INSTALLATION QUALIFICATION (IQ) PROTOCOL BLISTER PACKING MACHINE (ALU

INSTALLATION QUALIFICATION (IQ) PROTOCOL BLISTER PACKING MACHINE (ALU–ALU)

The Blister Packing Machine (Alu–Alu) is a high-speed, continuous motion packaging system designed for packing tablets and hard gelatin capsules. The machine operates on flat forming and sealing principles using compressed air and hydraulic pressure, ensuring precision, consistency, and high productivity. It is equipped with an automatic feeding system and advanced control features, making it suitable for pharmaceutical applications.

The complete machine is divided into the following main sections:

Forming Station

The forming station consists of a top plate and bottom plate designed to hold the forming tools (format plates).

In PVC/PVDC applications, the heated forming foil is clamped using hydraulic pressure, and cavities are formed using compressed air.
In Alu–Alu applications, the foil is clamped hydraulically and formed mechanically using forming plugs.
The opening and closing of the forming station are controlled by a hydraulic cylinder, ensuring precise and uniform cavity formation.

Feeding Station

The feeding station ensures accurate and uniform product filling into formed cavities.

It consists of a hopper, linear vibrator, and rotary feeder system.
Product flow sequence:
- Hopper → Linear Vibrator → Rotary Vibrator → Feeding Mechanism
The product is finally filled into cavities using a feeding shoe or feeding drum (in case of Alu–Alu).

Sealing Station

The sealing station is responsible for sealing the formed blister with lidding material.

It comprises top and bottom sealing plates.
Sealing is achieved using controlled temperature and hydraulic pressure.
The station operates through a hydraulic cylinder mechanism.
Recommended sealing temperature: 180°C to 200°C, depending on the format and material.

Overprinting Station

This station is used for printing batch details on the blister foil.

It consists of an ink cartridge, pressure roller, and stereo roller.
Printing is carried out using DIPL 39 ink and DIPL 20 thinner in a 60:40 ratio.
Ensures clear and legible batch coding.

Embossing / Perforation Station

This station includes a sliding plate, moving plate, and fixed plate.
It is used to:
- Provide embossed batch details (as an alternative to overprinting)
- Create perforation lines between blister cavities for easy separation

Cutting Station

The cutting station is designed to cut the blister into final pack sizes.

It consists of a sliding plate, punch, and cutting plate.
Cutting operation is synchronized with forming and sealing stations.
A separate servo motor ensures precise and accurate cutting as per blister design.

PLC and Control System

The machine is equipped with a Programmable Logic Controller (PLC) and Man-Machine Interface (MMI) for automation and control.

The PLC converts operator commands into digital and analog signals required for machine operation.
It collects real-time data from field instruments and displays it on the operator interface.
The MMI enables operators to:
- Monitor process parameters
- Control machine functions
- Respond to alarms and system conditions

Based on operator inputs, the PLC executes commands to ensure smooth, reliable, and controlled operation of the machine.

TABLE OF CONTENTS OF INSTALATION QUALIFICATION PROTOCOL

1.0 Approval
2.0 Objective
3.0 Responsibility
4.0 Equipment Identification
5.0 Equipment Location
6.0 Documentation
7.0 Prerequisites for Installation Qualification
8.0 Installation Qualification Procedure
9.0 System Description
10.0 Procedure
10.1 Installation Checklist (Form A)
10.2 Inspection Checklist (Form B)
10.3 Leveling and Alignment (Form C)
10.4 Material of Construction (Form D)
10.5 Guarantee/Warranty Certificates (Form E)
10.6 Drawings (Form F)
10.7 SOP Identification (Form G)
10.8 Supporting Utilities (Form H)
10.9 Critical Instruments Calibration (Form I)
11.0 Deviation and Corrective Action (Form J)
12.0 Change Control (Form K)
13.0 Revalidation Criteria
14.0 Acceptance Criteria
15.0 Summary
16.0 Conclusion

1.0 APPROVAL

Prepared By	Checked By	Approved By	Authorized By

2.0 OBJECTIVE

The objective of this protocol is to verify and document that the Blister Packing Machine (Alu–Alu):

Is installed as per approved design specifications.
Complies with manufacturer’s recommendations.
Meets current Good Manufacturing Practices (cGMP) requirements.
Has all utilities properly connected and functioning.
Has all critical components identified and calibrated.
Has no unauthorized modifications.
Is suitable for intended use.
Has relevant SOPs identified and available.

3.0 RESPONSIBILITY

The validation team shall include representatives from:

Engineering Department
Production Department
Quality Assurance Department

Responsibilities:

Engineering & Production: Execution of installation checks and documentation.
Head Engineering: Verification of installation data.
Quality Assurance: Review and approval of IQ protocol compliance.
GM – Formulations: Final authorization.

4.0 EQUIPMENT IDENTIFICATION

Parameter	Details
Equipment Name	Blister Packing Machine (Alu–Alu)
Model No.	BQS
Serial No.
Tag No.
Manufacturer	Pam Pac Machines Pvt. Ltd.
Purchase Order No.
PO Date

5.0 EQUIPMENT LOCATION

Parameter	Details
Facility	Oral Cephalosporin Facility
Floor	Ground Floor
Area	Primary Packing Area
Room Name	Alu-Alu Packing Room
Room ID

6.0 DOCUMENTATION

S. No.	Document	Annexure
6.1	User Requirement Specification (URS)	Annexure 1
6.2	Purchase Order Copy	Annexure 2
6.3	Design Qualification (DQ)	Annexure 3

7.0 PREREQUISITES

Equipment unpacked and accessible for inspection.
Installation area cleaned and ready.
Equipment location verified as per layout drawing.
Electrical and utility connections available.
Equipment installed as per manufacturer recommendations.

8.0 INSTALLATION QUALIFICATION PROCEDURE

Verify equipment installation as per layout and drawings.
Confirm proper assembly of components.
Check leveling and alignment.
Identify and verify critical components.
Verify Material of Construction (MOC).
Check utility connections.
Verify calibration status of instruments.
Review drawings and SOPs.
Record deviations, if any.

9.0 SYSTEM DESCRIPTION

The Blister Packing Machine (Alu–Alu) is designed for packing tablets and capsules using a continuous motion system.

Main Sections:

Forming Station:
Forms cavities using hydraulic pressure and forming tools.

Feeding Station:
Transfers product via hopper, linear vibrator, and rotary feeder into cavities.

Sealing Station:
Seals formed foil with lidding foil at controlled temperature (180–200°C).

Overprinting Station:
Prints batch details using ink system.

Embossing/Perforation Station:
Provides embossing or perforation between cavities.

Cutting Station:
Cuts blister packs as per design using synchronized motion.

PLC System:
Controls and monitors machine operations through an HMI interface.

10.0 INSTALLATION QUALIFICATION PROCEDURE

General Instructions

The Installation Qualification (IQ) shall be performed to verify and document that the equipment has been installed in accordance with approved specifications, manufacturer recommendations, and regulatory requirements.

Procedure

Verification of Equipment Installation

Verify that the equipment is installed at the designated location as per the approved layout drawing.
Confirm that all components and subassemblies are installed correctly in accordance with manufacturer’s drawings and specifications.
Record the installation details and assembly verification in Form A (Installation Checklist).

Leveling and Alignment

Check the leveling and alignment of the equipment using approved methods.
Ensure that the equipment is properly balanced and aligned for optimal performance.
Record observations in Form C (Leveling and Alignment Record).

Verification of Critical Components

Identify all critical components of the equipment.
Verify that each component meets the specified design and operational requirements.
Record the verification status in Form A and Form B.

Material of Construction (MOC) Verification

Verify the Material of Construction (MOC) of all product-contact and critical parts.
Ensure compliance with specified material grades.
Record observations in Form D (MOC Verification Record).

Utility Verification

Identify all required utilities such as power supply, compressed air, and cooling systems.
Verify that utilities are connected and meet the required specifications.
Record observations in Form H (Utility Check Record).

Instrument Verification and Calibration Status

Identify all critical instruments associated with the equipment and utilities.
Verify that instruments meet specified requirements.
Review and confirm the calibration status of each instrument.
Record details in Form I (Calibration Record).

Verification of Drawings

Review all available engineering and equipment drawings.
Record drawing numbers and ensure availability at designated locations.
Document details in Form F (Drawing Register).

Identification of SOPs

Identify all relevant Standard Operating Procedures (SOPs) for operation, cleaning, and maintenance.
Assign SOP numbers and record SOP titles.
Document in Form G (SOP Identification Record).

Deviation Handling

Record any deviations observed during the IQ process in Form J (Deviation Report).
Document the root cause, corrective actions, and closure status.

Documentation Requirement

All observations, verifications, and records generated during the Installation Qualification shall be documented, reviewed, and approved as per the defined protocol requirements.

10.1 Installation Checklist (Form A)

The following checks shall be performed to verify proper installation of the equipment:

Verify that the equipment position is as per the approved layout and correct room identification.
Ensure that all electrical connections are completed in accordance with the specified configuration.
Confirm that the main control panel is properly installed and accessible.
Verify proper power pack connection.
Ensure availability and proper connection of compressed air supply.
Check that all machine guards are installed securely.
Verify proper connection of chilled water system.
Confirm that the water cooler is correctly installed in the designated service area/floor.
Ensure that anti-vibration pads are properly mounted.
Verify installation of PVC/PVDC unwinding station.
Check proper installation of the heating plate assembly.
Verify correct assembly of the forming station.
Ensure proper installation of the feeding station.
Verify installation of the aluminum foil unwinding station.
Confirm correct installation of the sealing station.
Check proper assembly and functioning of the cooling station.

Note:
All observations shall be recorded as Complied / Not Complied / Not Applicable and duly signed by the responsible personnel with date.

10.2 Inspection Checklist (Form B)

The following parameters shall be verified to ensure proper installation and operational readiness of the equipment:

Overall Dimensions (L × W × H):
Verify and record the actual dimensions of the equipment in millimeters.
Level of Main Machine:
The equipment shall be perfectly leveled.
Air Pressure at Filter Regulator Unit:
The air pressure shall be maintained at 5 kg/cm².
Main Compressed Air Supply Pressure:
The supply pressure shall be 6 kg/cm².
Air Pressure at Pressure Switch:
The pressure shall be 6 kg/cm².
Air Filters:
Perform a visual inspection to check for any damage, blockage, or dust accumulation.
Pneumatic Connections:
Verify all connections by performing a leak test using soap solution.
Air Inlet Shut-off Valve:
Conduct a visual inspection to ensure there is no wear, damage, or misalignment.

Note:
All observations shall be recorded against specified parameters, along with remarks (if any), and signed by the responsible personnel with date.

10.3 Leveling and Alignment (Form C)

Item Description: Level of Equipment

Mode of Verification: Spirit Level / Water Level / Dial Indicator / Straight Edge

Observation: Leveling / Alignment – OK / Not OK

Method for Checking Leveling of Equipment

Using Spirit Level Indicator

Place the spirit level indicator at multiple locations on the machine frame.
Observe the position of the air bubble.

Acceptance Criteria:
The air bubble shall remain centered in the spirit level indicator at all measured points.

Using Water Level Indicator

Use a transparent tube filled with water of suitable length.
Place the tube at different corners of the equipment.
Compare the water levels at each location.

Acceptance Criteria:
The water level at all checked points shall be equal and aligned with the reference edges. The procedure shall be repeated for all sides to confirm uniform leveling.

Method for Checking Alignment

Dial Indicator Method

Mount the dial indicator on the coupling.
Slowly rotate the shaft manually.
Record the variation in readings during rotation.

Acceptance Criteria:
The total indicator reading (TIR) shall be not more than 0.305 mm.

Straight Edge Method

Place a straight edge across the circumference of both driver and driven pulleys.
Adjust the motor base to minimize any gap.
Measure the gap using a feeler gauge.

Acceptance Criteria:
The gap between the straight edge and pulleys shall be not more than 1.0 mm.

Note:
All observations shall be recorded, and any deviation from the acceptance criteria shall be documented and corrected before proceeding further.

10.4 Material of Construction (Form D)

The Material of Construction (MOC) of all product-contact and critical components shall be verified to ensure compliance with specified material requirements.

Component-wise MOC Verification

Capsule Hopper: