5.1 Health, safety and environment:
5.1.1 The general health condition of personnel must be satisfactory. Staff with open wounds, any skin ailment or any respiratory tract infection must not be permitted to work in microbiology/ laboratory.
5.1.2 Periodic health checks for the above mentioned conditions should be done.
5.2 Daily checks:
5.2.1 Record the room temperatures and differential pressure of different areas twice a day.
5.2.2 Temperature: The Temperature in the classified areas should be maintained between 20 to 25°C and unclassified areas NMT 25°C and relative humidity not more than 55 % (For Classified area).
5.2.3 Differential Pressure: The differential pressure between two areas of different grade should be minimum 1.5 mm of water column. Whereas differential pressure between two areas of same grade should be minimum 1.0 mm of water column.
5.2.4 For temperature and differential pressure of area can be monitored by using Area monitoring gauges/hygrometers respectively.
5.2.5 Record manometer readings of Isolator /LAF / Biosafety cabinet/ Garment cubicle / Dynamic pass box twice a day.
5.2.6 Manometer readings of the Isolator /LAF/Biosafety cabinet/ Garment cubicle/ Dynamic pass box should be within the set limit. It should be zero when Isolator /LAF/Biosafety cabinet/ garment cubicle/ dynamic pass box is in OFF condition.
5.2.7 The data logger printout should be taken daily for the temperature of all incubators (BOD Incubator, dual chamber incubator, cooling incubator) In case of a holiday or weekly off, the printouts should be taken on the next working day. Analyst should check and sign the printouts of the data logger. Any deviation in temperature should be noted and informed to the Section Head and incase failure of printout systems, the monitoring can be done manually by using display /HMI of incubator twice a day.
5.2.8 Record the temperature of water bath in the individual instrument SOP.
Different equipment’s setting range:
Refrigerator : 2 to 8°C
Deep freezer : -20°C
Incubators : 20°C to 25°C/ 18°C to 24°C / 30°C to 35°C / 55°C to 60°C / 42°C to 45°C
Water bath/steam pot. Boiling water temperature to be set as per requirement / for any other temperature setting required, range should be + 1°C of the set temperature. (37°C +1°C, 50°C +1°C, 95-100+2°C)
5.3 Equipment Monitoring:
5.3.1 Equipments to be validated as per the frequency: Autoclave used for “Media & Garment Sterilization”: Once 365 days.
5.3.2 Incubators: Once in 730 days
5.3.3 Water bath: Once in 365 days.
5.3.4 Hot Air Oven/Depyrogenation oven: One validation exercise once in 365 days.
5.3.5 Autoclave used for decontamination Once in 365 days.
5.3.6 Performance verification of all the above equipments shall be completed with in the period mentioned in schedule.