C/T and LHC/T Series • ICH Compliance

ICH Q1A/Q1B Stability Chambers

Stability chambers for pharmaceutical laboratories conducting stability and photostability studies according to ICH Q1A and Q1B guidelines. They maintain long-term (25°C/60% RH), intermediate (30°C/65% RH), and accelerated (40°C/75% RH) conditions and, with ICH lamps, achieve Q1B doses of 1.2 million lux·h of visible light and 200 Wh/m² of UV-A.

ICH Q1AICH Q1BGMP/GLP
ICH Q1A/B Test Chamber

140 – 2300 L

Available volume

−25° / +70°C

Temperature range

10 – 80% rH

Humidity control

ICH Q1A/B

Compliance

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1Test parameters
2Setup & Investment
3Your contacts

Step 1 of 3 · Test parameters

Define the test conditions

Thermal range and humidity management. Please indicate your chamber's operating specifications.

Temperature Range

Selected value: 0 °C
Select the minimum value of the operating range
Selected value: 0 °C
Select the maximum value of the operating range
Active Humidity
Required for corrosion testing, accelerated aging and climate simulation (5–98% RH)

TWO PROTOCOLS, ONE CHAMBER

ICH Q1A conditions in stability chambers

All versions, S and B, support the three ICH Q1A climatic conditions: long-term 25°C/60% RH, intermediate 30°C/65% RH, and accelerated 40°C/75% RH. The operating range with controlled humidity, from +10 to +60°C and from 10 to 80% RH, is the same on all sizes, from 140 to 2300.

LIGHT MODELS AND DATA

ICH Q1B photostability: visible light and UV-A

For ICH Q1B photostability, chambers use ICH lamps arranged vertically or horizontally. The time to reach Q1B doses—1.2 million lux h of visible light and 200 Wh/m² of UV-A—depends on the model's illuminance and UV-A irradiance: 92 to 267 hours for visible light, 1.4 to 25 hours for UV-A.

Lighting models and data

Model (size)Usable volume (L)Illuminance (lux)UV-A (W/m²)Hours for 1.2 Mlux·hHours per 200 Wh/m²
1401304 500826725
3703108 0001401571,4
44037010 0001101181,7
70053013 000100921,9
90081010 0001101181,7
1200102013 000100921,9
1500118013 000100921,9
2300183013 000100921,9

Operating conditions, all models: with humidity (ICH Q1A) from +10 to +60 °C and from 10 to 80% RH; with lamps on at 100% from +5 to +50 °C (S version) or from −5 to +50 °C (B version). Without humidity: S version from 0 to +70 °C, B version up to −25 °C (−20 °C on model 140).

Illuminance data from datasheets, measured with fluorescent lamps; with LED lighting, illuminance varies by approximately ±10% and UV-A is approximately 20% lower. Indicative values; configurations available upon request.

MAIN FEATURES

How FDM stability chambers are built

01

Temperature Control

Temperature from -25°C to +70°C and humidity 10-80% RH with uniformity ±0.5-2.5°C.

02

ICH Certified Lamps

LEDs for vertical or horizontal installation. Lux up to 13,000 and UV-A from 8 to 140 W/m² depending on the model.

03

Advanced Programming

revoFACE/stillFACE controller with 10 programs, 50 segments, integrated data logging.

04

Ultrasonic Humidification

Ultrasonic system with demineralized water filter and optional 16L tank.

05

CFR 21 Part 11

Compliant controller option for GMP environments and regulatory validations.

06

Complete Connectivity

USB, RS232, Ethernet, Wi-Fi, Mobile App for remote monitoring and data download.

TECHNICAL DATA

Technical specifications of ICH chambers

IQ/OQ documentation available upon request. Full datasheet in PDF format.

ISO 9001Made in Italy12 month warranty, extendable with FDM CareIQ/OQ available

OPERATIONAL DIAGRAM

Temperature — humidity range

Volume140 – 2300 L
Temperature range−25°C / +70°C
Humidity10 – 80% RH (+10 to +60 °C)
Temperature uniformity±0.5 – 2.5°C
ICH LED lamps, up to 13,000 lux / UV-A 8–140 W/m²
Lamp arrangementVertical or horizontal
revoFACE / stillFACE touchscreen controller
Programs10 programs, 50 segments
ConnectivityUSB, RS232, Ethernet, Wi-Fi
GMPCFR21 Part 11 option available
ICH Q1A, ICH Q1B, ISO 10977, GMP/GLP compliance

Controller

Controllers and Option 21 CFR Part 11

Each FDM chamber is equipped with the controller best suited to your work style. Both are designed and manufactured in Italy. For GMP environments, a 21 CFR Part 11-compliant controller with audit trail and electronic signature is available as an option.

stillFACE controller - FDM Environment Makers
Constant monitoring

stillFACE

Two dedicated displays for temperature and humidity. Manual setting, instant readings, zero distractions—the perfect controller for testing under constant conditions.

  • →High visibility LCD display — 2 separate channels
  • →Manual setting of setpoints and parameters
  • →Continuous monitoring under constant conditions
  • →Configurable audio-visual alarms
  • →Optional RS485 interface for data logging
Ideal for Stability Testing · Passive Monitoring
PROGRAMMABLE
revoFACE controller - FDM Environment Makers
Cyclic programming

revoFACE

Color touchscreen with intuitive interface. Program complex cycles with ramps, pauses, and transitions—up to 10 programs with 50 segments each.

  • →7″ color touchscreen with intuitive interface
  • →10 programs × 50 segments — cycles from 1 min to 999 h
  • →Ramps, stasis and programmed transitions
  • →USB data export · event log and setpoints
  • →RS485 · Ethernet · Dedicated mobile app
Ideal for automated cycles · advanced search

CONFIGURATOR

Set up your ICH chamber in 1 minute

Four steps: test parameters, camera configuration, budget and timeline, contact us. Receive a personalized quote within 24 business hours.

01

Test parameters

Temperature range · humidity · illumination

02

Configuration

Volume · accessories · controller

03

Budget & Time

Planned investment · project start-up

04

Contact

Proposal within 24 working hours

Frequently Asked Questions

Frequently Asked Questions about Stability Chambers

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ICH Q1A covers general stability testing to determine the shelf life of drugs through temperature and humidity control. ICH Q1B focuses on photostability testing, evaluating the product's resistance to prolonged exposure to light (UV-A and visible). Q1B requires specific ICH lamps in addition to climate control.
ICH lamps are certified to emit light according to the D65 standard defined in ISO 10977, faithfully reproducing the spectrum of sunlight with UV-A and visible light components. They are essential for ICH Q1B photostability testing of drugs, cosmetics, and packaging, ensuring results compliant with international guidelines.
Duration depends on the type of test. Accelerated tests typically last 6 months at 40°C/75% RH. Long-term tests can last 12-36 months at 25°C/60% RH. Our chambers allow you to program automatic cycles and constantly monitor parameters throughout the test.
ICH Q1B requires a minimum exposure of 1.2 million lux-h (visible light) and 200 Wh/m² (UV-A). Our chambers automatically track these values. With standard lamps, it takes approximately 92–267 hours to reach 1.2 million lux-h and 1.4–25 hours for 200 Wh/m², depending on the lamp configuration and intensity.
Yes, we offer a CFR 21 Part 11 controller option specifically for GMP-regulated environments. It includes electronic signatures, audit trails, user management, data integrity, and all the features required by regulatory authorities for pharmaceutical validation. We also provide the necessary IQ/OQ documentation.
Absolutely. ICH FDM chambers are designed to test both active pharmaceutical ingredients (APIs) and finished packaged products. Adjustable shelves accommodate different sample sizes. For ICH Q1B, you can test both the contents and the primary and secondary packaging.
ICH lamps typically have a lifespan of 1,000-5,000 hours. We recommend monitoring irradiance and replacing lamps when they reach approximately 80% of their useful life to maintain certified values. Replacement is simple and documented. LED lamps last longer than traditional fluorescent lamps.
Yes, we can customize chambers to comply with other standards such as ISO 10977, ASTM G155, or specific protocols from other national pharmacopoeias. Contact us to discuss your specific regulatory needs and we will configure the chamber accordingly.
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