Sabouraud Glucose Agar with LTHTh LI 30ML [Pack of 20]

Description

Ten settle plates each with a diameter of 90 mm are single-bagged in transparent, hydrogen peroxide impermeable sleeves (non-irradiated). The sleeves consist of polypropylene with a barrier of PE-EVOHPE.

The formulation of the basic medium (Sabouraud Dextrose Agar) is prepared according to the recommendations of the current European, Japanese and United States Pharmacopoeia (EP, 2.6.12.; JP, 4.05 and USP, 61) and supplemented with neutralizers.

Mode of Action

Sabouraud Dextrose Agar (SDA) is a complex medium for cultivation and isolation of yeasts and molds as well as the absence test for Candida albicans. According to pharmacopoeia and ISO 18415, the neutralizers lecithin, polysorbate (Tween®) 80, histidine and sodium thiosulfate are suitable for neutralization of disinfectant residues containing the following active agents:

• Aldehydes

• Bis-biguanides

• Oxidizing compounds

• Parabens

• Phenolic compounds

• Quaternary ammonium compounds

The high concentration of dextrose in addition with the low pH promotes the growth, the formation of spores (conidia and sporangia) as well as the formation of pigments of yeasts and molds. On the other side the growth of bacteria is inhibited.

Typical Composition

Casein Peptone 5 g/l

Meat Peptone 5 g/l

Dextrose 40 g/l

Lecithin 0.7 g/l

Polysorbate (Tween®) 80 5 ml /l

Histidine 0.5 g/l

Sodium Thiosulfate 0.3 g/l

Agar 18 g/l

The appearance of the medium is clear and yellowish. The pH value is in the range of 5.4-5.8. The medium can be adjusted and/or supplemented according to the performance criteria required.

Application and Interpretation

Each plate is provided with a label including a data matrix code for paperless plate identification. The code consists of a two-dimensional 20-digit serial number, which harbors the following information: Digits 1-3: here code 782 (corresponds to article 146052); digits 4-9: lot number; digits 10-14: batch specific individual number; digits 15-20: expiry date (YY/MM/DD).

Please check each agar plate before using it on sterility and pay attention to aseptic handling to avoid false positive results.

The plates may be used for passive or active air monitoring as described in USP chapter <1116> or ISO 14698. For active air sampling please follow the guidance of the air sampler. Typically, 1000 liter of air are sampled for quantification of CFU. The exposure time of opened settle plates should be validated with respect to the environmental conditions of the sampling area such as flow rates, temperatures and relative humidity to preclude desiccation. Afterwards the plates are closed and transferred to an incubator. To protect the plates from secondary contamination during transport and incubation outside of the Clean Room zone, sterile transport bags (article number 146509) may be used.

Several recommendations are given by different guidelines for incubation: according to USP <1116> the plates used for environmental monitoring should be incubated between 20 and 35 °C for not less than 72 hours. According to the FDA Aseptic Guide the plates for determination of the total yeast and mold count should be incubated at 20 to 25 °C for 5 to 7 days. Individual incubation conditions can be chosen and should be validated at the application side. Finally, the number of CFU per plate is examined. Grown colonies are recommended to be identified.

Storage and Shelf

The product can be used for sampling until the expiry date if stored upright, protected from light and properly sealed at +15 °C to +25 °C. Condensation can be prevented by avoiding quick temperature shifts and mechanical stress. The testing procedures as described on the CoA can be started up to the expiry date printed on the label.

Disposal

Please mind the respective regulations for the disposal of used culture medium (e.g. autoclave for 20 min at 121 °C, disinfect, incinerate etc.).