1.0 Air Flow Pattern
1.2 Burn the stick.
1.3 Place the burning stick in front of running Air Handling Unit (AHU).
1.4 Observed the flow of air with the help of smock distribution in the room.
1.5 Make chart diagram of flew of air in the room as annexure-I for each room.
2.0 Air Flow Velocity And Change Per Hour
2.2 For case of experiment, divide the area of the HEPA Filter into four equal, hypothetical grids.
2.3 Record the velocity readings taken at the center of the grids, and at the junction of dividing lines (center of HEPA Filter) in 5.5.
2.4 Calculate the Average Velocity (V in feet per minute ) as :
V = (V1+V2+V3+V4) (Eq.1)
Vi = Velocity observation at each point
2.5 Measure the dimensions of each air inlet i.e. HEPA Filter, in feet and record it.
2.6 Calculate the Area (A in square feet) of each Air inlet as product of the length and the width as :
A = l x w (Eq.2)
where l = length of inlet
w = width of inlet
2.7 Calculate the Total Air Volume (T in cubic feet per minute) supplied in each zone, by using the formula :
T = A x V (Eq.3)
where A = Area of particular Air inlet in square feet
V = Average air velocity at particular air inlet in feet per minute
2.8 Calculate the total volume of the room by multiplying length of room, breath of room and height of the room.
Volume = L x B x H
2.9 Total air change is divided by total volume of the room will give the air change per hour. Fill the record in the form as annexure-II.
3.0 Filter Leak Test
3.2 Check the velocity of air to the all corner of the AHU. The air velocity should be within the higher limit of HEPA filter.
3.3 If there is air velocity is more than higher limit change the gas cut to prevent the air leakage.
4.0 Particles Count
4.2 Collect the information from particle counter and fill them in the format.
4.3 Operate the particle counter when work is on progress in the area. The particles should be count when more than one hour work has been progressed in the area. Record the data in the format.
4.4 Operate the particle counter for all the room maintaining grade A, grade B, grade C & grade D.
5.0 Viable Monitoring
5.2 Monitor the microbial load on the surface of the sterile manufacturing area by swab sampling and testing follow the SOP. Carry out swab sampling daily in Vial Filling, Vial Sealing, Sterile Buffer and Blending III; and twice in a week in Sterile Passage, Change Room II, Change Room III and Degowning I. Similarly carry out the swab sampling once in a week in Change Room I, Degowning II, Vial Washing, Bung Washing and component preparation. Record the results.
5.3 Place the media strips or petridishs in the air sampler on operate the air sampler as per standard operating procedure of the equipment.
5.4 Record the data in the format.
5.5 Monitor the microbial load on surface of hand gloves of the operators daily once in each working shift at random during activity follow the SOP and record the result. Record the data in the format.
5.6 In case of repeated failure during two observations the corrective action shall immediately be planned and implemented.
5.7 Monitor the critical functions of HVAC system, Water System and personnel's behavior in sterile and investigate cause of adverse results immediately after observation.
6.0 Filter Integrity Test ( DOP/PAO Test)
6.2 Switch the photometer "ON" and allow to stabilize for five minutes.
6.3 Ensure that 100 % upstream concentration is achieved at all the terminal HEPA filters.
6.4 Scan the filter matrix and perimeter by passing the receptor probe 1 inch from the filter surface, in overlapping strokes traversing at approximately 10 fpm to check for leaks, if any.
6.5 Test all the HEPA filters as per the above steps and record the observations in the format.
7.0 Pressure Difference
7.2 On the air system in side tested area and wait to stabilize the pressure in the area.
7.3 Observed the pressure difference from all room and from room to room.
7.4 Record the data in the format.
8.0 Recovery (Temperature & Humidity)
8.2 If humidity of the area within in specification. Increase the humidity by spraying hot water in the area up to 75%.
8.3 Wait to stabilize the humidity in the area about 75%.
8.4 Operate the HVAC system and note the time. Wait to stabilize the humidity in the area within the specification limit.
8.5 Note and record the time in the format.
8.6 For the recovery test increase the temperature of the area by using hot air blower in the area and increase the temperature 400C.
8.7 Operate the HVAC system and note the time. Wait to stabilize the temperature in the area within the specification limit.
8.8 Note and record the time in the format.
9.0 Temperature and Humidity Uniformity Test
10.0 Fresh Air Determination
10.2 On the fresh air dumper for fresh air and observed and calculate the intake air by the dumper in the room. Observed and calculate the total air change in the room.
10.3 The intake fresh air is divided by the total air change in the room and multiply by 100 to calculate the % fresh air intake on each cycle by the HVAC system in the tested room.
10.4 Record the data in the performance format record.
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