4 Data trending, SPC (standard plate count), Shewhart charts and result processing were carried out using Microsoft Office Excel 2007, XLSTAT Version 2014.5.03, GraphPad Prism Version 6.01 and Minitab ® 17.1.0, which are being used concurrently in complementary projects on the same line. Water samples were tested using routine microbiological methods and the obtained results were interpreted as the number of CFU (colony forming units)/100ml. PuW from the return of the distribution loop was sampled on a daily basis during the first quarter of the year (Q1), covering January, February and March during working days. A worked case studyĪ well-established water treatment plant that has operated for more than 10 years receives source water from the municipal city line and processes it through several stages before delivering the finished PuW to be dispensed and distributed through a healthcare facility. Part of the inspection process includes assessing the microbiological quality of the processed water, such as purified water (PuW) of pharmaceutical grade. 2,3 Accordingly, the quality and safety of water are crucial parameters to be monitored regularly to ensure its suitability for use and consumption. Water is a crucial ingredient in many processes in the healthcare industry generally and the pharmaceutical sector specifically. Statistical process control (SPC) provides a useful tool to address these items quantitatively, which could be integrated with quantitative risk assessment tools.

Data trending regarding the microbiological density of water provides a comprehensive and informative means of assessing the quality, stability and safety of the microbial community in water.

Download graphpad prism anonimously