Micronclean takes an holistic approach to wipes

The whole is greater than the sum of its parts: this was the philosophy driving Micronclean's development of cleaning systems specifically for GMP users (see also pages 18/19).

Designing beyond the physical and quality attributes of the products, taking into account matters such as delivery to site, removal from site after use and waste management of packaging, leads to a true product life cycle concept that is totally compatible with quality requirements and commercial drivers such as cost and ecological impact minimisation, explains Phil Brennan, director of Skegness-based Micronclean. Clearly, adapting wipes developed for other industries to fit GMP regulated industry needs is not ideal. The company therefore undertook user requirement specification (URS) for GMP industry wipes, but only after much discussion with all raw materials suppliers to ensure that no "unachievable" requirements were included in the URS. The URS list went beyond the "boiler-plate" minimum quality requirements of raw materials qualification, endotoxin testing, viable and non-viable particulate testing, water for injection quality diluent isopropyl alcohol, manufacture in a class 100 cleanroom facility and full batch traceability, and progressed into the product life-cycle of logistics and necessary supporting services. Needless to say, cost-effective solutions were also high on the URS, the goal being to achieve lower costs and/or higher performance. The raw materials review was performed on a global basis and generated several suitable routes. In particular, a dual layer wipe was identified that is intended for use on hard surfaces in the cleanroom where a combination of physical removal and alcohol deposition is desired. A dual layer allows more alcohol to be held (without being too wet) and ensures that a good "pad" is generated, ensuring both even alcohol distribution and extended surface use, with the added benefit of potentially reduced re-folding. This is not only more efficient, but faster and more likely to foster adherence to site wiping procedure. Single layer wipes proved themselves to be more suitable for the "transfer process" where superior dexterity was required. Micronclean at Skegness has now started production of the Compliance 100 GMP wipe range of polyester wipes, both pre-impregnated and dry, with several packaging options to meet the needs of session users and large volume users. Clearly the development costs of a product designed "from the ground up" and complete with a life cycle view are higher than that of even a well-adapted product, but as Brennan points out, the whole is greater than the sum of the parts.