Design Qualification Sample Protocol

Pharmaceutical Guidelines DESIGN QUALIFICATION RAPID MIXER GRANULATOR (150 Liters) Document No: PG/DQ/001 PG/DQ/00 1

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Pharmaceutical Guidelines Design Qualification Equipment: Rapid Mixer Granulator Equipment ID: PG/MFG/EQ/001 Document No: PG/DQ/001

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Pharmaceutical Guidelines DESIGN QUALIFICATION RAPID MIXER GRANULATOR (150 Liters) Document No: PG/DQ/001

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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

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1.0 PRE-APPROVAL:

Prepared by

Designation

Signature

Date

Reviewed By

Designation

Signature

Date

Designation

Signature

Date

HOD Production

HOD Engineering

Executive Quality Assurance

Unit Head

Approved By

HOD Quality Assurance

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2.0

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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

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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 m achine. 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.

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Pharmaceutical Guidelines DESIGN QUALIFICATION RAPID MIXER GRANULATOR (150 Liters) Document No: PG/DQ/001 

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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

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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. No.

Component

Details 

1

Mixing Bowl

  

2

Support Structure

   

3

Top Lid



4

Discharge Port 

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Observation

Sign./ Date

Stainless steel 316, for contact parts. Inner surface mirror polished Outer surface, matt polished Cladded with SS 304 sheet. Top surface covered with 3 mm checkered plate. 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 air vent. The lid is opened by a pneumatic cylinder and swiveled manually. Made of SS 316 material & welded to the main bowl. The opening and closing will be



5

6

7

8

9

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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 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 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..  Motor Contractors Control Panel  Cooling fan & Filter  MCB  PLC  Small SS 304 material box, mounted on SS pipe support.  E 300 ”Beijer” Man Machine 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. Panel  The pneumatic components are placed in the same MS control panel.

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11.2 Sr. No.

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ELECTRICAL HARDWARE: Component

Details

Observation

Sign./ Date

Processor has 8k memory bifurcated in instruction and data memory as required  Instruction execution time is of 0.5 µ sec 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 X2 : Emergency stop push 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  Equipped with terminals to  accept 16 AWG wire  Outputs  Y0 : Mixer slow contactor  Y1 : Mixer fast contactor  Y2 : Chopper slow contactor 

1.

Processor

 

2.

Digital input section



         

3.

Digital output section

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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  Input range is 4 – 20 mA and input impedance shall not exceed 100   Compatible with PLC processor  Capable of displaying text, graphic and accepting digital or numeric data entry  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 the amperage  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 provided on the MMI Solenoid control valves shall be  configured as “normally open” 2 mm thick mild steel, powder  coated, foot mounted self supporting type containing the power components  Main switch for ON / OFF of control panel Motor contactors and overload  relay for preventing any damage in case of motor overload SMPS for converting 230 V AC  into 24 V DC for input to PLC Relay card   PLC – Mitsubishi make 

4.

Analog input / output module

5.

Operator interface terminal

6.

Digital input devices

7.

Digital output devices

8.

Control panel

9.

Control panel components

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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 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 operator  Alarm status and history data  Printing port for printing facility The following interlocks shall be  connected through PLC  Emergency push button  Impeller motor overload  Chopper motor overload  Bowl top lid open  Main line air pressure 

10.

Operating panel

11.

PLC controls

12.

Interlocks

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)

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COMPONENT FOR CERTIFICATION:

Sr. No. 1. 2. 3. 4. 14.0

Page no

Component Impeller motor Chopper motor Gearbox Material test certificate

Certification Manufacturers certificate Manufacturers certificate Manufacturers certificate Test report

LIST OF BOUGHT-OUT COMPONENTS:

Sr. No. 1. 2. 3.

Component Electric motors Gearbox Pneumatic components Pressure switches PLC Human Machine Interface (HMI) Silicon gasket Electrical components

4. 5. 6. 7. 8.

Manufacturer

Observation

Sign/Date

Crompton Greaves Greaves Limited Festo / SMC Pneumatics SMC Pneumatics Mitsubishi Beijer Acrosil Merlin Gerin, Shavison 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. 1.

2.

16.0

Type Of Utility

Operational Range

Specifications

Electrical Power Specifica tions Compres sed Air

Voltage: 415 + 10% Phase : 3 Phase Frequency : 50 + 5% Hz 5 to 7 kg/cm2

5 core Armored cable

Observation

P&ID DIAGRAM FOR REFERENCE & APPROVAL: Approval status: APPROVED/NOT APPROVED Any change in approved diagram: Yes/ No If yes, the reason for change

…………………………………………………………………………………………………………… ……………………………………………………………………………………………………………

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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

1.

Hardware Emergency switch at Operator Console Password protection at operator interface

For Operator Safety

2.

3.

Air pressure drop interlock Motor overload Relay

4.

Observation

For control over the operation process as well as compliance to 21 CFR. For safety of batch and process 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 i nterface. 19.3

COMPRESSED AIR FAILURE:

Failure or drop in pressure of the compressed air supply will result in the process. However, data till the stoppage occurred will get

stoppage

of

the

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:

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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 cGEP MS NON-FLP SS K.W. DQ RPM URS FAT NOM 23.0

Current Good Manufacturing Practices Current Good Engineering Practices Mild steel Non Flame Proof Stainless Steel Kilo Watt Design Qualification Revolution Per minute Users Requirement Specifications Factory Acceptance Test Nominal speed of motor

OBSERVED DEVIATION:

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24.0

RECOMMENDATIONS:

25.0

CONCLUSION:

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26.0 POST APPROVAL:

Reviewed By

Designation

Signature

Date

Designation

Signature

Date

HOD Engineering

HOD Production

Executive Quality Assurance

Unit Head

Approved By

HOD Quality Assurance

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