S R LAB INSTRUMENTS INDIA PRIVATE LIMITED

Goregaon East, Mumbai, Maharashtra

Cabinet Construction

This unit is double walled chamber. Interior made of stainless steel and exterior iseither mild steel Finished with powder coating or stainless steel. Glass wool/pufinsulation between both the wall is Provided. Full-lenght inner glass door and outsidemetal door with magnetic gasket & lock. Forced air Circulation for uniform temperature.One stainless steel perforated tray is provided. The tray can be Placed at variousheights to accommodate the change in sample height. The purpose of doing so is toVary the exposure intensity to reduce the test duration. PU wheels for easy move ability.

Illumination

Photo stability chambers provide lights as per option 2 mentioned inICH guidelines A cool white florescent light for 1, 2 million LUX hoursexposure. UV-A lights for 200 watt hours / square meter exposure.Both the lights have independent control to avoid over exposure.Chamber is illuminated using 4nos of flourescent tube light toproduce visible light (measure in lux). A one no. Near UV light ofwavelength 365nm ( measured in watt/sq. Meter) are fitted ontopside of the chamber.

Power SupplyThe unit works on 230 volts AC and 50Hz mains supply.

Cooling System

Hermitically sealed compressor coupled with evaporation coiland condenser, safe guarded by time delay circuit. CFC freerefrigerant.

ValidationWith 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.

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.

Controls

The equipment is PLC controlled and has controlled exposure withtemperature and humidity (optional). The light gets OFFautomatically once the exposure is achieved. Refrigeration and PIDcontrol heating systems are provided to carry out testing at aprecise Temperature. Humidity control system can also be provided.Temperature Controller with Ethernet Communication

Temperature Range

Temperature Range: +20 C To +60 CAccuracy : 0.2 CTemperature Uniformity : 1c

Humidity control

Temperature Range: 40% To 85% RH.Accuracy : 1% RH.Uniformity : 3% RH.

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.

Optional Accessories

ICDAS Software : Centralized work station for viewing, trending performance of equipment. Software complies to US FDA21 CFR Part 11. Calibrated LUX and UV-A meters to measure visible light and UV light intensities Touch screen display. To satisfy regulatory requirements the equipment has Ethernet interface for communication with ICDAS software. It records temperature control, LUX exposure, UV exposure and optional Humidity control parameters .

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.

ICH Guidelines

All stability chamber meet the ICH Q1A guidelines for stability testing including :

Long Term : 25 C/60% RH or 30C/60% RH

Intermediate : 30C/65% RH or 30C/75% RHAccelerated : 40C/75% RH.

Certification

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