Qualification Protocol for Strip Packing Machine

This article discusses the Strip Packing Machine qualification. In the strip packing machine wide range of products can be packed automatically / semi-automatically. Operating the machine is very simple. The product is fed through the hopper and the feeding device flows to the heat-sealing roller cavities, the desired laminated foil from the two rollers is drawn on the sealing rollers which pack and seal the products continuously. 

The sealed strip passes through the vertical and horizontal cutters to get desired strip sizes. Strip Packing Machine Suitable for Strip packs a wide range of products into an easily dispensable strip with economy and speeds. A strip packing machine is extensively used to pack tablets, capsules, caplets, coated tablets, and soft gelatin capsules.

Packing machine covers different types of qualification like design, installation, operational and performance qualification. It also includes the process involved in the strip. This article discusses the equipment qualification on strip packing machines which covers different types of qualification.

Types of Qualification

1. Design Qualification (DQ)
2. Installation Qualification (IQ)
3. Operational Qualification (OQ)
4. Performance Qualification (PQ)

It also includes the process involved in the strip packing machine and detailed description of equipment parts like the unwinding station, forming station, sealing station, heating station, cooling station, feeder, lidding material, and labeling through packaging. It also covers the details of packaging importance and its types. packing machine and detailed description of equipment parts like unwinding station, forming station, sealing station, heating station, cooling station, feeder, lidding material and labeling through packaging. 

Benefits of Strip Packing

• More user-friendly packaging option in comparison of bottled capsules and tablets
• A cost-effective packaging option
• A secure packaging method for the protection of pharmaceuticals
• Easy to consume a single capsule or tablet without touching other tablets

Advantages of Strip Packing Machine

• Easy and smooth operation
• High strength and efficient performance
• Easy maintenance and long service life
• Ideal for heat-sealable foils
• Easy process monitoring

Materials Supported by Strip Packing Machine

• Aluminium foil
• Cellophane
• Polyethylene
• Paper
• Plastic
• Other heat-sealable materials

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Design Qualification (DQ)

It is the documented verification that the proposed design of the equipment is suitable for the intended purpose.

DESCRIPTION	SPECIFICATIONS
Equipment	Satellite Engineers Strip Packing Machine.
Specification	Model   SE-210
Capacity	Maximum Sealing Width 210mm 6 Track –   900 to 2100 8 Track – 1200 to 2800 (Output depends on the Shape and Size of the Tablet.)
Model	The equipment should be a GMP model.
Overall dimensions	L 2080mm x W 1140mm x H 1900mm
Weight	Machine: 750 Kg.
Process	Feeding System: The product is fed into the hopper from where it is guided into the Bowl mounted on a Vibrator.  The product on the Bowl is evenly distributed and guided through the tracks on the Bowl into the Chute Channel and the feed rate of the Product from the Bowl to the Chute Channel is controlled by the Vibrator. The Product from the Chute is released onto the Sealing Roller by the Cam Operated Release Pin.   Sealing System: The set of Sealing Rollers draws the heat-sealing Packing Material (Foils) from 2 sets of front adjustable type of friction brake system Foil Holder Assembly and Foil running tubes. The sealing Rollers are heated to the required temperature by the Cartridge Heaters inserted into the individual Rollers.  Adequate pressure is applied onto the Sealing Rollers so that both the foils get sealed at the time of contact while passing through the sealing roller. At this stage the product which is released onto the cavity of the rollers gets packed and sealed in the foils.

Installation Qualification (IQ)

It is the documented verification that the equipment as installed complies with the approved design, the manufacturer’s recommendations, and/or user requirements.

The table below lists the tests to be performed as part of the Installation Qualification phase.

TEST No.	CRITICAL FEATURE
1	Documents & Drawings Verification.
2	Verification of Technical Specifications for In-House & sub-components / bought-out items.
3	Utilities Verification.
4	Material of construction verification.

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Operational Qualification (OQ)

It is the documented verification that the equipment as installed performs as intended throughout the anticipated operating ranges.

The table below lists the tests to be performed as part of the Operational Qualification phase.

TEST No.	CRITICAL FEATURE
1	Control Panel Testing
2	Safety Feature Verification
3	Batch Coding Verification
4	Travel of the product from the bowl to the chute and dropping into the pocket (Feeding of Product Verification)
5	Sealing of the foil when the foil passes through the sealing Rollers.   (Sealing of Strip Verification)
6	Slitting & Cutting the Strip Verification.
7	VFD function Verification.

Performance Qualification (PQ)

It is the documented verification that the equipment as connected together can perform effectively and reproducibly based on the approved process method and specifications.

The table below lists the tests to be performed as part of the Performance Qualification phase.

TEST No.	CRITICAL FEATURE
1	Machine Speed
2	Vibrator Speed
3	Sealing Temperature

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