Specification for Walk-In Humidity Chamber (Stability Chamber) 1. Physical Parameters Req. ID a) b) Description Requirement Liter capacity Dimensions specified in H x W x D format (Inner) 15000 liter 2400H X 2500W X 2500D c) d) e) Inner chamber MOC Outer chamber MOC Trays Size , qty and MOC f) g) h) Door with lock and key arrangement Observation window PUF Insulated Pre-fabricated panels which can be easily assembled at site. Illumination – Fluorescent tube light inside chamber Stainless steel 304 Stainless steel 304 48 No’s of Stainless steel Size: 725 X 800 mm Required size 300mm x 300mm with 80 mm PUF thickness i) Required 2. Process Requirement Req. ID a) b) c) d) e) f) g) h) i) j) k) l) m) n) Description Temperature Range: Temperature Accuracy: Temperature Uniformity: Humidity Range: Humidity Accuracy: Humidity Uniformity: Automatic control of temperature and humidity Auto start after recovery of power as per set parameters. Fully integrated PLC control system. Total system controlled by PLC with data storage of up to 1000 readings (i.e. If data-logging interval is of 30 mins then data upto 20 days is to be stored on the PLC itself) Data Storage to be inbuilt in the PLC itself without additional external hardware Facility to send emails from PLC in case of deviation from set values HMI: 4” Colour Touch Screen Display Alarms for deviation required for Temperature all sensors (High & Low) Humidity all sensors (High & Low) Other required alarms for Door opening Chamber Mains supply failure Chamber Water Supply failure Emergency Alarm (Man Inside) Component Failure, Circuit Failure Forced air circulation to maintain Uniformity Requirement 20 to 60°C ±0.2°C ±1°C 40% to 95%RH ±2% RH ±3% RH Required Required PLC make Allan Bradly (Preferred) Required Required Required Required Required Specification for Walk-In Humidity Chamber (Stability Chamber) Req. ID o) p) q) r) s) t) u) v) w) x) y) z) aa) bb) Description Sensors, data acquisition systems and alarms systems to be under UPS System have to be operational 24 hours a day CFC Free Cooling System Heating system – Humidity system- Humidity is by steam injection. System comprises of Humidifier Tank, Humidifier Heater & Reservoir tank. High quality Temperature & Humidity combo sensor. Temperature is displayed in °C with 0.1°C resolution. Humidity is displayed in %RH with 0.1%RH resolution Minimum 2 No. of sensor required for temperature and humidity. Stand by Humidity system to minimize down time. Stand by cooling system to minimize down time. Change over to standby Humidifier system & standby Cooling system in following ways. Scheduled Manually selected Automatic in case of failure of regular system Working hours calculation of following components for maintenance schedule Circulation motor Dry heater Humidifier heaters Compressors Standby Controlling Sensor: Automatic & Immediate Switchover from Primary Controlling Sensor to Standby Controlling Sensor in the event of failure of Primary Booster Cooling: If the chamber temperature deviation is 2°C more than the set value then both the primary and stand by cooling system switch on together to bring the temperature within range. Electrical supply: Requirement UPS In Scope of IIP Required R134A SS tubular heater Required Controlling sensor Testo/Rhotronic make Required 1 main and I Standby Required Required Required Required Required Required Single Phase (230 V 50 Hz) 3. Safety Requirement Req. ID a) b) c) d) e) f) g) h) i) j) Description Requirement Temperature overshoot protection Temperature undershoot protection Humidity overshoot protection Human safety Door can be opened from inside even though locked from outside Emergency bell switch inside the chamber Instrumentation safety in case of utility failure Delay timer to Safeguard the compressor MCB to cut off over current supply Surge Arrester to filter electrical noise Float Switches in both, reservoir tank & boiler tank Door Access System Required Required Required Required Required Required Required Required Required Optional Specification for Walk-In Humidity Chamber (Stability Chamber) Req. ID Description Requirement Password based access control Restricts access to unauthorized person. 4. Data Acquisition System Req. ID a) b) c) d) e) f) g) h) i) j) k) Description Requirement Communication on Ethernet (TCP/IP) Automatic transfer of data from PLC to computer hard disk. Data to be stored in secure SQL server Restricted access to system under user ID and password Compliance to 21 CFR Part 11 Facility to view / print / trend generation of data on daily, weekly, monthly and yearly basis A real time window user can see status of all connected chambers in one window at same time Automatic logging of alarms separately in alarm log Facility to update e-comments against the generated alarms Automatic & Manual daily data backup facility Facility for data backup and restore in the event of failure of PC System will run on Windows XP/ Window 7 Required Required Required Required Required Required Required Required Required Required 5. Documentation Requirement Req. ID a) b) c) d) e) f) g) h) i) j) Description Requirement Operating Manual/ Maintenance Manual General Assembly drawings Electrical connection drawings IQ, OQ, PQ protocols Preventive maintenance schedule MOC certificate Calibration certificate of sensors Calibration certificates of measuring instruments using for IQ, OQ, PQ Standard Operating procedures for Walk-in Humidity Chamber Data acquisition system Data backup and restore Air Distribution & Air Pattern Study Required Required Required Required Required Required Required Required Required Required 6. Principles and Constraints Availability: The chamber and monitoring system must be in operation 24 hours a day, 365 days a year. Maintenance: Engineer and IT support in working days under local staff’s responsibility. Specification for Walk-In Humidity Chamber (Stability Chamber) Technology Principles and Constraints: Components used for chamber should be available locally Dedicated PC for running the software connected to the chambers in scope of IIP
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