SIDVIN PLASTECH (P) LTD.

Installation Qualification: VP/MOLD/2018/02/IQ

Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

REVIEW AND APPROVAL

The report has been reviewed and approved by the following individuals. Our collective signatures
acknowledge that the document was reviewed, approved, is ready for implementation to satisfy the
requirements to validate VERUX FLIP-OFF BUTTON,13 mm – 80 Cavity, and we individually
agree with the contents and validation strategy of this report. The significance of each respective
signature is shown below.

Title / Significance Name Signature Date

Author- The information represented in this

report is an accurate reflection of the
validation work performed. The conclusions G. Radha Krishna
and recommendations are those of the
validation team.

Project Manager- I have reviewed the

contents of this report; agree with the
contents. K. Srinivasa Rao

Manager Quality Assurance- I have

reviewed the contents of this report; agree
with the contents L. Chandra srinivas

FROM CUSTOMER:

Title / Significance Name Signature Date

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

1.0 PURPOSE

The purpose of this Installation qualification (IQ) is to establish objective evidence that key
aspects of FMI 150T Nova Servo Moulding Machine and ancillary system installation adhere
to the manufacturer’s approved specifications and that the recommendations of the supplier of
the equipment are suitably considered.

2.0 SCOPE
2.1 This protocol is applicable to the injection moulding machine FMI 150T Nova Servo, set
up in Sidvin Plastech Pvt. Ltd. For the medical device parts. All the guidelines and
criteria state in this document shall follow strictly during the qualification, unless that is a
special requirement from the customer.
2.2 This protocol includes the following.
2.2.1 Installation Qualification (IQ)
Installation Qualification is performed to ensure that all parts and components of
the moulding machine are present and correctly installed.
2.3 The IQ for the above machine demonstrates the following:
2.3.1 The equipment meets the installation conditions documented prior to
delivery
2.3.2 The equipment has been installed and labeled in accordance with
documented specification and procedures, and with the manufacturer’s
recommendations where applicable.
2.3.3 Key documentation is present, this includes drawings, manuals and safety.

3.0 APPLICABLE DOCUMENTS

3.1 Manual – FMI 150T Nova Servo Injection Moulding Machine Operation manual.
3.2 Drawing – Control Room machine layout
3.3 Manual – Con Air Material feeding system
3.4 Manual – Chiller
3.5 Mould cooling system diagram

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

4.0 RESPONSIBILITIES
4.1 Production Manager
4.1.1 Prepare the validation protocol. Ensure that all validation steps are in
agreement with the scope and acceptance criteria
4.1.2 Execute the validation protocol. Direct and coordinate all validation steps
stated in the protocol and supervise that the validation steps are executed
according to training provided
4.1.3 Assist in exception impact analysis as needed. Provide expertise in the root
cause analysis and corrective actions in the event an exception occurs
4.1.4 Assist in process method generation.
4.1.5 Preparation of IQ summary report following execution of the protocol.
4.2 Project manager
4.2.1 Review the validation protocol. Ensure that all validation steps are in
agreement with the scope and acceptance criteria.
4.2.2 Assist in process method generation.
4.2.3 Train manufacturing personnel prior to protocol execution.
4.2.4 Assist in exception impact analysis as needed. Provide expertise in the root
cause analysis and corrective actions in the event an exception occurs
4.2.5 Review of IQ summary report following execution of the protocol.
4.3 QA Manager
4.3.1 Review and approve the validation protocol. Ensure that all validation steps
are in agreement with the scope and acceptance criteria.
4.3.2 Assist in data analysis and summary of results.
4.3.3 Ensure that all documentation and data generated during the validation study
conforms to company standard operating procedures and external quality and
regulatory requirements.
4.3.4 Lead the exception impact analysis.
4.3.5 Review and final approval of IQ summary report following execution of the
protocol.

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

5.0 TRAINING REVIEW

Prior to the execution of this protocol, all applicable personnel that will be involved in this
validation must be trained according to pertinent documents and to the steps of this protocol.
Training will be documented in F/QAD/24-01, Training attendance form.
6.0 EQUIPMENT DESCRIPTION AND BACKGROUND
6.1 Machine Overview
6.1.1 Injection Moulding Machine and its auxiliary equipment

DESCRIPTION REMARKS
Brand Name
Injection Moulding
Model / Tonnage
Machine
Serial No
Brand Name
Material Granular Model
Serial No
Brand Name
Hot Runner System Model
Serial No
Brand Name
Chiller Model
Serial No

6.1.2 Hot Runner System

6.1.3 Utilities – Electrical, Compressed Air and Chilled Water
6.1.4 Mould
Description Component
Part Name Verux Flip-Off Button, 13mm
Part Number M2311
Drawing Rev. No. 05
Mould No M2311
No. of cavities 80

6.2 For Operation of Injection Moulding Machine Refer SOP : SOP/PD/11

6.3 Safety
Refer to FMI 150T Nova Servo Operation manual.
6.4 Product Material Specification

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

6.4.1 Refer to PP H110MA Technical Data Sheet

6.4.2 Refer to PolyOne Polymers India Technical data sheets
7.0 PRE- REQUISITE
7.1 FMEA Documents updated.
8.0 INSTALLATION QUALIFICATION
8.1 Equipment Identification and Verification
Check equipment for correct identification and verification. Damaged equipment or
equipment not installed according to Manufacturer’s recommendation must be rectified
immediately.
8.1.1 Injection Moulding Machine
S.No. Description Criteria Yes/No/ NA Remarks
1 Correct Equipment Correct
received? Equipment
received
2 Received equipment No damage found
damaged? on the equipment
3 Was equipment Check
installed according to installation /
manufacturer’s calibration report
specification? availability
4 Clamping Cylinder No visual damage
found
5 Moving Platen No visual damage
found
6 Fixed platen No visual damage
found
7 Hydraulic Ejector No visual damage
found
8 Moving cover No visual damage
found
9 Control unit No visual damage
found
10 Plasticising Barrel No visual damage
found
11 Hopper No visual damage
found

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

12 Injection Unit No visual damage

found
13 Screw Drive No visual damage
found
14 Mains Isolator No visual damage
found

Verified by (Name/Sign/Date):

8.1.2 Grannulator
S.No. Description Criteria Yes/No/NA Remarks
1 Correct Equipment Correct
received? Equipment
received
2 Received equipment No damage found
damaged? on the equipment
3 Was equipment Check installation
installed according to / calibration report
manufacturer’s availability
specification?
4 Received the Must be present
Grannulator Manual?
5 Is there sufficient Space must be
space for equipment? sufficient

Verified by (Name/Sign/Date):

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

8.1.3 Chiller
S.No. Description Criteria Yes/No/NA Remarks
1 Correct Equipment Correct
received? Equipment
received
2 Received No damage
equipment found on the
damaged? equipment
3 Was equipment Check
installed according installation /
to manufacturer’s calibration report
specification? availability
4 Received the chiller Must be present
Manual?
5 Is there sufficient Space must be
space for sufficient
equipment?

Verified by (Name/Sign/Date):

8.1.4 Hot Runner System

S.No. Description Criteria Yes/No/NA Remarks
1 Correct Equipment Correct
received? Equipment
received
2 Received equipment No damage
damaged? found on the
equipment
3 Was equipment Check
installed according to installation /
manufacturer’s calibration report

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

specification? availability
4 Received the HRS Must be present
Manual?
5 Is there sufficient Space must be
space for equipment? sufficient

Verified by (Name/Sign/Date):

Critical Features and Functions

Description Affect safety Affect product Other
conformances
Temperature
Time
Cushion
Pressure

Completed by (Name/Sign/Date):

Safety Features
This can take the form of being protected from the event or from exposure to something that
causes health or economic losses. It can include protection of people or of possessions.
8.1.5 Injection Moulding Machine
S.No. Description Criteria Yes/No/NA Remarks
1. Do the safety features Operates normally
in moulding machine
operate as expected?
2. Safety Sliding Present and
located at each
side of the platen
3. Emergency Buttons Present and

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

located at both
sides of the
moulding
machine. (one
side is on the
control unit)

Verified by (Name/Sign/Date):

8.1.6 Chiller
S.No. Description Criteria Yes/No/NA Remarks
1. Do the safety features Operates normally
in moulding machine
operate as expected?
2. Safeguard tank and Present
motor
3. Emergency close Present and located
valve on the outlet
4. Motor Active electric Present and located
switch on the control unit

Verified by (Name/Sign/Date):

8.1.7 Granulator
S.No. Description Criteria Yes/No/NA remarks
1. Do the safety features Operates normally
in moulding machine

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

operate as expected?
2. Safeguard screw and Present
motor
3. Emergency Button Present and located
on the outlet
4. Motor Active electric Present and located
switch on the control unit

Verified by (Name/Sign/Date):

8.2 Prior to the execution of this protocol, all equipment described in this document must be
calibrated. List any measurement equipment used in or associated with this protocol in this
section.
Name of the Equipment Equipment ID Calibrated Calibration
(Yes/No/NA) due date
Digital Vernier
Digital Height Gauge
Dial Gauge with
comparator

Verified by (Name/Sign/Date):

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

8.3 Services connection check

S. No. Services required Manufacturer’s Actual performance when
Specification service connected
8.3.1 Electrical connection
8.3.2 Process control water
supply pipe (PCWS)
8.3.3 Process control water
return pipe (PCWR)
8.3.4 Vaccum

8.4 Environmental Conditions

Optimum environmental conditions are essential to ensure the products produced
conformed to requirements.
Description Manufacturer’s Actual value As per specification?
Specification Yes/No
Temperature
Humidity

8.5 Mould
S.No. Description Criteria Yes/No/NA Remarks
1. Correct mould Check according
received? to mould
drawing and
record mould
No.
2. Received Mould No damage
damaged on found on mould
periphery?
3. Verify the footprint of Mould fit to the
the mould moulding
machine, record
mould size and

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

tie bar distance

4. Open manually the The mould
mould opens without
problem
5. Close manually the The mould close
mould without problem
6. Verify the clamping The screw has
screw is correct to the tighten,
mount record screw
size
7. Activate manually the The ejector
ejectors slides correctly
8. Try to close the plates Moulding
with a component left machine stops
in the mould and alarm
sounds.
9. Verify the numeration All cavities are
of the cavities numbered
10. Activate manually the The cheek slides
slide movements without problem
11. Connection to the hot The hot runner
runner, verify the works correctly.
absence of short
circuit
12. Verify the nozzle Absence of resin
contact surface on leakage
spure bush
13. Verify the cooling Absence of
connection of the water leakage
mould as per the
cooling diagram

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

14. Is there sufficient Spare must be

mould spare part as sufficient
per spare part list?
15. Verify mould steel present
report for critical
dimensions?

Verified by (Name/Sign/Date):

9.0 DEVIATION REPORT

All deviations encountered in the validation shall be recorded in the Deviation Report.

All deviations need to be resolved before closure of the validation.

9.1 Identify the type of exception
9.2 Identify location in protocol exception was found
9.3 Provide a brief description of execution
9.4 Determine whether the exception has a significant impact on the validation
9.5 Identify potential root causes for the exception. In the event the root cause cannot be
identified, you must provide justifiable rationale
9.6 Establish and implement a corrective action to prevent the exception from happening
again.
9.7 Obtain concurrence and closure from QA and Manufacturing. All exception reports must be
closed prior to final validation report approval

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 SIDVIN PLASTECH (P) LTD.
Installation Qualification: VP/MOLD/2018/02/IQ
Validation Title: IQ for VERUX FLIP-OFF BUTTON, 13MM Mold – 80 Cavity

10.0 INSTALLATION QUALIFICATION CLOSURE

Final approval of this protocol, once executed will come in the form of an IQ Summary Report,
and will include for example:

 A statement indicating that the IQ was carried out as per the protocol

 A summary of any exceptions, including root cause and corrective action

 Final approval must come from those who approved the original protocol.

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