Qualification For Stability Chamber ( STABILITY DATA ACQUSITION SOFTWARE)

User requirement specification of stability chamber

INDEX

  • Objective
  • Scope
  • Basic of system
  • Control system
  • Temperature controller
  • Humidity controller
  • Pc/ printer interfacing unit
  • Data logger
  • Plc
  • Door access system
  • Control panel
  • Safety controller for low /high temperature
  • Optional accessories
  • Software
  • Water tank
  • Printer
  • Validation documentation
  • Approval

OBJECTIVE:   

This document is to identify the User requirements of the Stability Chamber. This is a basic document for the Stability system and it will be used for further life cycle of project. The requirements specified in this document will be verified in Performance Qualification tests.

The User Requirement for Procurement of Stability Chamber capable of maintaining desired temperature and humidity and accommodating required number of samples with a capacity of approximately 400 Liters

SCOPE: 

The scope of this document is applicable to the Stability Chamber with the following conditions:

25°C & 60% RH Condition

30°C & 65% RH Condition

40°C & 75% RH Condition

___°C & ___% RH Condition

BASIC OF SYSTEM:

  • Capacity:  400 liters.
  • Inner size (W X D X H): 600 W x 630 D x 1060 H mm
  • Material   of  construction
  • GMP Model : Inside S.S. 316 & Outside S.S 304
  • Standard Model : Inside S.S. 316 Powder coated MS
  • Total no. of trays :  _02_ Nos
  • Environment condition temperature and humidity specified requirement as per ICH guideline Running condition : Temperature ____°C & Humidity ___% RH 

TEMPERATURE AND HUMIDITY RANGE:

Range : Temperature 20°C to 60°C & Humidity 40% RH to 98% RH

Accuracy: Temperature + /- 0.2°C & Humidity + /- 2% RH

Uniformity : Temperature + /- 2°C & Humidity + /- 3% RH

STAND-BY SYSTEMS:

a) Humidity

A standby humidity system, which should work in case of failure of the regular humidity system

b) Refrigeration

A standby refrigeration system, which should work in case of failure of the regular refrigeration system

CONTROL SYSTEM: –  

  • Temperature Controller
  • Humidity Controller
  • PC/Printer Interfacing Unit
  • Safety controller
  • Data logger (Optional)
  • PLC (Optional)
  • Door Access System (Optional)
  • Mobile alert System (Optional)
  • Control Panel

TEMPERATURE CONTROLLER

  • Microprocessor based PID Temperature controller.
  • Access Control for setting parameters in controllers.
  • Low / High alarm setting

HUMIDITY CONTROLLER

  • Microprocessor based PID Humidity controller.
  • Access Control for setting parameters in controllers.
  • Low / High alarm setting

PC/ PRINTER INTERFACING UNIT

  • Settable Print interval as per requirement.
  • Real time clock in built
  • Capable for interfacing with pc

DATA LOGGER

  • Data logger/ scanner 8 channel (4-point temperature and 4-point RH) with a provision for increase in up to 16 channels. Microprocessor based Datalogger for continuous monitoring of temperature and humidity.
  • Data logger with printer port and computer interface port.
  • Adjustable period for scanning of channels.

PLC 

  • Automatic changeover of refrigeration system
  • Automatic changeover of humidity system

DOOR ACESS SYSTEM

  • Accept proximity card 24 hrs. access suitable for automatic and manual door.
  • Facility available to authorized entry to selected card holders
  • Facility to delete the card
  • No restriction on number of card holder
  • Chamber security system with access door security with multilevel password.

MOBILE ALERT SYSTEM                

  • SMS sending facility to three users.
  • Facility available to reprogrammed user number with the help of SMS software.
  • Up to 8 no of chambers can be connected to one unit.

 CONTROL PANEL:

  • MOC :  S. 304 ,
  • M.S  Powder Coated
  • Standard Model :GMP Model
  • Printer port : Position side Mounting
  • Electrical Component :  Solid State Relay, Contactor, MCB’s, Switch

SAFETY FEATURES

Control system should take care for avoiding overshooting or under shooting of control parameter in worst case it will give Audio and Visual Alarm

SAFETY CONTROLLER FOR LOW /HIGH TEMPERATURE:

There should be a cutoff in case of overshoot or undershoot of temperature with audio visual alarm.

SAFETY THERMOSTAT:

There should be provision for Safety relay which will be controlled by the controller and which will cut off the supply of heater in case of variation in the set conditions

WATER LEVEL SAFETY:

There should be provision for Magnetic Float switch in the reservoir tank.

COMPRESSOR SAFETY:

There should be provision for over load relay and time delay.

ELECTRICAL SAFETY

The wiring should be as per the IS code and it should be with various MCB’s for safety purpose.

OPTIONAL ACCESSORIES

SOFTWARE

  • CFR 21 Part 11 compliance window based communication software for data management.
  • Complete with RS 485 multi dropping to monitor multiple chamber to one

WATER TANK:

  • Water storage S.S tank of 30 liters capacity with 2 tap connection, lid and stand

 PRINTER:

  • Col Dot matrix printer along with S.S stand.

VALIDATION DOCUMENTATION :-

  • Design qualification
  • Installation qualification
  • Operational qualification
  • Performance qualification
  • Test and calibration certificates.
  • Preventive maintenance procedure
  • Standard operating procedure

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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