Liofilchem® GENTAMYCIN Supplement

The GENTAMYCIN Supplement is a selective, freeze-dried supplement containing Gentamycin, designed specifically for use with Sabouraud Agar (codes 610103 or 620103). This supplement enhances the isolation of yeasts and moulds by inhibiting the growth of Gram-positive and Gram-negative bacteria. It is commonly utilized in clinical, industrial, and environmental microbiology applications.

Key Features:

1. Selective Action:
   • Contains Gentamycin, a broad-spectrum antibiotic effective against a wide range of Gram-positive and Gram-negative bacteria.
   • Facilitates selective growth of yeasts and moulds by suppressing bacterial contamination.
2. Compatibility:
   • Formulated for use with Sabouraud Agar (codes 610103 or 620103), making it ideal for fungal isolation in diverse sample types.
3. Flexible Applications:
   • Suitable for clinical diagnostics, pharmaceutical quality control, food and beverage safety, and environmental monitoring.
4. Convenient Packaging:
   • Each kit contains 10 vials of lyophilized supplement, sufficient to prepare 5 liters of medium (1 vial per 500 mL of agar).

Composition:

• Gentamycin Content:
  • 25 mg per vial.
  • 50 mg per liter of prepared medium.

Preparation Instructions:

1. Reconstitution:
   • Aseptically reconstitute the content of one vial with 5 mL of sterile distilled water.
   • Mix until fully dissolved.
2. Incorporation:
   • Add the reconstituted supplement to 500 mL of Sabouraud Agar, pre-autoclaved and cooled to 45-50°C.
   • Mix thoroughly to ensure even distribution.
3. Dispensing:
   • Pour the supplemented medium into sterile Petri dishes under aseptic conditions.

Usage Guidelines:

• Use the prepared medium to isolate and enumerate yeasts and moulds from clinical and non-clinical samples, including environmental surfaces, food products, and pharmaceutical samples.
• Incubate plates at 30 ± 2°C for 18-48 hours to observe results.

Quality Control:

1. Physical Appearance:
   • Freeze-dried supplement: Pale yellow.
   • Reconstituted medium: Light amber and clear.
2. Microbiological Testing:
   • Plates prepared with Sabouraud Agar and GENTAMYCIN Supplement are inoculated with the following control strains:
     • Aspergillus niger (ATCC 16404): Good growth.
     • Staphylococcus aureus (ATCC 25923): Inhibited.
     • Saccharomyces cerevisiae (ATCC 9763): Good growth.
     • Candida albicans (ATCC 10231): Good growth.

Storage and Stability:

1. Unopened Vials:
   • Store at 2-8°C in the original packaging.
   • Avoid exposure to heat and temperature fluctuations.
2. Reconstituted Product:
   • Store at -20°C, protected from light.
   • Use within 30 days.
3. Shelf Life:
   • Refer to the expiry date on the packaging. Do not use if signs of contamination or deterioration are evident.

Precautions:

1. Health and Safety:
   • Classified as hazardous under directives 1999/45/CE and 2001/60/CE due to the presence of Gentamycin.
   • Handle using approved aseptic techniques and personal protective equipment.
2. Intended Use:
   • For in vitro diagnostic use only.
   • To be used by trained laboratory personnel.

Applications:

• Clinical Microbiology:
  • Isolate and identify fungal pathogens like Candida albicans and Aspergillus spp. from clinical samples.
• Pharmaceutical Industry:
  • Ensure the microbiological quality of non-sterile pharmaceutical products by detecting fungal contaminants.
• Food and Beverage:
  • Monitor fungal contamination in dairy, bakery, and other food products.
• Environmental Monitoring:
  • Use in cleanrooms, isolators, and other controlled environments to monitor fungal contamination.

Ordering Information:

Advantages:

1. Enhanced Selectivity:
   • Reduces bacterial overgrowth, allowing for clearer fungal isolation.
2. Versatility:
   • Compatible with various applications across industries.
3. Convenient Packaging:
   • Each vial is pre-measured for easy preparation.
4. Reliable Performance:
   • Validated with quality control strains to ensure reproducible results.

Limitations:

• Not suitable for testing organisms that are naturally resistant to Gentamycin.
• Requires Sabouraud Agar as the base medium for proper functionality.

References:

1. APHA (1963). Diagnostic procedures and reagents.
2. AOAC International (1995). Bacteriological analytical manual, 8th ed.
3. U.S. Pharmacopoeia 24, NF 19 (2000).