The Pharma Test PTSW-0 Suppository Hardness Tester/Suppository Breaking Point Tester is designed to determine the mechanical strength, crush resistance, and breaking point of various lipophilic suppositories, hydrohilic/PEG-based suppositories, glycerin suppositories, and vaginal suppositories. This instrument strictly follows the standards of the German Pharmacopoeia (DAB), the European Pharmacopoeia (EP), and the British Pharmacopoeia (BP) for evaluating the physical stability and mechanical compressive strength of suppositories. It is used to test the maximum external load that suppositories can withstand during manufacturing, demolding, packaging, storage, transportation, and clinical administration, preventing suppositories from cracking or deforming due to insufficient hardness.

I. Specifically designed to measure the mechanical compressive strength and ultimate tensile load of suppositories under constant temperature physiological conditions (such as 36.5°C or 37.0°C) or room temperature environments, effectively predicting the structural stability of finished product packaging, storage, transportation, and clinical use.

II. Standard configuration includes a double-jacketed test chamber with a transparent glass insulation, featuring a quick-release water inlet/outlet interface that can be connected to an external constant-temperature water bath circulation system to ensure a constant temperature uniformity of ±0.2°C during sample testing.

III. Equipped with a precisely calibrated stainless steel vertical guide pressure rod and a set of high-precision disc weights, supporting a standardized step-by-step progressive load test procedure.

IV. The entire machine is made of high-quality AISI 304/316 corrosion-resistant stainless steel and heat-resistant high borosilicate glass. The base has a built-in three-point leveling bubble, making the structure stable and durable. The machine comes with complete original IQ/OQ verification documents to meet cGMP and GLP specifications.

Equipment Introduction

• Pharmacopeial Standard Breaking Point Determination

  • Mechanical stress assessment: After curing, the suppository must have sufficient hardness to withstand packaging compression and finger pressure administration, while avoiding excessive hardness that could cause the base to crack. PTSW-0 uses standardized load testing to accurately determine the ultimate mass (in grams or nitrogen) of the sample when it cracks, deforms, collapses, or crushes.

  • Compliant with pharmacopoeia standards of various countries: Fully compliant with the technical guidelines of the German Pharmacopoeia (DAB), the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), and related industry standards for testing the mechanical tolerance and rupture point of suppositories.

• Double-Jacketed Thermostatic Test Chamber

  • Panoramic transparent observation: It adopts a high heat-resistant double-layer high borosilicate glass jacket design, which combines excellent heat insulation and 360° high light transmittance and visibility. Operators can clearly observe the micro-deformation, indentation and fracture of the suppository under pressure throughout the process.

  • External circulating water bath with constant temperature: Equipped with quick-connect inlet and outlet water connectors, it can be directly connected to an external circulating heated water bath (such as a constant temperature circulating water tank) to maintain the physiological body temperature (36.5°C ± 0.5°C or 37.0°C ± 0.5°C) or set to room temperature conditions according to specific research needs. The water bath circulation stability is better than ±0.2°C.

• Standardized Incremental Progressive Loading Mechanism

  • Precision Calibration Pressurization Assembly: The core of the system consists of a vertical stainless steel pressurization test rod (with a known tare weight, such as 600 g) that has been rigorously calibrated with counterweights. The rod runs vertically through the sample chamber and gently contacts the top of the plug.

  • Stepped counterweight pan: Standard configuration includes a set of precision stainless steel weight pans (such as 200 g increment weights) calibrated by the manufacturer, supporting standard pharmacopoeia procedures: adding one weight at fixed intervals (such as every 60 seconds) until the suppository ruptures or completely collapses, recording the cumulative total weight at the point of rupture.

• Universal Sample Support Base

  • Multi-dosage compatible geometry: The bottom of the test chamber is equipped with a precision-machined special sample positioning seat with V-shaped or arc-shaped positioning grooves, compatible with various suppositories and vaginal bulbs such as torpedo, cone, cylindrical, and bullet types.

  • Self-adaptive symmetrical centering: ensures that the pressure bar is applied precisely and vertically to the highest point of the sample center, eliminating eccentric load and shear force errors, and providing extremely high batch-to-batch test reproducibility.

• Rugged and corrosion-resistant fuselage and GLP Design & Leveling System

  • Medical-grade chemical corrosion resistant: The base and clamping bracket are made of AISI 304 stainless steel and anodized aluminum alloy, which can withstand wiping with various cleaning agents, alcohol, IPA and disinfectant.

  • Highly stable leveling base: Equipped with a three-point anti-slip adjustable leveling knob and a highly sensitive leveling bubble, ensuring that the test axis is absolutely perpendicular to the horizontal plane, in compliance with precision metrology and GLP laboratory standards.

• Regulatory Compliance & Validation Support

  • cGMP/GLP compliant: The instrument is free from electromagnetic interference, and the geometric tolerances and weights of each component are accompanied by traceability certificates from the manufacturer.

  • Complete IQ/OQ validation support: Original manufacturer test reports, material qualification certificates, and complete installation and operation validation (IQ/OQ) folders are provided to facilitate pharmaceutical companies' auditing and validation.