I. Slot Quantity, Specifications, Technical Positioning, and Selection Recommendations

1. 6-slot system: A traditional entry-level model that is gradually being phased out.

• Structural configuration : The mainstream layout is 3 × 2, with two rows in the front and back.

• Representative models : Pharma Test PTWS 130D/S, Logan UDT-818A-6.

• Technical limitations and limitations : It meets the minimum release standards of Stage 1 (S1, n=6) in various pharmacopoeias. However, due to the limited number of slots (only 6), it cannot accommodate additional standard or blank control slots. When connected to automated sampling, the lack of a constant-temperature replenishment tank makes it prone to temperature deviations during cold solvent refilling, failing to meet modern automation requirements.

• Purchase recommendation : Not recommended as a new main machine; only suitable for manual teaching and testing with a very limited budget or space.

2. 8-Tank System: The Global Gold Standard for Commercial Production QC Release

• Structural configuration : The mainstream layout is 4 × 2, with two rows in the front and back.

• Representative models : Pharma Test PTWS 820D / 830, Logan UDT-818-8 / 850DLA.

• Technical Positioning and Advantages : Utilizing a mature "6+2" configuration, six tanks hold test samples, the seventh tank holds blank or standard control solutions, and the eighth tank preheats fresh solvent. During automated sampling and replenishment, solvent at the same temperature can be injected immediately, completely avoiding turbulence and temperature interference. The compact and stable transmission mechanism easily achieves the mechanical validation requirement of less than 0.2 mm runout.

• Procurement recommendation : The first choice and standard configuration for daily batch release by the quality control laboratories (QC) of major pharmaceutical companies.

3. 12-Tank System: Core Equipment for Generic Drug Development, Prescription Screening, and Bioequivalence (BE) Exemption

• Structural configuration : The mainstream layout is 6 × 2, with two rows in the front and back.

• Representative models : Logan UDT-860-12 / 860DLA, Pharma Test PTWS 1420 (set to 12 mixing tanks).

• Technical Positioning and Advantages : Regulatory Compliance : ICH M9, TFDA, and NMPA regulations clearly require that 12 samples (n=12) be used for each set of conditions for dissolution curve comparison (f2 factor). Elimination of Inter-batch Errors : A single run can simultaneously test 12 samples, completely eliminating minor deviations in temperature, degassing, and human operation in batch experiments, avoiding expansion variation coefficient (%RSD). Parallel Comparison Mode : Features independent zone rate control, supporting simultaneous comparison of 6 original drugs and 6 generic drugs on the same machine.

• Procurement Recommendation : An essential model for pharmaceutical research and development (R&D), analytical method development, and bioequivalence (BE) comparison laboratories.

4. 14/15 Tank System: High-end equipment specifically designed for long-acting controlled-release formulations.

• Structural configuration : The mainstream configuration adopts a 7 × 2 (14 mixing tanks plus additional replenishment tank) or 15-tank multi-functional layout.

• Representative models : Pharma Test PTWS 1420, Logan UDT-818-15 / 870DLA.

• Technical Positioning and Advantages : Specifically designed for 12-24 hour long-release, enteric coating, and microcapsule formulations. Equipped with a large-capacity independent isothermal replenishment tank, it can automatically replenish isothermally and volumetrically fresh solvent during high-frequency, multiple sampling processes, strictly maintaining dissolution volume accuracy and sink conditions. Supports parallel testing of 7 control groups and 7 test groups.

• Procurement recommendation : Suitable for special controlled-release formulations, long-acting implants, and high-end CRO R&D centers.

5. 18-slot system: Flagship for high-throughput mass inspection and special regulatory applications

• Structural configuration : The mainstream layout adopts a 6 × 3 three-row high-density layout.

• Representative models : Logan UDT-818-18 / 880DLA.

• Technical Positioning and Advantages : Simultaneous Three-Batch Process Verification (PV) : Enables simultaneous verification of three consecutive batches (6 particles per batch, 18 particles total), eliminating cross-day testing variations and directly demonstrating consistency between commercial batches. Japan PMDA Multi-Media Testing : Allows parallel testing with three different pH media (6 particles each), significantly reducing testing time by 67%. High-Variability Product Risk Control : For 24-72 hour long-life patches or complex microspheres, obtains sufficient sample volume in a single run, avoiding the risk of time-consuming retesting due to minor boundary differences in the first stage. Space Efficiency : Saves over 50% of laboratory bench space compared to configuring three independent 6- or 8-slot instruments.

• Procurement recommendations : Large CDMO manufacturers, high-throughput testing centers, and leading pharmaceutical companies exporting to Japan or Europe and the United States are the preferred choices.

II. Key Points of Equipment Procurement Evaluation and Verification

• Mechanical validation (MQ) compliance : The wobble of the stirring shaft must be less than 0.2 mm, the verticality deviation of the shaft must be less than 0.5 degrees, and the distance between the stirring element and the bottom of the cup must be maintained precisely at 25 ± 2 mm; tool-free quick-positioning shaft systems (such as Pharma Test MonoShaft or Logan dual-section quick-positioning shafts) are preferred.

• Water bath circulation and temperature uniformity : Multi-tank systems need to be equipped with high-flow-rate, low-vibration isolation circulation heating pumps to ensure that the temperature of the entire water bath is uniformly maintained within 37.0 ± 0.2°C at all points.

• Automatic sampling flow path and material safety : The contact flow path must be made of highly inert materials (PTFE, FEP, PEEK), the pipeline adsorption rate and residual cross-contamination (carryover) must be less than 0.5%, and it must have dual solvent automatic cleaning and air purging functions.

• Data integrity and regulatory audit : The control software must fully comply with FDA 21 CFR Part 11, EU GMP Annex 11 and ALCOA+, have an immutable audit trail, multi-level access control, and support seamless integration with the LIMS system.

III. Quick Procurement Decision-Making Guide

• Commercial daily quality control (QC batch release) : The preferred system is an 8-tank system (compliant with standard S1 specifications, with both standard reference and constant temperature replenishment tank, offering the highest level of automation stability).

• Prescription development, generic drug consistency evaluation and BE exemption : 12-slot system is preferred (fully compliant with ICH M9 specification n=12 requirements, eliminating batch-to-batch operational bias).

• Long-lasting controlled-release formulations (12–24 hours multi-point sampling) : 14 or 15 tank system preferred (equipped with a dedicated constant-temperature replenishment module to maintain tank conditions).

• Large-scale CDMO, high-throughput inspection and process verification (PV) : 18-slot system is preferred (completes three batches of parallel verification or three media tests in a single run, maximizing capacity and avoiding the risk of retesting).

Learn more about dissolution solutions and flagship equipment.

For evaluation of next-generation multi-tank dissolution testing systems that comply with International Pharmacopoeia standards, please visit the Chinwei Technology official website for detailed technical catalogs and product specifications:

• Flagship Multi-Tank Dissolution Testing Systems : Logan UDT-860-12 / 860DLA (Fully Automated 12-Tank Dissolution System with Dual-Zone Speed Control, Front and Rear Discharge); Pharma Test PTWS 1420 (Premium 14-Tank Stirring Tank + 2 Preheating/Replenishment Tank Ultra-High Throughput System); Logan UDT-818-18 / 880DLA (High-Throughput 18-Tank Process Validation Flagship System).

• Comprehensive automation and data compliance expansion modules : Logan 860DLA / 880DLA multi-channel precision push-pull syringe pump sampling workstation (online syringe filtration and isothermal and isovolume automatic replenishment); Pharma Test PT-Node smart network interface (direct connection to LIMS system and FDA 21 CFR Part 11 paperless data transmission); Merel dissoGUARD® optical automatic geometric verification and real-time image monitoring system (universally compatible with major brands).

Professional Consultation and Online Sample Testing Planning: Welcome to visit the DS website or fill out the online consultation form. Our professional technical consultants will plan a customized regulatory compliance and equipment selection solution for your laboratory.

• Official website : www.dissolution.com.tw

• Product Zone : USP1/2/5/6 & Fully Automated Systems Equipment Zone

• Technical consultation hotline : 04-2241-1607