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.

Heating & Humidification

S.S Air heaters are provided for heating above ambient temperature. A S.S water boiler with reservoir with float value produces steam for humidifying the chamber. Ultra Sonic Humidification [Optional].

Air Circulation

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

Refrigeration System

A hermetically sealed compressor with CFC free refrigerant & optional stand by refrigeration System & Humidity System for uninterrupted operation. The both the systems 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.

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 chambersMean Kinetic Value (MKT) as per USP 24 NP 19 – Daily, Weekly, Monthly.

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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.

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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.

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Safety Features

Supervisory Safety Monitoring System has been introduced for additional Safety measures. Individual additional micro – controlled is used for this supervisory system. If the temperature & humidity value crosses set Hi & Low limits for either or both parameters, safety control action will be taken over by this controller. If the parameters sets within the limit value, main control action will resume automatically. 2 Min. Compressor ON delay time for safety of compressor. Float switch to cutoff the main supply & audio visual alarms in case of low water level.

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Documentation

To comply with the documentation requirements, we provide IQ, OQ & PQ protocols to be executed before taking the chamber in to for regular use, and support the supply with the following documents with the detail operational and service manual.
Standard Operating Procedure (SOP) Operational Manual for Controller IQ,PQ,OQ protocols certificate. Calibration certificate of all controlling modules with traceability. Certificate of MOC.
Test Report of chamber prior to supply with mapping certificate.
wiring diagram for ease of service maintenance.

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Certification

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

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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.

Specifications

Model SRL-SC-10AInternal Dimension (W X D X H)(cms)Capacity Ltrs
SC-A45 x 45 x 50100
SC-B50 x 50 x 80200
SC-C55 x 55 x 100300
SC-D60 x 60 x 110400
SC-E60 x 60 x 140500
SC-F70 x 60 x 145600
SC-G70 x 70 x 145700
SC-H75 x 75 x 145800
SC-I80 x 75 x 150900
SC-J80 x 80 x 1551000
SC-K90 x 83 x 1601200
SC-L130 x 83 x 1401500
SC-M140 x 92 x 1401800
SC-N150 x 95 x 1402000

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