Stability Chamber Manufacturer
Stability Chamber Manufacturer
Features
- Temperature Range from 5°C to 60°C,
- Relative Humidity from 5% to 90 %RH ±3RH
- Touch Screen Type, Programmable Controller
- Dual Turbo Fan Circulation and Fluorescent Lamp
- Low Water Level Alarm System
- Built-In RS-485 Communication Interface
- Optional Temperature/Humidity Chart Recorder without Microprocessor/PID/Digital Control with touch-screen type controller provides precise temperature control from 5°C to 60°C, relative humidity control from 5% to 90 %RH, timer, alarm, auto-tuning, and auto start-stop function
Contraction :-
- Touch Screen Type 5.7’/ 7.0”
- Double walled with PUF insulation of 80-150 mm
- Inner Chamber: Stainless Steel 304
- Outer Chamber: Mild Steel Powder Coated
- Danfoss Tecumseh CFC free cooling system with a hermetically sealed compressor with temperature sensors
- Stainless steel Trays
- Inner Door: Full-length inner glass door
- WiFi & LAN based data Communication
- Fluorescent light
- Forced air circulation for uniform temperature
- Safety devices: Low & high temperature cut-off settable thermostats & high humidity cut-off device
- Audio/Visual alarms for deviations
- DATA LOGGING- data Logging up logs for Temp.& Humidity
- RS232 Data Logger
Our Products
What is Stability Chamber:
Stability Chambers are specially designed equipment for the testing of products and also to determine their shelf life such as drug, electrical components, industrial materials, etc. which enables you to tweak parameters like temperature, humidity to conduct a thorough check over varied conditions.
Use of the stability chamber :-
It help for the testing of drugs in varied conditions of temperature, humidity, pH, radiations etc. They are also used to check for how long the product will be efficient to use.
What is the stability Guidelines :
ICH Guidelines, WHO Guidelines, cGMP guideline for shelf life study.
Objective of Stability Studies
| Objective | Type of study | Use |
| To select adequate formulations and containor closure system | Accelerated | Development of the product |
| To determine shelf-life and storage conditions | Accelerated and real time | Development of the product and of the registration dossier |
| To substantiate the claimed shelf-life | Real Time | Registration dossier |
| To verify that no changes have been introduced in the formulation or manufacturing process that can adversely affect the stability of the product | Accelerated and real time | Quality assurance in general, including quality control |
Storage Conditions:-
| Conditions Name | Storage temperature (C) | Relative humidity (%) |
| Real Time | 25 C +/- 2 C | 60 % +/- 5 % |
| Long Term | 30 C +/- 2 C | 65 % +/- 5 % |
| Long Term | 30 C +/- 2 C | 75 % +/- 5 % |
| Accelerated | 40 C +/- 2 C | 75 % +/- 5 % |
Why 21 CFR Software compliance require?
The major challenges that the auditor has that all the data submitted of the testing should be authentic and non tempered. This will only possible if it is 21 CFR Complied data is there. Thats why it is important to have stability chamber with 21 cfr complied compliance.
Control:-
What is DQ,IQ,OQ,PQ documents?
Normally Manufacture gives the User set of documents or say checklist kind of documents which on completition of doing will check the Stability chamber thoroughly on all the parameters.
| Terminology | Full Form | Use |
| DQ | Design Qualification | This confirm that How de design the chamber and why certain component has been selected. |
| IQ | Installation Qualification | This confirm How to Install the equipment by checking all the component Make, sl No and certificate, Preinstallation requirement and Utilities. |
| OQ | Operational Qualification | This confirm the operation wise checking of all the paramenter of the equipment. |
| PQ | Performance Qualification | This confirm the performance qualification of the stability chamber. |
What is Validation of the chamber and its protocol?
Validation means checking the performance of the chamber on accuracy and uniformity by placing sensors at different location for specified time interval and checking report for its Confirmatory. Normally Validation will be Onsite ( Checked by the Manufactory on its location ) and offsite at Buyer location. It will be empty, Part load and Full Load depending on the validation protocol.
Why ROCH?
ROCH has reach experience in designing and manufacturing stability chamber since last 15 years. We are having more than 1000 successful installation in India and globe. We are strong service support with In house manufacturing and software design capabilities.
Type of stability chamber.
ROCH is making below said Table series stability chamber
| Series | What it Includes | Benefits |
| PID Series | ROCH 44 Series | Chamber Only. No USFDA, WHO , GMP Compliance |
| Normal series | Consist of Chamber (ROCH 44 series) + RS 485 communication Card (PCI-1) + Data Logger (RCR-11 + SOFTD-21 (Desktop browser based Software Part 11 21 CFR )
|
WHO Complied |
| ECO Series | Consist of Chamber (ROCH 44 series) + RS 485 Communication card(PCI-1) + HMI PLC ( 4.3 Touch Screen PLC Display ) + DS ( Door Access System ) + SOFTW-21 (Web based Software Part 11 21 CFR ) | WHO, USFDA, GMP Complied |
| Premium Series | Consist of Chamber (ROCH 44 series) + Ethernet Based Connectivity + HMI PLC (7 Touch Screen PLC Display) + DS (Door Access System) + SOFTW-21 (Web browser based Software Part 11 21 CFR) + S.REF-1 (Standby Refrigeration System) + SH-1 (Standby Humidification system) + SCN-44 (4 Temp + 4 RH sensor) + VAL (Validation) | WHO, USFD, GMP Complied.
Redundency for Failure of any component for Long studies. Scanner for Auto validation of the chamber. Mobile and E-mail alert for critical alarm to deliver on mobile or e-mail. |
| DESCRIPTION | BTI-STC-171 | BTI-STC-280 | BTI-STC-420 | BTI-STC-560 | BTI-STC-840 |
|---|---|---|---|---|---|
| Temperature Range | 5°C to 60°C | ||||
| Temperature Accuracy | ± 0.2°C | ||||
| Temperature Uniformity | ± 1°C | ||||
| Humidity Accuracy | ± 2% RH | ||||
| Humidity Uniformity | ± 3% RH | ||||
| Temperature sensor | 3 wire RTD | ||||
| Humidity range | 5% RH to 90% RH | ||||
| Humidity Stability | ±2% or Better | ||||
| Humidity Sensor | Capacitive | ||||
| Light | 10000 LUX (optional) | ||||
| Interior construction | Stainless steel 304 | ||||
| Exterior Construction | CRCA Powder coated | ||||
| Internal Door | Glass Sheet door with complete visibility of components. | ||||
| Option for electrical interface | Standard connector | ||||
| Trays | SS 304 perforated. | ||||
| Electrical | 220 to 240 volts AC 50 Hz single phase | ||||
| Timer cyclic | 0 to 24 hrs day night | ||||
| Alarm | Audio and visual | ||||
| Dimensions | 505 x 415 x 830 | 570 x 550 x 875 | 700 x 640 x 900 | 700 x 700 x 1100 | 825 x 825 x 120 |
| Capacity | 171 ltrs | 280 ltrs | 420 ltrs | 560 ltrs | 840 l |
Frequently Asked Questions (FAQs)
A stability test chamber is a controlled environmental chamber used to assess the long-term stability and performance of products and materials under various temperature and humidity conditions.
Stability test chambers are essential for evaluating the shelf life, quality, and reliability of products such as pharmaceuticals, food, cosmetics, and electronics over an extended period.
These chambers are used for accelerated aging tests, shelf life studies, and stability tests to determine how products will perform under real-world storage conditions.
Many stability chambers offer customization options for temperature ranges, humidity levels, and shelving configurations to meet the specific needs of different products and industries.
Industries such as pharmaceuticals, food, cosmetics, electronics, and materials science rely on stability test chambers to ensure product quality and compliance with regulations.