Mastering Low-Humidity Stability Testing: The Labonce-LGS Solution for Moisture-Sensitive Packaging
Mastering Low-Humidity Stability Testing: The Labonce-LGS Solution for Moisture-Sensitive Packaging
Introduction: The Challenge of "Dry" Stability In pharmaceutical stability testing, high humidity is often the primary stressor. However, for a specific class of products—semi-permeable containers (such as infusion bags, plastic ampoules, and ocular cartridges)—the challenge is the opposite. According to ICH Q1A (R2), aqueous-based drug products packaged in semi-permeable containers must be evaluated for potential water loss. This requires testing environments with low relative humidity (RH), such as 25℃/40%RH or even lower. Maintaining a stable low-humidity environment at low temperatures is technically difficult for standard chambers. This is where the Labonce-LGS Series (Low Humidity Stability Chamber) excels, offering precise control for critical packaging tests. 1. Engineered for Extremes: The Labonce-LGS Capabilities Standard stability chambers often struggle to maintain humidity below 40% without significant fluctuation. The Labonce-LGS Series is specifically engineered to bridge this gap. Critical Testing Conditions The LGS series is capable of sustaining the rigorous low-humidity conditions required for: Long-term testing: 25℃ ± 2.0℃ / 40%RH ± 5%RH Accelerated testing: 40℃ ± 2.0℃ / < 25%RH Specialized drying tests: Can achieve conditions as extreme as 60℃ / 10%RH. This capability makes it the ideal solution for testing cartridges, infusion bags, and plastic bottles where moisture loss is a critical quality attribute. 2. Precision Airflow: Eliminating Micro-Climates In low-humidity testing, "dead zones" in the chamber can lead to localized humidity spikes, invalidating test results. The Labonce-LGS Series utilizes a brand-new air-way structural design. Three-Sided Airflow: By circulating air from three sides, the chamber ensures that dry air is distributed evenly across all shelves. Uniformity: This design achieves a temperature uniformity of ≤ 2.0℃ and minimizes humidity deviation, ensuring that samples in the corner of the shelf experience the same "dryness" as those in the center. 3. Data Integrity & Audit Readiness Just like the flagship GS series, the LGS Low Humidity chambers are fully integrated with Labonce’s FDA 21 CFR Part 11 compliant control system. This is non-negotiable for GMP manufacturing of sterile injectables and packaging. Audit Tracking: The system records every parameter change and alarm event. Secure Export: Data can be exported via USB flash drive in a format that prevents tampering. Three-Level Authority: Access is strictly controlled via passwords for Operators, Admins, and QA personnel. 4. Robust Hardware for Continuous Operation Low-humidity testing often runs for 6 to 12 months. The LGS series is built to endure this continuous operation without drift. Imported Core Components: The system features an original imported fully enclosed industrial compressor, known for high efficiency, low noise, and long life. Superior Insulation: The chamber uses overall high-density polyurethane foam technology, which provides excellent insulation. This reduces the thermal load on the cooling system, ensuring stable performance even during ambient temperature fluctuations. Cleanroom Ready: The exterior is coated with high-quality steel, while the liner is made of mirror stainless steel 304. This provides a pollution-free source that is easy to clean, essential for maintaining cleanroom standards in packaging zones. 5. Selection Guide: Is the LGS Right for You? If your laboratory is performing standard shelf-life testing on tablets or capsules (e.g., 25℃/60%RH), the standard GS/FS Series is sufficient. However, you should choose the Labonce-LGS Series if you are testing: Semi-permeable containers: Infusion bags (PVC/Non-PVC), plastic ampoules. Liquids in plastic bottles: Ophthalmic solutions, nasal sprays. Moisture-sensitive devices: Inhalers or drug-device combination products requiring
February 18, 2026 6
1 2 3 4 5 6 7 8 9 10 11 12

Home

Products

About

Contact