Pharma test PTWS 820-MA 8-vessel dissolution tester
The Pharma Test PTWS 820-MA pharmaceutical media addition station is designed for automatic media half-change of sustained-release and enteric-coated formulations. It can be seamlessly integrated with the PTWS 820D tablet dissolution tester to achieve a high-precision two-stage automatic media conversion and continuous dissolution test process.
I. Fully compliant with the United States Pharmacopeia (USP) <711>, the European Pharmacopeia (EP) <2.9.3>, and the Canadian Pharmacopeia (CP) <931> standards, precisely meeting the statutory dissolution test requirements for delayed-release and enteric-coated formulations.
II. Supports a standard two-stage automated media replacement process: The initial stage involves an acid resistance test in 750 mL of 0.1 N hydrochloric acid solution; after 2 hours, the system automatically and rapidly injects 250 mL of preheated concentrated buffer solution into each dissolution vessel.
III. It has high-precision pH value and volume adjustment capabilities. After injecting buffer, it can quickly replenish the total volume of the medium to 1,000 mL and accurately adjust the pH value to 6.8, so that the preparation can be started and dissolved according to the standard procedure.
IV. Through connection with the PTWS 820D dissolution apparatus main unit for programmable control and buffer preheating design, temperature fluctuations inside the cup caused by cold liquid injection are avoided, completely eliminating the time difference and operational errors of manual liquid addition, ensuring the reproducibility and data integrity of dissolution curve data.
Equipment Introduction
Specifically designed for delayed-release and enteric-coated media half-change formulations .
It fully complies with USP <711>, EP <2.9.3> and CP <931> specifications.
Automatically switch between the acidic and buffer phases (e.g., after 2 hours of testing with 750 mL of 0.1 N HCl, precisely inject 250 mL of preheated concentrated buffer solution to adjust the total volume to 1000 mL and the pH value to 6.8).
Built-in independent preheating media reservoir to prevent sudden temperature drops in the dissolution tank .
Equipped with a dedicated heating and temperature control circulation module, the concentrated buffer is preheated to 37°C (or the specified test temperature) before injection.
During the liquid addition process, the temperature inside the dissolution vessel must be strictly maintained within the range of 37.0 ± 0.5 °C as required by the pharmacopoeia to prevent data interference caused by cold liquid injection.
Multi-channel high-precision synchronized dispensing enhances experimental reproducibility .
A multi-channel high-precision quantitative delivery system (usually 6 or 8 channels in parallel) is adopted to ensure that the volume of liquid added to each dissolution cup is highly consistent (volume accuracy within ±1%).
Accelerating the liquid addition process reduces the time difference between tanks, significantly improving the reproducibility and reliability between test batches.
Seamless integration with PTWS Dissolution Testers enables fully automated, unattended testing .
Connect to the dissolution tester host (such as PTWS 820D/830, etc.) via RS-232 / CAN-Bus / I/O trigger interface.
The liquid addition process is automatically triggered according to the set test method schedule, without the need for manual intervention by operators, which significantly reduces human error and labor intensity.
The entire process complies with GMP and 21 CFR Part 11 regulations .
The integrated system operation logs allow for the traceability and recording of parameters such as liquid addition time, volume, and temperature, ensuring data integrity during the testing process.
Product Features
Automated design for media half-change in sustained-release/enteric-coated formulations.
Built-in independent preheating
temperature control circulation system
prevents sudden drops in liquid temperature during refrigerant addition
PTWS 820D / PTWS: Perfectly Integrated High-Precision Quantitative Measurement
Overall Specifications
System Model : PTWS 820-MA
Manufacturer : Pharma Test Apparatebau AG, Germany
Version Specification : Version 1.0
Product positioning and operating principles :
A fully automated secondary buffer preparation and solvent semi-replacement workstation specifically designed for use with an 8-vessel solubility tester.
Automatic acid-base conversion test specifically applied to delayed-release formulations and enteric coating formulations.
The experiment began with 750 mL of 0.1 N HCl medium. After a 2-hour acid tolerance test, 250 mL of preheated concentrated buffer solution was rapidly and simultaneously injected into each dissolution vessel by fully automated system.
Immediately after injection, the pH of the dissolution medium is adjusted to 6.8 and precisely maintained at a total volume of 1000 mL, allowing the enteric-coated preparation to immediately enter the neutral dissolution phase.
This technology completely overcomes the cumbersome problems of traditional manual measuring cylinders, such as the inability to synchronize the addition of multiple cups, rapid heat loss during preheating, differences in operator technique, and the need for 2-hour on-call monitoring. It enables fully automated continuous testing at night or without human intervention.
Regulatory compliance standards :
Fully compliant with USP <711>, EP <2.9.3> and ChP <0931> specifications for dissociation testing of delayed-release and enteric-coated formulations.
The timing and duration of the infusion must be strictly controlled within ±2% of the time tolerance specified in the pharmacopoeia.
The system is connected and controlled via dissolution management software, fully compliant with FDA 21 CFR Part 11 data integrity and electronic record requirements.
All key components of the machine comply with EP and USP standards and have complete CE and EMC certifications.
Automatic media replacement and rapid dispensing mechanism :
Pump-free gravity-driven architecture: This innovative system utilizes a gravity flow channel combined with a microcomputer-controlled solenoid valve for rapid liquid dosing. The system completely eliminates the need for a mechanical peristaltic pump or syringe pump, thus avoiding tubing wear and pump pulsation interference.
Ultra-high-speed synchronous injection: The injection time for a single 250 mL concentrated buffer solution is less than 30 seconds, which translates to a flow rate of 500 mL/min. All six dissolution cups are filled synchronously with zero time difference.
Intelligent scheduling with automatic opening and closing: When the system reaches the 2-hour acidic stage endpoint, the solenoid valve assembly will automatically and synchronously open and precisely release the buffer fluid, then automatically close.
Independent preheating water bath and high-precision temperature control system :
Independent preheating module: Equipped with a dedicated independent constant-temperature water bath and a high-power circulating heating unit, ensuring that the 6 sets of 250 mL concentrated buffer to be added are precisely maintained at 37.0°C.
Temperature control of the dissolution vessel: Through the rapid injection of the preheated medium, the temperature inside the dissolution vessel will not suddenly drop or fluctuate during the injection process, and will be strictly maintained within the USP specification tolerance of 37.0 ± 0.5°C throughout the entire process.
External independent heating circulation: A 1500W high-power rapid heater combined with a high-lift water circulation pump ensures that the water flow is evenly distributed through special diffuser nozzles within the water bath, achieving a temperature control accuracy of ±0.2°C.
Spring-loaded vibration damping mechanism: The external heating unit and circulating pump assembly adopt a spring-suspended vibration damping design to completely eliminate the interference of mechanical vibration on the melt-off test.
Technical specifications :
Number of dissolution cup stations: 8 stations
Standard package includes a 250 mL high-purity borosilicate glass container, each with a unique identification code.
Low evaporation lid design: A specially designed, ultra-low evaporation sealing lid with a media evaporation loss of <0.7% over 24 hours.
Heating temperature range: 25.0 to 45.0°C
Water bath temperature control accuracy: ±0.2°C
Heating power specification: 1500 W high-speed heating unit
Software integration and connectivity: Supports fully automated process control, method scheduling, and parameter setting via dissolution test computer control software.
External dimensions and weight specifications :
Preheated water bath dimensions: approximately 600 x 250 x 640 mm (W x D x H)
External heating unit dimensions: approximately 260 x 370 x 210 mm (W x D x H)
Preheated water bath net weight: approximately 12 kg
External heating unit net weight: approximately 5 kg
Standard equipment list :
PTWS 820-MA Preheating Constant Temperature Water Bath Body
External high-power heating circulation unit
One set of 250 mL original code borosilicate glass storage cups
Ultra-low evaporation sealed cup lid set
Specialized fast drainage manifold and automatic solenoid valve assembly
One bottle of water bath anti-algae and antibacterial protectant
Complete original manufacturer technology and valid folder
Quality certification and validation documents :
The standard configuration includes a complete set of original manufacturer operation and maintenance manuals.
Provide factory inspection specifications, design confirmation, and quality confirmation conformity test certificates.
Provide original standard installation confirmation documents.
Provide original manufacturer standard operating procedure confirmation documents.
Provides a dedicated instrument resume logbook
Provide pharmacopoeia standard compliance documentation for contact components and glass containers.