Walk In Stability Chambers for Pharmaceutical & Product Testing

Bio Gene Walk In Stability Chamber are high-capacity environmental systems engineered for long-term, accelerated, and intermediate stability testing of pharmaceuticals, cosmetics, and packaged products. Manufactured and exported by Biotechnologies Inc., these chambers ensure precise temperature and humidity control, uniform air circulation, and compliance with ICH Q1A(R2), WHO, and GMP guidelines. Designed for bulk testing and ideal for large-scale production facilities and R&D labs, BioGene Walk In Chambers support data logging, alarm systems, and backup safety features. Built in India and trusted internationally, they offer reliable, scalable solutions for regulatory stability testing.

Applications

Walk in chamber’s allows the user to have an advantage in stability Environment test due to persuit of reliability in speedy test results in given time from work with reliable repeat performance of products for durability performance before the product market launch.

Feature

  • Walk in  Stability 
  • Large Touch Screen Control’s Display
  • 21 CFR port 11  software
  • Prefabricated PUF Panels
  • CAM Hinge Locking Device
  • French Compressor 
  • Data Transfer RS 485 or WiFi
  • Temperature: -5˚C- 60˚C

Control

  • Standards : ICH-Q1AR2
  • ISO – 13485 Standards,
  • EN 61000-6-3 : 2001
  • EN: 60101
  • IEC – 60068-2-1 COLD
  • IEC – 60068-2-2 Dry Heat
  • IEC – 60068-2-14 Temperature change
  • IEC – 60068-2-38

Construction

  • Prefabricated Panel with CAM locks
  • Large 7”/9” LCD Display
  • Touch Screen Controls
  • Inner Stainless Steel or Polypropylene
  • Forced Air Circulation
  • French cooling unit
  • Large Door
  • Flexible Storage system
  • Safety Alarm

Specification

DESCRIPTION  BTI-WSC-35 BTI- WSC-60 BTI- WSC-150 BTI- WSC-220
Temperature Range on 5°C to 60°C
Temperature Range Lights On 5°C to 55°C.
display Digital
Temp. Deviation Between +1°C and +25°C @ 80% RH (lights off)
Temperature Uniformity +2°C at +25°C @ 80% RH (lights off)
Temperature Control +/- 0.1° c deg.
Temperature uniformity +2°C @ 25°C @ 80% RH (Lights off)
Temperature sensor PT-100 Ω RTD
Humidity range 5% RH to 90% RH
Humidity deviation 3% RH
Humidity uniformity + 5% RH
Humidity control accuracy ± 1%
Interior construction SS 304
Exterior Construction CRCA Powder coated.
   
Construction Panel Type PUFF Insulation for better thermal insulation.
Electrical 220 to 240 volts/ 50 Hz.
Alarm High and low
Light Intensities @ 25 °C
Size 1500 x 1500 x 1500 mm 1500 x 2000 x 2000 mm 2500 x 2500 x 2500 mm 3500 x 2500 x 2500 mm
Capacity 3500 ltrs 6000 ltrs 15600 ltrs 22000 ltrs

A Walk-In Stability Chamber is a large, room-sized environmental testing enclosure designed to hold products, pharmaceuticals, or materials under precisely controlled temperature and humidity conditions for extended periods. It is primarily used by pharmaceutical, biotechnology, food, and cosmetic companies to conduct long-term and accelerated stability studies as required by regulatory bodies such as ICH, WHO, and USFDA, helping determine shelf life, storage conditions, and product behavior over time.

Most walk-in stability chambers are designed to maintain temperatures typically ranging from 0°C to 60°C and relative humidity levels between 10% RH and 95% RH, depending on the specific model and manufacturer specifications. The exact range can be customized based on the client's testing requirements, such as standard ICH conditions of 25°C/60% RH, 30°C/65% RH, or 40°C/75% RH for accelerated studies.

Uniform temperature and humidity distribution is achieved through a combination of advanced airflow design, multiple sensors placed throughout the chamber, and precision PID or microprocessor-based controllers. Regular calibration of sensors, along with continuous monitoring systems, ensures that conditions remain accurate and consistent across all zones of the chamber, minimizing variation between different storage locations.

Walk-in stability chambers typically come equipped with safety features such as door safety locks that allow opening from inside, over-temperature protection, power failure alarms, and emergency ventilation systems. Additionally, they often include 21 CFR Part 11 compliant data logging software, real-time remote monitoring, audit trails, and alarm notifications via SMS or email to ensure continuous compliance and immediate response to any deviations.

Routine maintenance includes periodic calibration of sensors, cleaning of humidity generation systems, inspection of door seals and gaskets, and servicing of refrigeration or HVAC components to ensure long-term reliability. For regulatory compliance, chambers should undergo Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ), along with regular mapping studies to confirm that temperature and humidity uniformity meet required standards throughout the chamber's operational life.
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