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Glass Grain Sampler for Hydrolytic Resistance – QualiGGS™

Glass Grain Sampler for Hydrolytic Resistance
Product Categories
Pharmaceutical Testing Equipment
Standards
EP 3.2.1
ISO 719
ISO 720
USP <660>
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Glass Grain Sampler for Hydrolytic Resistance – QualiGGS™

Glass Grain Sampler for Hydrolytic Resistance – QualiGGS™ is a fully automated laboratory instrument designed for the standardized preparation of glass granules used in hydrolytic resistance testing of pharmaceutical glass containers.

By integrating crushing, sieving, and sample collection into a single enclosed system, QualiGGS™ ensures repeatable grain size distribution, contamination-free handling, and strict compliance with international pharmacopeial and ISO standards.

Engineered for pharmaceutical quality control and packaging laboratories, this Glass Grain Sampler minimizes operator exposure, improves workflow efficiency, and delivers highly consistent sample preparation for reliable hydrolytic resistance evaluation

Glass Grain Sampler for Hydrolytic Resistance – QualiGGS™ Applications

The QualiGGS™ is used for hydrolytic resistance sample preparation of:

Infusion Bottles

Used to prepare standardized glass grains for evaluating hydrolytic resistance of large volume parenteral infusion containers.

Injection Vials

Supports hydrolytic resistance testing to verify chemical durability of glass vials used for injectable drug products.

Ampoules

Enables controlled glass grain preparation to assess leaching behavior and water resistance of sealed glass ampoules.

Oral Liquid Bottles

Assists in determining glass stability for containers used in oral pharmaceutical formulations exposed to aqueous media.

Pharmaceutical Glass Containers

Provides compliant sample preparation for routine quality control and regulatory testing of pharmaceutical packaging glass.

Standards:

ISO 719 Compliance Testing

Prepares glass grains for hydrolytic resistance testing at 98 °C in accordance with ISO requirements.

ISO 720 Compliance Testing

Produces standardized glass particles for high-temperature hydrolytic resistance testing at 121 °C.

EP 3.2.1 Testing

Supports European Pharmacopeia glass container testing by ensuring repeatable and contamination-free sample preparation.

USP <660> Testing

Enables compliant glass grain preparation for U.S. Pharmacopeia hydrolytic resistance evaluations of glass containers.

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Glass Grain Hydrolytic Resistance Sampler

Glass Grain Sampler for Hydrolytic Resistance – QualiGGS™ Key Features

Standard-Compliant Mortar and Pestle

Manufactured to meet ISO and pharmacopeial dimensional requirements.

Integrated Crushing and Sieving System

Combines grinding and classification in one compact enclosure.

Fully Automated Operation

Reduces manual handling, operator variability, and exposure to glass fragments.

High-Precision Vibratory Sieving

Ensures consistent particle size distribution per ISO specifications.

HMI Touch Screen Interface

Intuitive control for parameter setting and operation monitoring.

Enhanced Safety Design

Protective covers and automated striking mechanisms improve operator safety.

High Repeatability and Reproducibility

Ideal for regulated pharmaceutical testing environments.

Glass Grain Sampler for Hydrolytic Resistance – QualiGGS™

Theory and Method

The Glass Grain Sampler operates on a controlled mechanical preparation principle to produce standardized glass granules required for hydrolytic resistance testing.

Test Method Workflow:

  1. The glass sample is placed into the integrated standard mortar.
  2. An automatic pestle descends to crush the glass into grains under controlled conditions.
  3. A high-precision vibratory sieve system activates automatically to classify particles.
  4. Only granules within the specified size range are collected.
  5. The process ensures uniform particle size distribution, minimal contamination, and high repeatability.

This automated method provides consistent and reliable sample preparation, which is critical for accurate hydrolytic resistance testing of pharmaceutical glass containers

Glass Grain Sampler for Hydrolytic Resistance – QualiGGS™ Technical Specifications

ParameterSpecification
Mortar / Pestle DimensionΦ50 / Φ48 mm
Sieve A Aperture425 µm
Sieve B Aperture300 µm
Sieve O Aperture600 µm
Sieve Shaking Duration5 minutes
Gas Pressure0.5 MPa
Gas Port SizeΦ6 mm
VoltageAC 110–220 V, 50/60 Hz

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