The Pharma Test PTS 3E Suppository Penetration / Softening Time Tester is specifically designed for the research, development, process control (IPC) and quality control (QC) testing of lipophilic suppositories, rectal suppositories, vaginal suppositories, and lipophilic bases (such as cocoa butter, semi-synthetic fatty acid glycerides, Witepsol, etc.). This instrument is designed in strict accordance with the European Pharmacopoeia (EP) <2.9.22> Apparatus A ("Time of softening of lipophilic suppositories") specifications. Through a precise constant-temperature circulating water bath and a standardized penetration load mechanism, it accurately measures the critical time for a sample to soften upon heating and withstand penetration by a specific weight.

I. Standard configuration includes 3 independent parallel test stations, which can simultaneously perform continuous parallel comparison tests on 3 samples, significantly improving laboratory throughput and testing efficiency.

II. Fully compliant with the European Pharmacopoeia EP <2.9.22> Apparatus A, British Pharmacopoeia BP, German Pharmacopoeia DAB, and other national pharmacopoeia standards for the determination of softening time of lipophilic suppositories.

III. Built-in high-precision water bath circulating constant temperature heating control system, with water temperature uniformity and stability better than ±0.2°C, ensuring that the entire testing process meets the stringent temperature control requirements of 36.5°C or 37.0°C as specified in the pharmacopoeia.

IV. Equipped with high-precision borosilicate optical glass test tubes and proprietary standard penetration probes, the device is intuitive and easy to operate, and comes with complete original IQ/OQ validation documentation to comply with cGMP and GLP specifications.

Equipment Introduction

• The device is fully compliant with EP <2.9.22> Apparatus A.

  • Standardized measurement framework: Designed according to the geometry and hydrodynamics of Device A as specified in EP <2.9.22>, specifically for measuring the time (Softening Time) of lipophilic base suppositories softening, melting, deforming, and losing structural support at human physiological body temperature.

  • High reproducibility testing: By using standardized glass sample tubes, precise tapered positioning bases, and standard weight penetrating bars, experimental biases caused by manual observation and homemade fixtures are completely eliminated.

• High-throughput three-parallel test stations

  • Three-channel synchronous testing: It has 3 fully symmetrical test stations and can accommodate 3 sets of standard suppository test glass components to operate simultaneously.

  • Parallel comparison analysis: Supports simultaneous parallel testing of 3 samples from the same batch, quickly obtaining the average softening time, maximum value, minimum value and relative standard deviation (%RSD), significantly shortening the release time.

• High-precision thermostatic bath and circulation system

  • Uniform thermal circulation technology: Equipped with an integrated acrylic constant temperature water bath and a high-reliability circulation pump, the water bath circulates without dead zones, ensuring the consistency of sample temperature between each test station.

  • Microprocessor-based precise temperature control: Built-in digital electronic temperature control unit, setting range covers room temperature to 50.0°C, temperature control stability is better than ±0.2°C (the pharmacopoeia standard test temperature is usually 36.5°C ± 0.5°C or 37.0°C ± 0.5°C).

• Modular Test Units and Ergonomic Design (Modular Glass Assembly & Ergonomics)

  • Special glass test tube: Made of high-transparency borosilicate glass, with a standard tapered end at the bottom for precise sample placement, and excellent chemical corrosion resistance and thermal stability.

  • Standard Penetration Rod: Standard penetration rod with precision counterweight, equipped with a dedicated contact indenter at the lower end, and its total weight and geometric specifications fully comply with the requirements of Apparatus A of the Pharmacopoeia.

  • Clear Penetration End Point Determination: The highly transparent water bath and glass tube design, along with clearly identifiable markings, allows operators to visually determine the exact moment when the penetrating rod reaches the bottom.

• Independent timers and cGMP Qualification

  • Three-channel independent timing: Supports independent start, pause and timer reading of 3 test stations to adapt to the differences in softening processes of different suppository samples.

  • Regulatory compliance assurance: All manufacturing and contact materials comply with cGMP/GLP standards, and come standard with original manufacturer test reports, material declarations, and complete IQ/OQ compliance documentation.