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Installation Operational &performance Qualification FOR

This document provides qualification documentation for a hot air oven. It includes sections for system description, design qualification to ensure the instrument can be operated as specified, installation qualification to check for any damage or improper installation, operational qualification to verify correct operation of controls and displays, performance qualification to test the oven's temperature accuracy at different settings, and maintenance procedures. The document confirms that the hot air oven meets all specifications for construction, dimensions, temperature range, and controls through inspection and testing of its installation, operation, and temperature performance.
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0% found this document useful (0 votes)
122 views

Installation Operational &performance Qualification FOR

This document provides qualification documentation for a hot air oven. It includes sections for system description, design qualification to ensure the instrument can be operated as specified, installation qualification to check for any damage or improper installation, operational qualification to verify correct operation of controls and displays, performance qualification to test the oven's temperature accuracy at different settings, and maintenance procedures. The document confirms that the hot air oven meets all specifications for construction, dimensions, temperature range, and controls through inspection and testing of its installation, operation, and temperature performance.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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INSTALLATION,

OPERATIONAL &PERFORMANCE
QUALIFICATION
FOR

NAME : HOT AIR OVEN


MAKE : DD-LAB

MODEL : DD-HAO-90

SERIAL NO : DD/22-23/2455397

HSN CODE: 8514


PO Date : 04.01.2023

Prepared By: Date: __________

Prepared By Checked By Verified By


Date: Date: Date:
CONTENT

 System Description (as offered)

 Design qualification

 Installation qualification

 Operational qualification

 Performance qualification

 Cleaning

 Maintenance program
SYSTEM DESCRIPTION
 Double walled construction with Inner & Outer body is made of chamber made
of STAINLESS STEEL (304) Steel Chamber having 60-70mm glass wool.
 Forced air circulation fan unit is fitted to ensures good mixing, strong dispersion and maintains
 higher temperature uniformity inside the chamber & no cross contamination.
 The gap between two walls is filled high density mineral wool.
 Synthetic door gasket for proper sealing.
 Fitted with heavy hinges made of brass with a ball catcher, spring loaded door closing device.
 Robust door hinge with integrated cable ducts.
 Adjustable two ventilation slides control inner air / vapor circulation on two sides.
 Standard air heating elements made of high quality NICHROME material are placed in the path of
 air for uniform heat distribution and isolated from the.
 Inner chamber has support for placing the shelves at convenient levels. Supplied with stainless
steel shelves.
 Temperature is controlled by microprocessor based PID digital temperature indicator cum
 controller.
 Temperature is displayed by Digital LED with SV and PV display at front of the oven.
 Front Panel is provided with ON/OFF switch, temperature controller and two pilot lamps
 (indicators).
 If there is a difference of 5 – 8 deg C from any set value, then temperature recovery time up to set
 value is 20-40 min.
 Temperature accuracy will be stable in 15-20 minutes after reaching the set value.
 USB Printer Facility Inbuilt

Technical Detail:
Capacity: 90 liters (approx.)
Size- : 18 x 18 x 18 Inch
Inner Chamber: Stainless Steel (304 Grade) With
USB Print Facility for Date Time Temperature For per minute
Working Temp Range: Ambient (37°C) +5°C to 300°C
Door lock : Yes
Display : Digital LED display Power : 220-240 V AC / 50-60 Hz

DQ OF HOT AIR OVEN


DQ: DESIGN QUALIFICATION

PURPOSE: - The purpose of the design qualification [DQ] is to ensure that the instrument
can be operated as expected

PARTICULARS (IN SWITCH ON CONDITION) REMARKS


Body is constructed of material as per specification:
Double Walled Construction Unit
OK
COMPLETE GMP MODEL Stainless Steel (304 Grade)

Dimensions of the instrument as per specification: - 18*18*18 Inches OK

Forced air circulation blower assembly at back as per specification OK

Stainless steel shelves OK

Microprocessor based PID temperature indicator cum controller OK

Air tight door gasket & Heating element OK

Door handle with lock OK

Separate ON/OFF switch, Temperature controller OK

Checked by:

IQ OF HOT AIR OVEN


IQ: INSTALLATION QUALIFICATION FOR HOT AIR OVEN

PURPOSE: -

1) To have visual checking of the instruments for any damage during transportation

2) To check for all accessories of the instruments meeting the specifications.

3) To ascertain and approve that the adequate facilities shall be provided that meets the
requirement for the installation of the instruments

PARTICULARS REMARKS
Any breakage/Leakage in HOT AIR OVEN :- No OK
Level /Balance of HOT AIR OVEN :- Properly balanced OK
Power cables :- Fixed with the instruments OK
Any loose connection / fittings :- No OK
Rust if any :- No OK
Properly insulated :- Yes OK
Fan motor properly fixed and checked :- Yes OK
Electric power supply 220-230V AC (single phase) Shall be available earthing must
OK
be proper before installation :- Yes
Insulated double walled front door properly balanced and fitted
OK
:- Yes
Door handle with and Feet :- Yes OK
Control panel
Microprocessor based temp. controller :- Yes
OK
Main ON/OFF Switch :- Yes
Power cable :- Yes

Checked by:
OQ OF HOT AIR OVEN

OQ: OPERATIONAL QUALIFICATION

PURPOSE: - The purpose of the operation qualification [OQ] is to ensure that the instrument
can be operated as expected and described and further to established the
standard operating procedure [SOP]

PARTICULARS (IN SWITCH ON CONDITION) REMARKS


Power ON / OFF :- ON OK
LED display showing the initial positions of SV, PV, etc. as per the set
OK
values :- OK
Indicators and Switches :- OK OK
When we soft touch switch for SET/ ENT and Increment/Decrement key
OK
(as per instructions Working or Not) :- WORKING
Forced air circulation fan :- WORKING OK

Temperature controller and Switches :- WORKING OK

Checked by:
PQ OF HOT AIR OVEN
PQ: PERFORMANCE QUALIFICATION

PURPOSE: - The purpose of the performance qualification [PQ] is to ensure that the instrument can be operated

As expected and describe and further to establish the standard operating procedure [SOP]

After cleaning the chamber & front door is closed, the instrument is switched ON and LED will on.

There are FOUR KEYS on the keypad provided for setting the required parameters.

1- SET KEY
2- UP KEY
3- DOWN KEY
4- ENT KEY

With the help of 4 keys are available Press ENTER to start

By the following procedure provided, the following parameters are observed.

PARTICULARS REMARKS
Set mode by SET key
Change setting in set mode by Increment & Decrement key OK

Digital LED display to see the parameter :- OK OK


Temperature reading of chamber using special sensor :- OK OK
Observation:
At Temperature : 500C, Accuracy :- ±10C approx
At Temperature : 1000C, Accuracy :- ±10C approx
At Temperature : 1500C, Accuracy :- ±10C approx OK
At Temperature : 2000C, Accuracy :- ±1.0 to ±1.50C approx
At Temperature : 2500C, Accuracy :- ±1.0 to ±2.00C approx

Note:- accuracy will be maintained within 30-40 min after achieving the set value

All the reports are verified by

Name Signature Date


PREVENTIVE MEASURES PROTOCOL

1. Close Down Operation:


a) Switch 'OFF' the instrument from the panel, i.e. press 'POWER ‘key.
b) Switch 'OFF' the voltage stabilizer.
c) Switch 'OFF' the mains.

2. Cleaning Operation:
a) Wipe all the traces of organic solvent I water I moisture by tissue paper.
b) Clean all the dust from the working table by tissue paper.
c) Close the door/sash of the instrument.

3. Maintenance Program:
 When the instrument is under breakdown I maintenance I not functioning, put the tag stating 'OUT OF ORDER'
and inform to the instrument manufacturer I servicing person as per the requirement.
 After completion of repairing Servicing job, instrument should be checked for appropriate working by the Q.C.
Officer I Chemist.
 Engineer prepares the service report and Q. C. Department retains one copy of the report.
 Calibrate the instrument prior to use.

4. Records:
 Adequate records shall be maintained showing the calibration observation.
 Records of all maintenance shall be maintained.

5. Distribution: Q. C. I Q. A. I R. & D. I Production (D. P. I.)

The following information available:

Service information : Customer support Department

Contact :

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