The Pharma Test SPT-6 six-station Suppository and Pessary Disintegration Tester is specifically designed for the research, development, process control (IPC) and quality control (QC) testing of various lipophilic suppositories, water-soluble suppositories (such as polyethylene glycol PEG-based suppositories), glycerin gelatin suppositories, vaginal suppositories, and vaginal tablets. This instrument is designed in strict accordance with the European Pharmacopoeia (EP) <2.9.2> "Disintegration of Suppositories and Pessaries", the British Pharmacopoeia (BP), the German Pharmacopoeia (DAB), and the specifications of various national pharmacopoeias. It features a patented automatic 180° timed reverse rotation mechanism and a high-precision constant temperature water bath, which can accurately evaluate the disintegration, dissolution, softening, or base disintegration behavior of samples under human physiological body temperature conditions.

I. Standard configuration includes 6 independent parallel test stations, which can simultaneously test 6 samples at a time, fully meeting the pharmacopoeia's statistical throughput requirements for single-batch sample sampling and testing.

II. Strictly compliant with the European Pharmacopoeia EP <2.9.2> specifications, it features a built-in precision electric drive flipping mechanism that supports automatic 180° horizontal inversion every 10 minutes, completely reproducing the liquid disturbance and test conditions specified in the pharmacopoeia.

III. Equipped with a high-precision external circulating constant temperature water bath heating system, the water temperature uniformity and stability are better than ±0.2°C, ensuring that the temperature of all 6 stations in the tank is stable at 36.5°C ± 0.5°C or 37.0°C ± 0.5°C as specified in the pharmacopoeia.

IV. It adopts a transparent acrylic/glass sleeve and a 316L stainless steel porous metal mesh assembly that conforms to pharmacopoeia geometric dimensions, making disassembly and cleaning easy. A complete set of original IQ/OQ validation document folders is provided to meet cGMP and GLP requirements.

Equipment Introduction

• Fully compliant with EP <2.9.2>.

  • Pharmacopoeia standard test framework: Based on EP <2.9.2> standard specifications, applicable to various fat-based and water-soluble base suppositories and vaginal tablets.

  • Standardized judgment criteria: Accurately monitor the disintegration process of suppository samples in a set medium, including the complete melting, deformation and release of fatty base agents, the complete dissolution of water-soluble base agents, or the endpoint when sample components completely detach from the porous mesh and pass through the mesh.

• Six Parallel Test Stations (High-Throughput Synchronous Testing)

  • High-capacity parallel testing: The machine body is equipped with 6 sets of independent sample testing sleeves and screen components, which can simultaneously load 6 samples for parallel comparison.

  • Complies with statistical sampling standards: Meets the stringent regulations of the pharmacopoeia that require testing 6 samples at a time for the release of suppository batches (if any do not disintegrate, 12 more samples need to be tested again), eliminating the need for multiple tests, significantly shortening the experimental cycle and reducing energy consumption.

• Automated Motorized 180° Inversion Mechanism

  • Electric smooth rotation drive: The built-in precision stepper motor drives the transmission shaft, which drives the 6 test sleeves to perform a smooth and stable 180° rotation without removing them from the water bath medium, preventing mechanical impact from damaging the fragile and disintegrating sample.

  • Intelligent cycle control: The default mode is "automatic 180° rotation every 10 minutes" which meets the pharmacopoeia standard. The rotation interval and number of rotations can also be customized according to different research and development experimental needs, eliminating the tediousness of manual rotation and human time error.

• High-precision thermostatic bath and circulation system

  • Complete convection circulation: It adopts a large-capacity transparent Plexiglas acrylic water bath, with external/built-in high-efficiency low-vibration circulation pumps, ensuring uniform water flow distribution and ensuring that the temperature difference between the 6 workstations is less than ±0.2°C.

  • Precise temperature control via microcomputer: The digital temperature control unit provides a wide temperature setting range from room temperature to 50.0°C, with a temperature control resolution of 0.1°C, and is optimized and calibrated specifically for pharmacopoeia-standard physiological body temperature detection conditions of 36.5°C or 37.0°C.

  • Panoramic transparency and visibility: The highly transparent water bath combined with the high-transmittance test sleeve allows operators to clearly observe the deformation, melt flow, particle shedding and dispersion of the suppository during the disintegration process from 360°.

• Standardized Modular Test Baskets with Quick-Release Cleaning Design

  • Medical-grade contact material: The upper and lower perforated metal plates inside the test sleeve are made of AISI 316L medical-grade corrosion-resistant stainless steel. The hole diameter and hole spacing strictly comply with EP geometric standards and are resistant to acid, alkali and surfactant media.

  • Tool-free quick-release structure: The test sleeve and the fixing bracket adopt a snap-on quick-release design, which can be quickly removed for soaking and rinsing after the test, effectively preventing cross-contamination of oily/fatty base agent residues.

• Intuitive Operation Interface and cGMP/GLP Validation (Intuitive Operation & Regulatory Compliance)

  • Multifunctional digital panel: Equipped with an LCD screen and waterproof membrane buttons, it displays the current water temperature, set temperature, test cumulative time, and countdown timer for the next flip in real time.

  • Complete set of verification documents: Includes original manufacturer test reports, material certificates of conformity, factory inspection certificates, and complete IQ/OQ validation documents, fully meeting the compliance requirements for FDA review, EU GMP, and PIC/S pharmaceutical factory inspections.