PHARM PROTOCOL NO.

:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 1 of 13

DESIGN QUALIFICATION
PROTOCOL CUM REPORT
FOR
VIBRO SIFTER 48”
OF
GRANULATION-I,
GENERAL BLOCK

SUPERSEDES NO. NIL

DATE OF QUALIFICATION

FORMAT No: F03-00/QAD 046

 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 2 of 13

PROTOCOL CUM REPORT CONTENT

SL.N TITLE PAGE
O. NO.
1. PROTOCOL CUM REPORT PRE APPROVAL 3

2. OBJECTIVE 4

3. SCOPE 4

4. RESPONSIBILITY 5

5. BRIEF ABOUT DESCRIPTION 5

6. PROJECT REQUIREMENT 7

7. EQUIPMENT DETAILS 7

8. CRITICAL VARIABLES TO BE MET 8

9. EQUIPMENT PARAMETERS 8

10. UTILITY REQUIREMENT/LOCATION SUITABILITY 9

11. TECHNICAL SPECIFICATION/ KEY DESIGN FEATURES 9

12. MATERIAL OF CONSTRUCTION 10

13. SAFETY 10

14. VENDOR SELECTION 11

15. DOCUMENT TO BE ATTACHED 11

16. REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) 11

17. ANY CHANGES MADE AGAINST THE FORMALLY AGREED PARAMETERS 11

18. RECOMMENDATION 11

19. ABBREVIATIONS 12

20. PROTOCOL CUM REPORT POST APPROVAL 13

FORMAT No: F03-00/QAD 046

 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 3 of 13

1. PROTOCOL CUM REPORT PRE APPROVAL:

PREPARED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
OPERATING MANAGER
(ENGINEERING)

HEAD
(ENGINEERING)

HEAD
(PRODUCTION)

APPROVED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(QUALITY ASSURANCE)

AUTHORISED BY:
DESIGNATION NAME SIGNATURE DATE
PLANT HEAD

2. OBJECTIVE:

FORMAT No: F03-00/QAD 046

 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 4 of 13

The objective of this design qualification protocol is,

 To verify that the design of the equipment, system or facility is according to the requirements of user
and cGMP.
 The Design Qualification Protocol cum report shall specify the Design Parameters of the equipment
Vibro Sifter 48” being manufactured by Tapasya Engineering Works Pvt. Ltd. for M/s. Shangrila
Industries Pvt. Ltd. having their manufacturing plant at Sikkim.
 This protocol shall confirm that the machine being manufactured shall comply with the specifications
laid down in this protocol cum report.

3. SCOPE:
The Scope of this design qualification document is limited to design of Vibro Sifter 48” as per
functional requirements and as well as design specification, including its all accessories for preset
acceptance criteria at Granulation-I, General Block, Shangrila Industries (P) Ltd., Sikkim. The Vibro
Sifter is equipment used to separate mass composition of solids from solids, liquid from solid and for
gradation of materials as per particle size for a very wide range of applications.

4. RESPONSIBILITY:
FORMAT No: F03-00/QAD 046
 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 5 of 13

The validation group, comprising of a representative from each of the following department shall be
responsible for the overall compliance of this protocol cum report;
Departments Responsibilities

Manufacturer  To provide the complete technical details of the equipment pertaining

to its operational functions.
 To perform the DQ
Quality Assurance  Preparation, review and approval of the design qualification protocol
cum report
 To review the specifications from cGMP aspects
Production  Review of protocol cum report
 To review the specifications from cGMP aspects
Engineering  Review of protocol cum report
 Co-ordination and technical support in qualification activity.
 To review the specifications from cGMP aspects

5. BRIEF ABOUT DESCRIPTION:

The Vibratory-Sifter is an efficient, compact and portable machine used for sieving, straining and
grading operations. The conventional type of sieving machines has proved to be inefficient in terms of
output and uniform grading of materials. This is basically due to the working principle employed in its
mechanism. The conventional type of sieving machine operates using rotary or longitudinal movements
whereas, this new Vibro-sifter functions using principle of "Gyratory Motion" which has proved to be
advantageous hence performs better sieving, straining and grading operations in comparison to the
conventional one.
Working Principle:-
The Vibro Sifter works on the principle of gyratory principle, Which states that states that if a body is
allowed to rotate at high speed on its own axis, in any plane and is free to move in all the three planes
the Gyratory Forces developed are such that they tend to bring the axis of rotation of the body parallel
to the axis of the earth.
In Vibro Sifter the required vibratory motion is obtained from specially designed gyro motor, which is
fitted underneath of vibrating assembly. The complete vibrating assembly is isolated from base by
means of specially designed rugged springs. Gyro motor is fitted with top and bottom eccentric weights

FORMAT No: F03-00/QAD 046

 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 6 of 13

designed as per required centrifugal force. Top weight of the motor gives horizontal component of
vibration due to which material is spread over the screen going away from the center, bottom weight of
the motor gives vertical component of vibration due to which material, both weights gives tangential
movement, due to which material starts rotating throughout the periphery.
The system comprises of:
Base Structure
The Base Structure is an SS 304 solid structure which is used to support the entire sieving unit. There
are 8 Nos specially designed rugged springs mounted on the top portion of the base structure to isolate
the vibrating assembly from the base. There is an SS cover provided around the spring unit.
Main Drive Unit
It consists of a 0.5 HP FLP vibratory motor with eccentric weights provided on the top and bottom end
of the motor shaft. The top weight causes vibration in the horizontal plane, which causes the material to
move across the screen towards the periphery. The lower weight acts to tilt the machine, which causes
vibration in the vertical tangential axis. The angle of lead of the lower weight with relation to the upper
weight provides variable control of the screening pattern. By changing relative angle between top and
bottom weight, different flow patterns can be arranged on the screen as per type of material to have
optimum efficiency from the equipment. The vibratory motor with the eccentric weights is mounted
circular plate which is in direct contact with the vibratory springs on the base structure.
Hopper Assembly
Charging Hopper – It is an SS 316 solid structure from which the desired charging of the desired
product for sieving takes place. The Charging Hopper is clamped to the upper portion of the respective
deck. Designing of charging hopper is such that the whole surface area of the sieve mesh is used for
sieving.
Sieving Hoppers – The Sieving hoppers of SS 316 construction can be divided into two units. The top
hopper is clamped to the charging hopper. A discharge nozzle with manually operated gate is provided
for the top hopper for discharging the un sieved material which can be recharged into the equipment.
The bottom hopper provided is clamped with the top hopper. There is an SS 316 sieve of the desired
mesh provided between the top and bottom hoppers. A discharge nozzle is provided with the bottom
hopper for discharge of the material collected after passing through the sieve provided between the top

FORMAT No: F03-00/QAD 046

 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 7 of 13

and bottom hoppers. A conical profile is provided inside the bottom hopper to facilitate easy discharge
of the material sieved.
Control System
The Control System consists of a FLP Panel with Push Buttons.

6. PROJECT REQUIREMENT:
The project for set up of Vibro Sifter 48” based on product, safety, regulatory and cGMP requirements
and to prevent cross contamination in product. The Vibratory-Sifter is an efficient, compact and portable
machine used for sieving, straining and grading operations.

7. EQUIPMENT DETAILS:
Equipment Name Vibro Sifter 48”
Equipment ID SP/PRD/17/VS001
Manufacturer’s Name Tapasya Engineering Works Pvt. Ltd.
Supplier’s Name Tapasya Engineering Works Pvt. Ltd.
Location of Installation Granulation-I, First Floor, General Block

8. CRITICAL VARIABLES TO BE MET:

FORMAT No: F03-00/QAD 046
 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 8 of 13

Sl. No. Description Details

1. Size 48”
2. Sieving / Gradation of the desired product as per
Concept for usage
particle size
3. External Zone - Mirror Finish
Surface finish
Internal Product contact Zone – Mirror Finish
4. Mode of machine cleaning Manual
5. Main Motor 1.0 HP Vibratory Motor, FLP
6. Sieves size 40#, 16#, 20#, 30#, 60#, 80#, 100#, 24#
7. Charging port height 1300 mm
8. Discharge port height 930 mm
Dimension Specification
1. Machine Dimensions (in mm) - 1200 (L) x 1200 (W) x 1300 (H)
Approx

9. EQUIPMENT PARAMETERS:
Sl. No. Description Details
1. Name Vibro Sifter 48”
2. Make Tapasya Engineering Works Pvt. Ltd.
3. Model TAP-VS-48”

Sl. No. Sieve Designate Width of Aperture Corresponding Mesh

(In mm) In Tyler Std.

1. 4.75 4.75 4
2. 3.35 3.53 6
3. 2.36 2.36 8
4. 1.70 1.70 10
5. 1.40 1.40 12
6. 1.18 1.18 14
7. 1.00 1.00 16
FORMAT No: F03-00/QAD 046
 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
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ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 9 of 13

8. 850 microns 0.85 20

9. 710 microns 0.71 24
10. 600 microns 0.60 28
11. 500 microns 0.50 32
12. 425 microns 0.425 35
13. 355 microns 0.355 42
14. 300 microns 0.300 48
15. 250 microns 0.250 60
16. 212 microns 0.212 65
17. 180 microns 0.180 80
18. 150 microns 0.150 100
19. 106 microns 0.106 150
20. 75 microns 0.075 200
21. 63 microns 0.063 250

10. UTILITY REQUIREMENT/LOCATION SUITABILITY:

Sl. No. Utility Requirement
Power Consumption
1. Electricity 3 Phase, 415 ± 5% V
2. Frequency 50 Hz + 5%
3. Connected Load 1.0 HP / 2.0 Amp

11. TECHNICAL SPECIFICATION/ KEY DESIGN FEATURES:

Sl. No Description Specification
Mechanical
1. Gaskets Acrosil / Equivalent
2. Wheels Paramount / Swiss / Equivalent, 4PU wheel
Size - 100 mm diameter x 38 mm width, Fix Plate
3. Sieves S Pharma Equipment’s /Pharma Spares / Equivalent

FORMAT No: F03-00/QAD 046

 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 10 of 13

Electrical
1. Vibratory Motor Make – Ital Vibras,
1.0 Hp, 50 Hz,
FLP Type
2. Starter Siemens / Crompton/ Equivalent
3. Air Manifolds FESTO / Equivalent
4. FLP Make – Flame & Explosion Proof Co.

12. MATERIAL OF CONSTRUCTION (MOC):

Sl. No. Name of Parts MOC
1. Charging Hopper SS 316
2. Top Hopper SS 316
3. Bottom Hopper SS 316
4. Gasket Silicon

13. SAFETY:
Sl. No. Safety feature Specified function
1. In the event of power failure, the process For Operator & equipment safety.
shall halt and will start on restoring of
power failure & by operator
intervention.
2. Hardware Emergency switch at Operator For Operator Safety.
Console
3. Electro Static Earthing Control For Operator & equipment safety.
4. Motor overload Relay For Motor & equipment protection.

14. VENDOR SELECTION:

FORMAT No: F03-00/QAD 046

 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 11 of 13

These are the following parameters to select a vendor;

 Having years of business & constantly supplying business
 Ability to supply all the products required or the complete analysis
 Flexibility to allow changes in orders or product lines
 Sustainability and financial stability
 Delivery time on time & Having good customer service

15. DOCUMENT TO BE ATTACHED:

 All relevant documents

16. REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY):

......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
.........................................................................................................................................................

17. ANY CHANGES MADE AGAINST THE FORMALLY AGREED PARAMETERS:

......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
........................................................................................................................

18. RECOMMENDATION:
......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
.......................................................................................................................

FORMAT No: F03-00/QAD 046

 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 12 of 13

19. ABBREVIATIONS:
SS : Stainless Steel
QA : Quality Assurance
GA : General Arrangement
cGMP : Current Good Manufacturing Practices
MOC : Material of Construction
DQ : Design Qualification
Sl. No. : Serial Number
HP : Horse Power
FLP : Flame Proof
V : Volt
MS : Mild Steel
PLC : Programmable Logic Controller
HMI : Human Machine Interface
Mtrs : Meter
RPM : Revolution per Minute
Sq. cm : Square Centi Meter
Hz : Hertz
Mm : Mili meter
kW : Kilo Watt
Cu : Copper
DOL : direct-on-Line
PU : Polyurethane

FORMAT No: F03-00/QAD 046

 PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/VS001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA VIBRO SIFTER 48” SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 13 of 13

20. PROTOCOL CUM REPORT POST APPROVAL:

PREPARED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
OPERATING MANAGER
(ENGINEERING)

HEAD
(ENGINEERING)

HEAD
(PRODUCTION)

APPROVED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(QUALITY ASSURANCE)

AUTHORISED BY:
DESIGNATION NAME SIGNATURE DATE
PLANT HEAD

FORMAT No: F03-00/QAD 046