ASTM F838-83 PDF

The ASTM Fa method is the standardized procedure used to conduct the bacteria retention test (bacterial challenge test) and determines the filter’s. accordance with ASTM Standard. F Following that standard, the organism is cultured in saline .. tration, ASTM Standard F,. (ASTM. ASTM-F Standard Test Method for Determining Bacterial Retention of ASTM-F › Historical Revision Information ASTM-F

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Necessary materials You need certain materials to conduct the test. The suspension created this way can then be used for the test, but is usable only for a maximum of eight hours stored in the fridge.

The bacterial retention test according to ASTM Fa

At first the cells are counted under the microscope. Accordingly, colonies of a different color for example light red or Gram-positive bacteria mean that f838-3 has been a contamination by external germs.

The PDA 26 report additionally includes a positive control. The same applies if bacteria colonies on the negative control are found. After that, the real test can be performed. The filter asrm mounted in a specified device and a defined bacteria solvent is pushed through the filter. What is method validation? The aim is to determine how many log-levels of bacteria the filter can reduce.

As always I am available to help with filtration training or discuss regulatory guidance with respect to filtration as it is an industry topic I really enjoy working with. Good to know Filter validation: I also previously worked with one of the authors Maik Jornitz who is an expert on process filtration and has published many books and articles on the topic. Janet Thode Trainings – Dr. For this purpose the filter to be tested must be mounted in the filter housing of the device and then be sterilized f838-3 example in the autoclave.


Bacteria of this size are considered to be very small and should be retained by a sterile filter with a pore size of 0. Here is a link to the article and I hope you find a wealth of information there:. Afterwards, the testing device has to be assembled under the sterile workbench.

Product-specific studies that need to be performed by the filter user Filter integrity tests — principles and influencing variables The bacterial retention test according to ASTM Fa HPLC troubleshooting and method optimization Examples for technical scientific documents.

Since the test is conducted with B. With the usage of our services you permit us to use cookies. Cookies make it easier for us to provide you with our services. Feel free to contact me anytime if you need help with Filtration!

Filter validation: The bacterial retention test according to ASTM F838-15-a

Conducting the test For the test performance, a negative control has to be prepared in advance. After incubating the plates for 48 hours, the grown colonies are counted and the viable cell concentration is calculated.

Subsequently, the filter to be tested is flooded after opening the first valve and the excess of compressed air is released. What is the ISO ? Finally, it can be concluded that the standardized performance of the bacterial retention test bacterial challenge test according to the ASTM Fa method during filter validation, guarantees the receipt of reliable results independent of the contract laboratory conducting the test.


After the incubation period, the negative control, as well as the sample, has to be checked for the growth of bacterial colonies. The entire device must be prepared according to the defined requirements explained in the following paragraph to perform the test method. If other bacterial strains are found on the nutrient medium of the sample, the test has to be declared invalid.

This also applies to all tubes and connecting pieces. This filter is mounted on an agar plate for cultivating possible bacteria as well and is incubated for up to 7 days. First, a microbial strain from the ATCC culture needs to be cultivated.

The cultivation of B. Why do I need 0. This is done with Gram staining that has to be evaluated microscopically. If bacterial growth is detected on the sample, it f8838-83 to be determined which bacteria it is.

You need certain materials to conduct the test. Janet Thode Michael Thode.