MICROBIOLOGICAL EVALUATION OF NITROGEN GAS IN PHARMACEUTICAL INDUSTRY

Nitrogen gases are used at different stages of the pharmaceutical manufacturing process for several applications. Nitrogen gas sampling for microorganisms plays vital part in the contamination control. The aim of the work was to evaluate the aerobic and anaerobic microbial count in nitrogen gas during drug manufacturing process. The Nitrogen samples were collected at two different sites about 1000 liters of air sampled by using M-Air- T air sampler and petri plates containing soya bean casein digest agar used for sampling. The processed plates were incubated for aerobic microbial count at 20-25° C for 3 days for fungal count, followed by 30-35° C for 3-5 days for bacterial count. Incubated anaerobic microbial count at 30-35°C for 3 days using anaerobic jar and anaerobic gas pack. After incubation the plates were evaluated for microbial count. The results observed during the study met the acceptance limits as per the ISPE guideline, the microbial count for non-sterile applications limit is to be established based on the product bioburden limits. Typical level NMT 5 cfu/m3 and for sterile applications as per the viable particle requirements for grade area where the product is exposed to the compressed gas (eg.Grade A, Grade A/B, Grade B or Grade C). The pharmaceutical manufacturing industries are supposed to set up the limit and acceptance criteria based on the periodic evaluation. Keywords: Nitrogen gas, Aerobic, Anaerobic microbial count, Sterile, Non-sterile Pharmaceutical industry