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:

1. Semi-permeable containers: Infusion bags (PVC/Non-PVC), plastic ampoules.

2. Liquids in plastic bottles: Ophthalmic solutions, nasal sprays.

3. Moisture-sensitive devices: Inhalers or drug-device combination products requiring <20% RH storage.

Conclusion

For pharmaceutical packaging engineers, ensuring that a container prevents water loss is just as important as protecting it from moisture ingress. The Labonce-LGS Series offers the specialized, high-precision low-humidity environment needed to validate these containers with confidence.

Backed by imported compressors, GMP-compliant data systems, and precision airflow, the LGS series ensures your packaging withstands the test of time—and dryness.

Need specs for 25℃/40%RH testing? Contact Labonce today to configure your LGS Low Humidity Stability Chamber.

This article is sourced from Labonce.