Dawn Analytics Page 1 of 10

INSTALLATION QUALIFICATION
S. No Contents Page No

1 Index of Installation qualification 1

2 Object 2

3 Scope 2

4 Responsibilities 2

5 Instrument origin and identification 3

6 Instrument specification 4

7 Environment and siting 5

8 Packing List 6

9 Instrument delivery and documentation 7

10 Instrument safety 8

11 Assembly and installation 9

12 Summary report 10

75 M, M Block, Model Town Ext, Lahore-Pakistan

dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152
 Dawn Analytics Page 2 of 10

Objective:
To qualify the Dawn Friability testing apparatus, for use in friability testing of tablet

Scope:
The scope of this report is limited to Dawn Friability tester

Responsibilities:
Vendor
Purchaser/ Buyer

75 M, M Block, Model Town Ext, Lahore-Pakistan

dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152
 Dawn Analytics Page 3 of 10

Instrument origin and Identification

Instrument Friability Tester

Model FT-09

Instrument Description Microprocessor based friability test apparatus

Manufacturer Dawn Analytical supplies

Tel: +92-42-35846571
Service Contact Tel/Fax: +92-42-35864077
E-Mail: dawncalibrate@gmail.com
Serial Number
New ✓

Condition when received Used

Date Received

Installation Location Instrument Room-1 Quality control

Purchase Order Number

Identification/ Asset Number:

75 M, M Block, Model Town Ext, Lahore-Pakistan

dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152
 Dawn Analytics Page 4 of 10

Instrument Specification
User Required Specification of Friability apparatus
S. Decision
User Requirements Desired features Functions
No Pass Fail
Standard requirement for
1 Rotation per minutes 25(±02)RPM
rpm setting in a equipment ✓
As per USP, BP and EP
monographs the 100 ✓
2 Timer 01 to 200 revolutions required at 25
RPM min, total time required
for testing is 4min
To check the equipment
3 Time setting difference 1 minute
performance is robust, ✓
accurate and precise during
testing

Comments: the equipment received as per URS and USP Specified standards

Environmental requirements of Equipment

75 M, M Block, Model Town Ext, Lahore-Pakistan
dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152
 Dawn Analytics Page 5 of 10

Decision
S. No User Requirements Desired features Functions
Pass Fail
Ambient temperature of Equipment defriend range for best
1 (5 to 40) ºC ✓
Lab performance
80% upto 31◦C,
2 Max relative humidity decreasing linearly to The humidity threshold of lab set ✓
50% at 40◦C
Supply voltage and Standard voltage supplies available in
3
frequency
220V @ 50/60 Hz
laboratory ✓
This is general requirement to avoid
No direct sun light
4 Sun light
exposure
equipment corrosion and abrasion of ✓
equipment surfaces
Should be inert to The equipment should be designed to avoid
5 Reactive gases
reactive gases any corrosive reaction with reactive gases ✓

The equipment should be designed to align

6 Place Level Leveled
balanced. ✓

Comments: environment and sitting of equipment is satisfactory

75 M, M Block, Model Town Ext, Lahore-Pakistan

dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152
 Dawn Analytics Page 6 of 10

Packing List

S. No Description Quantity

1 Drum 1

2 Power Cord 1

3 Instruction Manual 1

Instrument Delivery and documentation

75 M, M Block, Model Town Ext, Lahore-Pakistan

dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152
 Dawn Analytics Page 7 of 10

Unpack the equipment carefully, Are any items missing against packing list?

Yes No ✓

If Yes State the missing items:________________________________________________

Is there any damage to the instrument or accessories?

Yes No ✓

If Yes Damage Description: __________________________________________

Corrective action: ____________________________________________

manufacturer Informed Yes No

Is all documentation included?

Service Manual Yes ✓ No

Qualification Documents Yes ✓ No

Instrument Safety

75 M, M Block, Model Town Ext, Lahore-Pakistan

dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152
 Dawn Analytics Page 8 of 10

Manufacturers Safety Recommendations: Status

 Allow enough space for the instrument ✓

✓
 Position on level, noncombustible surface indoor

✓
 Area free from aggressive/ explosive chemical mixture

✓
 Ensure correct power supply and all power switches easily accessible

✓
 Read operator manual before use

Comments: All Instrument safety tests “pass”

Assembly and complete installation

75 M, M Block, Model Town Ext, Lahore-Pakistan
dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152
 Dawn Analytics Page 9 of 10

Assembly and User Specialized Engineer ✓

installed by

Installation Procedure Ok Discrepancy N/A

✓
Unpack and retain packaging

✓
Assembly

✓
Site and content to power supply

✓
As mentioned on instruction manual

Comment (Including Discrepencies): Assembly and installation done by a specialized engineer

Model No: FT-09

75 M, M Block, Model Town Ext, Lahore-Pakistan

dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152
 Dawn Analytics Page 10 of 10

Summary Report:

Instrument: Microprocessor based Friability test apparatus Manufacturer: Dawn

Assessment of complete installation qualification:

No Deviations: ✓ Deviations: (List Below)

Deviation Impact on operation Justification for acceptance

Remarks: successful completion of the proceeding activities and checks indicate that this
instrument has been successfully delivered and installed. The instrument has passed installation
qualification procedure and may now be submitted for operation qualification

IQ Completed By: Date:

Deviation Approved By: Date:

IQ Approved By: Date:

75 M, M Block, Model Town Ext, Lahore-Pakistan

dawnanalyticals@gmail.com
info@dawnanalyticals.com
+92 334 9814152