ASTM F838-83 PDF

January 11, 2019

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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The aim is to determine how many log-levels of bacteria the filter can reduce. Moreover, buffer solutions and nutrient media like for example SLB — saline lactose broth — or TSB – tryptic soy broth must be provided. The cultivation of B.

The bacterial retention test according to ASTM Fa

The filter is mounted in a specified device and a defined bacteria solvent is pushed through the filter. If other bacterial strains are found on the nutrient medium of the sample, the test has to be declared invalid.

Cookies make it easier for us to provide you with our services. This filter is mounted on an agar plate for cultivating possible bacteria as well and is incubated for up to 7 days. Conducting the test Ashm the test performance, a negative control has to be prepared in advance.

Good to know Filter validation: Why do I need 0. Necessary materials You need certain materials to conduct the test. I have been working in filtration for many years here in the Bay Area and many times the simple question comes up – what is a sterilizing grade filter? The entire device must be prepared according to the defined requirements explained in the following paragraph to perform atm test method.


During this, instead of the asfm filter to be tested, a filter with a pore size of 0. As I am actively working on projects where these same discussions are raised I wanted to share an asmt I recently discovered that gives the history of sterilizing grade membranes, the regulatory standards that developed, and offers great insight on the topic.

Sterilizing Grade Membranes ASTM F and What You Need to Know! — C Cubed Biotech

What is method validation? This also applies to all tubes and connecting pieces. Operating conditions pressure, temperature, flow rate etc.

Identification of the filter type of filter, manufacturer, batch number, pore size, etc. Janet Thode Michael Thode. For the f883-83 performance, a negative control has to be prepared in advance. This is done with Gram staining that has to be evaluated microscopically.

First, a microbial strain from the ATCC culture needs to be cultivated. For this purpose the filter to be tested must be mounted in the filter housing of the device and then be sterilized for example in the autoclave. For this purpose, different dilutions 10 -3 asrm 10 -5 of bacterial suspension have to be prepared and plated as a defined quantity 0.

Information from the filter supplier Filter validation: What is the ISO ? The test bacteria B.

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

The same applies if bacteria colonies on the negative control are found. Accordingly, colonies of a different color for example light red or Gram-positive bacteria mean that there has been a contamination by external germs. At first the cells are counted under the microscope. 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.


After incubating the plates for 48 hours, the grown colonies are counted and the viable cell concentration is calculated. 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.

Evaluating the test After the incubation period, the negative control, as well as the sample, has to be checked for the growth of bacterial colonies. Why is one filter called a “Biorburden” reduction filter and the other certified as “Sterilizing Grade”.

After that, the real test can be performed. The bacterial retention test is a parameter of filter validation that has to be evaluated accordung to the requirements of the PDA 26 report and the guidance of the FDA.

Here is a link to the article and I hope you find a wealth of information there:. The laboratory must also have a sterile workbench as well as an autoclave and an incubator. Aspects to be considered Filter validation: Preparing the device The entire device must be prepared according to the defined requirements explained in the following paragraph to perform the test method.

Janet Thode Trainings – Dr. You need certain materials to conduct the test. Afterwards, the testing device has to be assembled under the sterile workbench. The PDA 26 report additionally includes a positive control.