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AIM: Qualification of Hot Air Oven. REFERENCE: Potdar AM. Pharmaceutical Quality Assurance, 1

This document summarizes the qualification process for a hot air oven. There are four key parts to qualifying a hot air oven: design qualification to verify device specifications, installation qualification to confirm proper installation, operational qualification to ensure the device performs as intended, and performance qualification which includes testing heat distribution across the chamber. A hot air oven is validated at temperatures of 120C for 1 hour and 126C for 40 minutes to kill microorganisms through dry heat sterilization.

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ravi sathwara
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3K views

AIM: Qualification of Hot Air Oven. REFERENCE: Potdar AM. Pharmaceutical Quality Assurance, 1

This document summarizes the qualification process for a hot air oven. There are four key parts to qualifying a hot air oven: design qualification to verify device specifications, installation qualification to confirm proper installation, operational qualification to ensure the device performs as intended, and performance qualification which includes testing heat distribution across the chamber. A hot air oven is validated at temperatures of 120C for 1 hour and 126C for 40 minutes to kill microorganisms through dry heat sterilization.

Uploaded by

ravi sathwara
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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AIM: Qualification of Hot Air Oven.

REFERENCE: Potdar AM. Pharmaceutical Quality Assurance, 1st ed. Published by Nirali
Prakashan; 2006.P. 8.13-8.20

REQUIREMENTS: Hot air oven, Thermometer, Chemical indicator, Biological indicator.

THEORY:

Hot air oven is used for the dry heat sterilization. Two hours exposure to a temperature of
180.C. or 40 min at 2600c normally can be expected to kill spore as well as vegetative forms
of all microorganism. It is useful in case of laboratory glassware as well as oils, powder etc.
Three principles are involved in the validation process.

1) To build sterility into a product.


2) To demonstrate a certain maximum level of probability that the processing &
sterilization method have established sterility to all unit of product batch.
3) To provide greater assurance and support of the result of the end product sterility test.

1.DESIGN QUALIFICATION:

The physical dimension of the equipment a nd accessories and suitable operating enviroment of
the instrument with safety requirement.

 NAME OF COMPANY: Nova instrument private lm.CAN ISO 9001:2000


 MODEL NO: NV-858/DIGI
 SERIAL NO: 2T181

2.INSTALLATION QUALIFICATION:

The IQ is designed to compare the system against the manufacture specifications for
proper installation. A schematic of all utilities supplying the sterilizer should be available
to conform that all connection are as specified & meet design limit ,local & state codes.
cGMP

For hot air oven following IQ parameters are checked

Sr.no Features Observation


1 Chamber
2 Construction material
3 Locking system
4 Heating element
5 Structure
6 Power Rating
7 Temperature control
8 Temperature
9 Accuracy
10 Air circulation

3.OPERATIONAL QUALIFICATION

After the equipment has been checked for proper installation as in IQ it is necessary to
determine that the sterilizer performs as designed. The components of the system must
satisfy the operating ranges as determined by the purchase order specification.

For OQ following operating procedures are checked temperature monitors:

Sr.no Features Observation


1 Main switch
2 Main indicator
3 Digital temperature
4 Rotatory switch
5 Forced air indicator
6 Forced air circulation operating switch
7 Connect
8 Timer
Performance Qualification:

1) Heat distribution

Temperature range is ± 15⁰C at all monitored location and temperature less then 15⁰C of
standard is consider as cold spot.

PROCEDURE:

For Heat Distribution Studies:-

1. This study is conducted in an empty chamber.


2. Pre –calibrated thermometers are selected & labelled as T1, T2, T3,T4,T5, T6, T7 and
arrange in trays at different location in such way that they covered all the heat
distributions points.
3. This temperature measuring device are maintain for all temperature at which oven is
validated (120⁰C for I hr.).
4. After arranging all thermometer in specified pattern the door oven is closed and
thermostat is adjusted (120⁰C for I hr.) .After the thermometer are checked record the
temperature in specified order

OBSERVATION TABLE:

a) Heat distribution study:

Time Temperature(120ͦ)
(min) T1 T2 T3 T4 T5 T6
15
30
45
60
RESULT:

CONCLUSION:

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