PSYCHOTROPICS INDIA LIMITED

Plot No-46 & 49, Sector-6A,IIE, SIDCUL, Haridwar-249403, (Uttarakhand), INDIA

Department : Quality Assurance Document No. QA/PQR/AHU/00

Revision No. R-00
Subject: HVAC Performance Qualification Report Effective Date. 21.10.2013
Review Date 20.10.2015
Page No. 1 of 8

PERFORMANCE QUALIFICATION
REPORT
FOR
HVAC SYSTEM
 PSYCHOTROPICS INDIA LIMITED
Plot No-46 & 49, Sector-6A,IIE, SIDCUL, Haridwar-249403, (Uttarakhand), INDIA

AHU QUALIFICATION REPORT

Department : Quality Assurance Document No. QA/PQR/AHU/00
Revision No. R-00
Subject: HVAC Performance Qualification Report Effective Date. 21.10.2013
Review Date 20.10.2015
Page No. 2 of 8
REPORT

The Performance Qualification of Air handling system has been done as per the validation protocol no.
QA/PQP/AHU/00, the description of system has been given below-:

SR No. DESCRIPTION SPECIFICATION

1. Make

2. Model

3. Capacity

4. AHU No.
 PSYCHOTROPICS INDIA LIMITED
Plot No-46 & 49, Sector-6A,IIE, SIDCUL, Haridwar-249403, (Uttarakhand), INDIA

AHU QUALIFICATION REPORT

Department : Quality Assurance Document No. QA/PQR/AHU/00
Revision No. R-00
Subject: HVAC Performance Qualification Report Effective Date. 21.10.2013
Review Date 20.10.2015
Page No. 3 of 8

LAY OUT OF AHU SYSTEM :

DATA SHEETS 1:
 PSYCHOTROPICS INDIA LIMITED
Plot No-46 & 49, Sector-6A,IIE, SIDCUL, Haridwar-249403, (Uttarakhand), INDIA

AHU QUALIFICATION REPORT

Department : Quality Assurance Document No. QA/PQR/AHU/00
Revision No. R-00
Subject: HVAC Performance Qualification Report Effective Date. 21.10.2013
Review Date 20.10.2015
Page No. 4 of 8

PARTICULATE MATTER COUNT TEST

Limit: 5 micron particle size ( For room Area) : Less then 3520000
0.5micron particle size (For room area) : less than 2900

No of sampling Location:

NL = A
= 84.78

= 9

SAMPLING POSITION:

L1 L2 L3

L3 L4 L5 L6

L7 L8

L9

OBSERVATION:

Area Location Area (in m2) No of particles Remarks

 PSYCHOTROPICS INDIA LIMITED
Plot No-46 & 49, Sector-6A,IIE, SIDCUL, Haridwar-249403, (Uttarakhand), INDIA

AHU QUALIFICATION REPORT

Department : Quality Assurance Document No. QA/PQR/AHU/00
Revision No. R-00
Subject: HVAC Performance Qualification Report Effective Date. 21.10.2013
Review Date 20.10.2015
Page No. 5 of 8
0.5  5

L1
L2 84.78
Liquid L3
manufacturing L4
Area L5
L6
L7
L8
L9

Comments: _____________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

Done by: Reviewed by:

Sign/date Sign/date
 PSYCHOTROPICS INDIA LIMITED
Plot No-46 & 49, Sector-6A,IIE, SIDCUL, Haridwar-249403, (Uttarakhand), INDIA

AHU QUALIFICATION REPORT

Department : Quality Assurance Document No. QA/PQR/AHU/00
Revision No. R-00
Subject: HVAC Performance Qualification Report Effective Date. 21.10.2013
Review Date 20.10.2015
Page No. 6 of 8
DATASHEET-2

NUMBER OF AIR CHANGES PER HOUR

Limit: No.of Air changes: Not less than 20 /hour

Total Volume of the area: 7992 ft3
Calculation for number of air changes/hour:

Average velocity of air (fit/min) x Effective Filter area (Sq.m.) x 60 =

Volume of cubicle/ area

Sr Filter no. Observed Velosity (ft/min) Filter Total air

N V1 V2 V3 V4 V5 Surface flow
o. area (ft2 ) (in ft/min)
1
AHU-22/LM/FG/SUP-01
2
AHU-22/LM/FG/SUP-03
3
AHU-22/LM/FG/SUP-04
4
AHU-22/LM/FG/SUP-05
5
AHU-22/LM/FG/SUP-06
6
AHU-22/LM/FG/SUP-07
7
AHU-22/LM/FG/SUP-08
8
AHU-22/LM/FG/SUP-09
9
AHU-22/LM/FG/SUP-10

No of Air Change /hour:

Comments:______________________________________________________________________

_________________________________________________________________________________________

Done by: Reviewed by:

Sign/date Sign/date
 PSYCHOTROPICS INDIA LIMITED
Plot No-46 & 49, Sector-6A,IIE, SIDCUL, Haridwar-249403, (Uttarakhand), INDIA

AHU QUALIFICATION REPORT

Department : Quality Assurance Document No. QA/PQR/AHU/00
Revision No. R-00
Subject: HVAC Performance Qualification Report Effective Date. 21.10.2013
Review Date 20.10.2015
Page No. 7 of 8
DATASHEET-3

TEMPERATURE, HUMIDITY & DIFFERENTIAL PRESSURE MONITORING

Li mits : 1) Temperature : NMT 25°C

2) Humidity : NMT 50%
3) Differential Pressure : Not Less Than 5 Pascal

Area. Date. Time. Temp. Humidity Differential

Pressure

Liquid Manufacturing Area

Comments:______________________________________________________________________

________________________________________________________________________________________

________________________________________________________________________________________

Done by : Reviewed by:

Sign/date Sign/date
 PSYCHOTROPICS INDIA LIMITED
Plot No-46 & 49, Sector-6A,IIE, SIDCUL, Haridwar-249403, (Uttarakhand), INDIA

AHU QUALIFICATION REPORT

Department : Quality Assurance Document No. QA/PQR/AHU/00
Revision No. R-00
Subject: HVAC Performance Qualification Report Effective Date. 21.10.2013
Review Date 20.10.2015
Page No. 8 of 8

REPORT APPROVAL

It has been verified that all tests required by this protocol are completed, reconciled and attached to this
protocol or included in the qualification summary report. Verified that all amendments and discrepancies are
documented, approved and attached to this protocol.

Signature in the block below indicate that all items in this performance qualification report of air handling unit
have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily
resolved and the system is qualified for its routine use.

NAME DESIGNATION DEPARTMENT SIGNATURE DATE

ENGINEERING

PRODUCTION

QUALITY
ASSURANCE