MONITORING OF POSITIVE PRSSURE, AIR TEMERATURE AND RELATIVE HUMIDITY

ST — 069
MONITORING OF POSITIVE PRSSURE, AIR TEMERATURE AND RELATIVE HUMIDITY


Area under consideration: Class 100 to Class 10,000 under the same air handling units and air-conditioning plant and component preparation area (Class 10,000). Temperature Monitoring: Limit: Not to exceed 23ºC.

1. One calibrated thermometer permanently fixed on the body of 12’ LAF unit, which can be seen from the view panel in corridor.
2. The supervisor of sterile area must read and record the temperature of sterile room at any time between 11.30 hours – 14.00 hours on all filling days.
3. The chart is can annual record for the temperature in the one room.

The instrument is not calibrated semi-annually

Positive Pressure Monitoring: Daily Record

1. Filing room and change room pressure indicating manometers are mounted on a board outside the filling room in the adjoining passage.
2. the supervisor must read and record the pressure of the rooms in the ‘Daily Pressure Record’ chart at the time of recording temperature during the working hours.
3. Simultaneously, the pressure reading of each manometer mound on the LAF mentioned below should be similarly recoreded.

A. Filling Room

2 manometers mounted on one ft LAF (horizontal)

1 manometer mounted on one down-flow Gradvel laminar used for ampoule filling

1 manometer mounted on one4 ft. Gradvel down-flow laminar used for aseptic filtration

1 manometer mounted on the down-flow laminar above small right angle conveyor

1 manometer mounted on the down-flow laminar large turntable

Pressure Differential Across Terminal HEPA Filter Monitoring






The manometers indicating pressure differential across the terminal HEPA filter in the filling room and change rooms are mounted on a board outside the filling room in the adjoining passage. The pressure differential reading are recorded monthly

B. Component Preparation Area

One monometer on the vertical down-flow Gradvel laminar on the vial/ampoule washing machine.

One monometer on the vertical down-flow laminar on the final rubber stopper washing machine.

One monometer on vertical down-flow laminar above the table used for component wraping.

One manometer on vertical down-flow laminar flow hood above the vial sealing machine.

4. The filling room pressure must be grater than the adjacent 3rd change room pressure by 1.25 mm of water gauge (i.e.0.05 inches of water gauge).Similarly the 3rd change room pressure must be greater than the 2nd change room pressure by 1.25 mm water gauge. The 2nd change room pressure must be grater than 1st change room pressure by 1.25 mm water gauge and the 1st change room pressure must be grater than the outside passage by 1.25 mm water gauge.

Relative Humidity Monitoring

Sterile filling room is daily monitored for relative humidity. Dial type ‘Barigo’ brand instrument for measuring humidity is kept near the temperature indicator in the filling room. Humidity is recorded on all filling days in the prepared format. Limit not more than 55%. The instrument is calibrated semi-annually.