Technical Information

The following case studies are available either viewable on screen, for downloading as a PDF file or a hard copy can be requested.

Case Study 1 - The effect of different cleaning methods on environmental monitoring
Dr Julian Smith Phd, MRPharms Reproduced from a poster originally presented at the National QA Symposium 23-24th Sept 1999. The case study compares the effect of different cleaning regimens upon the microbiological environment within different classifications of cleanrooms. Three different regimens were investigated; the unit's current cleaning regime using a single bucket system, using a triple bucket system, such as the Klercide Cleaning System, and using a triple bucket system with Klercide-CR rotational disinfectants. The results showed the use of a triple bucket and Klercide-CR cleanroom biocides significantly improved the environmental monitoring results over the traditional cleaning methods used in the non-sterile and aseptic isolator preparation rooms. The results in the sterile preparation clean room remained within appropriate standards.
	PDF 673Kb

Case Study 2 - Evaluation of the Effectiveness of Polymeric Flooring compared with "Peel-off" Mats to reduce Wheel-and Foot-borne Contamination within Clean Room Areas
Dr. Caroline Clibbon, Research Microbiologist at Glaxo SmithKline, Ware, Hertfordshire, UK. Initially presented at Cleanrooms 2001 and in the European Journal of Parenteral Sciences It has been established that in order to maintain the highest levels of cleanliness within a clean room environment, it is essential to prevent the ingress of particles and micro-organisms into the critical area from the surrounding environment. Principles of good manufacturing practice (GMP) and quality assurance demand that particle and microbiological contamination levels within any critical area should be minimised to prevent contamination entering the product. Two major sources of viable and non-viable particle contamination entering critical environments originate from operators' feet and from trolley wheels. This paper compares two different types of floor covering used to reduce foot-and wheel-borne contamination, the "peel-off "/ acrylic mat and "polymeric" floor covering. The results of this comparison demonstrate that "polymeric" flooring is a more effective means of controlling foot-and wheel-borne contamination, thereby effectively reducing the number of micro-organisms entering the critical environment.
	PDF 40Kb