Tryptic Soy Broth for „Media Fills“
Art.-No. 502 10l b; 502bulk
Intended Use
Multi layer foil bags filled with up to 10 litres or up
to 200 litres with Tryptic Soy Broth are developed
especially for the use as “media fill” medium.
Tryptic Soy Broth is a universal complex fluid culture medium for cultivation of fastidious bacteria,
yeasts and moulds.
The formulation of Tryptic Soy Broth is in compliance with the recommendations of the actual European Pharmacopoeia (EP, Broth Medium A)
and the United States Pharmacopoeia (USP,
Soybean Casein Digest Medium).
Typical Composition per litre
Casein Peptone
Soy Peptone
Glucose (Dextrose)
NaCl
K2HPO4
17 g
3g
2.5 g
5g
2.5 g
pH 7.3 ± 0.2
The medium is clear and yellowish.
Description
Tryptic Soy Broth supports the growth of a wide
variety of aerobic and facultative anaerobic micro
organisms including fungi due to the content of
two highly nutritious peptones.
10 litre bags: The autoclaved medium is filled into
the previously γ-sterilised multi layer foil bags via
sterile filtration. The 10 litre bags are packed into
two further safety bags followed by a second γirradiation at a dose of 9-20 kGy.
The bags are supplied with an 80 cm outlet connection tube and short outlet tube each containing
a MPC-male connector for the removal of the
medium. In addition a separate septum is applied
for supplementing the broth.
200 litre bags: The autoclaved medium is filled
into the previously γ-sterilised, self-collapsing,
multi layer foil bags via sterile filtration. Within the
filling line three further 1-litre bags are filled for
growth promotion tests, sterility control and retain
sample.
The 200 litre bag is supplied with two tubes with
MPC-male and ACD connectors for removal of the
medium. One outlet tube is designed as a dip tube
through which the medium can be pumped out of
the container. The second outlet tube is positioned at the bottom side of the bag for removal of
the medium by gravity. After filling the bags are
packed into a transport container which is provided with an opening for the base tube outlet.
For control of the medium before or after use in
media fill an empty sample bag is supplied with
the medium bag.
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For 200-litre bags during filling 3 separate 1-litre
bags are filled for growth promotion tests, sterility
control and as retain sample.
The table below will show a typical growth promotion test for Tryptic Soy Broth for “Media Fills” 10
litre (Art. No. 502 10l b). After the indicated incubation conditions a clearly visible growth must
occur.
Culture Conditions
According to the recommendations of the current
GMP guidelines the broth should be incubated
after finishing the “media fill” for not less than 14
days at a temperature of 20-35°C. The temperature should be maintained within ± 2.5°C from the
target temperature. If two temperatures are used
for the incubation of media fill units, the units
should be incubated at least 7 days at each temperature (starting with the lower temperature).
Quality Control
After γ-irradiation of the complete system one bag
is used for growth promotion tests and sterility
control of the medium.
Test organism
Incubationconditions
Staphylococcus aureus
ATCC 6538
1d 34 ± 1°C
Escherichia coli
ATCC 8739
1d 34 ± 1°C
Pseudomonas aeruginosa
ATCC 9027
1d 34 ± 1°C
Bacillus subtilis
ATCC 6633
1d 34 ± 1°C
Candida albicans
ATCC 10231
2d 22.5 ± 2.5°C
Aspergillus niger
ATCC 16404
3d 22.5 ± 2.5°C
Further Identification
In the case of growth it is recommended to identify
the micro organisms.
References
European Pharmacopoeia 5.0 (2004): 2.6.1. Sterility.
United States Pharmacopoeia XXVIII (2005):
<71> Sterility tests.
Guidance for industry: Sterile Drug Products Produced by Aseptic Processing – Current Good
Manufacturing Practice (September 2004) Pharmaceutical cGMPs.
.
heipha Dr. Müller GmbH
Lilienthalstraße 16
D-69214 Eppelheim
A member of the Biotest Group
Tel. +49 (0) 62 21 -7 59 01 -0
Fax +49 (0) 62 21 -7 59 01 -9 90
e-mail info@heipha.de
www.heipha.de
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