closed trigger spray operates as a closed system thanks 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.
As part of the company’s commitment to best practice, it also conducts impartial reviews of cleaning and disinfection processes. SiteCheck is carried out by fully qualified microbiologists and quality experts, who have experience in offering technical support and regulatory guidance to upstream production and QC laboratories.
Tucker says: ‘We understand how the development of disinfection and cleaning regimes tend to evolve organically, shaped by regulatory, supplier and staff changes. Our specialist team is ideally placed to provide an impartial perspective on compliance procedures, which can save time and internal management resources, while preventing costly regulatory issues in the future.’
All site checks are supported by a detailed report, designed to help prioritise and focus on the process optimisation and cost saving opportunities available.