Product Groups and
Quality Control (QC) of
Culture Media
Manufacturing
Tamás Ferenci
Biolab Inc.
16 September 2010
Topics
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Culture Media Manufacturing – Standards
and Goals
Product Groups of Culture Media
Questions of QC in Production
Part I: Culture Media
Manufacturing –
Standards and Goals
Goals of Culture Media Manufacturing

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The manufacturing of culture media
complying with the partner’s qualityneeds, having good price-to-value?
Assurance of constant good quality
Fast reaction to the needs of the market
Assurance of appropriate quality with
regular control
Complying with the principles of control
during development as well
Part II: Product
Groups of Culture
Media
Product groups of culture
media

Systematically compiled product
groups, specialized according to
usage?

Clinical microbiology

Basic media, Basic enrichment media, Antimicrobial
susceptibility testing agars, Selective and differential
media, Biochemical media, Sugars in ‘Hugh-Leifson’
of medium base or peptone water or phenol red agar
base, Blood cultures, Mycological media, Media for
enteric pathogens, Stains and reagents, Transport
sets
Product groups of culture
media (contd.)


Genetic studies
Water microbiology

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Microtiter plate media, Liquid media,
Solid media
Food microbiology
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Liquid media, solid media
Specialized product groups

Products with distinctive…
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pricing (EcoBio®)
composition (ChromoBio® / FluoroBio®)
quality (PharmaBio®)
Registered trademarks of Biolab Inc.
EcoBio®

Special characteristic

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Cheaper products made from economic grade
raw materials
There is no separate EcoBio® price list
as we always want to give the current
best prices to our customers. So if you
are interested in this, please let us know
the exact type and quantity of the
culture media you need and then we will
calculate our best EcoBio® prices for
you.
ChromoBio® / FluoroBio®

Special characteristic

Chromogenic and flurogenic media
PharmaBio® I.

Special characteristic


Specific media manufactured for laboratories of
pharmaceutical industry
Media conforming to Ph. Hg. VII. in
quality and composition
PharmaBio® II.

Below the following quantities of
each prepared media, 10 EUR
testing cost is incurred:
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500ml – 20pcs
100ml – 50pcs
Tubes – 200pcs
Plates – 500pcs
Part III: Questions of
QC in Production
QC Aspects of Culture Media
Manufacturing I.

Raw materials and their quality indicators

Agar

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Peptons, meat extract

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cultivation ability
Antibiotics, other supplement

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clarity, gel strength
inhibition, selectivity, colour reactions
The selection of the quality of raw materials
consistent with the culture media is important
Formula
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Experimenting to reach the best composition, taking
quality aspects into account
In case of PharmaBio®: conforming to Ph. Hg. VII.
QC Aspects of Culture Media
Manufacturing II.

The first step of manufacturing is the mixing
of dehydrated media
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The quality of the culture media depends on this
in 90%!
Components of quality
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Proper raw materials
Proper knowledge (teams, technological background)
Proper QC protocol throughout the production process
Constant self-checking
Laboratory controls
Monitored parameters in QC I.
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Physicochemical parameters
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Clarity, colour
pH, pH stability
Homogeneity, deposit
Gel strength
Microbiological quality indicators
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Cultivation ability, colony morphology
Selectivity
Differentiation
Colour- and other reactions
Monitored parameters in QC II.

Regain (%)
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Min. 70% in case of positive (+) control
Max. 5% in case of negative (-) control
(In case of PharmaBio®: for every degree of
processing – dehydrated, prepared, plates)
In nutshell: colony count on the
investigated culture media batch is
compared to the one obtained with a
reference culture media
Methodology of QC
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Check WITH what?
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Standard, properly maintained strains of
controlled quality
Compare TO what?
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Earlier production batch
Standardized, reference culture media
Production process and QC
Dehydrated media
QC
Prepared media
Sales
Plated media
Tracing of production batches
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Composition of the LOT numbers
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Dehydrated media: BPA111204036
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Prepared media: BPA361223
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BPA: code of the media
036: batch number
11 – day, 12 – month, 04 – year
BPA: code of the media
36: batch number
12 – month, 23 – day (of preparation)
Plated media: BPA360117
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BPA: code of media
36: batch number
01 – month, 17 – day (of pouring)
Thank you for your attention!