Trypticasein Soy Agar (TSA) EP/USP/ISO. Triple Wrapped. Irradiated

Technique

This medium can be inoculated directly or after enrichment broth.

Spread the plates by streaking methodology or by spiral method.

The inoculated plates are incubated at 30-35 °C for 24-72 h (bacteria) and 3-5 days for fungi (yeasts and molds). Examined daily.

(Incubation times greater than those mentioned above or different incubation temperatures may be required depending on the sample, on the specifications.)

Each laboratory must evaluate the results according to their specifications.

Attention: Petri plates are used for monitoring the microbiological contamination of surface and air inside cleanrooms, isolators, RABS, food industries and hospitals. The double/triple irradiated wrapping ensures that the package itself doesn't contaminate the environment as the first wrapper is removed just before entering the clean area.

LC-4533, contact plates

Contact plates are used in the microbiological control of disinfection and cleaning of surfaces. They act simultaneously as a sampler and incubation culture medium without the need for any other intermediate steps.

The plates come in a form appropriate for this function and can be used with different culture media depending on the type of microbe that needs to be controlled. On average the plates provide a contact surface of approximately 25 cm².

To use, remove the cover and gently press the culture medium on the surface to be controlled, ensuring contact between the two surfaces. The contact plate is removed and covered with the lid to prevent air contamination. It is advisable that the lid is secured with adhesive tape and the bottom labelled with the sampling data (place, date and time).

If the sample surfaces are rough, the contact plates will not make good contact, even when the pressure is increased. In these cases it is advisable to delineate a sample surface area of 25 cm² and rub this area vigorously with a wet sterile swab and then rub the swab over the contact plate.

If verifying the effectiveness of a cleaning or disinfection process, contact plates should be used within two hours after the end of the process, ensuring that the sample surface is dry. It is advisable to always include positive controls, sampling the area before disinfection or dirty areas beside the disinfected area.

The technician will determine the frequency of sampling and disinfection according to performance criteria. Apply the agar directly onto the surface to be monitored ensuring that the pressure is distributed over the whole plate for 10 seconds. Clean the surface where the sample was collected in order to remove any traces of agar.

The inoculated plates are incubated at 30-35 °C for 24-72 h (bacteria) and 3-5 days for fungi (yeasts and molds). Examined daily.

Note: Contact plates are used for monitoring the microbiological contamination of surface and air inside cleanrooms, isolators, RABS, food industries and hospitals. The double/triple irradiated wrapping ensures that the package itself doesn't contaminate the environment as the first wrapper is removed just before entering the clean area.

The plates must be kept in their original packaging (blisters) to guarantee their stability until the end of their expiration date.

Physical/chemical control

Microbiological control

Growth Promotion Test according to harmonized pharmacopoeial monographs and test methods and ISO 11133:2014.

Spiral spreading: practical range 50-100 CFU (productivity).

Aerobiosis. Incubation at 30-35 °C. Read after 18-24 h to 72 h for bacteria and 3-5 days for fungi.

LC-4533: microbiological control

Growth Promotion Test 50-100 CFU according to harmonized pharmacopoeial monographs and test methods and ISO 11133:2014/Amd 1:2018.

Inoculate: practical range 100 ± 20 CFU; min. 50 CFU (productivity).

Analytical methodology according to ISO 11133:2014/Amd 1:2018; A2:2020.

Aerobiosis. Incubation at 30-35 °C. Read after 18-24 h to 72 h for bacteria and 3-5 days for fungi.

Sterility control

Incubation 48 hours at 30-35 °C and 48 hours at 20-25 °C: NO GROWTH.

Check at 7 days after incubation in same conditions.

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