ICH Q1A(R2) & WHO GMP & 21 CFR Compliant

Pharmaceutical ICH Stability Chamber (TI-SC Series)

🌡️ Strict Compliance with ICH Q1A(R2) & WHO Guidelines

💧 European Rotronic RH Sensor with ±1.0% RH Precision Feedback

TEMPO INSTRUMENTS • STABILITY & CLIMATE CHAMBERS

(64 Technical Reviews)

ICH Stability Chamber (Standard / GMP)

Name: Stability Chamber
Brand: Tempo Instruments
Availability: InStock

Model / Reference: TI - 716 S / G Factory Calibrated & IQ/OQ Ready

The TEMPO Instruments Stability Chamber is engineered to deliver unwavering temperature and relative humidity uniformity for long-term, intermediate, and accelerated drug shelf-life studies according to ICH Q1A(R2) and WHO standards. Features mirror-finished SS 316 inner chambers, high-efficiency CFC-free hermetic refrigeration, non-condensing steam boiler humidification, and 21 CFR Part 11 touchscreen control.

1. SELECT STABILITY CHAMBER TYPE & COMPLIANCE GRADE *

2. SELECT CHAMBER MODEL & CAPACITY *

Download Tech Datasheet

Validation Packages & Accessories

Add mandatory validation documentation and monitoring items for your audit inspection.

Official Factory Services

Validation Factory Ready

IQ, OQ & PQ Validation Documentation

Full operational qualification protocol binder with calibrated trace sensors certificate.

Compliance Software Pack

21 CFR Part 11 Windows Software

Multi-level password protection, non-editable audit trail logs, and automated PDF reporting.

Water System Protection

Automatic Water Softener & Reservoir

De-mineralizing water conditioning tank for continuous steam boiler feed without scaling.

Precision Environmental Stability Testing

TEMPO Instruments Stability Chambers are engineered for high-accuracy temperature and relative humidity testing, adhering strictly to global ICH Q1A(R2) Guidelines (International Council for Harmonisation) and WHO Technical Report Series.

ICH Standard Testing Matrix

Long Term (Zone IVb): 30°C ± 2°C / 75% ± 5% RH

Long Term (General): 25°C ± 2°C / 60% ± 5% RH

Accelerated Study: 40°C ± 2°C / 75% ± 5% RH

Intermediate Condition: 30°C ± 2°C / 65% ± 5% RH

Industry Applications

• Pharmaceutical: Long-term & accelerated shelf-life stability testing
• Cement & Construction: Mortar & concrete cube curing moisture studies
• Food & Beverage: Package integrity & moisture absorption tests
• Cosmetics & Rubber: Accelerated thermal degradation analysis

Construction & Heating/Cooling Architecture

Constructed with double-walled modular framing filled with 3" (75mm) high-density CFC-free Polyurethane Foam (PUF) insulation. Heat is supplied via open ceramic-core U-shaped nichrome heaters, while moisture is introduced via a dedicated steam boiler reservoir equipped with a non-condensing steam injection head and Rotronic electronic sensor feedback loop.

Models & Optional Features

Models	Capacity (litres)	Internal Dimensions H × W × D (cm)	Trays
TI – 710 S / G	100	50 × 50 × 40	2
TI – 711 S / G	170	70 × 60 × 40	2
TI – 712 S / G	200	60 × 60 × 60	2
TI – 713 S / G	285	80 × 60 × 60	3
TI – 714 S / G	325	90 × 60 × 60	4
TI – 715 S / G	400	110 × 60 × 60	4
TI – 716 S / G	600	125 × 70 × 70	4
TI – 717 S / G	800	125 × 80 × 80	5
TI – 718 S / G	1000	157 × 80 × 80	5
TI – 719 S / G	1500 (Double door)	146 × 150 × 69	10
TI – 720 S / G	2000 (Double door)	146 × 150 × 92	10

Working Hours- 10 a.m. to 6.30 p.m. | Email: enquiry@tempo.net.in

ICH Stability Chamber (Standard / GMP)