Walk-In Stability Chamber

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Walk-In Stability Chamber

Walk In Stability Chamber
Walk In Stability Chamber

MODEL NO : SRL / WISC-12

Application :

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.

Ecocentric System :

Chamber runs on the basis of Dewpoint control. Less deviations during short-term door opening & power failure. Less utility area Increased storage area. Low operating cost. Minimum power & water consumption. Reduced deviations. Less breakdowns due to standby refrigeration & humidification system. Due to PLC HMI & controlling through microprocessor based PID Temp. & RH operations the on time of both Temp. & RH system is reduced & efficiency of this system is increased with reduced energy consumption.

Construction : {As Per GMP Guideline}

MOC of the Chamber will be: Double walled Chamber with Inner of stainless steel 304 grade & outer of stainless steel 304 grade. PUF Insulation in between two walls.
(I) Flooring: 2 mm aluminum chequer plates.
(ii) The unit will be made of double walled leak proof metal door with lock, with a provision of opening door from inside.
(iii) Forced air circulation for uniform temperature.
Insulation of Walls, ceiling and floor : 80mm thick puff panels with puff in-place density of minimum of 1kg per cubic foot or its equivalent. Insulation with expended polystyrene or any equivalent material having R factor of minimum 34. Insulation material shall maintain its dimensional stability in an operating temperature range of 5°C to +60 °C Insulation puff.
Doors : Flush type doors of metal surfaces (as per above specification of metal) with proper puff insulation of above mentioned standard. Doors shall have magnetic snap-in perimeter gasket or its equivalent, self-closing cam lift gravity hinges or its equivalent, a posi-seal door closure or its equivalent. Door shall have key lockable latch handle. Doorjambs shall be made fiberglass reinforced plastic or any other suitable material compatible with constructed door.

Air Circulation :

The Walk in stability chamber is provided with best air circulation to give better temperature uniformity this is achieved by using one set of motor & blower in baffle wall Compartment to push treated air in working chamber. This system gives better than 1 deg c. temperature uniformity in working chamber, evaporator, heaters & steam injection system is from back side, behind baffle wall, the air circulation blower is also fitted in this compartment only. This arrangement helps to mix steam and air together and pass well mixed air inside the working chamber. Due to above system the temperature and humidity (R.H.) in complete chamber almost remains equal.

Heating / Humidification & Dehumidification :

A good quality SS tubuler Heater. Will consist of humidifier tank fitted with boiler heaters, and give alarm if fault occurs or Ultrasonic Humidification System. Water reservoir tank will be connected to the humidifier.
De-humidification coils are installed below the cooling coils for lower humidity.

Controller :

Standard PID:Provides Precise Temperature, Maintain Uniform And Accurate Growth Environment, Timer, Alarm, Auto-Tuning And Auto Start Stop Function. Technical Design and Construction Silent Fan Motor to Maintain Uniform Temperature Over Temp. and Current Protection Capability Ensure User Safety, Adjustable Sliding Rack, Alert Unexpected Interruption Of Electrical Power Or Unauthorized Change.
Optional :
PLC with HMI Control system with touch screen display & HMI for data Storage, data logger reading & audit trail, Door access & SMS records, Email alert. Data Logger 1 temp + 1 RH. Data Logger with LCD display window capable to store non volatile data memory up to 5000 readings with audit trail facility complies 21 CFR Part 11. Change over to stand by system automatically as per schedule or on detecting fault with current system Temp. & Humidity overshoot and under shoot protection Mobile Alarm system, Door Access, system setting reset , Graph, SMS, Email alert, etc.

Trays & Racks :

Removable SS perforated trays are provided, adjustable and will slide out for easy clean up. Assembled Stainless Steel racks to accommodate trays

ICH Guidelines :

All stability chamber meet the ICH Q1A guidelines for stability testing including :
Long Term : 25°C/60% RH or 30°C/60% RH
Intermediate : 30°C/65% RH or 30°C/75% RH
Accelerated : 40°C/75% RH.

Power Supply :

Single phase 230V AC, 50 Hz / Three phase 440V AC, 50 Hz.

Temp. & Humidity Range :

+20°C to +60°C
Accuracy : ±0.2°C, Uniformity : + 1°C, Resolution : 0.1°C
Relative humidity from 40% to 95%
Accuracy : ± 1% RH , Uniformity : ± 3% RH., Resolution : 0.1% RH

Refrigeration system : (Air Cooled)

Emerson /Danfoss/Tecumseh: make compressors, 1 stage cooling system for TEMP. & Humidity Control. All accessories such as HPCO/LPCO, Oil Separators, Dryers,Relays, OLP etc. of Danfoss/Tecumseh Emerson Make. CFC free refrigerant to be used to comply with the New Environmental Regulation. Will have suitable tonnage compressor for maintain temperature with lights on. Will have hermetically sealed condensing unit compressor coupled with Evaporation coil and condenser, safe guarded by time delay circuit. Cabinet shall be supplied with air-cooled condensing unit with extended compressor life and close temperature control. Cooling system will be split type to place condenser unit in a ventilated area to avoid hot air in growth chamber. Cooled air shall be delivered in such a way to reduce or eliminate condensation within media dishes and to provide maximum uniformity In different research vessels. This may be through silent and durable fan motors or through any kind of advanced air diffusers. Air Cooled Condenser with solenoid & LP to pass hot gas to the chamber for uniformity & long life of compressor for continuous usage. Phenolic coating for cooling & condensing coils (All weather proof).

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.
ISO 14001:2015 & WHO-GMP
NSIC & MSME registered
Calibration & validation certificates traceable to NABL / ERTL accredited labs.

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.

Safety Features :

2 minute compressor “on” delay timer to safeguard the compressor. Compressors overload relay protector. Electronic low water level cut off device to cut off the supply to boiler heater in case of low water level. Safety Temp. Controller. MCB for mains. (I) Unit will be provided with safety devices for temperature and humidity overshoot in case of malfunction.
(ii) Built-in temp. Deviation, audio/visual alarms. Safety thermostat for over shooting of temp. Safety circuit to cut off the whole system.
(iii) OLP (Overload Protector) & Time delay Circuit for safety of compressors.
(iv) HRC fuses for compressors, Heaters & Mains.
(v) Interior safety release knob for door.
(vi) Hooter with switch inside (Alarm).

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.