About Sejong 77 station Model HRC 77S AWC:
Test: Measuring the noise level emitted by the machine.
The Sejong 77 station Model HRC 77S AWC machine is a high-speed, double-sided tablet press designed for mass production in the pharmaceutical industry. It is capable of producing up to 646,000 single-layer tablets per hour and 184,000 double-layer tablets per hour
The machine features a large 15-inch touch screen for easy operation and monitoring, as well as an Automatic Weight Control (AWC) system for accurate tablet weight control. It also has a disk change system that maximizes productivity and a double-side discharge system for efficient tablet collection.
The HRC 77S is a reliable and efficient tablet press that is ideal for high-volume production of pharmaceutical tablets. It is available in a variety of configurations to meet the specific needs of different customers.
Specification of HRC-S Series
Specification taken from: www.keyinternational.com
Performance Qualification (PQ) is a critical step in ensuring the consistent performance of Sejong 77 Station Model HRC 77S AWC machine. It involves a series of tests to verify that the machine operates within specified parameters and produces tablets that meet predefined quality standards.
Key Parameters for the Sejong 77S AWC Machine for PQ:
Tablet Weight Uniformity:
Test: Weighing a sample of tablets and calculating the weight variation.
Parameter: Percentage of tablets within specified weight limits.
Tablet Hardness:
Test: Measuring the force required to break a tablet.
Parameter: Minimum and maximum hardness limits.
Tablet Thickness:
Test: Measuring the thickness of a sample of tablets.
Parameter: Specified thickness range.
Tablet Friability:
Test: Subjecting tablets to abrasion and measuring weight loss.
Parameter: Maximum allowable weight loss.
Tablet Disintegration Time:
Test: Immersing tablets in a dissolution medium and measuring the time taken for them to disintegrate.
Parameter: Maximum disintegration time.
Machine Efficiency:
Test: Calculating the percentage of time the machine is producing tablets.
Parameter: Minimum efficiency.
Machine Noise Level:
Parameter: Maximum allowable noise level.
Performance Qualification Protocol
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Table of Contents:
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Objective
Scope
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Responsibility:
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Perforformance Qualification:
Prerequisites
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Raw material requirement:
For the execution of PQ required material details are given below
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Required Instrument:
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Procedure:
For the execution of PQ required system description is mentioned below
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Major Process stages and configurable parameters detail has given below
Performance verification stratergy given below
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Measurement criteria
Performance verification criteria
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AWC Performance Verification
Acceptance Criteria
Process Parameter
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Machine Parameter
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Key Parameters of Motors
Performance of Turret Motor
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Key Parameters of Motors
Performance of Feeder Motor LHS
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Key Parameters of Motors
Performance of Feeder Motor RHS
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Key Parameters of Motors
Performance of Oil Pump Motor
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Detail of Instrument Used:
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Deviation from pre-approved Protocol
Actions of deviation from pre approved protocol
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Summary of PQ
Conclusion of PQ
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Post approval of PQ
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Tablet Hardness Measurement sheet
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Tablet Thickness Measurement sheet
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Individual Tablet Weight Measurement sheet
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Individual Tablet Weight Measurement sheet
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Group Weight Measurement sheet
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Tablet Physical Verification sheet
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Machine Parameter Verification sheet
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