Introduction to

BioLumix

MIKROBIOLOGIE

BRAUEREITECHNOLOGIE

ZELLBIOLOGIE

BIOTECHNOLOGIE

I&L BIOSYSTEMS GmbH (D)

1991

The I&L Group

LA BIOSYSTEMS BV (NL)

2007

I&L BIOSYSTEMS FRANCE SAS (F)

2015

I&L BIOSYSTEMS UK Ltd. (UK)

2016

What is BioLumix?

rapid microbiological testing system

growth based – photometric measurement

ready-to-use vials with prepared media

CO2 as universal metabolite

Sensor detects CO2 produced by microorganisms

Separation of incubation and detection

Principle of Detection

Measurement of light intensity

Color change of indicator

Detection by Color Change

Measurement every 6 minutes

Light intensity increases with color change

Increase triggers detection event

Incubation and Monitoring

BioLumix is … simpler

almost no maintenance

intuitive sample preparation

easy to operate

1 min 8h 22 h

Faster results…

…for faster release

Sensitivity = one viable cell per vial

single bacterial cell detects in 8-18 h

single yeast cell detects in 20-30 h

mould cells detect in 35-48 h

Sensitivity

Organism Incubationtemp.

Colony count (CFU)

1,00E+00 1,00E+01 1,00E+02 1,00E+03 1,00E+04 1,00E+05

A. brasiliensis¹ 28 ˚C 32,37 28,12 23,86 19,61 15,35 11,10

A. brasiliensis² 28 ˚C 42,76 37,69 32,61 27,53 22,46 17,38

C. albicans¹ 28 ˚C 26,02 22,54 19,05 15,57 12,08 8,60

C. albicans² 28 ˚C 27,75 23,44 19,13 14,82 10,51 6,20

E. coli¹ 35 ˚C 10,19 9,18 8,18 7,17 6,16 5,16

E. coli² 35 ˚C 12,15 11,04 9,93 8,81 7,70 6,59

P. aeruginosa¹ 35 ˚C 16,51 14,81 13,11 11,40 9,70 8,00

P. aeruginosa² 35 ˚C 17,83 16,08 14,34 12,59 10,84 9,10

S. aureus¹ 35 ˚C 16,55 14,97 13,38 11,79 10,20 8,61

S. aureus² 35 ˚C 16,98 15,32 13,66 12,00 10,34 8,68

Detection times in hours of some selected strains in relation to CFU

1 = pure culture2 = pure culture damaged by product (preservatives)

Detection Times with BioLumix

quadruplicate tests with pure cultures

standard deviation approx. 0.3 h

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High Reproducibility

BioLumix is … convincing

comprehensive validation (USP)

versatile application

practice-approved

hands-on:

1 min / sample

Example:

spec. level

Liquid culture can be used for further tests

Automated monitoring & evaluation

Significant reduction of hands-on time

Semiquantitative Results

White = no growth = compliance with limits

Red = growth = out of specification

Clearance Demand for action

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Test for pathogenic organisms

Examples of neutralizers:

Dilute product 1:10 with neutralizer

Add 0.1-1.0 ml to Biolumix vial and incubate

Use vials with pre-added neutralizers

D/E Neutralizer

Letheen broth

TAT

TSB + Tween und Lecithin

Neutralizing Preservatives

Sample Preparation

Tests for effective neutralization of

preservatives

Control sample and spiked product

must yield similar detection times

Suitability test prevents false

negative tests due to incomplete

neutralizationFigure 4: TAC controls; blue, B.subtilis (10.0h); red, sample

1 spiked (12.1h); cyan, sample 6 spiked (17h); green,

negative control (TSB)

Liquid soap - spiked

Suitability Test

swab the surface

cut of the swab and directly incubate in the Biolumix vial

alternatively: dilute in buffer

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Environmental Monitoring

Total Aerobic Count

Yeast & Mould

Coliforms

Enterobacteriaceae

Heterotrophs (for water)

E. coli

Pseudomonas

Staphylococcus

Salmonella

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Available Assays