Document No.

SOPQCMIC06

Revision No.
Page No

00
Page 1 of 2

Quality Control DEPARTMENT

DRYHEATOVEN
Prepared By:

checked By:

Approved By:

Microbiologist

Manager Quality Control

Plant Manager

PURPOSE
To describe the procedure for sterilization or depyrogenation.
SCOPE
This procedure is to be followed in the Microbiological Lab of Q.C department.
RESPONSIBILITY:
QCM
Microbiologist
Lab Attendant
PROCEDURE
1. Before loading the material in oven it must be cleaned. Cleaning steps are as follows.
a. Clean all the inner surfaces of oven by dry duster.
b. Wet duster can be used where the particles shedding patches observed.
2. Check the temperature gauges are in properly functioned.
3. Then adjust and make sure the display of temperature monitoring gauge shows the desired temperature
according to Table No. 01
4. Make sure the door is properly closed.
5. Turn ON the oven and record on an approved log format.
6. The temperature gradually rises and for a while it reaches up to the desired temperature.
7. Set the time by using time knob according to Table No. 01
8. After completion of sterilization and depyrogenation cycle, turn OFF the switch.
9. Leave if for 30 minutes, open the door then get the load out and put it on dedicated SS
Trolley using thermal gloves.
10. Write the date of depyrogenation on the material / glassware.

_____________________________________________________________________________________________________
This document is the exclusive property of Industries Limited and its contents must not be communicated to unauthorized
persons or persons outside the company with out written consent of Departmental Head.

Document No.

SOPQCMIC06

Revision No.
Page No

00
Page 2 of 2

Quality Control DEPARTMENT

DRYHEATOVEN
Prepared By:

checked By:

Approved By:

Microbiologist

Manager Quality Control

Plant Manager

Safety & Precautions:

1. Heat resistant gloves should be used during operation of equipment.
2. After process completion, before opening the door make sure the hot air eliminate from the
sterilizer.
Time & Temperature for Sterilization and Depyrogenation:
Table No. 01
Process

Temperature C

Time

Sterilization

160

2 Hour

Depyrogenation

250

0.5 Hour

Refrence USP 32, NF 27

(85) Page 91

_____________________________________________________________________________________________________
This document is the exclusive property of Industries Limited and its contents must not be communicated to unauthorized
persons or persons outside the company with out written consent of Departmental Head.