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Nalagarh Road,Baddi
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EFFECTIVE REVIEW DATE:
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CC
PERFORMANCE QUALIFICATION
EQUIPMENT NAME: AIR HANDLING UNIT
EQUIPMENT NUMBER:
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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Signing of this approval page of Protocol indicates agreement with the qualification
approach described in this document. If modification to the qualification approach
becomes necessary, an addendum shall be prepared and approved .The protocol cannot
be used for execution unless approved by the following authorities.
This Performance Qualification Report of Air handling unit has been reviewed and
approved by the following persons:
PREPARED BY QUALITY
ASSURANCE
REVIEWED BY PROJECTS /
ENGINEERING
REVIEWED BY QUALITY
CONTROL
REVIEWED BY PRODUCTION
APPROVED BY QUALITY
ASSURANCE
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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2.0 OVERVIEW:
2.1 OBJECTIVE:
The objective of this protocol is to demonstrate and provide documented evidence,
that the Air handling unit consistently provide and maintain an environmental condition
suitable for carrying out the respective operations. The performance qualification of Air
handling unit is a proof that the entire Air handling unit performs as intended under
actual production conditions. It is the beginning of the ongoing verification that the
system meets acceptance criteria for carrying out process validation.
2.2 PURPOSE:
The purpose of this protocol is to establish documentary evidence to ensure that the
installed Air handling unit will operate reproducibly and consistently within its full
dynamic range of operation according to manufacturer’s specifications.
2.3 SCOPE:
The Performance Qualification protocol describes the procedure, documentation,
references, acceptance criteria & revalidation criteria to be used for proving the
Qualification of Air handling unit installed.
2.4 RESPONSIBILITY:
The following shall be responsible;
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Execution team is responsible for the execution of operation of air handling unit. All
executors involved with this protocol shall sign within the prescribed format given
below:
DEPARTMENT DESIGNATION
NAME SIGNATURE DATE
PROJECTS /
ENGINEERING
QUALITY CONTROL
PRODUCTION
QUALITY ASSURANCE
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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3.0 PREREQUISITES:
Installation and operational qualification shall be successfully completed before
starting performance qualification.
Ensure that all equipment used in Validation activity are duly calibrated with
national / international traceability certificate. And copy of calibration certificates
shall be enclosed.
All the personnel involved in the validation activities shall be trained on the
operational and documentation aspects of the HVAC validation.
1) Equipment No
2) Services to
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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5
3 4
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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The variation among the average velocity across the terminal grill supplying to the same
room should not be more than ±20%.
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Evaluation of result
Results, complying with the acceptance criteria, shall establish the integrity of the HEPA
filter suitable for clean area.
If any leakage is observed from the mounting, it has to be rectified through, adjustment
and application of food grade silicone sealant.
If leakage is observed from the Filter media more than the acceptable limit, filter shall be
replaced with new one and qualified.
Any leakage greater than 0.03% of the upstream challenge aerosol concentration is
considered unacceptable and wants repairs and resetting.
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Acceptance Criteria
Pressure differentials across the two rooms of different class should be more than 1.5 mm
WG
Pressure differentials across the two rooms of same class should be more than 0.5 mm
WG
Pressure differentials should be maintained as indicated in the design conditions under
standard operating condition.
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6.5.1 Objective
To demonstrate the ability of the HVAC system to provide temperature and Relative
Humidity within the specified range.
The system shall be considered acceptable if the temperature and RH monitored during
72 hours at all locations falls within the specified temperature range.
The temperature of the area should be 25 ± 2OC and the Humidity should be 50±5%.
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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6.5.5 Results
Measure and record temperature and RH at the locations, specified for every room in the
drawing attached as Attachment. Record the observations in the Annexure # 5 at an
interval of 120 minutes for a period of 72 hours in each location, which includes both static
and dynamic conditions.
At rest condition: Room with lights on and no machine in operation. Only operator will be
present in the area for recording.
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6.7.1 Objective:
To determine the viable air borne microbial contamination level in air for the Process
rooms.
6.7.2 Procedure
SCDA / SDA plates shall be exposed on the working plane in the area at the designated
locations as per layout /sampling plan attached . Plate exposure shall be done under
dynamic condition. Plate shall be exposed for 4 hours. Exposed plate shall be incubated
for 30 to 35°C for 48 Hrs followed by 20 to 25°C for further 72 Hrs. Plates shall be
observed for any microbial growth after 5 days.
In dynamic condition, normal man movement shall be there.
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6.7.4 Procedure
Operate the Air sampler as per the SOP and collect air samples of 1000 L volume at the
designated locations as the sampling plan attached. Sampling shall be carried out in
dynamic condition. After sampling to remove the plate from the sampler aseptically. Label
the location number, block and date on plate. Exposed plates shall be incubated at 30 to
35°C for 48 Hrs followed by 20 to 25°C for further 72 Hrs.
In dynamic condition, normal man movement shall be there.
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6.8.1 Purpose:
To Measure the air borne sound pressure levels produced by operating AHU.
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Discrepancies:
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Reviewed by:
Date:
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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1. PQ Performance qualification.
7. RH Relative humidity.
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HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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Conclusion:
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PROJECTS/
ENGINEERING
PRODUCTION
QUALITY
ASSURANCE
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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12.1 ANNEXURE - 1
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Comments:
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12.2 ANNEXURE - 2
Upstream Downstream
Checked
Sr.No. Room Name Filter No. Concentration Concentration
By
% %
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Comments:
Reviewed By: Date:
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PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
Comments
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PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
Comments:
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PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
Comments:
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PRESSURE PRESSURE
Time Checked By Time Checked By
DIFFERENTIAL DIFFERENTIAL
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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Comments:
12.4 ANNEXURE – 4
AIR FLOW PATTERN TEST
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12.4 ANNEXURE – 4
AIR FLOW PATTERN TEST
Comments:
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12.4 ANNEXURE – 4
AIR FLOW PATTERN TEST
Comments:
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12.4 ANNEXURE - 4
Comments:
12.5 ANNEXURE - 5
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Checked
Time
Air Lock Clean IPC store By
(Hrs)
Sign/Date
Temp RH Temp RH
(°C) (%) (°C) (%)
Date Day
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Date Day
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12.6 ANNEXURE - 6
NON -VIABLE PARTICLE COUNT TEST
ROOM NAME: ROOM No:
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Particulate Count
Sample Trial-I Trial-II Trial-III Mean (Trial I+II+III)
Location No
> 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0
1
2
3
4
5
Comments
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12.6 ANNEXURE - 6
NON -VIABLE PARTICLE COUNT TEST
ROOM NAME: ROOM No:
Particulate Count
Sample Trial-I Trial-II Trial-III Mean (Trial I+II+III)
Location No
> 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0 > 0.5 > 5.0
1
2
3
4
5
12.6 ANNEXURE - 6
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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Comments
12.6 ANNEXURE - 6
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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Comments
12.6 ANNEXURE - 6
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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Comments
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12.6 ANNEXURE - 6
NON -VIABLE PARTICLE COUNT TEST
ROOM NAME: ROOM No:
Comments
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12.6 ANNEXURE - 6
NON -VIABLE PARTICLE COUNT TEST
ROOM NAME: ROOM No:
Comments
12.7 ANNEXURE - 7
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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EFFECTIVE REVIEW DATE:
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Date: From________To____________
Comments
Reviewed By:
Approved By:
Date: From________To____________
Comments
Reviewed By:
Approved By:
12.7 ANNEXURE - 7
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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EFFECTIVE REVIEW DATE:
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Date: From________To____________
Comments
Reviewed By:
Approved By:
Date: From________To____________
Comments
Reviewed By:
Approved By:
12.7 ANNEXURE - 7
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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EFFECTIVE REVIEW DATE:
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Date: From________To____________
Comments
Reviewed By:
Approved By:
Date: From________To____________
Comments
Reviewed By:
Approved By:
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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12.7 ANNEXURE - 7
Date: From________To____________
Comments
Reviewed By:
Approved By:
Date: From________To____________
Comments
Reviewed By:
Approved By:
HEALTH BIOTECH LIMITED
Nalagarh Road,Baddi
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12.8 ANNEXURE - 8
SOUND LEVEL TEST
Sound level
(db)
2.