Bioburden test method for rubber plugs 1. Principle The purpose of this test is to detect all aerobic plants and fermented materials and soil residues attached to the rubber plug by means of membrane filtration, and culture these filters. .
2. Test Procedure 2.1 Preparation of Leachate 2.2 Leaching 2.3 Filtration 2.4 Culture 2.5 Results 3. Passing Standard 1. Principle The purpose of this test is to detect all aerobic plants at neutral temperature attached to the rubber plug by membrane filtration. Residues of fermented matter and soil, and culturing these filters.
2. Test Procedure 2.1 Preparation of Leachate The leachate was a 0.9% NaCl solution (with distilled water) and 1 ml of a nonionic active agent was added.
The above leachate was poured into a suitable glass container to a mark of 400 ml, and then the container was placed in an autoclave and kept at 121 ° C for 30 minutes for thorough sterilization.
Note: This experiment requires two glass containers, one for filtering aerobic plant residues adapted to neutral temperatures and the other for filtering the ferment and soil residues.
2.2 Leaching Determine the number of rubber plugs with a total area of ​​200 square centimeters.
Next, the above amount of rubber stopper was placed in 400 ml of the pyrolyzed solution.
Shake the container vigorously and hold for 1 hour, shake the container for another 30 minutes, and shake again 1 minute before filtration.
Follow the above steps again without the rubber plug.
2.3 The equipment used for the filtration test was a vacuum stainless steel filter with a funnel. The stainless steel portion of the filter must be sterilized prior to use.
For each test you must: (all aerobic plants and ferments and soils adapted to neutral temperatures)
- Place the sterile film on the funnel of the filter with a sterile tool.
- Filter the leachate.
- Place the filtered residue in a suitable culture with a sterile tool.
Aerobic plant residues adapted to neutral temperature: Soybean medium ferment and soil residue: Saubouraud medium - arbitrarily operated as described above.
According to the above operation procedure, the distilled water was changed to a normal city water, and 400 ml of the solution was not sterilized and filtered.
2.4 The temperature of the residue on the cultured membrane is as follows:
- Aerobic plants (soybean medium) adapted to neutral temperature: maintained at 36 ° C ± 1 ° C for 48 hours.
- Fermentation and soil (Saubouraud medium): 27.5 ° C ± 2.5 ° C for 5 days.
2.5 results compare each film.
The results are expressed as follows:
N: The number of rubber plugs with a total area of ​​200 square centimeters.
R: film mark (indicated by CFU).
R/20: expressed as CFU/10 cm 2 .
R/N: expressed as CFU/gel plug.
3. Pass the standard
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