Design Qualification Sample Protocol

Pharmaceutical Guidelines
DESIGN QUALIFICATION
RAPID MIXER GRANULATOR (150 Liters)

Document No: PG/DQ/001 Page no 1 of 16
Design Qualification
Equipment: Rapid Mixer Granulator
Equipment ID: PG/MFG/EQ/001
Document No: PG/DQ/001
info@pharmaguideline.com © www.pharmaguideline.com

TABLE OF CONTENTS
Sr. No. Content Page No.
1.0 Pre Approval 3

2.0 Purpose 4
3.0 Scope 4
4.0 Reference 4
5.0 Study of Qualification 4
6.0 Responsibility (Client and Manufacturer) 4
7.0 Documentation 5
8.0 Machine Description 7
9.0 Basis of Design and Assumption 9
10.0 Variations 10
11.0 Technical Specifications 17
12.0 Process Parameter 18
13.0 Component for Certification 18
14.0 List of Bought-out Components 18
15.0 Supporting Utilities 19
16.0 P & ID Diagram for Reference & Approval 19
17.0 Equipment Orientation with Room Layout 20
18.0 Safety Features 20
19.0 Limiting Conditions for Performance of Equipment 20
20.0 Fat Procedure 20
21.0 Change Control Procedure 20
22.0 List of Abbreviations 20
23.0 Observed Deviations 20
24.0 Recommendations 20
25.0 Conclusion 20
26.0 Post Approval 20

1.0 PRE-APPROVAL:
Prepared by Designation Signature Date
Reviewed By Designation Signature Date
HOD Production
HOD Engineering
Executive Quality
Assurance
Unit Head
Approved By Designation Signature Date
HOD Quality
Assurance

2.0 PURPOSE: To provide the documentary evidences that the Rapid Mixer Granulator
RMG 150 is Designed, Installed, Operating and performing as per design specifications.
3.0 SCOPE: This qualification protocol will define the responsibilities, acceptance criteria,
basis of design, technical specifications(of mechanical components, electrical hardware &
embedded software if any used), list of major brought out parts, utility requirements, safety &
GMP features and documentation requirements.
The Design Qualification is an essential part of GMP documentation and serves as a base
document for the validation activity.
3.1 INTENDED USE: For uniform mixing of powder.
3.2 LOCATION: ABC Pharmaceuticals Ltd.at Location.
4.0 REFERENCE: Operating Instruction Manual for Rapid Mixer Granulator RMG 150.
4.1 ATTACHMENTS: Purchase order Drawing
5.0 STUDIES FOR QUALIFICATION:

Design Qualification: To design, engineer, and supply the Rapid Mixer Granulator RMG 150
as per cGMP and cGEP and to provide assurance that the machine is manufactured as per
the URS and it complies with the Scope of Supply.
This is a validation document for the machine, to prove that each operation proceeds as per
the design specification prescribed there in the document.
Installation Qualification: To check that machine and accessories are supplied as per
purchase order requirement.
To check that the machine is installed at its specified location
To check that the utilities required by the machine is provided

Operation Qualification: To measure the dimension wherever possible.

To ensure that all the instruments if any associated with the machine are calibrated before
operation qualification.
Performance Qualification: To operate the machine as per proposed procedure.

To challenge the operating parameters associated with the machine.
To challenge the safety features associated with the machine.
6.0 RESPONSIBILITY:
6.1 CLIENT:
1. To provide the URS for the equipment.
2. To perform the Factory Acceptance test (FAT).
6.2 MANUFACTURER:
To design, engineer and provide the complete technical details of the equipment pertaining to
its design qualification viz.
1. Machine overview,
2. P&ID drawing,
3. Equipment orientation with layout,
4. Specifications of the sub-components/ bought out items, and their make, model & quantity,
and backup records/ brochures,
5. Details of Utilities,
6. Identification of components for calibration
7. Material of construction of all components
8. Brief process description
9. Safety features
10. Pre-installation requirements

 To facilitate the client for the Factory acceptance test of the machine at their works/ site.
 To confirm the safe delivery of the equipment to the user site.

 To ensure that no un-authorized or unrecorded design modifications shall take place. If any
point of time, any change is desired in the agreed design,
 Change control procedure shall be followed and documented.
7.0 DOCUMENTATION:
All documentation work shall be completed concurrently during execution of the qualification.
However the protocol does not define the sequence of the test/ documentation to be carried
out.
1. Use indelible black ink for the recording.
2. Fill out complete information in the format provided.
3. Do not leave any blank space.
4. Correct the wrong entry by drawing single line through incorrect data, recording the correct
data and then signing and dating the change.
5. Enter “N/A” in space that is not applicable.
6. During execution of the protocol any deviation must be implemented as per defined
procedure.
7. During protocol execution, report shall be prepared with following details.
 Discussion of all study in observation column.
 Qualification is successfully completed or not
 Conclusion.
 Recommendation, if any.
8.0 MACHINE DESCRIPTION:

The Rapid Mixer Granulator is a high shear machine, developed for mixing as well as
granulation. The multibladed dual speed impeller & chopper performs the mixing and breaking
of materials. The granulating solution is gently distributed in the base material as it is added.
The Impeller makes the uniform mixer of materials and binder. Impeller is designed to mix by
circulating the materials from up to low and vise versa while running. The chopper set in the
centerline of the material flow has the effect of constant cutting action by which it breaks the
mass. The effect of the impeller blades is often to compact the material during discharge. So

the Lumps can be easily crumbled but the dense particles that they are composed of retain
their form.
9.0 BASIS OF DESIGN AND ASSUMPTION:

The design of Rapid Mixer Granulator will be based on technical specifications derived from
User Requirement Specification, cGMP requirements, performance requirements and control
logics as approved by the client in the Design Qualification.
The supplier, based on its expertise and technology will work out the complete specifications
of all the components required for the manufacture of the equipment.
10.0 VARIATIONS:
If there are any variations sought by the client after approval of the drawings, documents &
Design Qualifications in the equipment from the original design, then the same will be
incorporated by supplier in the equipment design after receipt of approval in writing from the
client. This will form the basis for finalizing the documentation.
11.0 TECHNICAL SPECIFICATION:

11.1 MECHANICAL COMPONENTS:
Sr. Sign./
Component Details Observation
No. Date
 Stainless steel 316, for contact
parts.
1 Mixing Bowl
 Inner surface mirror polished
 Outer surface, matt polished
 Cladded with SS 304 sheet.
 Top surface covered with 3 mm
Support
2 checkered plate.
Structure
 Operating panel provided on top
of the platform by pipe support.
 Made of SS 316 material
 A top lid is provided with charging
port for addition of material and an
3 Top Lid
air vent. The lid is opened by a
pneumatic cylinder and swiveled
manually.
 Made of SS 316 material &
4 Discharge Port welded to the main bowl.
 The opening and closing will be

assisted by a pneumatic cylinder

 Gear Box – V1000, Ratio 10: 1,
Greaves make
 Motor 10/15 HP, 720/ 1440 rpm,
Crompton Greaves / Hindustan
Motor make
5 Main Drive
 Motor Pulley OD 10”, Gearbox
Pulley: OD 14”.
 Impeller made of SS 316 material.
 Impeller has a triangular cross
section blade.
 MOC: Stainless Steel 316.
 Motor 2 / 3 HP, 1440 / 2800 rpm,
Crompton Greaves / Hindustan
6 Chopper Motor make.
 Chopper And motor shaft
assembled through C.I bearing
housing.
 MS. Powder coated, 2mm thick,
foot mounted and is placed in the
service area..
7 Control Panel  Motor Contractors
 Cooling fan & Filter
 MCB
 PLC
 Small SS 304 material box,
mounted on SS pipe support.
 E 300 ”Beijer” Man Machine
8 Operating Panel Interface with complete mimic
graphic & programming to allow
process management and
diagnostics will be supplied.
 Pneumatic valve with solenoid
coil, Festo make.
Pneumatic  Pressure regulator with filter.
9
Panel  The pneumatic components are
placed in the same MS control
panel.

11.2 ELECTRICAL HARDWARE:
Sr. Sign./
Component Details Observation
No. Date
 Processor has 8k memory
bifurcated in instruction and data
memory as required
 Instruction execution time is of
0.5 µ sec
1. Processor  14 digital inputs and 10 digital
outputs
 A to D converter for current
readout is 8 bit resolution when
inputted from 4 –20 mA analog
signal
 The digital input section accepts
24 V DC at nominal current of 8
mA per point and maximum
inrush current of 20 mA
 Capacity of 14 input points
 Equipped with terminals to
accept 16 AWG wire
 Inputs
 X0 : RPM proximity
 X1 : Air pressure switch
2.
Digital input  X2 : Emergency stop push
section button
 X3:Discharge port lid proximity
 X4 : Main motor overload
 X5 :Chopper motor overload
 X6 : Spare
 X7 : Chopper fast feedback
 X10 : Mixer slow feedback
 X11 : Mixer fast feedback
 X12 : Chopper slow feedback
 X13 : Spare
 X15 : Top lid proximity
 All outputs are transistor driven
24 V DC and 24 V double contact
relay
 Capacity of 10 output points
Digital output  Equipped with terminals to
3.
section accept 16 AWG wire
 Outputs
 Y0 : Mixer slow contactor
 Y1 : Mixer fast contactor
 Y2 : Chopper slow contactor

 Y3 : Chopper fast contactor

 Y4 : Discharge port SOV
 Y5 : Spare
 Y6 : Spare
 Y7 : Spare
 The input resolution is 12 bit and
repeatability shall be + 1 LSB
Analog input /
4.  Input range is 4 – 20 mA and
output module
input impedance shall not exceed
100 
 Compatible with PLC processor
 Capable of displaying text,
Operator
graphic and accepting digital or
5. interface
numeric data entry
terminal
 Capable of storing the software
in EPROM or flash memory card
 Motor Auxiliary Contact and
Overload Relay
 Contactors are 230 V, 30 A
capacity normally open
 An overload relay shall include
an adjustable set point to set
Digital input the amperage
6.
devices  Emergency Stop Switch shall be
connected to the control system
and shall disable the digital
outputs when pressed
 Indfos pressure switch shall be
provided for detecting low
pressure.
 Status indicating LEDs shall be
Digital output provided on the MMI
7.
devices  Solenoid control valves shall be
configured as “normally open”
 2 mm thick mild steel, powder
coated, foot mounted self
8. Control panel
supporting type containing the
power components
 Main switch for ON / OFF of
control panel
 Motor contactors and overload
relay for preventing any damage
Control panel
9. in case of motor overload
components
 SMPS for converting 230 V AC
into 24 V DC for input to PLC
 Relay card
 PLC – Mitsubishi make

 Current transducer
 Current transformer
 Terminals
 Material of construction SS 304,
wall mounted
 Human Machine Interface model
E-300 with complete mimic
graphic and programming to
10. Operating panel
allow process management and
diagnostic
 Emergency push button to stop
the working in case of
emergency situation
 Three levels of password for
manager, supervisor and
11. PLC controls operator
 Alarm status and history data
 Printing port for printing facility
 The following interlocks shall be
connected through PLC
 Emergency push button
12. Interlocks  Impeller motor overload
 Chopper motor overload
 Bowl top lid open
 Main line air pressure
12.0 PROCESS PARAMETER:

Maximum Volume : 150 liter
Maximum Working Volume : 100 liter (Depend upon the Bulk density of powder to be
mixed)
Minimum Working Volume : 60 liter
Impeller RPM (fast) : 98 to 102
Impeller RPM (slow) : 49 to 51
Chopper RPM (Fast) : 2800
Chopper RPM (Slow) : 1425
Direction of Rotation for Impeller : Anti-Clockwise (looking from top)
Direction of Rotation for Chopper : Clockwise (looking from chopper blade side)

13.0 COMPONENT FOR CERTIFICATION:
Sr. No. Component Certification

1. Impeller motor Manufacturers certificate
2. Chopper motor Manufacturers certificate
3. Gearbox Manufacturers certificate
4. Material test certificate Test report
14.0 LIST OF BOUGHT-OUT COMPONENTS:
Sr. No. Component Manufacturer Observation Sign/Date

1. Electric motors Crompton Greaves
2. Gearbox Greaves Limited
3. Pneumatic Festo / SMC Pneumatics
components
4. Pressure SMC Pneumatics
switches
5. PLC Mitsubishi
6. Human Machine Beijer
Interface (HMI)
7. Silicon gasket Acrosil
8. Electrical Merlin Gerin, Shavison
components Electronics, Connect well,
Siemens or Compatible
15.0 SUPPORTING UTILITIES:

Following are the utilities required to operate the system to be arranged by the customer at
site.
Sr. No. Type Of Operational Range Specifications Observation

Utility
1. Electrical Voltage: 415 + 10% 5 core Armored
Power Phase : 3 Phase cable
Specifica Frequency : 50 + 5%
tions Hz
2. Compres 5 to 7 kg/cm2
sed Air
16.0 P&ID DIAGRAM FOR REFERENCE & APPROVAL:

Approval status: APPROVED/NOT APPROVED
Any change in approved diagram: Yes/ No
If yes, the reason for change
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………

17.0 EQUIPMENT ORIENTATION WITH ROOM LAY OUT:

Attached as G.A. Drawing
Approval status: APPROVED/ NOT APPROVED
Any change in the approved orientation layout: Yes/ No.
If yes, the reason for change
…………………………………………………………………………………………………………….
…….………………………………………………………………………………………………………
18.0 SAFETY FEATURES:
Sr. No. Safety Feature Specified Function Observation

1. Hardware Emergency For Operator Safety
switch at Operator
Console
2. Password protection For control over the
at operator interface operation process as well
as compliance to 21 CFR.
3. Air pressure drop For safety of batch and
interlock process
4. Motor overload Relay For Motor & equipment
protection
19.0 LIMITING CONDITIONS FOR PERFORMANCE OF EQUIPMENT:

19.1 POWER FAILURE:
In the event of power failure, the process shall halt, but the PLC through a battery backup
facility will save the data recorded for retrieval. Suitable alarms will be provided in the Operator
interface.
19.2 CONTROL PANEL FAILURE:
Failure in the control panel shall result in the stoppage of the process. However, data till
the stoppage occurred will get saved in the memory of the PLC system. Suitable alarms will
be provided in the operator interface.
19.3 COMPRESSED AIR FAILURE:
Failure or drop in pressure of the compressed air supply will result in the stoppage of the
process. However, data till the stoppage occurred will get saved in the memory of the PLC
system. The System will start at the same point once the compressed air is restored.
20.0 FAT PROCEDURE:
Factory Acceptance Test Procedure shall be as follows:

1. After the completion of erection work of the machine, client shall be informed to perform
the factory acceptance test (FAT).
2. Client shall perform the FAT at the manufacturer site and record all the data in the
prescribed FAT document as per the details given below:
 Test criteria
 Design Verification Check list
 Deficiency & Corrective Action report
 Pre-installation requirements
 Final report
21.0 CHANGE CONTROL PROCEDURE:
Change in the agreed design shall be addressed through the well defined Change control
procedure.
22.0 LIST OF ABBREVATIONS:

cGMP Current Good Manufacturing Practices
cGEP Current Good Engineering Practices
MS Mild steel
NON-FLP Non Flame Proof
SS Stainless Steel
K.W. Kilo Watt
DQ Design Qualification
RPM Revolution Per minute
URS Users Requirement Specifications
FAT Factory Acceptance Test
NOM Nominal speed of motor
23.0 OBSERVED DEVIATION:

24.0 RECOMMENDATIONS:
25.0 CONCLUSION:

26.0 POST APPROVAL:
Reviewed By Designation Signature Date
HOD Engineering
HOD Production
Executive Quality
Assurance
Unit Head
Approved By Designation Signature Date
HOD Quality
Assurance

Design Qualification Sample Protocol

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Pharmaceutical Guidelines

RAPID MIXER GRANULATOR (150 Liters)

RAPID MIXER GRANULATOR (150 Liters)

Sr. No. Content Page No.

1.0 Pre Approval 3

RAPID MIXER GRANULATOR (150 Liters)

Prepared by Designation Signature Date

Reviewed By Designation Signature Date

Approved By Designation Signature Date

RAPID MIXER GRANULATOR (150 Liters)

3.1 INTENDED USE: For uniform mixing of powder.

3.2 LOCATION: ABC Pharmaceuticals Ltd.at Location.

4.1 ATTACHMENTS: Purchase order Drawing

5.0 STUDIES FOR QUALIFICATION:

RAPID MIXER GRANULATOR (150 Liters)

Operation Qualification: To measure the dimension wherever possible.

Performance Qualification: To operate the machine as per proposed procedure.

3. Equipment orientation with layout,

6. Identification of components for calibration

7. Material of construction of all components

8. Brief process description

10. Pre-installation requirements

RAPID MIXER GRANULATOR (150 Liters)

8.0 MACHINE DESCRIPTION:

RAPID MIXER GRANULATOR (150 Liters)

9.0 BASIS OF DESIGN AND ASSUMPTION:

11.0 TECHNICAL SPECIFICATION:

RAPID MIXER GRANULATOR (150 Liters)

assisted by a pneumatic cylinder

RAPID MIXER GRANULATOR (150 Liters)

11.2 ELECTRICAL HARDWARE:

RAPID MIXER GRANULATOR (150 Liters)

 Y3 : Chopper fast contactor

RAPID MIXER GRANULATOR (150 Liters)

12.0 PROCESS PARAMETER:

RAPID MIXER GRANULATOR (150 Liters)

13.0 COMPONENT FOR CERTIFICATION:

Sr. No. Component Certification

14.0 LIST OF BOUGHT-OUT COMPONENTS:

Sr. No. Component Manufacturer Observation Sign/Date

15.0 SUPPORTING UTILITIES:

Sr. No. Type Of Operational Range Specifications Observation

16.0 P&ID DIAGRAM FOR REFERENCE & APPROVAL:

RAPID MIXER GRANULATOR (150 Liters)

17.0 EQUIPMENT ORIENTATION WITH ROOM LAY OUT:

Sr. No. Safety Feature Specified Function Observation

19.0 LIMITING CONDITIONS FOR PERFORMANCE OF EQUIPMENT:

RAPID MIXER GRANULATOR (150 Liters)

22.0 LIST OF ABBREVATIONS:

23.0 OBSERVED DEVIATION:

RAPID MIXER GRANULATOR (150 Liters)

RAPID MIXER GRANULATOR (150 Liters)

26.0 POST APPROVAL:

Reviewed By Designation Signature Date

Approved By Designation Signature Date

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