Digerui DKRDA-18 Plastic Disintegration and Degradation Analyzer
| Brand | Digerui |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | DKRDA-18 |
| Price | USD 13,800 (FOB Qingdao) |
Overview
The Digerui DKRDA-18 Plastic Disintegration and Degradation Analyzer is a purpose-built, benchtop instrument engineered for standardized assessment of disintegration behavior and early-stage degradation kinetics of plastic materials under controlled environmental conditions. Designed in alignment with ISO 16929:2021 (“Plastics — Determination of the degree of disintegration of plastic materials under defined composting conditions in a laboratory-scale test”) and ASTM D5338–23 (“Standard Test Method for Determining Aerobic Biodegradation of Plastic Materials Under Controlled Composting Conditions”), the DKRDA-18 enables reproducible simulation of solid-phase composting environments—including regulated temperature (up to 60 °C ± 0.5 °C), humidity (≥90% RH), and aerobic airflow—while monitoring physical breakdown via real-time weight loss, visual disintegration scoring, and dimensional stability tracking. Unlike generic dissolution testers, this system integrates programmable agitation cycles, multi-vessel parallel testing (18 stations), and calibrated humidity/temperature logging compliant with GLP documentation requirements.
Key Features
- 18-position stainless-steel sample holder rack with independent thermal and humidity control per zone
- Precision PID-controlled heating system maintaining ±0.5 °C accuracy across 30–60 °C operational range
- Integrated high-capacity humidification module delivering ≥90% relative humidity with continuous condensate drainage
- Programmable orbital agitation (0–60 rpm, adjustable amplitude) simulating mechanical stress in compost matrices
- RS-485 and USB-C interfaces supporting time-synchronized data export to external LIMS or ELN platforms
- IP54-rated enclosure with corrosion-resistant 316L stainless steel chamber and borosilicate observation window
- Compliance-ready audit trail functionality including user login, method versioning, and parameter change logs
Sample Compatibility & Compliance
The DKRDA-18 accommodates diverse polymeric formats: films (up to 150 × 150 mm), molded specimens (max. 50 mm diameter × 10 mm thickness), fibers, and composite packaging laminates. Sample holders are designed to replicate ISO-defined compost contact geometry while minimizing edge effects. The system supports validation against regulatory frameworks including EU Directive 2019/904 (Single-Use Plastics), EN 13432:2000 (Packaging—Requirements for packaging recoverable through composting and biodegradation), and FDA guidance on environmentally degradable polymers used in pharmaceutical primary packaging. All firmware and calibration procedures adhere to ISO/IEC 17025:2017 general requirements for competence of testing and calibration laboratories.
Software & Data Management
The embedded DKR-Soft v3.2 application provides intuitive method configuration, real-time graphing of mass loss (%) vs. time, and automated generation of ISO-compliant test reports (PDF + CSV). Each test session records timestamped environmental parameters (T, RH, rpm), operator ID, and digital image capture intervals (optional external USB camera integration). Data integrity safeguards include 21 CFR Part 11–compliant electronic signatures, role-based access control (Admin / Technician / Reviewer), and immutable audit trails stored locally on encrypted SD card (16 GB included). Exported datasets are structured to align with FAIR principles (Findable, Accessible, Interoperable, Reusable) for integration into enterprise quality management systems (QMS).
Applications
- Pre-market evaluation of bio-based polyesters (e.g., PLA, PHA, PBAT) for food-contact packaging compliance
- Comparative disintegration profiling of multilayer barrier films under simulated industrial composting
- QC release testing of medical device packaging components claiming “compostable” labeling per ASTM D6400
- Research-grade kinetic modeling of hydrolytic chain scission in aliphatic-aromatic copolyesters
- Supporting sustainability declarations under CDP (Carbon Disclosure Project) and Science Based Targets initiative (SBTi)
- Validation of accelerated aging protocols correlating lab-scale disintegration with field trial outcomes
FAQ
What standards does the DKRDA-18 directly support?
ISO 16929:2021, ASTM D5338–23, EN 13432:2000, and ASTM D6400–22.
Can the system operate without continuous PC connection?
Yes—onboard memory stores full test data for up to 90 days; PC connection is required only for method upload and report export.
Is third-party calibration certification available?
Yes—NIST-traceable calibration certificates (temperature, humidity, rotational speed) are provided with each unit and annually renewable.
Does the analyzer meet GMP documentation requirements for pharmaceutical packaging validation?
Yes—audit trail, electronic signatures, and method version control satisfy Annex 11 (EU GMP) and FDA 21 CFR Part 11 for computerized systems used in regulated environments.
What maintenance is required for long-term operational reliability?
Quarterly verification of humidity sensor drift and annual recalibration of thermal sensors; no consumables beyond standard laboratory-grade distilled water for humidification.
