Stability Chamber (Complete S.S.)

//Stability Chamber (Complete S.S.)
Stability Chamber (Complete S.S.) 2019-05-09T04:28:26+00:00

Project Description

Stability Chamber (Complete S.S.)

Stability Chamber (Complete S.S.)
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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 : ±0.2’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 Electronics Capacitance type.
  • Heating : ‘U’ Shaped Nichrome wire Air 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 Mett 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.
OR
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