Meets FDA 21 CFR Part 11 – Data Integrity for Stability Studies

Pharmaceutical and biotech laboratories face strict regulatory demands for stability testing. Any environmental chamber used for drug shelf‑life studies must produce auditable, tamper‑proof electronic records. The fully compliant Stability Chamber with 21 CFR software (Model MSHDE702500K10SWISS) is custom‑engineered to satisfy GMP manufacturing standards and FDA 21 CFR Part 11 requirements. Below you will find the exact performance parameters that make this unit a trusted choice for regulated stability storage.

Technical Specifications (Model MSHDE702500K10SWISS)

• Model Number: MSHDE702500K10SWISS

• Capacity: 500 liters

• Temperature Control Range: 10°C to 70°C

• Temperature Fluctuation: ±0.5°C

• Temperature Uniformity: ±1°C

• Humidity Control Range: 20% to 90% RH

• Humidity Fluctuation: ±2% RH

• Humidity Uniformity: ±3% RH

• Rated Power: 2300 W

• Operating Power: 1100 W

• Power Supply: 220V, 50 Hz

• Internal Dimensions: 100 × 45 × 98 cm (fits standard sample baskets)

• Shelving: 4‑layer sample trays, adjustable at 1‑inch increments

• Test Port: 30mm validation port for external sensors

• Control Interface: Programmable LCD display, 30 segments & 99 cycles

• Timer Setting: 0‑9999 minutes (hours)

• Communication: RS485 with computer network connectivity via included software

Key Benefits – Regulatory Confidence and Reliable Storage

Data Integrity Without Compromise
The built‑in 21 CFR Part 11 compliant software provides user access controls, audit trails, and electronic signatures. This advanced Stability Chamber for regulated industries eliminates manual data recording errors and ensures every temperature/humidity reading is fully traceable.

Stable Conditions for Long‑Term Studies
With ±0.5°C temperature fluctuation and ±2% RH fluctuation, your samples experience virtually no environmental drift. Running stability tests for 6 to 24 months becomes predictable and repeatable.

Flexible Sample Loading
Trays can be repositioned every inch along the interior height. Whether you store bulk drug substances or finished packaged products, the 500L Stability Chamber adapts to your sample dimensions without wasted space.

Solving Common Laboratory Pain Points

Pain point: Audit failures due to incomplete environmental records
Regulators demand proof that temperature and humidity never exceeded protocol limits. This 21 CFR Part 11 compliant Stability Chamber automatically logs all parameters and blocks unauthorized changes. During an FDA inspection, you export the audit trail in minutes – not days.

Pain point: Uneven conditions across different shelf levels
Poor air circulation ruins stability batches. Thanks to ±1°C temperature uniformity and ±3% RH uniformity, every shelf experiences nearly identical conditions. You no longer need to discard “edge” samples.

Pain point: Complicated programming and downtime
The LCD interface allows 30 segments and 99 cycles – enough for accelerated, intermediate, and long‑term protocols in one program. Plus, the built‑in timer (0‑9999 minutes) automates start/stop. This user‑friendly Stability Chamber reduces operator training time to under one hour.

Feature Spotlight – What Makes This Chamber Unique

• 30mm validation port – Insert external calibrated probes without opening the door

• RS485 + PC software – Network multiple chambers into one centralized monitoring system

• Custom build – Specially adapted for Samuda Spec‑Chem Ltd., but available to all regulated labs

• Low operating power (1100W) – Runs 24/7/365 without excessive electricity costs

Physical Installation & Maintenance

Internal dimensions (100×45×98 cm) fit through standard doorways. The 2300W rated power (1100W typical) uses a standard 220V outlet. Four adjustable leveling feet ensure stable operation on any lab bench or floor.

Ready to Secure Your Stability Program?

Do not risk product approval delays because of non‑compliant environmental chambers. Invest in the validated Stability Chamber with full 21 CFR software – designed for GMP manufacturing, backed by Master Science Switzerland quality. Order Model MSHDE702500K10SWISS for your stability suite today.

Contact our compliance specialists for IQ/OQ/PQ documentation packages and on‑site installation support.