ENCAPSULANDO LTD.

Customer : Effective Date 27/04/2021

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EQUIPMENT VALIDATION QUALIFICATION

Equipment Wet Granulator – GH-1

VALIDATION
PROTOCOL
OF
WET GRANULATOR
GH-1

Wet Granulator – GH-1

 ENCAPSULANDO LTD.
Customer : Effective Date 27/04/2021
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Equipment Wet Granulator – GH-1

PROTOCOLS APPROVALS FOR USE

Approvals Name Designation Signature Date

Written by

Reviewed by

Client approvals

Production
Representative

Quality
Representative

DOCUMENT CONTROL AFTER APPROVAL

Original This Copy

Original Held By Copy No

Effective Date of
Issued To
Document

Issued By

Wet Granulator – GH-1

 ENCAPSULANDO LTD.
Customer : Effective Date 27/04/2021
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Equipment Wet Granulator – GH-1

TABLE OF CONTENTS
WET GRANULATOR – GH-1

Sr No. Content Page No.

1. Design Qualification ---------------------------------------------------------------- 06

2. Installation / Operational Verification -------------------------------------------- 07

3. Material Of Construction ---------------------------------------------------------- 11

4. Final Approval ------------------------------------------------------------------------ 12

5. Inspection cum Warranty Certificate ------------------------------------------ 13

Wet Granulator – GH-1

 ENCAPSULANDO LTD.
Customer : Effective Date 27/04/2021
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Equipment Wet Granulator – GH-1

EQUIPMENT NAME
GH-1
Wet Granulator

TYPE
HWGS

MODEL NO.
GH-1

M/C SERIAL NO.

2 1 0 3 0 1 3

2 1 0 3 0 1 4

2 1 0 3 0 1 5

CUSTOMER

Wet Granulator – GH-1

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Customer : Effective Date 27/04/2021
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Equipment Wet Granulator – GH-1

Name of Equipment : Wet Granulator – GH-1

Equipments Serial no. : 2103013 , 2103014 , 2103015

Name of Customer :

Purchase Order no. :

The purpose of the document is to Qualify Wet Granulator – GH-1, M/s. ENCAPSULANDO LTD.

This document provides evidence that the Wet Granulator – GH-1 Designed, Manufactured,

Supplied, Installed and Commissioned as per the requirement of the user. This also confirms &

meets all the requirement of Product, Process, Safety, Regulatory Bodies and CGMP obligations.

Functional Area Name Signature Date

Engineering

R&D

Quality Control

Wet Granulator – GH-1

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Equipment Wet Granulator – GH-1

1. DESIGN QUALIFICATION

1.1 Purpose

The purpose of Design Qualification is to ensure that all the critical aspect of Product

Requirement, Process, CGMP and Safety has been considered in designing the

Equipment.

1.2 Design Specification

Sr No. Features

1. Working Capacity 20/25 Kg / Hr.- Max

2. Rotor Oscillation 0-410 / Per minute

3. Oscillation Angle 900 (Degree)

41” x 27” x 17”

4. Dimension
[L x W x H]

1.3 Principle

The unit operates on the oscillating rotor principle, compressing granules a pre-

determined size of sieve. Granules are collected in Tray.

2. INSTALLATION / OPERATIONAL VERIFICATION

Wet Granulator – GH-1
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2.1 Design Verification For Important Assembly - (Refer Manual)

Part Meet Requirements

Part No. Part Name Remarks
No. Yes / No
1 HM21064 Drive Shaft Yes

5 HM21104 Handle Yes

6 HM21170 Rotor Assembly Yes

8 HM21284 Pressure Spindle Yes

12 HM21463 Wire Mesh Yes

13 HM21254 Shaft Rear Yes

Meets Requirements : Yes/No

Remark :

Verified by : ____________________ Reviewed by : ____________________

2.2 Equipment installation operational check list

Wet Granulator – GH-1

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Meets
Sr. no. Description Specified Requirements Remarks
Yes/No

Visual Check • No physical Damage.

1.
• All Visible Parts are as per

Manual Assembly Drawing.

2. Rotor • Material Use as specified.

• Mounted with Four Blades.

• Good Finish as per GMP.

Pressure • Material use as per GMP.

3.
Spindle
• Engaged with Rotor (6).

• Fitted with Spindle nut & Handle

wheels are mounted.

4. Sieves with • Sieve size & material used as

Starching specified

Handle • Sieve is hold in slot of pipe (15)

5. Housing • Outside surface paint finish.

Drive/Rear • Inner side are with cover as per

GMP.

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Meets
Sr. no. Description Specified Requirements Remarks
Yes/No

6. Cleaning • Loosen Hand Wheel (11).

• Rotate Hand Wheel (10)

clockwise for dislocating & Anti-

clockwise for repositioning after

cleaning.

• Loosen Ratchet pin (9) & pull-out

starching handle (5) for replacing

or cleaning wire mesh.

• Repeat The above Process (5)

7. Performance
• Ensure No Axial Movement of

Rotor.

• Sieve is not Strached too much.

• Mount Unit With Tightly Secured

with Nuts on Main Drive.

• Switch on the Drive and

Gradually Increase the speed

Rpm Max.

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• Repeat the process as per (6)

8. Performance
with suitable size of Sieve.

• Keep collecting tray below the

Unit.

• Switch On the Unit.

• Feed moistened powder/Slug to

be granulated with required

speed.

• Clean the unit as per Point (5) at

the end of process.

Remark :

Verified by : ____________________ Reviewed by : ____________________

Wet Granulator – GH-1

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3. MATERIAL OF CONSTRUCTION / IMPORTANT /

CRITICAL PARTS

Meets
Sr No. Part Name M.O.C. Reference Requirement
Yes/No
1 Rotor S.S.316 As per specification Yes

2 Sieves S.S.316 As per specification Yes

Remark :

Verified by : ____________________ Reviewed by : ____________________

Wet Granulator – GH-1

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4. FINAL REPORT

Verified by : ____________________ Reviewed by : ____________________

Dated : ____________________ Dated : ____________________

Wet Granulator – GH-1

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INSPECTION CUM WARRANTY CERTIFICATE

Model : Wet Granulator -GH-1

Serial No. : 2103013 , 2103014 , 2103015

This is to certify that the above said equipment is inspected and tested for its relevant specification

and performance is satisfactory. We give warranty for the above said equipment for Twelve Month

from the date of dispatch to repairs/replace any defective parts because of defective material or

bad workman ship which are manufactured by US. The Electrical and Electronic parts are brought

out parts are excluded. And do not carry any warranty.

The warranty will lapse if its parts are tempered, altered by un authorized persons or not

maintained / followed in use as per our instruction, under no circumstance we under liability for

indirect loss or damage of any nature.

For, ENCAPSULANDO LTD.

(Authorized Signatory)

Wet Granulator – GH-1