The microbiological department is responsible for ensuring medications do not contain harmful levels of microbes – such as bacteria, yeasts and moulds. This is an intense process which commands a practice of a great level of caution in controlled environments. It has to be very detailed, to the extent Curex’s microbiological department tests the water to be used, epidermis of the staff, the sterility of the equipment to be used in production, and every minute detail that cannot be overlooked. The major responsibilities of the microbiological department include environmental monitoring, complete analysis of water, limit test, identification of pathogens, and microbial tests of raw materials as well as finished products. Viable monitoring is designed to detect levels of bacteria and fungi present in defined locations/areas during a particular stage and the activity of processing and filling a product. Viable monitoring is designed to detect mesophilic micro-organisms in the aerobic state.
Surface methods include testing various surfaces for numbers of microorganisms, such as:
• Product Contact Surfaces • Floors • Walls • Ceilings
Using techniques like:
• Contact Plates • Touch Plates • Swabs • Surface Rinse Method
For air monitoring, this is undertaken using agar settle plates (placed in the locations of greatest risk) or active (volumetric) air-samplers (to provide a quantitative assessment of the number of microorganisms in the air per volume of air sampled). Active air-samplers generally fall into the following different models:
• Slit to Agar • Membrane Filtration • Centrifugal Samplers
Monitoring methods all use either a general purpose culture medium like tryptone soya agar (TSA), which is used at a dual incubation regime of 30°C – 35°C and 20°C – 25°C or two different culture media are used at two different temperatures, of which one of the media is selective for fungi (e.g. Sabouraud Dextrose agar, SDA). The choice of culture media, incubation times and temperatures requires validating.