Solace Engineers (Mktg) Pvt. Ltd.

DESIGN QUALIFICATION FOR PASTE KETTLE

DESIGN QUALIFICATION
FOR
PASTE KETTLE
(50 LITRE)
Machine Serial Number: 15301/20-21
CUSTOMER: M/S GLOBEX PHARMACEUTICALS LTD.

Solace Engineers (Mktg) Pvt. Ltd.

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Solace Engineers (Mktg) Pvt. Ltd.
DESIGN QUALIFICATION FOR PASTE KETTLE

Contact Info:
3rd Floor, Gokulesh Commercial Complex,
Sun Pharma Road,
Tandalja, Vadodara - 390020,
Gujarat, India.
Phone :+91-265-2681545
Fax : +91-2662-222719
Email: info@solaceeng.com

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Solace Engineers (Mktg) Pvt. Ltd.
DESIGN QUALIFICATION FOR PASTE KETTLE

PROTOCOL CONTENTS

S.No. TITLE PAGE No.

1.0 Protocol Pre-Approval 3

2.0 Objective 4

3.0 Scope 4

4.0 Responsibility 5

5.0 Project Requirements 6

6.0 Brief Equipment Description 6

7.0 Equipment Specification 6

8.0 Critical Variables to be Met 6

8.1 Equipment Parameters 6

8.2 Utility Requirement/Location Suitability 7

8.3 Technical Specification/Key Design Features 7,8

8.4 Material of Construction 9

8.5 Safety 9,10

8.6 Vendor Selection 10

9.0 Documents to be Attached 10

10.0 Review(Inclusive of Follow Up Action, If Any) 11

11.0 Any Changes Made Against the Formally Agreed Parameters 11

12.0 Recommendation 11

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DESIGN QUALIFICATION FOR PASTE KETTLE

13.0 Abbreviations 12

14.0 Reviewed By 13

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Solace Engineers (Mktg) Pvt. Ltd.
DESIGN QUALIFICATION FOR PASTE KETTLE

1.0 PROTOCOL PRE-APPROVAL:

PREPARED BY:

DESIGNATION NAME SIGNATURE DATE

ENGINEER
(SOLACE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)
(GLOBEX)
HEAD
(ENGINEERING)
(GLOBEX)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITYASSURANCE)
(GLOBEX)

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DESIGN QUALIFICATION FOR PASTE KETTLE

2.0 OBJECTIVE:
 To prepare the Design Qualification document on basis of URS and information given by
Supplier.
 To ensure that all Critical Aspects of Process/Product Requirement, cGMP and Safety
have been considered in designing the equipment and are properly documented.

3.0 SCOPE:
 The Scope of this Qualification Document is limited to the Design Qualification of PASTE
KETTLE (Make: SOLACE,India, Capacity: 50 Litre) for M/S Globex
Pharmaceuticals,Bangladesh

 The equipment shall be operated under the dust free environment and conditions as per
the cGMP requirements.
 The drawings and P &IDs provided by Vendor shall be verified during Design Qualification

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DESIGN QUALIFICATION FOR PASTE KETTLE

4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following departments,

shall be responsible for the overall compliance of this Protocol cum Report:

DEPARTMENTS RESPONSIBILITIES
 Preparation, Review and Approval of the Protocol cum Report.
 Assist in the verification of Critical Process Parameters, Drawings as
per the Specification.
Quality Assurance  Co-ordination with Production and Engineering to carry out
Design Qualification.
 Monitoring of Design Qualification Activity.
 Review of Design Qualification Protocol cum Report after Execution.

 Review of Design Qualification Protocol cum Report.

 Assist in the verification of Critical Process Parameters, Drawings as
Production
per the Specification.
 Review of Design Qualification Protocol cum Report after Execution.

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DESIGN QUALIFICATION FOR PASTE KETTLE

 Review of Design Qualification Protocol cum Report.

 Assist in the Preparation of the Protocol cum Report.
 To co-ordinate and support the Activity.
 To assist in Verification of Critical Process Parameter, Drawings as
per the Specification i.e.
 GA Drawing.
 Specification of the sub-components/bought out items, their
Engineering
Make, Model, Quantity and backup records / brochures.
 Details of utilities.
 Identification of components for calibration.
 Material of construction of all components.
 Brief Process Description.
 Safety Features and Alarms.
 Review of Design Qualification Protocol cum Report after Execution.

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DESIGN QUALIFICATION FOR PASTE KETTLE

5.0 PROJECT REQUIREMENTS:

To confirm that safe delivery of the equipment from the supplier site. To ensure that
no un-authorized or unrecorded design modification shall take place.

If at any point in time, any change is desired in the mutually agreed design, change
control procedure shall be followed and documented.
6.0 BRIEF EQUIPMENT DESCRIPTION:
Paste kettle is designed as per good manufacturing practice in terms of clean ability of components, surface
finish, absence of sharp corners, assembling and de-assembling of components and control devices.
Machine should be designed to be of jacketed type, electrically or steam heated, thermostatic control with
the unit, safety valve, insulated with suitable insulating material, tilting with hand wheel. Easy transfer of
paste while tilting, unit should be provided with suitable lid to discharge. Bottom valve steam water, which
should be easily removable and easily cleanable.

7.0 EQUIPMENT SPECIFICATION:

Equipment Specifications are based on User Requirement Specification prepared by Globex and The
manufacturer of equipment ensures complies with User Requirement Specification.

8.0 CRITICAL VARIABLES TO BE MET:

8.1 EQUIPMENT PARAMETERS:

CRITICAL VARIABLES ACCEPTANCE CRITERIA REFERENCE

Application: Paste Kettle should meet the requirement Process Requirement
The Paste Kettle should be able to for Pate of materials for manufacturing of
dry the wet granulated mass or Oral Solid Dosage Form.
powdery wet product to the final
required
degree.

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DESIGN QUALIFICATION FOR PASTE KETTLE

Working: The Paste Kettle should be able to perform Process Requirement

Working of Paste Kettle paste, mixing with granulated mass or
powdery wet product to the final required
degree.
Electrical Control Panel The system should have Electrical Control Design Requirement
Panel.

8.2 UTILITIY REQUIREMENTS/LOCATION SUITABILITY:

CRITICALVARIABLES ACCEPTANCECRITERIA REFERENCE

Electrical Supply Power for Electric Drive: GMP Requirement

Power: 40 HP
Voltage:415 V,3 Phase,50Hz
Room Condition Temperature and RH required as per Process Requirement
requirement of product.

Steam Consumption 2.5-4 Kg/cm2 Process Requirement

Compressed Air 8-10Kg/cm2Pressure Process Requirement

8.3 TECHNICAL SPECIFICATIONS/KEY DESIGN FEATURES:

CRITICALVARIABLES ACCEPTANCECRITERIA REFERENCE

Equipment Paste Kettle Design Requirement

S. No. SOLACE/50cGMPModel Design Requirement

Capacity Process Requirement

Motor

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DESIGN QUALIFICATION FOR PASTE KETTLE

Make Crompton Greves Design Requirement

Type SCR Design Requirement

HP 2.5 HP Design Requirement

RPM 1000 RPM Design Requirement

Volt 415V±10% Design Requirement

Amp 20 Delta Design Requirement

Sr .No. ANH0581 Design Requirement

Auto Control Steam Valve

Make Dancal Design Requirement

Type Double Acting(150NBx 75) Design Requirement

Quantity 2Nos Design Requirement

Pressure Relief Valve

Make Dancal Design Requirement

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DESIGN QUALIFICATION FOR PASTE KETTLE

TECHNICAL SPECIFICATIONS/KEY DESIGN FEATURES:

CRITICALVARIABLES ACCEPTANCECRITERIA REFERENCE

Main Drive
Make N.K. Filter Design Requirement

Type Polypropylene Design Requirement

Pore Size 10 Micron Design Requirement
Inverter
Make Rotex Design Requirement
Type Rotary Design Requirement

Power Relay Card

Make ‘’Netfil’’ Design Requirement

Type Flange Type Design Requirement

Pore Size 5Micron Design Requirement

Size(Inch) 24 x24x12withFlange Design Requirement

Control Panel
MOC SS304 Design Requirement
Temp Controller Make: ‘’L’’ &‘’T’’ Design Requirement
Temp Indicator Make: Radix Design Requirement
Digital process Timer Make: Radix Design Requirement
Capacity Make: Radix Design Requirement
Earthing Relay Make: Jayron Design Requirement
Bloweron/off Push Button Make: “Technic’’ Design Requirement
Selector Switch Make: “Technic’’ Design Requirement
off Selector Switch Make: “Technic’’ Design Requirement
Steam & Earthing Indicatinglamp Make: “Technic’’ Design Requirement
Sensor PT-100HeadType Sensor Design Requirement

8.4 MATERIALOF CONSTRUCTION:

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DESIGN QUALIFICATION FOR PASTE KETTLE
S.No. PARTSNAME MOC REFERENCE

CONTACTPARTS
1. Product Container AISI 316 L GMP Requirement
2. Retention Chamber AISI 316 L GMP Requirement
3. Mechanical Stirrer AISI 316 L GMP Requirement
4. Perforated Plate AISI 316 L GMP Requirement
5. Sampling Device AISI 316 L GMP Requirement
NON-CONTACTPARTS
6. Base Plate MS Powder Coated/AISI304/ GMP Requirement
Pre-Coated (Outer Skin)

7. Control Pannel AISI304 GMP Requirement

8. WIP Spray Nozzles AISI 304 (Optional) GMP Requirement
9. Control Valve AISI304 GMP Requirement
10. Supporting Leg AISI304 GMP Requirement
11. Power Panel MS Powder Coated GMP Requirement

8.5 SAFETY:

CRITICALVARIABLES ACCEPTANCECRITERIA REFERENCE

Joints Welding of joints without any welding burrs. Safety Requirement
Metal Parts All the metal parts should be properly Safety Requirement
Grounded without any sharp edges.
Leveling and Balancing Equipment should be properly balanced& Safety Requirement
leveled.
Temperature Control Temperature gauge controls the temperature probe Safety Requirement
& gives input to the temp controller
For steam flow or shut off.
Inlet Air Flow Butter fly valve control quantity of in let air as Safety Requirement
per user requirement.
Low Air Pressure Switch If line pressure drops to less than set pressure (5 to 6 Safety Requirement
Kg/ sq.cm).the machine stops.
Inflatablegasketoffingerbagissetat1.5
Kg/sq.cm.max
Earth Safety Relay If the bowl is not in contact with both the Safety Requirement
Probes the machine will not start.
High Air Temperature System will turn off as temp exceeds set Safety Requirement
temperature.
Over Load Relay Motor will tripped as it gets over loaded. Safety Requirement

Interlock Safety:

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DESIGN QUALIFICATION FOR PASTE KETTLE
S.No. SAFETY FEATURE TRIGGERING CONDITION
1. Inlet temperature low Inlet temperature has decreased below the negative allowed deviation.
2. Inlet temperature high Inlet temperature has increased above the positive allowed deviation.
3. Outlet temperature low Outlet temperature decreased below the negative allowed deviation.
4. Outlet temperature high Outlet temperature increased above the positive allowed deviation.
5. temperature low Bed temperature decreased below the negative allowed.
6. temperature high Bed temperature increased above the positive allowed deviation.

8.6 VENDOR SELECTION:

CRITICALVARIABLES ACCEPTANCECRITERIA REFERENCE

Selection of Vendor for Selection of Vendor is done on the basis of ProcessRequirement
supplying the PASTE KETTLE review of vendor.
machine. Criteria for review should include vendor
background (general/financial), technical
knowhow, quality standards, inspection of
site, costing, feedback from market
(customers already using the equipment).

Reference:(1)Specifications and Requirements as specified in P.O. and URS.

(2)Operating and service manual for Paste Kettle.

9.0 DOCUMENTS TO BE ATTACHED:

 Technical details for Equipment Requirement with Engineering Drawings.
 Approved Design and Specifications.
 Purchase Order Copy.
 Any other relevant document

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10.0 REVIEW(INCLUSIVEOFFOLLOWUPACTION,IFANY):
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11.0 ANYCHANGESMADEAGAINSTFORMALLYAGREED PARAMETERS:
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12.0 RECOMMENDATION:
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13.0 ABBREVIATIONS:
AISI : American Iron &Steel Institute
C.I : Cast Iron
cGEP :Current Good Engineering Practice
cGMP :Current Good ManufacturingPractice

db : Decibel
DQ : Design Qualification
GA : General Arrangement
GB : General Block
HP : Horse Power
Hr : Hour
Kg : Kilogram
MCB : Miniature Circuit Break
mm : Millimeter
MMI : Man Machine
Interface MOC:Material of Construction

NA : Not Applicable
P & ID :Piping and Instrumentation Diagram
QA : Quality Assurance
RH : Relative Humidity
Sr. : Senior
SS : Stainless Steel
STD : Standard
URS :User requirement specification
OD : Oral Solid Dosage Form

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DESIGN QUALIFICATION FOR PASTE KETTLE

14.0 REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(ENGINEERING)

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITYASSURANCE)

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