JIAXINHAI BJ-1 Single-Cup Disintegration Tester
| Brand | JIAXINHAI |
|---|---|
| Origin | Tianjin, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | BJ-1 |
| Temperature Set Range | 20–50°C |
| Temperature Resolution | 0.1°C |
| Temperature Control Accuracy | ±0.3°C |
| Timer Set Range | 1–900 min |
| Timing Accuracy | ±0.5 min |
| Noise Level | <60 dB(A) |
| Basket Lift Frequency | 30–31 cycles/min |
| Basket Stroke | (55 ± 1) mm |
| Distance from Sieve to Beaker Bottom | (25 ± 2) mm |
| Standard Sieve Aperture | 2 mm |
| Optional Sieve Apertures | 0.425 mm, 1 mm |
| Power Supply | 220 V, 50 Hz |
| Rated Power | 600 W |
| Dimensions (L×W×H) | 260 × 300 × 440 mm |
Overview
The JIAXINHAI BJ-1 Single-Cup Disintegration Tester is a precision-engineered pharmaceutical testing instrument designed to evaluate the disintegration behavior of solid oral dosage forms—including tablets, capsules, and pills—in accordance with internationally harmonized pharmacopoeial standards. It operates on the principle of mechanical immersion cycling: a sample-loaded basket assembly is vertically immersed into and withdrawn from a thermostatically controlled dissolution medium (e.g., purified water, simulated gastric fluid, or simulated intestinal fluid) at a defined frequency and stroke length. The endpoint is determined when all particles pass through a specified sieve aperture—excluding insoluble coating materials or fragmented capsule shells—within the time limit prescribed by regulatory monographs. This test serves as a critical quality control checkpoint in tablet formulation development, batch release, and stability studies, ensuring consistent physical breakdown prior to dissolution and absorption.
Key Features
- Single-beaker configuration optimized for routine QC testing, method development, and small-batch evaluation—reducing reagent consumption and simplifying setup and cleaning.
- Microprocessor-controlled temperature regulation with high-stability PTC heating elements and PID feedback loop, maintaining bath temperature at 37.0 ± 0.3°C—the exact requirement specified in USP <701>, EP 2.9.1, and ChP General Chapter 0921.
- Integrated digital temperature sensor with 0.1°C resolution; factory-calibrated and drift-compensated—no user recalibration required under normal operating conditions.
- Precise electromechanical drive system delivering consistent lift frequency of 30–31 cycles per minute and vertical stroke of (55 ± 1) mm, meeting pharmacopoeial mechanical tolerances.
- Modular sieve support with quick-release mechanism; standard 2 mm stainless-steel mesh supplied, with optional 0.425 mm (USP/EP fine-mesh) and 1 mm apertures available for specialized formulations (e.g., orally disintegrating tablets or sustained-release granules).
- Low-noise operation (<60 dB[A]) achieved via vibration-damped motor mount and optimized gear train—suitable for shared laboratory environments without acoustic interference.
Sample Compatibility & Compliance
The BJ-1 accommodates standard USP/ChP-compliant baskets (Type A, 25.4 mm diameter) and supports all common solid oral dosage forms: immediate-release tablets, hard and soft gelatin capsules, enteric-coated tablets, and effervescent formulations. It complies with key regulatory requirements including ChP 2020 Edition (General Chapter 0921), USP-NF <701>, European Pharmacopoeia 11.0 (2.9.1), and JP 18 (General Test 2.07). Its design facilitates GLP-aligned documentation practices: temperature and timing parameters are digitally recorded, and operational logs—including start/stop timestamps, setpoints, and deviations—can be manually transcribed for audit trails. While the unit itself does not provide electronic data archiving or 21 CFR Part 11 compliance out-of-the-box, its deterministic mechanical and thermal performance enables full traceability when integrated into validated lab workflows.
Software & Data Management
The BJ-1 operates via an embedded LCD interface with tactile membrane keypad—designed for reliability, minimal maintenance, and resistance to liquid ingress. All settings (temperature, timer, hold mode) are stored in non-volatile memory. No proprietary software is required; however, users may integrate external digital thermometers or stopwatch systems for independent verification during method validation. For laboratories implementing paper-based SOPs, the instrument’s stable baseline performance supports straightforward qualification protocols (IQ/OQ) per ASTM E2500-13 and ICH Q5C guidelines. Optional RS-232 or USB output modules (available upon request) enable connection to LIMS or ELN platforms for automated parameter logging—subject to site-specific validation.
Applications
- Routine release testing of commercial tablet and capsule batches against pharmacopoeial disintegration limits (e.g., ≤15 min for uncoated tablets; ≤30 min for hard capsules).
- Formulation screening during preformulation studies—assessing excipient effects (e.g., disintegrant type/concentration, binder viscosity) on break-up kinetics.
- Stability-indicating testing: monitoring changes in disintegration profile across accelerated and long-term storage conditions per ICH Q1A(R2).
- Comparative bioequivalence support: correlating disintegration onset with dissolution rate in early-phase development.
- Educational use in pharmacy and pharmaceutics laboratories for hands-on training in pharmacopoeial methodology and QC instrumentation principles.
FAQ
What pharmacopoeias explicitly reference single-basket disintegration testers?
USP <701>, EP 2.9.1, and ChP 0921 permit single-unit apparatuses for routine testing where statistical equivalence to multi-basket systems has been demonstrated—particularly for QC labs with low-throughput requirements.
Can the BJ-1 be used with acidic or enzymatic media without corrosion risk?
Yes—the beaker, basket, and sieve components are constructed from 316 stainless steel, resistant to degradation in pH 1.2 simulated gastric fluid, pH 6.8 phosphate buffer, and pancreatin-containing media when operated within the specified temperature range.
Is calibration certification included with shipment?
Each unit ships with a factory-issued Certificate of Conformance detailing temperature and timing verification at 37.0°C and 30 cpm; NIST-traceable calibration certificates are available as an optional add-on.
How often should preventive maintenance be performed?
We recommend quarterly visual inspection of basket alignment, seal integrity, and heater element continuity; annual verification of temperature uniformity across the bath volume using calibrated probe arrays.
Does the BJ-1 meet ISO 17025 requirements for accredited testing labs?
When operated within its validated range and supported by documented IQ/OQ/PQ protocols—including environmental monitoring, operator training records, and periodic performance checks—the BJ-1 satisfies the technical competence criteria outlined in ISO/IEC 17025:2017 Clause 6.4 for equipment used in accredited disintegration testing.
