Pharma test media preparation system
The Pharma Test PT-DDS4 Dissolution Media Preparation and Degassing Dispensing System is designed for pharmaceutical quality control (QC), R&D analysis, and dissolution testing laboratories. It provides fully automated heating, efficient vacuum degassing, precise volume dispensing, and automated tubing cleaning for various dissolution testing media. This instrument fully complies with the United States Pharmacopeia (USP) <711>, the European Pharmacopoeia (EP) <2.9.3>, FDA dissolution testing guidelines, and cGMP international regulations.
I. The system integrates efficient vacuum pumping, temperature-controlled heating, and dynamic circulation degassing technologies, which can quickly remove dissolved air and oxygen from the medium and completely eliminate the interference of bubbles on the drug dissolution rate.
II. Equipped with a high-precision volumetric metering pump and an ergonomic dispensing handle, it supports precise automatic dispensing of 250 mL to 1000 mL (and larger) with a dispensing accuracy of < ±1%, eliminating the human error of traditional graduated cylinder measurements.
III. Patented low-foaming flow channel and degassing mechanism, fully compatible with pure water, hydrochloric acid solution, phosphate buffer and various foaming and dissolving media containing surfactants (such as SLS, SDS, Tween).
IV. The highly mobile trolley design features a built-in large-capacity liquid storage tank and an automated CIP tubing cleaning program. It also boasts an intuitive touchscreen operation screen and complete method storage capabilities, significantly improving the daily pretreatment throughput of multiple dissolution apparatuses.
Equipment Introduction
High-Efficiency Vacuum & Thermal Degassing Technology
Complete removal of dissolved gases : Combining high vacuum negative pressure, precise temperature control heating and continuous flow circulation mechanism, it effectively reduces dissolved oxygen (DO) and air in the dissolution medium to below the pharmacopoeia standard.
Eliminate bubble interference and flow field deviation : prevent microbubbles from adhering to the tablet surface, filter head, or stirring paddle, and avoid abnormal deviations in the dissolution curve caused by changes in buoyancy or obstruction of effective dissolution surface area.
Precise preheating and constant temperature control (Integrated Media Pre-Heating System)
The temperature can be directly preheated to the target temperature of 37°C before dispensing : The built-in high-efficiency heating and temperature control module can directly preheat the medium to the test target temperature (such as 37.0°C ± 0.5°C) during the medium preparation stage.
Significantly reduces test waiting time : Eliminates the time-consuming process of waiting for the water bath to reheat after the medium is injected into the dissolution vessel, significantly improving the efficiency of daily batch testing.
High-Precision Ergonomic Dosing Handpiece
Single-button rapid quantitative injection : Equipped with an ergonomic electronically controlled dispensing gun, simply press the start button to inject the set volume (such as 250, 500, 900, 1000 mL) into each dissolution cup at high speed and with precision.
High-precision volume control : Employing a high-resolution metering pump and micro-valve control, the volume accuracy of dispensing is < ±1%, completely eliminating reading and operational errors caused by manual pipetting with graduated cylinders.
Surfactant-Friendly & Anti-Foaming Design
Special anti-foaming flow channel design : Degassing and optimized transport of surfactants (such as Sodium Lauryl Sulfate / SLS, Tween series) commonly used for poorly soluble drugs.
Stable degassing without overflow : While maintaining high-efficiency degassing capacity, it effectively inhibits the generation of large amounts of foam, ensuring that the volumetric distribution of various surfactant media remains precise and stable.
Automated Cleaning-In-Place / CIP Routines
One-button automatic pipeline cleaning : Built-in standardized CIP automatic flushing and draining program, eliminating the need for cumbersome disassembly when changing different buffers or media.
Prevent cross-contamination : Ensure that there are no residues or salt crystal deposits in the pipeline and nozzles, extend valve life and meet cGMP cleaning effectiveness standards.
Product Features
Integrated high efficiency; vacuum degassing and precise preheating
High-precision, rapid quantitative dispensing; foaming medium compatibility.
Mobile cart design for quick and effective cleaning.
Overall Specifications
Product Model : PT-DDS4
Manufacturer : Pharma Test, Germany
Version Specification : Version 2.0
Product positioning and operating principles :
Mobile fully automated solvent preparation, heating, vacuum circulation degassing, and high-precision quantitative dispensing system
Continuous vacuum circulation degassing and preheating are performed in a sealed storage tank to completely eliminate undissolved gases and microbubbles, preventing bubble adhesion in the dissolution vessel from affecting the dissolution rate of solid preparations.
Supports manual feeding or automatic vacuum feeding via factory pure water pipeline and external container.
International Pharmacopoeia and regulatory compliance :
Fully compliant with the United States Pharmacopeia, European Pharmacopeia, and US Food and Drug Administration (FDA) standards for solvent degassing.
Effectively reduces the interference of physicochemical variables in dissolution tests on the results, ensuring the suitability of the dissolution system and the accurate reproduction of comparative test results.
Degassing and heating efficiency :
The total amount of residual gas has been reduced to approximately 35%.
The dissolved oxygen concentration inside the container dropped to below 5 ppm.
Storage tank capacity: Approximately 24 liters (for electrolytically polished stainless steel storage tanks, minimum filling volume is 1 liter).
Degassing and heating time: 24 liters of solvent completes heating and degassing in approximately 30 to 45 minutes.
Temperature control range: 30.0 to 50.0°C
Temperature control accuracy: ±0.5°C
Heating system power: 900 watts
Vacuum system specifications: Absolute vacuum of 0.4 bar, maintaining constant vacuum during the cycle.
Quantitative dispensing parameters and accuracy :
Weight dispensing mode: 250 to 5,000 grams, dispensing accuracy ±0.5% (maximum error ±1 ml), real-time weighing via built-in load cell.
Volumetric dispensing options: 250 to 5,000 ml, dispensing accuracy ±0.8%, metered via digital flow meter.
Dispensing speed: Approximately 45 to 60 seconds to dispense 1 liter of medium.
Density correction function: Allows input of medium density to correct for dispensing volume errors caused by temperature or different solvents.
Online buffer preparation and special media treatment :
Online buffer mixing function: The buffer dispensing weight (100 to 5,000 grams) and density can be set, and the buffer will be automatically injected into the storage tank for uniform mixing.
Special components for foaming media: Optional arc-shaped feed pipe guides the liquid flow smoothly along the tank wall, effectively suppressing the generation of excessive foam in media containing surfactants.
Operation and control interface :
9-inch backlit LCD screen with a resolution of 320 × 240 pixels (approximately 90 × 120 mm diagonally).
A full-function alphanumeric keyboard that allows direct input of product information, batch numbers, and parameters such as medium density.
Built-in memory can store up to 16 degassing preparation methods.
The remaining solvent volume in the storage tank is displayed in real time.
Piping cleaning and fluid replacement residue :
The preheating tank features an open, easily removable design for convenient daily cleaning and maintenance.
When changing the medium, the system automatically executes a dedicated pipeline flushing procedure, and the residual waste liquid after fluid replacement is less than 2 liters.
Data output and communication interface :
Built-in 24-character thermal printer for real-time printing of packaging weight, volume data, and calibration results.
Equipped with a serial communication port to support data transmission
Calibration and validation functions :
Built-in calibration guide program for digital load cell, digital flow meter and temperature control system
Supports software-guided validation and calibration using a 1 kg standard weight.
Built-in strain gauge for repackaging performance testing
Institutional specifications and operating environment :
Machine structure: Integrated mobile trolley design, equipped with load-bearing casters, can be stored under most experimental tables.
Packaging arm height: approximately 130 cm from the ground
Body dimensions: Approximately 550 × 700 × 900 mm (Length × Width × Height)
Packaging dimensions: Approximately 1070 × 970 × 780 mm (Length × Width × Height)
Instrument weight: Net weight approximately 75 kg, gross weight approximately 110 kg
Operating noise: Maximum noise level below 55 decibels
Validation and Certification :
The wetted components fully comply with the specifications of the United States Pharmacopeia and the European Pharmacopeia.
Possesses complete electromagnetic compatibility and safety certifications
Standard configuration includes complete original manufacturer installation and operation verification documentation, conformity certificate, and instrument history logbook.