Pharmaceutical Division Microbiology

Water Testing

Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient, or used for reconstitution of products, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, etc...

As such water needs to be montiored as a raw material and the water system needs to be evaluated and monitored at part of GMP.

Various groups of organisms can be tested for dependant on the type or purpose of the water being produced or the system monitored.

Total Viable Colony Count at 37ºC and 22ºC

Colony counts are enumerations of the population of heterotrophic bacteria present in water supplies. These bacteria may have water as their natural habitat or may have originated from soil or vegetation.

Whilst it is recognised that the methods employed will not enumerate all bacteria present, the colony count is nevertheless useful for monitoring trends or detecting sudden changes in water quality.

Comparison of the counts obtained at 37ºC with those obtained at 22ºC can sometimes provide an early indication of deterioration in quality.

Coliforms and  Escherichia coli (E.coli)

Tests for coliform bacteria and E. coli provide a means for assessing the effectiveness of water treatment and disinfection, for monitoring water quality and for detecting faecal contamination.

Pseudomonas aeruginosa and Pesudomonas spp

Pseudomonas aeruginosa is an opportunistic pathogen commonly found in fresh water, sewage and soil. It can grow in water containing low nutrient levels and should be absent in bottled waters or in water used for the manufacture of food, drink and pharmaceutical products.

Sulphite Reducing Clostridia and Clostridium perfringens

Clostridia form spores which are resistant and their presence may indicate soil contamination. Clostridium perfringens is associated with faecal contamination.

Salmonella spp

Salmonella spp. are members of the Enterobacteriaceae. They show little host specificity and most can cause gastroenteritis when ingested by man. The incubation period is typically between 6 and 48 hours. The principal symptoms of mild fever, nausea and vomiting, abdominal pain and diarrhoea last for a few days but, in some cases, can persist for a week or more.

Meat, milk, poultry and eggs are primary vehicles but transmission can occur by water contaminated with faecal material.
 
Staphylococcus spp

Staphylococci, in particular Staphylococcus aureus are of concern because of their ability to cause infections. Whilst not usually present in drinking water supplies their detection may be required in food and pharmaceutical manufacture and in hospitals.

Contact ILS for more information and prices on pharmaceutical water testing.