Document 20 460 234 - Bionova Technologies s.r.l....L234 test report compliance to EN 12469 Document Number: 20 460 234 Document Version: 1.0 Document Responsible TGA Page 1 of 12

L234 test report compliance to EN 12469

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Content

1 Scope ............................................................................................................................................ 3

2 Definitions and Acronyms ............................................................................................................ 3

3 How to obtain compliance to the Standard ................................................................................. 3

3.1 Type testing ........................................................................................................................... 3

3.1.1 Retention at front aperture ........................................................................................... 3

3.1.2 Leaktightness of carcass ................................................................................................. 3

3.1.3 Filters .............................................................................................................................. 4

3.1.4 Product protection ......................................................................................................... 4

3.1.5 Cross contamination ...................................................................................................... 4

3.2 Installation testing ................................................................................................................. 4

3.2.1 Volumetric airflow rate measurements ......................................................................... 4

3.2.2 Check airflow patterns ................................................................................................... 4

3.3 Guidance on manufacture ..................................................................................................... 4

3.3.1 Front aperture height .................................................................................................... 4

3.3.2 Lightning ......................................................................................................................... 4

3.3.3 Sound ............................................................................................................................. 5

3.3.4 Vibration ......................................................................................................................... 5

3.3.5 Stability........................................................................................................................... 5

3.3.6 Materials, general .......................................................................................................... 5

3.3.7 Glass and front window ................................................................................................. 5

3.3.8 Electrical safety .............................................................................................................. 5

3.3.9 Gas supply safety ........................................................................................................... 6

3.3.10 Ergonomics ..................................................................................................................... 6

3.3.11 Temparature .................................................................................................................. 6

4 Tests done .................................................................................................................................... 6

5 Person .......................................................................................................................................... 6

6 Instrument / Series number / calibrated ..................................................................................... 6

7 Conclusion .................................................................................................................................... 7

8 Annex A ........................................................................................................................................ 8

9 Annex B ........................................................................................................................................ 9

9.1 Normal conditions ................................................................................................................. 9

9.2 If MSC is turned off after use ................................................................................................ 9

10 Annex C ...................................................................................................................................... 10

11 Annex D ...................................................................................................................................... 12


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1 Scope

The scope of this document is to describe the compliance of the K-Systems L234 workstation to

the standard EN 12469:2000.

In general three types of performance testing can be distinguished: Type testing, Installation

testing and routine maintenance testing. (See table 5 in EN 12469)

Routine maintenance testing is a sub part of the installation testing as described in the standard.

We have therefore chosen to verify that L234 comply type testing and relevant installation testing,

as stated in table 5 in the standard.

2 Definitions and Acronyms

15 060 04 Definitions

Testing is passed (P).

Not applicable (n/a).

Testing is failed (F)

3 How to obtain compliance to the Standard

The following paragraphs refers back to the test specifications listed in table 5 of the standard.

See table 5 in annex D.

3.1 Type testing

3.1.1 Retention at front aperture

KI method chosen and done testing. (See annex A) P

3.1.2 Leaktightness of carcass

Soap solution test method chosen and done testing. (See annex B) P


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3.1.3 Filters

Aerosol challenge method chosen and done testing. (See annex C) P

3.1.4 Product protection

Microbiological method or alternative KI method. n/a

3.1.5 Cross contamination

Microbiological method or alternative KI method. n/a

3.2 Installation testing

3.2.1 Volumetric airflow rate measurements

Measurements must be made in the horizontal plane 50 mm to 100 mm above the top

edge of the front aperture. Requirements in the standard states that the mean downflow

velocity to achieve product protection must be within 0,25 m/s to 0,50 m/s. No individual

measurements should differ from the mean by more than 20%.

We measure mean 0,35 m/s. with a difference at min 9% and max 13% (See annex C). P

3.2.2 Check airflow patterns

Same as 3.2.1. (See annex C) P

3.3 Guidance on manufacture

3.3.1 Front aperture height

The height of the front aperture should be between 160 mm and 250 mm.

We have 163,5 mm. P

3.3.2 Lightning

Lightning at the work surface should be at least 750 lux.


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We measure around 900 lux at the working positions. P

3.3.3 Sound

The sound level should not exceed 65 dB A-weighted.

We have measured 57 dB A-weighted. P

3.3.4 Vibration

We have less than 0,005 mm RMS. At work surface between 20 Hz and 20000 Hz. P

3.3.5 Stability

Equipment is tilted in each direction to an angle of 10° from its normal position. Equipment has a force applied at its top, or at a height of 2 m if the equipment has a height more than 2 m. The force is 250 N, or 20 % of the weight of the equipment, whichever is less, and is applied in all directions except upwards. Conforming EN 61010-1 for stability. P

3.3.6 Materials, general

The material where micrio-organisms have contact whould be corrosion resistant,

non-flammable and non-adsorbing.

The tabletop where micro-organisms should be at is made of stainless steel, which

is corrosion resistant, non-flammable and non-adsorbing. P

3.3.7 Glass and front window

Glass side windows complying to EN 61010-1. P

Transparent front window, can be taken off while system is not running, but must

be mounted while in use. When working with IVF only a small opening is needed.

3.3.8 Electrical safety

The MSC has been designed to, and are being tested at UL in Denmark, to conform

EN 61010-1. In test


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3.3.9 Gas supply safety

No flammable gas installed n/a

3.3.10 Ergonomics

The design should ensure that maintenance can safety be carried out on the

cabinet after installation. P

- Easy to remove back panel for filter replacement

- Easy to open tray for cleaning

- Powder coated cabinet for easy cleaning

- Stainless steel tabletop accept all normally use detergents and alcohol for cleaning

3.3.11 Temparature

With no heat in tabletop temperature will not rise by more than 8 ˚C. P

4 Tests done

- Downflow measurements

- Inflow measurements

- DOP (HEPA filter leakage)

- KI-Discus

5 Person

Mechanical Engineer Thomas Grau-Andersen

6 Instrument / Series number / calibrated

- Testo 425 / 02052833 / 01-08-2012

- TDA-2G / 15747 / 03-09-2012

- Ki-Discus MK2 / K03/05-0188 / 22-08-2012


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7 Conclusion

Relevant tests from EN 12469:2000 is listed and show how L234 workstation comply to the class II

standard.

L234 workstation have successful ergonomics and the design ensure that maintenance can safety

be carried out on the cabinet after installation.

Performance results in brief:

All airflow measurements such as downflow and inflow are complying to EN 12469:2000.

DOP test (HEPA filter test) are complying to EN 12469:2000.

The sound level are complying to EN 12469:2000.

The vibration level are complying to EN 12469:2000.

General design are complying to EN 12469:2000.


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8 Annex A

The KI Discus test was performed:

By: Thomas Grau-Andersen Date: 27-08-2012 On L234 S/N: Proto 2

Instrumentation / calibration: Ki-Discus MK2 / 22-08-2012

The photo above shows the 4 filters suction in front of the cabinet, at the KI-Discus setup.

Conclusion: We have less than 62 brown dots at each filter.


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9 Annex B

9.1 Normal conditions

Under normal running conditions non-filtered air under

positive pressure is encapsulated by surroundings

negative pressure. Therefore positive pressure leaking to

the surroundings under running conditions is only

theoretical possible through sample port for DOP testing.

This sample port is double secured with both a valve and

a silicone cap.

9.2 If MSC is turned off after use

Soap solution test with an internal pressure at approximately 250 Pa and observe the soap

applied.


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The Soap solution test was performed:

By: Thomas Grau-Andersen Date: 20-08-2012 On L234 S/N: Proto 2

Instrumentation: Soap solution

The previous photos shows how soap solution is added to the cabinet.

Conclusion: If the MSC is turned off nothing indicating leaks.

10 Annex C

Downflow is measured by use of an anemometer. With the anemometer inside the MSC, make air

velocity measurements in the horizontal plane 50 mm to 100 mm above the top edge of the front

aperture. Make measurements over a period of at least 1 min in each position for at least eight

positions. The exact height and placement can be seen in the tables(s) below.

Inflow is measured by use of an anemometer. With the anemometer outside the MSC, make air

velocity measurements pointing towards front opening. The exact height and placement can be

seen in the tables(s) below.

DOP test (HEPA filter test) is measured by use of an aerosol photometer. With this device test

filters and edges along workspace filter and exhaust filter. If an aerosol photometer is used, the

local penetration of a HEPA filter should be not more than 0,01 %. Test results can be seen in the

tables(s) below.


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11 Annex D

Document 20 460 234 - Bionova Technologies s.r.l....L234 test report compliance to EN 12469 Document Number: 20 460 234 Document Version: 1.0 Document Responsible TGA Page 1 of 12

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