Labthink RSY-R2 Thermal Shrinkage Tester for Pharmaceutical Blister Foils and Composite Hard Sheets
| Brand | Labthink |
|---|---|
| Model | RSY-R2 |
| Application | Thermal shrinkage measurement of pharmaceutical PVC hard sheets, aluminum-plastic blister laminates, shrink films, and thermoplastic packaging substrates |
| Temperature Range | Ambient to 200 °C |
| Temperature Control Accuracy | ±0.3 °C |
| Specimen Size Capacity | ≤140 mm × 140 mm |
| Heating Medium | Liquid bath (oil or water, user-selectable) |
| Control System | Microprocessor-based PID temperature regulation with LCD menu interface |
| Power Supply | AC 220 V, 50 Hz |
| Dimensions (L×W×H) | 440 mm × 370 mm × 310 mm |
| Net Weight | 24 kg |
| Compliance | ASTM D2732, GB/T 13519–1992, YY/T 0698.3–2011 (for pharmaceutical packaging) |
Overview
The Labthink RSY-R2 Thermal Shrinkage Tester is a precision-engineered instrument designed specifically for quantifying the free linear thermal shrinkage behavior of rigid and semi-rigid polymeric packaging materials under controlled liquid-bath heating conditions. It operates on the principle of dimensional change measurement—where specimens are immersed in a thermostatically stabilized liquid medium (e.g., silicone oil or deionized water), subjected to defined elevated temperatures for a specified duration, and then measured for length and width reduction before and after exposure. This method directly reflects the residual internal stresses, crystallinity relaxation, and molecular orientation memory inherent in thermoplastic films and laminates—critical parameters for blister packaging integrity, seal strength consistency, and post-forming dimensional fidelity in pharmaceutical unit-dose packaging systems.
Key Features
- Microprocessor-controlled PID temperature regulation ensures stable thermal environment across the full operating range (ambient to 200 °C) with ±0.3 °C accuracy—essential for reproducible shrinkage profiling per ASTM D2732.
- Liquid-bath immersion design eliminates convective air-current artifacts and provides uniform heat transfer, minimizing edge-effect deviations common in oven-based methods.
- Integrated digital timing module initiates and terminates exposure automatically upon reaching target temperature, eliminating operator-dependent start/stop variability.
- Modular specimen holder system includes five stainless-steel mesh frames and three adjustable support racks, enabling simultaneous multi-sample evaluation while maintaining consistent immersion depth and mechanical restraint.
- Intuitive LCD menu interface with PVC membrane keypad allows direct parameter input (temperature setpoint, dwell time, measurement units) without external software dependency.
- Compliance-ready architecture supports GLP documentation workflows: all test parameters (set temperature, actual bath temperature history, exposure duration) are logged internally and exportable via optional RS232 or USB interface.
Sample Compatibility & Compliance
The RSY-R2 accommodates flat, non-porous specimens up to 140 mm × 140 mm—including pharmaceutical-grade PVC hard sheets, PVDC-coated laminates, aluminum-plastic blister foils (e.g., Al/PVC, Al/PVDC/PVC), polyolefin shrink films, and thermoformed backing plates. Its liquid-bath configuration meets the immersion requirement stipulated in ASTM D2732 and aligns with the methodology referenced in Chinese pharmacopoeial standard YY/T 0698.3–2011 for heat-shrink characteristics of sterile barrier packaging. The instrument’s thermal stability profile satisfies ISO/IEC 17025 calibration traceability requirements when operated within accredited laboratory environments.
Software & Data Management
While the RSY-R2 operates as a standalone benchtop unit with embedded firmware, optional Labthink TS2100 Data Acquisition Software enables real-time temperature logging, automated shrinkage calculation (ΔL/L₀ × 100%), statistical reporting (mean, SD, CV%), and PDF report generation compliant with FDA 21 CFR Part 11 Annex 11 audit-trail requirements. All raw thermal profiles and dimensional measurements are timestamped and digitally signed, supporting GMP-compliant record retention for regulatory submissions and internal quality audits.
Applications
- Validation of thermal stability in cold-forming blister laminates prior to high-speed packaging line integration.
- Comparative shrinkage screening of alternative PVC formulations during material qualification (e.g., plasticizer migration effects).
- Stability assessment of peel-open force consistency in push-through blister cards under accelerated aging conditions.
- Root-cause analysis of blister cavity deformation or foil wrinkling observed during thermoforming or post-sealing storage.
- Supporting ICH Q5C biopharmaceutical container-closure system qualification where dimensional drift impacts sterility assurance.
FAQ
What liquid media are compatible with the RSY-R2 bath system?
Standard operation uses silicone oil (up to 200 °C) or deionized water (up to 100 °C); users must verify chemical compatibility with specimen materials to prevent solvent-induced swelling or degradation.
Is calibration certification included with shipment?
The instrument ships with factory calibration verification at 50 °C, 100 °C, and 150 °C; NIST-traceable calibration certificates are available as an optional add-on service.
Can the RSY-R2 be integrated into a LIMS environment?
Yes—via optional RS232-to-Ethernet gateway or USB-to-serial adapter, enabling bidirectional data exchange with validated LIMS platforms supporting ASTM E1384 or HL7 messaging protocols.
Does the system meet requirements for pharmaceutical quality control laboratories?
It fulfills core functionality requirements for QC labs operating under USP , ISO 11607-1, and EU Annex 1; full validation support packages (IQ/OQ/PQ protocols) are provided upon request.
