CERTIFICATE
No. Z2 05 01 24776 004

Certificate Holder:

WESSO® AG
Martin-Luther-Straße 1091217 Hersbruck
GERMANY

Production Facility:

24776

Test Mark:

Product:

Water and Air Hygiene Products

Type:

WESSO® Air

Data:

concentrated solution in PE-cansof 5, 10, and 20 liters

Tested according to:

PPP 40008:2004

The product was checked for compliance with basic requirements on a voluntary basis
and is allowed to be shown with the test mark represented above. The following noticemust be respected.
Study Report No.:

70083088

Valid before:

2010-01-12

Date, 2005-01-25

Page 1 out of 1
TÜV Product Service GmbH ·TÜV SÜD Group · Certification Body · Ridlerstrasse 65 · 80339 Munich · Germany

Technical Report No. 70083088
Rev. 01
Date: 2005-01-11
Client:WESSO® AG
Martin-Luther-Straße 10
D-91217 HersbruckCompetence.
Certainty.
Quality.

Production Facility:

see above

Subject of Examination:

WESSO® Air

Test Specification:

TÜV Product Service test programme for water and air
hygiene products
PPP 40008, 2004-11, Rev. 01

Study Demand:

testing according to test specification

Study Result:

The product WESSO® Air meets the applicable biologicaltoxicological requirements with respect to hygiene,effectiveness and safety of use.
WESSO® Air is effective in reducing unpleasant smell andgerms, and it is biologically degradable.

This Technical Report must not be reproduced but as complete text. Use in marketing requires a consent
statement in written form. The report includes the result of a single investigation with the product provided
for testing and does not represent a generally binding decision on properties of current production.

File: Wessogreen Air rev 01.doc
Report No.: 70083088
Page 1 of 5

Project Manager: Phone: +49 (0)89 50 08 – 41 63
Karl-Heinz Reiche Fax: +49 (0)89 50 08 – 42 87
Date: 2005-01-11 Karl-Heinz.Reiche@tuev-sued.deTÜV Product Service GmbHTÜV SÜD Group
Munich Branch
Ridlerstraße 6580339 MunichGermany

1Device Description

1.1

Function
Producer information on use according to instructions:
The product WESSO® Air serves for the elimination ofgerms from air, and for that, the product is distributed byultrasound (cold) air nebulizing in the air of closed spaces.
As nebulizers, devices may be applied which produce a steady stream of cold fog(aerosol) with particles of a size less than 5 µm.
WESSO® Air is utilized with well defined methods of active substance nebulizing,
among others in food, medical devices and pharmaceutical industries, but also in
public and private institutions.
Producer information on predictable misuse:
None

1.2

Technical DataWESSO® Air is an aqueous concentrated solution containing agents in aconcentrated solution (the exact recipe is known to the certification body) which
for use will be diluted with completely desalted (deionized) water and nebulized
cold by ultrasound at concentrations from 0,04-0,1 ml/m3 space.
The product is marketed in Lupolene cans of 5, 10, and 20 l content.
Shelf life amounts to 12 months.
The product is identified by the UBA (German Federal Environmental Agency)
no. 12910302.

2Order2.1

Date of Order, Client Reference
2004-09-20

File: Wessogreen Air rev 01.doc
Report No.: 70083088
Page 2 of 5

Project Manager: Phone: +49 (0)89 50 08 – 41 63
Karl-Heinz Reiche Fax: +49 (0)89 50 08 – 42 87
Date: 2005-01-11 Karl-Heinz.Reiche@tuev-sued.deTÜV Product Service GmbHTÜV SÜD Group
Munich Branch
Ridlerstraße 6580339 MunichGermany2.2

Receipt of Test Product Samples/Documentation
October 2004

2.3

Test Date
November 2004

3Study Results••WESSO® Air is defined as an agent eliminating germs from air, or as anactive substance improving quality of air in closed spaces, respectively.
The product is of importance as an additional and supporting measure incontext of production hygiene. Based on a well established hygienic
regimen and HACCP plan, microbiological hygiene of the environment can
additionally be improved by applying WESSO® Air.

•

Concomitant service consultations of the producer or contracted agentsand the application of defined procedures are essential to ensure safety
and suitability of use.

•Germ reduction up to bactericide properties was proved by competentexpert reports. A germ reducing effect in the use as an agent eliminating
germs from air also was confirmed by application accompanyingverifications.

•Reports being in favour of it, based on analysis of applications in foodindustries, indicate that with the use according to the specified purpose inreported fields of utilization an improvement of production andenvironmental hygiene, respectively, is obtained by a reduction of germ
pollution in the air of closed spaces. This again has a positive effect on
product quality with respect to preservability and germ contamination.

•WESSO® Air is comparable to the product WESSO® Claris concerning its
combination of active substance. In comparison, WESSO® Air contains
much lower concentrations of the agents. Therefore, the results of the TÜV
Bavaria-Institute for Safety in Biotechnology study from 1996-02-28 aretransferable with respect to the properties biologically degradable andsaving material.

File: Wessogreen Air rev 01.doc
Report No.: 70083088
Page 3 of 5

Project Manager: Phone: +49 (0)89 50 08 – 41 63
Karl-Heinz Reiche Fax: +49 (0)89 50 08 – 42 87
Date: 2005-01-11 Karl-Heinz.Reiche@tuev-sued.deTÜV Product Service GmbHTÜV SÜD Group
Munich Branch
Ridlerstraße 65
80339 MunichGermany

3.1

•

So far, damage to material in adequate use was notobserved.

•There are no concerns about regulations on food law
in view of the agents and concentrations applied.

•Toxicological and adverse effects in man could
neither be assessed in expert statements nor be proved in test series andbiological indicator testing (CMT: ciliate mobility test).

•WESSO® Air does not come under labelling regulations concerning
additives.

Positive Study Results
WESSO® Air has smell and germ reducing effects and is biologically degradable.
The requirements according to test programme PPP 40008 Rev. 01 are met.

3.2

Items which are not in accordance with test specification
None

4Annotation••

4.1

The actual laboratory analysis concerning the composition of theWESSO® Air stock solution must be handed in later.
This study should be considered in context of the results of the production
facility visitation.

Comment on production
At present, the production facility is relocated and should be inspected as late as
the 1st quarter of 2005.

File: Wessogreen Air rev 01.doc
Report No.: 70083088
Page 4 of 5

Project Manager: Phone: +49 (0)89 50 08 – 41 63
Karl-Heinz Reiche Fax: +49 (0)89 50 08 – 42 87
Date: 2005-01-11 Karl-Heinz.Reiche@tuev-sued.deTÜV Product Service GmbHTÜV SÜD Group
Munich Branch
Ridlerstraße 6580339 MunichGermany

5Conclusion
The product WESSO® Air meets the applicable biologicaltoxicological requirements with respect to hygiene,effectiveness and safety of use.

TÜV PRODUCT SERVICE GmbHMHS 2 - Non-active Medical Products

Project Manager

Jürgen Kunte

Karl-Heinz ReicheTranslation:
p.p. Dr. med. Wolfgang Stengel

File: Wessogreen Air rev 01.doc
Report No.: 70083088
Page 5 of 5

Project Manager: Phone: +49 (0)89 50 08 – 41 63
Karl-Heinz Reiche Fax: +49 (0)89 50 08 – 42 87
Date: 2005-01-11 Karl-Heinz.Reiche@tuev-sued.deTÜV Product Service GmbHTÜV SÜD Group
Munich Branch
Ridlerstraße 6580339 Munich
Germany