Microbiological Water Samples – a Perishable Product A Study for the Validation of Shelf Lives and Temperatures Lothar Bomblies Labor L+S AG, Bad Bocklet (Germany) Correspondence: Dr. Lothar Bomblies, Labor L+S AG, Mangelsfeld 4, 97708 Bad Bocklet (Germany), e-mail: lothar.bomblies@labor-ls.de The microbiological status of pharmaceutical water is a quality relevant parameter that is subject to frequent monitoring. Water samples must often be transported for a certain period of time before reaching their final destination at a suitable laboratory.
Since explicit specifications for the duration and temperature of transport do not exist, a transport validation study was carried out. The most common germ species, frequently encountered in several thousands of water samples, were used in this study. Adapted germs were incubated over several days under different temperature conditions and, thereafter, quantified by using common microbiological analysis. A cooled storage proved to be suitable for nearly two days of storage. The isolates from pharmaceutical water systems tested under these conditions were not eliminated nor did they multiply excessively. Freezing of water samples should be strictly avoided since the number of germs of many species reduced considerably under these conditions. Hence, a temperature recording system becomes a necessity during the transport. Key words Pharmaceutical water • Transport validation • Microbiological test • Water systems | 
