Walk-In Stability Chamber

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Applications

Used for large number of sample in hospitals, Research institution. Public health laboratories etc. These chamber can be used for environment testing of production sample & large size equipments where temp. & humidity are to be controlled. They are suitable for storage of electronic components, biological specimen & accelerated ageing test of large number of pharmaceutical samples. They can also used for botany, cytological, Deptsrturents, plan & animal breeding laboratories where controlled condition of temp. humidity & illumination are required.

Construction

Pre-fabricated molecular panels with PUF insulation. Which can be easily assembled on site. Which are light weight & easy to handle. If can be assembled / disassembled for relocating. Interior is made of AISI S.S. 304 & Exterior is made of AISI S.S. 304 with PUF / Glasswool insulation, double walled door with PUF & Door heaters insulated tight fit doors & viewing windows with illumination.

Air Circulation

Efficient forced air circulating system is provided to ensure uniform conditions inside the Chamber

ICH Guidelines

All stability chamber meet the ICH Q1A guidelines for stability testing including :
Long Term : 250C/60% RH or 300C/60% RH
Intermediate : 300C/65% RH or 300C/75% RH
Accelerated : 400C/75% RH.

Refrigeration System

A hermetical sealed compressor with CFC free refrigerant & optional stand by refrigeration system & humidity system for uninterrupted operation. The both system can be operated alternately for a certain period, thus increasing the life of the system & In case of break down the alternate stand by system can be operated for uninterrupted services.

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Temperature Control

Programmable Temp. & RH Controller 4-20 mA o/p for RPM Control Data Logger 8 Temp. +RH Data logger with LCD Display window capable to store non- volatile data memory up to 500 reading with audit trail facility complies USFDA 21 CFR part 11. Touch Panel Change over to stand by system automatically as per schedule or on detecting fault with current system. Temperatures & Humidity overshoot and under shoot protection. Mobile Alarm System.In built PC port for connectivity for PC base operation of data management. Protection of UPS system in built with the controller for safe and uninterrupted functioning.

Validation

With 8 Temp. & 8 RH point scanner with sensor printer interface & Data storage facility, 24 hrs with load & 24 hrs w/o load, 8 hrs power failure test, 15 mins door opening test for one condition only.

Certification

ISO 9001:2015 Certified Co. D&B registered & CE marked product.
Calibration & validation certificates traceable to NABL / ERTL accredited labs.

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Stability Data Management Software 21 CFR Part 11 Compliance

21 CFR part 11 Compliance.
Online & Offline Data representation in Tabular as well as Graphical Form.
Separate display formats for Real time Data & Acquired Data for single or multiple chambers
Mean Kinetic Value (MKT) as per USP 24 NP 19 – Daily, Weekly, Monthly.

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