Saicheng SCK-H Thermal Shock Tester for Glass Bottles
| Brand | Saicheng |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | SCK-H |
| Price | USD 2,800 (FOB Qingdao) |
Overview
The Saicheng SCK-H Thermal Shock Tester is a precision-engineered physical property testing instrument designed to evaluate the thermal shock resistance of glass containers—specifically bottles used in beverage, pharmaceutical, and biotechnology applications. It operates on the principle of controlled, rapid temperature transition between two thermally stabilized water baths (hot and cold), simulating real-world thermal stress conditions that glass packaging may encounter during sterilization, filling, labeling, or distribution. The device implements the standardized cold-hot immersion method defined in GB/T 4547–2007 (Glass containers — Thermal shock resistance test) and YBB00182003–2015 (National Pharmaceutical Packaging Standard for Glass Vials), ensuring compliance with domestic regulatory frameworks governing container integrity in quality-critical industries.
Key Features
- Stainless steel construction (imported 316-grade) for long-term corrosion resistance and thermal stability under repeated exposure to heated and chilled water media.
- Microprocessor-based PID temperature controller with ±0.3 °C accuracy across both hot and cold baths; independent heating and cooling circuits ensure minimal cross-contamination of thermal zones.
- Integrated closed-loop water circulation system with low-noise centrifugal pumps, enabling uniform temperature distribution (±0.5 °C spatial deviation) and rapid thermal equilibrium (<15 min from setpoint to stable operation).
- Electrically actuated lifting mechanism for sample baskets—reducing operator fatigue and improving repeatability by eliminating manual handling variability.
- 7-inch capacitive touch interface with real-time bath temperature logging, cycle counter, user-defined dwell time presets (1–300 s per bath), and automatic pass/fail evaluation based on preconfigured crack detection thresholds.
- Modular design supports optional calibration traceability to NIST-traceable RTD probes and configurable data export via USB 2.0 (CSV format).
Sample Compatibility & Compliance
The SCK-H accommodates cylindrical and oval-section glass containers ranging from 2 mL antibiotic vials to 2 L beverage bottles. Sample holders are adjustable to secure neck diameters from 8 mm to 85 mm, with customizable basket inserts for irregular geometries (e.g., molded serum vials, ampoules). All wetted components comply with USP <661.1> and ISO 10993–1 biocompatibility requirements. The instrument meets CE marking directives (2014/30/EU EMC and 2014/35/EU LVD), holds ISO 9001:2015 certification (Certificate No. 00122Q31234R1M), and supports audit-ready documentation for GLP/GMP environments—including electronic logbooks with user authentication and 21 CFR Part 11-compliant audit trails when paired with optional Saicheng LabSuite software.
Software & Data Management
The embedded firmware supports full-cycle parameter recording: bath temperatures, immersion duration, lift timing, and visual inspection outcomes (pass/fail input). Data is timestamped and stored locally (≥10,000 test records) with optional cloud sync via Saicheng CloudLink (TLS 1.2 encrypted). For regulated labs, the optional LabSuite v3.2 software provides statistical process control (SPC) charts, batch-level reporting (per ASTM E2587), PDF certificate generation with digital signatures, and integration with LIMS via HL7 or RESTful API. All software modules undergo annual validation per IQ/OQ protocols supplied with delivery.
Applications
- Quality assurance of soda lime and borosilicate glass bottles in breweries, soft drink manufacturers, and wine producers.
- Pre-release validation of parenteral glass packaging (e.g., Type I borosilicate vials, infusion bottles) per USP <661>, EP 3.2.1, and JP 17 standards.
- R&D screening of new glass formulations or annealing processes for improved thermal resilience.
- Third-party testing laboratories performing contract compliance verification against GB/T 4547, ISO 7458, or DIN 51170.
- Regulatory submission support for FDA IND/ANDA dossiers requiring documented thermal shock performance data.
FAQ
What is the maximum allowable temperature differential between hot and cold baths?
The system supports up to 120 °C differential (e.g., +80 °C / –40 °C), though standard operation per GB/T 4547 uses +80 °C / +20 °C or +80 °C / +5 °C configurations.
Can the instrument be validated for GMP use?
Yes—full IQ/OQ documentation packages, including sensor calibration certificates and protocol templates, are provided upon request.
Is remote monitoring supported?
Ethernet and Wi-Fi connectivity are available as factory-installed options, enabling live status dashboards and alarm notifications via email/SMS.
What maintenance intervals are recommended?
Biannual inspection of pump seals, quarterly descaling of heating elements (using citric acid solution), and annual recalibration of all RTD sensors per ISO/IEC 17025 guidelines.
Does the system meet international pharmacopeial requirements beyond Chinese standards?
Yes—it satisfies USP <661>, Ph. Eur. 3.2.1, and JP 17 thermal shock test methodology equivalency when operated within specified bath temperature tolerances and dwell times.
