Download as docx, pdf, or txt
Download as docx, pdf, or txt
You are on page 1of 23

PHARM PROTOCOL NO.

:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 1 of 23

DESIGN QUALIFICATION
PROTOCOL CUM REPORT
FOR
RAPID MIXER GRANULATOR (RMG)
OF
GRANULATION-I,
GENERAL BLOCK

SUPERSEDES NO. NIL


DATE OF QUALIFICATION

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 2 of 23

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 4

5. BRIEF ABOUT DESCRIPTION 5

6. PROJECT REQUIREMENT 9

7. EQUIPMENT DETAILS 9

8. CRITICAL VARIABLES TO BE MET 9

9. EQUIPMENT PARAMETERS 11

10. UTILITY REQUIREMENT/LOCATION SUITABILITY 11

11. TECHNICAL SPECIFICATION/ KEY DESIGN FEATURES 12

12. MATERIAL OF CONSTRUCTION 19

13. SAFETY 20

14. VENDOR SELECTION 21

15. DOCUMENT TO BE ATTACHED 21

16. REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) 21

17. ANY CHANGES MADE AGAINST THE FORMALLY AGREED PARAMETERS 21

18. RECOMMENDATION 22

19. ABBREVIATIONS 22

20. PROTOCOL CUM REPORT POST APPROVAL 23

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 3 of 23

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/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 4 of 23

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
Rapid Mixer Granulator (RMG)-600 liter being manufactured by Tapasya Engineering Works Pvt.
Ltd., Thane 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 Rapid Mixer Granulator (RMG)
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
equipment shall be intended in mixing and granulation of the product.

4. RESPONSIBILITY:
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:
FORMAT No: F03-00/QAD 046
PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 5 of 23

The RMG 600 is a machine developed for mixing as well as granulation of the desired product
(pharmaceutical bulk powders). The multi-bladed impeller is fitted close to the base of the mixing bowl
whereas the chopper is mounted on the wall of the mixing bowl. The Impeller and Chopper are of a
Dual speed motors. The RMG is designed to meet special needs of pharmaceutical granulation. This is
achieved by reducing processing time, more homogeneous mixing, uniformity of granule size and
above all maintaining improved hygiene compliant to cGMP norms.
This RMG is designed to achieve all the requirements of cGMP-Current Good manufacturing Practices.
The components can be easily dismantled, cleaned thoroughly and assembled in quick time the shaft
seals are very effective to check an leakages and cross contamination due to adherents. The bowl and
all the components are of highly polished stainless steel with smooth contours and is crevice less.
Bowl:
It is circular with a large diameter and flat base. The top portion of the bowl is conical in shape to
assist mixing of cohesive powders. The bowl is constructed from SS 316 material. A hub pipe which is
on bottom flat dish surrounds the drive shaft where it enters the base of the bowl, where the mechanical
seal is provided for sealing & holding the partial vacuum inside the bowl. The air cooling is provided to
mechanical seal. The beater blade which having three numbers blade of triangular shape which is
fabricated from SS 316 material. The blade is fitted on drive shaft by bolting with sleeve which is
mounted on the drive shaft. The blade is used for dry & wet mixing of powders of different products, to
prepare the tablet formulations.
Bowl Finish: Inside and outside surfaces is mirror polished.
Mechanical Seal: The single dry mechanical seal at impeller end is provided to withstand the bowl for
partial vacuum.
Lid Lifting:
The hydraulic lid lifting arrangement is given on bowl for ease of opening & closing of lid. The
telescopic hydraulic cylinder is mounted on bowl & connected with lid. The cylinder is operated by
hydraulic power pack unit. The hydraulic unit is placed inside the drive frame.

Granulator:

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 6 of 23

A high speed granulator (Chopper) is inserted horizontally through the wall of the bowl to assist
blending of the powder and to break the product to granules of required size. The special design
chopper blade has two “U” shaped blades which is welded 90 degree apart from each other. The “U”
shape blade is provided with knife edge to assist breaking of lumps which forms during the wet mixing.
The granulator rotates at single speeds- 2840 RPM. The AC drive is used for varying the speed of
chopper from 284 to 2840 RPM.
The granulator head is of highly polished stainless steel and is easily removable for cleaning. The
granulator shaft where it enters the bowl is provided with mechanical seal. The air flushing/cooling is
provide to mechanical seal. The motor is provided with a removable stainless steel shroud which covers
it to meet cGMP norms.
Discharge Valve:
It is provided on the bowl bottom side of the shell. It is operated by a SS Piston connected to a
pneumatic cylinder. The hinge type cover is provided for easy opening & closing for cleaning of the
inside portion of the discharge. A safety lock in the form of a limit switch is provided at the discharge
cover to prevent the motors to start during the operation. The pneumatic cylinder is covered by a
stainless steel shroud.
Cone Mill:
The in-line cone mill is used for breaking the lump formed during wet mixing of powder into the RMG.
The cone mill is used to enhance the drying efficiency. The cone mill is in built with discharge of
RMG. So final mix material of RMG directly passed through cone mill. The cone mill blade is
triangular in shape and rotates at a speed of 2850 RPM (nom) the cone mill is provide with 10 mm dia.
Mesh.
The discharge of the cone mill is provided with a vacuum transfer chute which has a 20
Micron sintered filter for easy transfer of product into FBD. A flexible hose is provided to connect in
between FBD nd cone mill for the transfer of product.
Saizoner improved processing:
 Uniform distribution of all formulation ingredients.
 Short mixing and granulation time.
 Useful working capacity of upto 80 % to 40% of bowl volume.
FORMAT No: F03-00/QAD 046
PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 7 of 23

 Uniform granules by gentle processing.


 Wide range of applications.
 Easy scale up & scale down between machine sizes.
 Bowl shape design to have no dead spaces.
Electricals:
Saizoner Mixer Granulator is offered in Nonflame Proof constructions. The machine has two panels.
Main Panel: made out of MS Powder coated casing, housing the main contactors, overload relays,
MCB'S and the various other control instrumentations. The main panel is located in technical area.
Operating Panel: the panel is air purged and made in SS 304. The machine is programmable logic
control base. The panel is consists of MMI & emergency button, control ON/OFF switch. The PLC is
has a printer port to connect the printer.
Automation:
To achieve consistency in the product quality it is desirable to minimize / eliminate the human elements
in monitoring the operational parameters of the machine including the end point control. It is also
desirable to record / store the critical data which may contribute to product quality. The operational
recipe data can be saved and hard copy can also be taken out. To incorporate suitable provision in the
system of data storage, customer has to specify parameters which are required to be reproduced. As a
standard, following parameters are recorded.
 Product Name
 Operator Name
 Batch No.
 Batch Date
 Batch Cycle Timer
 Dry Mixing Time
 Wet Mixing Time
 Granulation Time
 End Point time
 Various Faults if any during cycle

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 8 of 23

AC Drive:
(A) The AC drive is used for varying the speed of the beater blade to get the uniform granules and to
control feed of the cone mill at time of discharge. Three speeds are set on the AC drive.
1. High Speed (50 Hz- Variable)
2. Low Speed (25 Hz- Variable)
3. Creep Speed (10 Hz- Factory Settable)
(B) The AC drive is used for varying the speed of the chopper blade. The speed of chopper is varying
from 288 to 2880 RPM. Two speeds are set on the AC drive.
Drive:
The gear box and motor are coupled with pulleys and belts to rotate the beater blade. On the gear box
MS Lantern is bolted on which RMG Bowl is mounted.
Frame:
The RMG Frame is fabricated from MS Square pipe. The frame legs are cladded with SS sheet on the
top of the frame SS Dimple plate is welded and safety railing is provided all around the frame. Inside
the frame Gear box, motor and pneumatic panel are mounted. All sides of the frames are coverd with
SS Panel and a safety lock in the form of a limit switch is provided on the drive side SS Panel to
prevent the motors to start if any panel is in open condition.
Blade Removing Arrangement:
The blade lifting arrangement is given to remove the blade from the bowl for cleaning or other
maintenance work. The blade lifting arrangement consists of the SS pipe, wire rope & gear motor. The
SS swivel pipe is mounted on the machine frame and wire rope is passed through the pipe for lifting the
blade. On one end of the rope, lifting hook if fitted & other end of the rope is fitted with rope drum
which is fitted with gear box shaft. To rotate the drum Gear box is coupled with motor by which blade
is lifted up & down for removing or placing it into the bowl.
Separator with Vacuum Pump:
The vacuum pump with separator is provided for creating the vacuum into the RMG bowl for charging
the material by vacuum from existing drum. The separator is fabricated from SS 304 plate. The outside
& inside portion of the separator is dull polished. The vacuum pump & separator are mounted on skid
and placed in the technical area.

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 9 of 23

6. PROJECT REQUIREMENT:
The project for set up of Rapid Mixer Granulator based on product, safety, regulatory and cGMP
requirements and to prevent cross contamination in product. The Rapid Mixer Granulator is equipment
used for mixing and granulation of the product.

7. EQUIPMENT DETAILS:
Equipment Name Rapid Mixer Granulator (RMG)-600 Ltr.
Equipment ID SP/PRD/17/RG001
Manufacturer’s Name Tapasya Engineering Works Pvt. Ltd., Thane
Supplier’s Name Tapasya Engineering Works Pvt. Ltd., Thane
Location of Installation Granulation-I, First Floor, General Block

8. CRITICAL VARIABLES TO BE MET:


Sl. Description Details
No.
1. Gross Capacity (in liters) 600
2. 480 liter (Maximum) (240 kg @0.5 BD)
Working Capacity (in liters)
180 liter (Minimum) (90 kg @0.5 BD)
3. Output (in kg.) Depending on the BD of the product
4. Type Fully Automatic with PLC and HMI
5. Integration of dry blending and wet granulation process
Concept for usage
into one-step mixing and granulation
6. Surface Finish- Bowl Bowl (Inside)- Mirror Polished
Bowl (Outside)- Mirror Polished
7. Surface Finish- Frame External surface to have a dull polished & internal
portion are painted with epoxy paints.
8. Mode of machine cleaning Manually
9. Component for mixing ingredients 3 blade (triangular type) Impeller
10. Component for granulation 4 blade Chopper
11. Direction of Rotation for Impeller Anti-Clockwise (from top)

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 10 of 23

12. Direction of Rotation for Chopper clockwise (from chopper blade side)
13. Main Motor 50 HP, 415 V, 50 HZ, NFLP
14. Drive Gearbox Ratio - 10:1, Type – Upward shaft
15. Chopper Motor 7.5 HP, 415 V, 50 HZ, NFLP
16. Cone mill motor 5 HP, 415 V, 50 HZ, NFLP
17. Nozzles a. Charging hole-200 dia
b. Vent- 200 dia. Tri-clover with 10# sintered filter
with valve
c. Discharge- 200 dia. Pneumatically Operated
d. View Port- 200 dia. With cover
e. WIP nozzle-150 dia. Tri-clover with spray ball &
spray nozzle
f. Vacuum charging port-100 dia. TC with pipe &
elbow & pneumatic valve.
18. Electrical Non flame proof
19. Drive Specification Motor and gear box are connected with pulley and belts
20. Connectivity Discharge- FBD bowl below the discharge port or
direct transfer into FBD by connecting flexible pipe
between RMG discharge and FBD charge port
charging- by vacuum
21. Mechanical seal For beater & chopper, make-eagle burgmann/SEAL
WELL or equivalent
22. Operating Panel Consist of MMI & emergency off, control ON/OFF
switch. All are enclosed in SS panel Box. The panel is
mounted on the machine frame.
23. Control Panel Non Flameproof placed in Technical area.
24. Separator Placed in the technical area along with the vacuum
pump assemble
Design pressure – Full vacuum
Operating pressure – 300 mm of Hg.
25. Machine Dimensions (in mm) - 3506 (L)×2060 (W)×3395 (H)
Approx

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 11 of 23

9. EQUIPMENT PARAMETERS:
Sl. No. Description Details
1. Name Rapid Mixer Granulator (RMG)-600 Ltr.
2. Make Tapasya Engineering Works Pvt. Ltd., Thane
3. Model TAP- HSMG 600 - NFLP
4. Filled Volume 655 Ltr.
5. Capacity 600 Ltr.
6. Net Weight (in kg.) – Approx. 4500 kg Approx.
7. Impeller Speed 105 RPM ±10% Variable from 10 to 105 RPM
8. Chopper Speed 2880 RPM ±10%Variable from 288 to 2880 RPM
9. Cone Mill Speed 2850 RPM ± 10%
10. Lid Lifting Mechanism Automatic
11. Cone Mill Sieve 10 mm dia. Sieve is supplied with machine

10. UTILITY REQUIREMENT/LOCATION SUITABILITY:


Sl. No. Utility Requirement
Utility Consumption
1. Air Supply 6.0 kg/cm2 (Oil, Dust & Water free purified air)

2. Electrical 415 Volt, 3 Phase, 50 Hz

3. Water for Cleaning 3.5 kg/sq.cm

Power Consumption
1. Electricity 3 Phase, 415 Volts, 50 Hz. Cycles, Earth + Neutral
Control Volts: 110 V, 3 Phases, 50 Cycles
Control: PLC based
AC Drive: Yes (Main & Chopper Motor)

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 12 of 23

11. TECHNICAL SPECIFICATION/ KEY DESIGN FEATURES:


Sl. No Description Specification
1. Gear Box
Make Premium energy
Type Worm & worm wheel
Specification V-1000, Ratio-10/1
Location Inside the derive frame
Purpose For reduction of speed
2. Main Motor
Make Crompton
HP 50 HP
RPM 1475 (NOM)±10%
FLP/ Non FLP NFLP
Mounting Foot Mounted
Phase 3 Phase
Voltage 415 V
Frequency 50 Hz
Location Inside the drive frame
Purpose For Supply of power to gear box
3. Pulley
Make Fenner
Specification 350 PCD, “C” section, 6-groove
Location On gear box shaft
Purpose For power transmission
4. Pulley
Make Fenner
Specification 250 PCD, “C” section, 6-groove
FORMAT No: F03-00/QAD 046
PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 13 of 23

Location On main motor box shaft


Purpose For power transmission
5. “V” Belt
Make Fenner
Specification “C” section
Location On Pulley of motor & gear Box
Purpose For power transmission
6. Cone Mill Motor
Make Crompton
HP 5 HP
RPM 2850 (NOM)
FLP/ Non FLP NFLP
Mounting Foot Mounted
Phase 3 Phase
Voltage 415 V
Frequency 50 Hz
Location Above the cone mill assembly
Purpose For breaking lumps during discharge
7. Chopper Motor
Make Crompton
HP 7.5 HP
RPM 2880 (NOM)
FLP/ Non FLP NFLP
Mounting Flange Mounted
Phase 3 Phase
Voltage 415 V
Frequency 50 Hz
Location On bowl chopper assembly
FORMAT No: F03-00/QAD 046
PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 14 of 23

Purpose For breaking lumps during wet mixing


8. Hydraulic power pack unit
Make Indo Hydraulic
HP 1.5 HP
LPM 5 LPM
Type Double station, 70 Bar
Tank Capacity 30 L
Location Inside the drive Frame
Purpose For operating Hydraulic cylinder
9. Motor For Hydraulic Unit
Make Crompton
HP 1.5 HP
RPM 1440 (NOM)
FLP/ Non FLP NFLP
Mounting Flange Mounted
Phase 3 Phase
Voltage 415 V
Frequency 50Hz
Location On power pack unit
Purpose For operating lid / blade lifting hydraulic cylinder
10. Hydraulic Cylinder
Make Indo Hydraulic
MOC SS 304
Specification 165 & 160 MM Stroke
Piston 85 & 48 MM
Type Both End Clevis
Pressure 70 BAR
Location On Bowl
FORMAT No: F03-00/QAD 046
PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 15 of 23

Purpose For Lid Opening / Closing


11. Hydraulic hose Pipe
Make Shanti Industries / Yash Industries
MOC Rubber
Size 3/8” BSP
Type Both Side swivel nut, SAE 100
Location On power pack
Purpose For oil transfer
12. Hydraulic hose Pipe
Make Shanti Industries / Yash Industries
MOC S.S Wire Braided
Size 3/8” BSP
Type Both Side swivel nut, SAE 100
Location On Hydraulic Cylinder
Purpose For oil transfer
13. Blade Removing Gear Box
Make Bonfiglioli
Type Worm & Worm Wheel, Hollow shaft
Specification W-63, Ratio-100/1
Location Inside the drive frame
Purpose For Reduction of speed
14. Blade Removing Main Motor
Make Crompton/Bonfiglioli
HP 0.5 HP
RPM 1440 (NOM)
FLP/ Non FLP NFLP

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 16 of 23

Mounting Flange Mounted


Phase 3 Phase
Voltage 415 V
Frequency 50Hz
Location Inside the drive frame
Purpose For supply of power to gear box
15. Discharge Cylinder
Make Festo
Model DNC-80-350-PPV-A
Type Flange Mounted
Location On Discharge Port
Purpose For open/close of discharge piston
16. Pressure Gauge
Make Festo
Model FMA-63-10-1/4
Type Panel Mounted
Range 0-10 kg/sq cm
Location On operational panel
Purpose For indication of main air pressure
17. Filter Regulator
Make Festo
Model 1/4-D- MINI
Location On pneumatic plate inside drive frame
Purpose For air filter & regulator
18. Pressure Switch

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 17 of 23

Make Festo
Model PEV-1/4-B
Location On Pneumatic plate
Purpose For main air supply
19. Vacuum Pump
Make Rotovac
Model RSVP-160
Location In technical area
Purpose For crating vacuum inside the bowl
20. Peristaltic Pump
Make Flow Tech
Model FP-05
Flow Rate 22LPM (For Water)
Location Near the machine
Purpose For supply binder solution into the bowl
21. A.C. Drive
Make Allen Bradley/ Siemens
Model 7.5 HP
Location Control Panel
Purpose Chopper motor VFD
22. A.C. Drive
Make Allen Bradley/ Siemens
Model 50 HP
Type Power Flex 753
Location Control Panel

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 18 of 23

Purpose Impeller Motor VFD


23. HMI
Make Allen Bradley
Type Panel view-700
Location Operating Panel
Purpose Human Machine Interface
24. PLC
Make Allen Bradley
Type Micrologix-1400
Location Control Panel
Purpose Automated Machine Operation

12. MATERIAL OF CONSTRUCTION (MOC):


Sl. No. Name of Parts MOC
1. Bowl SS 616

2. Top Cover SS 316

3. Beater Blade SS 316

4. Chopper Blade SS 316

5. Frame MS with SS Cladded & Covered

6. Gasket Silicon Food Grade

7. Cone Mill Main Body SS 316

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 19 of 23

8. Mill Shaft SS 316

9. Mill Blade SS 316

10. Mill Mesh SS 316

11. Bottom Dish SS 316

12. Shell SS 316


13. Top Dish SS 316
14. Cone SS 316

15. Body Flange on top dish SS 316

16. Body Flange on cone SS 316

17. Impeller Patta SS 316

18. Impeller Flat SS 316

19. Impeller Flange SS 316

20. Impeller Cone Flange SS 316

21. Charge Cover SS 316

22. View Port Cover SS 316

23. Hub Patta SS 316

24. Hub Flange SS 316

25. Chopper Shaft SS 316

26. Chopper Blade SS 316

27. Chopper Cone SS 316

28. Cone Bolt Rod SS 316

29. Piston Flange SS 316

30. Discharge Flange SS 316

31. Discharge Shell SS 316

32. Discharge Pipe SS 316

33. Discharge Cover SS 316

34. Discharge Flange SS 316

35. Comill Shell SS 316

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 20 of 23

36. Comill Shaft SS 316

37. Comill Blade SS 316

38. Comill Hopper Flange SS 316

39. Non-Contact Parts SS 304

40. Gasket Silicon Food Grade

13. SAFETY:
Sl. No. Safety feature Specified function
1. Bowl Top Lid Interlock For Operator Safety
2. Discharge Port Interlock For Safety of the operator, batch & the process
3. Hardware Emergency switch at Operator For Operator Safety.
Console
4. Password protection at operator To assign specific controls to the operator,
interface supervisor and Manager.
5. The drive side panels are interlocked For Safety of the operator, batch & the process
with pressure switch through pneumatic
limit switch
6. The common pressure switch is For Equipment safety
provided for incoming air pressure low.
7. All moving Parts of the machine are For operator safety & Batch Safety
totally enclosed
8. Emergency Stop Button For Operator Safety & Batch Safety
9. All corners rounded For Operator Safety
10. SS Railing provided surround the For Operator Safety
plateform

14. VENDOR SELECTION:


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

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 21 of 23

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:
......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
......................................................................................................................................................................
.....................................................................................................................................................

19. ABBREVIATIONS:
SS : Stainless Steel
QA : Quality Assurance
GA : General Arrangement
FORMAT No: F03-00/QAD 046
PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 22 of 23

cGMP : Current Good Manufacturing Practices


MOC : Material of Construction
DQ : Design Qualification
Sl. No. : Serial Number
ISO : International standard Organization
Kg : Kilogram
HP : Horse Power
FLP : Flame Proof
V : Volt
mm ID : Mili meter Internal Diameter
MS : Mild Steel
BD : Bulk Density
PLC : Programmable Logic Controller
HMI : Human Machine Interface
Mtrs : Meter
MCB : Miniature Circuit Breaker
Ltr : Liter
RPM : Revolution per Minute
Sq. cm : Square Centi Meter
Hz : Hertz
VFD : Variable frequency Drive
MS : Mild Steel
DQ : Design Qualification

20. PROTOCOL CUM REPORT POST APPROVAL:

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

FORMAT No: F03-00/QAD 046


PHARM PROTOCOL NO.:
DESIGN QUALIFICATION DQ/RG001-00
A
DIVISI PROTOCOL CUM REPORT EFFECTIVE DATE:
ON FOR
SH
ISSUE BY:
ANGRILA RAPID MIXER GRANULATOR (RMG) SIGN & DATE
INDUSTRIES (P)
LTD., SIKKIM PAGE NO.: 23 of 23

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

You might also like