STANDARD OPERATING PROCEDURE PROCEDURE FOR HVAC VALIDATION

1.      PURPOSE:

1.1. To verify that HVAC system performance complies with specifications.

2.      SCOPE:

2.1.This SOP is applicable to all areas/ sections where HVAC system is installed.

3.      RESPONSIBILITY:

3.1. Quality Assurance Manager.

3.2. Quality Assurance Officer.

4.       PROCEDURE:

Heating ventilation and air conditioning system Validation tests

4.1.  Air Flow Velocity and Changes  Per Hour

4.1.1.        Scan the area for HEPA Filter, with the anemometer probe. 6 inches from the filter face.

4.1.2.        For ease of experiment, divide the area of the HEPA Filter into four equal, hypothetical grids.

4.1.3.        Record the velocity reading taken at the center of the grids, and at the junction of dividing lines (center of HEPA Filter).

4.1.4.        Calculate the Average Velocity (V in feet per minute) as

                                       V= (V1+V2+V3+V4)                                         Eq. 1

                                                         4

                                       V1= Velocity observation at each point

4.1.5.        Measure the dimensions of each air inlet i.e. HEPA Filter, in feet’s and record it.

4.1.6.        Calculate the Area (A in square feet) of each Air inlet as product of the length and the width as:

                                  A = l × w                                                         Eq. 2

        Where              l = length of inlet

                                 W = width of inlet

4.1.7.        Calculate the Total Air Volume (T in cubic feet per minute) supplied in each zone, by using the formula:

                                    T = A × 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

4.1.8.        Calculate the total volume of the room by multiplying length of room, breath of room and height of the room.

                                                        = L × B × H

4.1.9.        Total air change is divided by total volume of the room will give the air change per hour. Fill the record in the form (“HVAC AIR CHANGES FORM” Ref. Format # G/F/99)

4.2. Filter Leak Test.

4.2.1.         Place the anemometer at the front of AHU.

4.2.2.        Check the velocity of air to the all corners of the AHU. The air velocity should be within the higher limit of HEPA filter.

4.2.3.        If the air velocity is more than higher than the limit, change the gas cut to prevent the air leakage.

4.3. Particle Count

4.3.1.        On the air system before one hour of test operation. Take the suitable particle counter and operate it to check the particles in the room at non working operation.

4.3.2.        Collect the information from particle counter and fill them in the format. (ref. Format # G/F/100).

4.3.3.        Operate the particle counter when work is in 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.

4.3.4.        Operate the particle counter for the entire room maintaining grade A, grade B, grade C, and grade D.

4.4. Viable Monitoring.

4.4.1.        Record the results of viable monitoring (ref. Format # MC-002)

4.5. Filter Integrity Test (DOP)

4.5.1.        Filter integrity test (DOP) is performed through an outside source.

4.6. Pressure Difference

4.6.1.        Attach all concerning room (under test) to the manometers which are attached to the wall of adjacent area.

4.6.2.        Turn on the air system, inside tested area and wait to stabilize the pressure in the area.

4.6.3.        Observe the pressure difference from all rooms and from room to room.

4.6.4.        Record the data in the format.(“record of positive pressure” ref. Format G/F/56)

4.7. Recovery (temperature and Humidity)

4.7.1.        Turn off the HVAC system. Check the humidity of the area.

4.7.2.        If the relative humidity of the area is within specification increase the relative humidity by spraying hot water in the area up to 75 %.

4.7.3.        Wait for stabilization of humidity in the area about 75%.

4.7.4.        Operate the HVAC system and note the time. Wait to stabilize the humidity in the area within the specification limit.

4.7.5.        Note and record the time in the format (ref. Format G/F/49 & G/F/50).

4.7.6.        For the recovery test, increase the temperature of the area by using hot air blower in the area and increase the temperature up to 40 C.

4.7.7.        Operate the HVAC system and note the time. Wait to stabilize the temperature in the area within the specification limit.

4.7.8.        Note and record the time in the format.

4.7.9.        Temperature and humidity uniformity test.

4.7.10.    Place the calibrated thermometer on the different locations.

4.7.11.    Operate the HVAC system and note the time. Wait for stabilization of temperature in the area within the specification limit.

4.7.12.    Check and record the temperature of the area in format.

4.7.13.    Place the calibrated hygrometer on different locations.

4.7.14.    Operate the HVAC system and note the time. Wait to stabilize the humidity in the area within the specification limit.

4.7.15.    Check and record the humidity of the area in format (ref. Format G/F/49 & G/F/50)

5.       LIST OF RECIPIENTS:

1.1. Quality Assurance Manager

1.2. Maintenance Manager

  

6.      Attached Forms/ Documents:

6.1.Temperature & Humidity Record (ref. Format #)

6.2.Pressure record (ref. Format # )

6.3.Viable count record (ref. Format #)

6.4.DOP test certificates