YPD-350N-TK Intelligent 4-Parameter Tablet Tester – Hardness, Diameter, Thickness & Width

Tablet Friability Instruments

YPD-350N-TK Intelligent 4-Parameter Tablet Tester — Hardness, Diameter, Thickness & Width

The YPD-350N-TK Intelligent 4-Parameter Tablet Tester is a state-of-the-art pharmaceutical testing instrument designed to accurately measure the hardness, diameter, thickness, and width of tablets in a single test. This tablet hardness tester ensures that tablets meet required mechanical strength for packaging and transportation. Widely used in pharmaceutical quality control laboratories, the YPD-350N-TK provides reliable hardness, diameter, thickness, and width data to maintain product integrity and compliance with industry standards.

Description

The tablet hardness test plays a vital role in the development, production, and quality control of pharmaceutical products. The YPD-350N-TK model accurately measures the maximum, minimum, and average hardness values of tablets, together with diameter, thickness, and width. It also automatically records and stores test data, ensuring precise and efficient quality assessment.

 

Customizable options are available for 500N and 700N models.

 

Product Features

 

1. Advanced Data Management

   •  Built-in three-tier user permissions, audit trails, and test record management.

   •  USB connectivity for exporting test data and generating reports.

 

2. Precision and Reliability

   •  Automatically records and calculates maximum, minimum, and average values for accurate analysis.

   •  Updated sensor system ensures consistent measurement accuracy.

   •  NEW: Integrated tablet thickness measurement — hardness, diameter, and thickness captured in a single test cycle.

   •  NEW: Integrated tablet width measurement — a 4th dimensional parameter alongside hardness, diameter, and thickness, for complete tablet QC in a single test.

 

3. High-Speed Testing

   •  Completes a single test cycle in less than 15 seconds.

   •  Supports up to 1000 consecutive tests with uninterrupted operation.

 

4. User-Friendly Design

   •  Equipped with a touch-screen human-machine interface for ease of operation.

   •  Compact and portable design with DC12V power supply and universal voltage adapter.

 

5. Compliance and Certification

   •  Includes IQ/OQ certification documentation for validation.

   •  Designed with features that support a 21 CFR Part 11 workflow — built-in user permissions, audit trail, and data export help support documentation for FDA 21 CFR Part 11-related data integrity requirements.

 

Product Specifications

 

l   Parameter    Specification

l   Model    YPD-350N-TK

l   Hardness Measurement Range       10–350N

l   Resolution     0.01N

l   Accuracy     ±1.5% ±1 digit

l   Unit N/kg (customizable)

l   Testing Method    Single test/Continuous test (up to 1000 cycles)

l   Tablet Diameter Range     2–25mm

l   Diameter Resolution   0.1mm

l   Diameter Accuracy   ±0.1mm

l    Tablet Thickness Measurement    Integrated — hardness, diameter, and thickness given in one test (detailed range/accuracy to be published at launch)

l    Tablet Width Measurement    Integrated — 4th parameter alongside hardness, diameter, and thickness (detailed range/accuracy to be published at launch)

l   Power Supply       DC12V, 3.0A

 

YPD-350N-TK intelligent tablet hardness, diameter and thickness tester with FDA 21 CFR Part 11-oriented data management — Huanghai Pharmaceutical Instruments

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Note: Our lab instruments support basic audit trails strictly per USP/ChP standards.

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Frequently Asked Questions

Q: What hardness range is required for tablets to pass QC?

A: Tablet hardness specifications vary by formulation, but typical QC acceptance criteria fall between 50–200N (5–20 kP) for standard compressed tablets. Effervescent tablets are typically softer (20–80N), while modified-release matrix tablets may require 100–300N+ for controlled erosion. The YPD-200C covers 10–200N for standard QC ranges. For development or specialized tablets requiring higher ranges, data export, and thickness/width measurement, the YPD-350N-TK adds audit trail, diameter, thickness, and width measurement, and PC connectivity. Contact us for pricing.

Q: What is the difference between hardness units N and kP?

A: Both measure the same physical property (force required to crush a tablet) in different units. 1 kP = 9.81 N (approximately 10 N). Some pharmacopoeial standards express specifications in kP (kilopond), while modern instruments increasingly use Newtons (N) per ISO/SI conventions. Huanghai YPD-series testers display both units simultaneously, allowing labs to directly compare results against legacy specifications (kP) and modern regulatory submissions (N) without conversion errors.

Q: Does USP specify a hardness test method for tablets?

A: USP <1217> provides guidance on tablet breaking force measurement but does not mandate a specific acceptance criterion—hardness specifications are set in individual product monographs or internal QC specifications. The standard defines the measurement geometry (flat-faced anvils, load application rate) to ensure instrument-to-instrument comparability. Huanghai YPD-series testers are designed to comply with USP <1217> measurement geometry, ensuring data generated on our instruments is transferable to regulatory submissions.

Q: Can hardness testing predict tablet coating durability?

A: Hardness provides an indirect indicator of coating durability—harder core tablets generally support coat adhesion better, but coating performance depends equally on surface roughness, tablet shape, and coating process parameters. For direct coating durability assessment, combine hardness testing with friability (USP <1216>, CJY-300E). The SY-6DN 4-in-1 tester integrates hardness, friability, disintegration, and dissolution in a single platform, enabling comprehensive pre-coating characterization from a single instrument.