Project Description
Stability / Humidity Chambers
PSI Test Chambers are developed as a result of intensive R & D, and confirming international standards, our offering services are Calibration, validation and comply IQ, OQ, and PQ protocols.*
ICH GUIDELINES*
PSI chambers are specialized designed to carry out stability & shelf list test on drug & drugs substance according ICH Guidelines.
TECHNICAL SPECIFICATIONS :
Temperature Rang: 10.0’C to 60.0’C. Accuracy / Uniformity :+_0.1’C / +_1.0’C
Humidity Range: 40% to 95% Rh. Accuracy / Uniformity +_2%RH/+_3%RH
Temperature / Humidity Display : Digital LED 3 ½ Digit, Resolution :0.1’C / 1% RH
Control : Microprocessor based PID Control with auto tune CE Marked
Temperature Sensor: PT -100,
RH Sensor: Direct Capacitance type.
Heating : ‘U’ Shaped Nichrome wire heater in SS Sheathing
Cooling: CFC Free Copeland compressor utilizing R 134A eco friendly refrigerant
Steam Injection : Boiler with reservoir made of thick stainless steel, with heater, water inlet control, low water level safeguard and insulation
Air circulation : Flange motor with impeller / Blower
CONSTRUCTION: Double Walled, gap between walls filled with PUF Insulation
GMP model : Stainless steel mirror polished chamber and exterior of dull finish stainless steel.
Double door : Inner full viewing door and outer door insulated with lock and key arrangement Control panel with electrical switch gear and refrigeration system (CFC Free) mounted on top for easy service accessibility.
Unit mounted on castor wheels
| Size Inch. |
| 18 x 18 x 18 (90ltr) |
| 20 x 20 x 28 (175ltr) |
| 22 x 22 x 36 (280ltr) |
| 24 x 24 x 36 (340ltr) |
| 24 x 24 x 48 (440ltr) |
| 28 x 28 x 48 (600ltr) |
| 30 x 30 x 55 (800ltr) |
| 32 x 32 x 60 (1000ltr) |
Optional:
Microprocessor Auto Tune PID Controller with Data Login System with Software.
Microprocessor touch screen HMI colour display with PLC for data logging
Data Record :
- 21 CFR Part 11 Compliance Secured audit trail
- Multilevel Passwords
- Print Interval Programmable Between 1 to 240 minutes
- Multi Chamber data acquisition on Single Software.
- Data Generated on PDF Report
- Auto logout, account Blocking and reactivating facility.
- Log data, event and audit trail data recording
- Tabular and graphical report, audit trail report