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MISC_2007003_0028_01 December 22nd 2016

Functioning and Composition (light)

®
Novelia
Preservative-Free Multi-Dose eye dropper

Functioning and Composition (light)

CONFIDENTIAL – DO NOT USE FOR REGULATORY FILING PURPOSES


This document is the property of Nemera and must not be copied, reproduced, duplicated nor disclosed totally or partially 1.
to any Third Party, Nor used in any manner whatsoever without the prior written consent of Nemera © Nemera 2016.
MISC_2007003_0028_01 December 22nd 2016

Functioning and Composition (light)

Table of Content

1 Functioning of our P-free system Novelia® .................................................................. 4


2 Novelia® parts and materials ...................................................................................... 6

CONFIDENTIAL – DO NOT USE FOR REGULATORY FILING PURPOSES


This document is the property of Nemera and must not be copied, reproduced, duplicated nor disclosed totally or partially 3.
to any Third Party, Nor used in any manner whatsoever without the prior written consent of Nemera © Nemera 2016.
MISC_2007003_0028_01 December 22nd 2016

Functioning and Composition (light)

1 Functioning of our P-free system


Novelia®

Step 3: Valve reclosing


Silver ions: no toxicological concern expected

Some residual liquid can remain on the outside of the tip as the liquid is prevented from returning
into the container by the one-way valve.

The liquid remaining on the outside of the one-way valve (residual drop) is protected from bacterial
growth by the presence of silver ions in the outer components (Top and Cap). The residual drop is
further protected by the cap reclosing. Note that this does not influence the shelf life, as even
without the cap reclosing, the remaining liquid dries, minimising the likelihood of bacterial growth.

It is to be noted that the silver ions act only on the residual drop. The content of the bottle is
protected by the non-return valve which acts as a mechanical barrier.

CONFIDENTIAL – DO NOT USE FOR REGULATORY FILING PURPOSES


This document is the property of Nemera and must not be copied, reproduced, duplicated nor disclosed totally or partially 4.
to any Third Party, Nor used in any manner whatsoever without the prior written consent of Nemera © Nemera 2016.
MISC_2007003_0028_01 December 22nd 2016

Functioning and Composition (light)

Step 4: Air compensation


PureFlow® Technology for maximum safety

Permeability technology: Patented PureFlow®


Technology!!

- Homogeneous and continuous material


(injected silicone parts)
- Air flow through the silicone
- All germs too large to go through the
silicone membrane
- Permeation :
Absorption at the surface
Diffusion in the free volume of
the polymer
Desorption
- 100% online product control

Not using the filtration technology (used by some


competitors)

- Pore size <0,22µm


- Local pore size greater than 0,22 µm
- Impossible to control it during
manufacturing
- Risk of contamination with bacteria growth
through wet filter

CONFIDENTIAL – DO NOT USE FOR REGULATORY FILING PURPOSES


This document is the property of Nemera and must not be copied, reproduced, duplicated nor disclosed totally or partially 5.
to any Third Party, Nor used in any manner whatsoever without the prior written consent of Nemera © Nemera 2016.
MISC_2007003_0028_01 December 22nd 2016

Functioning and Composition (light)

2 Novelia® parts and materials

PureFlow®

CONFIDENTIAL – DO NOT USE FOR REGULATORY FILING PURPOSES


This document is the property of Nemera and must not be copied, reproduced, duplicated nor disclosed totally or partially 6.
to any Third Party, Nor used in any manner whatsoever without the prior written consent of Nemera © Nemera 2016.

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