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Hepa filter validation testing, D.o.p. testing, Class 100 testing – Despatch LCC/LCD2-14-4 Oven Series with Protocol 3 User Manual

Page 20: Validation testing, Caution

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T

HEORY OF

O

PERATION

LCC/LCD2-14 Series Oven

Owner’s Manual

20

Version 1

Copyright © 2013 by Despatch Industries.

All rights reserved. No part of the contents of this manual may be reproduced, copied or transmitted in any form or by any
means including graphic, electronic, or mechanical methods or photocopying, recording, or information storage and
retrieval systems without the written permission of Despatch Industries, unless for purchaser's personal use.

If an unpackaged HEPA filter unit must be placed with its face on the floor or other surface, clear
the surface entirely of every object or irregularity which might damage the filter pack.

3.3.3. HEPA Filter Validation Testing

Despatch Industries guarantees the HEPA filters will meet specified efficiency ratings when the
following recommendations are followed:

The filter is properly installed

The filter is run at or below 180°C, at a constant temperature

The filter is burned off at 260°C for 48 hours before running

3.3.3.1. D.O.P. Testing

Caution!

Despatch does not recommend D.O.P. filter testing.



D.O.P. testing uses aerosol particles of submicron size to spot defects or measure filter efficiency.
Degenerative by-products of this test are distributed throughout the oven chamber upon heat-up.
These and other organic challenge agents present a fire hazard for LCC/LCD2-14 Non-Class A
(NFPA 86) ovens. Despatch does not recommend D.O.P. filter testing.

3.3.3.2. Class 100 Testing

Despatch guarantees a Class 100 environment within the oven. This classification is based on
measurement of the particulate level within the oven work chamber.

Class 100 testing may be performed before or after a proper filter burn-off procedure has been
performed. Despatch guarantees Class 100 condition measurements based on two methods of test.
The direct method employs an extraction-type particulate analyzer. The indirect method involves
particle settling over a specified period of time onto a clean disk. Please consult factory for
expected levels.

3.3.3.3. Validation Testing

Despatch recommends the following test sequence for pharmaceutical Class 100 ovens.
1. Proper installation of the HEPA filters (Section 4.3).
2. Ambient air challenge to determine integrity of oven chamber and filter gaskets.
3. Proper filter burn-off procedure.
4. Class 100 testing inside the work chamber.