BHAVANI DESIGN QUALIFICATION

ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED

WORKS. MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

TABLE OF CONTENTS

Sr. No. Contents Page No.

1. Objective 2
2. Scope 2
3. Responsibilities 3
4. Machine Description 3
5. Technical specification 4
6. Technical specification of component & Bought out 5
items
7. Consumption (Utility and Power) 6
8. Material Of Construction 7
9. Test Certificates / Inspection Reports 7
10. FAT Procedure 8
11. Change Control Procedure 8
12. Reference documents 9
13. Summary 9
14. Abbreviations 10
15. Approval Sheet 11
16. Customer’s Approval 12

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

1. Objective

The objective of this qualification documents is to design, engineer,

and supply the Tube filling machine, manufactured by M/s. Bhavani
Engineering Works, India. (Hereafter referred as BEW), for M/s.
CHIAN BIO PRIVATE LIMITED

To prove that each operation proceeds as per the design specification
and the tolerances prescribed there in the document is the same at
utmost transparency.

2. Scope

The scope of this qualification document is limited to the Design
Qualification of Tube filling machine for M/s. CHIAN BIO PRIVATE
LIMITED

Qualification of support utilities is not within the scope of this

qualification document.

The equipment shall be used for filling ointment in tubes & tube
sealing purpose

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

3. Responsibilities
CUSTOMER:

To perform the Factory Acceptance Test (FAT).

MANUFACTURER:

To design, engineer and provide the complete technical details of the

equipment pertaining to its design.

To facilitate the client for the Factory Acceptance Test of the machine at
their works/ site.

To ensure that no un-authorized and/or unrecorded design modifications

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.

To ensure the proper installation and commissioning of the equipment.

4. Machine Description

The Tube filling machine is designed for filling ointment/gel/paste filling

Sealing & Coding of tubes.

The Tube filling machine has Tube placement unit in which tube placed to
turret after “I” mark sensor for tube positioning after that filling done at filling
station, After filling For (Aluminum Tubes) crimping unit in which single
fold & double fold done after that coding done in coding station For
(Laminated tube) after filling tube moves in heating section in which tube
heated by hot air tool after heating tube moves in coding section in which
tube coding done after coding tube moves in cutting section in which
cutting done, tube at the last ejection unit in which tubes ejected.

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

5. Technical Specification

Sr. No. Description Specifications

1. Model BEW-40

2. Type Tube filling machine

3. Capacity 30 to 40 Tubes per minute

4. Stirrer Type Angle type as per hopper

5. Stirrer RPM 24 Rpm fix

6. Heating Media By heater Hot air Leister make

7. Motor 1 HP , Make:-- Vansoprash

8. Power 1HP/ 3 Phase / 415 V, 50 Hz

S.S. 316
9. Contact Part

10. Hopper Size 40 kg depend upon density

11. Tube Hopper Made by S.S 304 and acrylic

12. Vacuum NA

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

6. TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB

COMPONENTS USED / BOUGHT OUTS:

Sr. Description Specifications Observation Remarks

No. Yes / No
1. Electric Motor Position- Below the main plate
machine
Make: Vansoprash
2 HP, 1390 RPM , 415 V ,50 Hz
2. Main Gear Gear Position – Below the main plate
Box machine
Make: Vansoprash
I=30 , Box Type-CM075

3. Stirrer Gear Box Position – Up side of the Filling

hopper
Make: Eurotechnikansoprash , Model
:-- , Size:-Box 40
Ratio :- 60:1,
4. AC Drive Position – In the Control Panel
Make: Delta,

5. Heater Leister make

6. Temp. Indicator Position – In the Control Panel
Make: Selec, Model: TC-513

7. MCB Position – In the Control Panel

Make: Schneider, C 20A

8. SMPS Position – In the Control Panel

9. Timer Position – In the Control Panel

Make: Emtec

10. Main Switch Position – In the Control Panel

Make: SELECT , 16 A

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

11. Temperature Position – on the head of the machine

Sensor Type:PT-100
Length: 2.5meter

12. Contactor Position – In the control panel of the

machineLc1 E09 10
Make: Schneider

13. Solenoid Valve Position – below the main plate Back

side
Make: SMC
MFH-5-1/8 part no-9982
14. Air cylinder Position – on the machine
Make- SMC
15. Stepper motor NA

16. Viper motor NA

17. Indexing Unit NA

18. Jacketed hopper Bhavani
Heater 1.5kw

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

7. Consumption (Utility and Power)

Motor Rated Specification

• Main motor

Voltage 415 V +/ - 10 %

H.p 3.H.p

Phase 3

Frequency 50 Hz.

 Compressed Air – 6 K.g

 Thermic Oil – Nil
 Steam – Nil
 Hot , Plain, D.M Water – For Washing required.

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

8. Material Of Construction

Sr. No. Component Material Of Construction

1. Structure Mild steel powder coat Cover

SS 304

2. Hopper SS 316

3. Stirrer SS 316

4. Valve SS 316

5. Panel box SS 304

6. Syringe Piston SS 316

7. Nozzle SS 316

8. Cup Holder Nylon

9. All Gears/Chain EN 24

Sprocket

10. Chain Size-3/8 Make China

11. Pneumatic connection SMC

& Cylinders

12. Tube loader Guards Acrylic

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

9. Test Certificates / Inspection Reports

Sr. No. Documents Type

1. Main Motor Test Certificate

2. Gear box Test Certificate

3. A C Drive Test Certificate/Manual

4. Indexing Unit Test Certificate

5. Temp. Controller Manual

6. SMPS Manual

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

10. FAT Procedure

Factory Acceptance Test Procedure shall be as follows:

After the completion of erection work of the machine, client /
representative on behalf of the client, shall be informed to perform the
factory acceptance test (FAT)

Customer / representative on behalf of the 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:
1. Test Criteria
2. Design verification check list
3. Deficiency and corrective action report
4. Pre – installation requirements
5. Final reports.

11. Change Control Procedure

Change in the agreed design shall be addressed through the well-

defined change control procedure.

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

12. Reference documents

Sr. No. Documents

1. Data Sheet, duly commented

2. Equipment Brochure

3. Instruction Manual

4. General Arrangement Drawing

13. Summary
(Should be handwritten)

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

14. Abbreviations

Abbreviated Form Expanded Form

GMP Good Manufacturing Practice

FAT Factory Acceptance Test

SS Stainless Steel

HP Horse Power

V Volts

Hz Hertz

kW Kilo Watt

mm Milli Meter

H Height

VFD Variable Frequency Drive

RPM Revolution per minute

RHS Right Hand Side

LHS Left Hand Side

MOC Material Of Construction.

BEW Bhavani Engineering Works.

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

15. Approval Sheet

Prepared By: BEW

The signature below claims to have compiled the protocol with respect to

the User Requirement Specification

Name Designation Department Signature Date

Jatin Mewada Executive Q.C

Reviewed By: BEW

The Reviewer’s signature claims to have verified the specifications as

laid in the defined qualification protocol.

Name Designation Department Signature Date

Suchit Mevada Manager Design

Approved By: BEW

The Reviewer’s signature claims to have verified the specifications as

laid in the defined qualification protocol.

Name Designation Department Signature Date

Dhaval Mevada Prod. Director Production

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 BHAVANI DESIGN QUALIFICATION
ENGINEERING CLIENT CHIAN BIO PRIVATE LIMITED
WORKS MACHINE SEMI-AUTOMATIC TUBE FILLING MACHINE
PROTOCOL NO. BEW-40
AHMEDABAD, INDIA PO NO.
DATE

16. Customer’s Approval

Reviewed By: CHIAN BIO PRIVATE LIMITED

The Reviewer’s signature claims to have verified the specifications as laid

in the defined qualification protocol.

Name Designation Department Signature Date

Approved By: CHIAN BIO PRIVATE LIMITED

The Approver authenticates the protocol to have met with the

specifications as laid in the User Requirement Specification and that the

machine is as per the defined protocol.

Name Designation Department Signature Date

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