Tryptic Soy (CASO) Broth, irradiated

Tryptic Soy Broth, Irradiated

Cat. No. 1.00800.5007
(5 kg)

Dehydrated culture medium sterilized by irradiation for the microbiological validation of aseptic filling (Media Fill Test).

The dehydrated culture medium is irradiated with 48-62 kGy gamma. The intensity of irradiation guarantees that even spores are destroyed. The test for sterility is carried out by incubation of part of the prepared medium.

Mode of Action	Experimental Procedure and Evaluation
Typical Composition (g/liter)	Quality Control
Preparation	Literature

Mode of Action
The medium complies with the recommendations of USP XXIII (1995), EP (1999) and the Ph Eur. (1999) German edition.
Due to the rich nutrient base, this medium is also suitable for the cultivation of even fastidious microorganisms.

Typical Composition (g/liter)
Peptone from casein 17.0; peptone from soymeal 3.0; D(+)glucose 2.5; sodium chloride 5.0; di-potassium hydrogen phosphate 2.5.

Preparation
Dissolve 30 g in 1 liter of sterile, purified water and use according to the purpose required.
pH: 7.3 ± 0.2 at 25°C.
The prepared medium is clear and yellowish-brown.

Experimental Procedure and Evaluation
The medium is very suitable for the simulation of aseptic filling of sterile powder. The filled powder is readily soluble in sterile purified water and can be dissolved directly together with the filled units. The previously aseptically prepared medium can be used for the simulation of the aseptic filling of liquids. For the validation of the aseptic filling at least 3,000 units per run are expected to be filled. The contamination rate should be <1/1000 at a probability of 95 %. (EU-GMP Guidelines, Annex 1, ISO 13408-1). A growth control should be carried out for each run. The strains listed in the table below serve as growth controls, whereby bacteria should demonstrate good growth after 3 days of incubation at the latest and yeasts and molds after 5 days.

Quality control (inoculum about 10-100 microorganisms)

Test strains	Growth	max. incubation time
Escherichia coli ATCC 8739	good	3 days
Staphylococcus aureus ATCC 6538-P	good	3 days
Streptococcus pneumoniae ATCC 6301	good	3 days
Bacillus subtilis ATCC 6633	good	3 days
Pseudomonas aeruginosa ATCC 9027	good	3 days
Candida albicans ATCC 10231	good	5 days
Candida albicans ATCC 2091	good	5 days
Aspergillus niger ATCC 16404	good	5 days
Sterility test (2 weeks at 20-25°C and 30-35°C):	no growth

Literature

Product Brochure

Deutsches Arzneibuch, 10. Auflage; European Pharmacopeia II, United States Pharmacopeia XXIII; ISO 13408-1, 1998-08-01, Aseptic processing of health care products – Part 1: General requirements.