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 bacterial retention test according to ASTM Fa
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? Janet Thode Michael Thode. What is the ISO ? Cookies make it easier for us to provide you with our services. Afterwards, the testing device has to be assembled under the sterile workbench. Verification of compendial methods Method transfers – good to know Procedure and requirements for method transfers Planning phase — Preparing a method transfer Types of transfer and transfer strategy Content of a transfer plan Acceptance criteria of comparative method transfers Filter validation: After the incubation period, the negative control, as well as the sample, has to be checked for the growth of bacterial f388-83.
Why do I need 0. Janet Thode Trainings – Dr.
Filter validation: The bacterial retention test according to ASTM F838-15-a
Accordingly, colonies of a different color for example light red or Gram-positive bacteria mean that there has been a contamination by external germs. Since the test is conducted with B. Operating conditions pressure, temperature, flow rate etc.
Moreover, astj solutions and nutrient media like for example SLB — saline lactose broth — or TSB – tryptic soy broth must be provided. At first the cells are counted under the microscope. As I am actively f83-883 on projects where these same discussions are raised I wanted to share an article I recently discovered that gives the history of sterilizing grade membranes, the regulatory standards f38-83 developed, and offers great insight on the topic.
This filter is mounted on an agar plate for cultivating possible bacteria as well and is incubated for up to 7 days. Furthermore, a testing device with a pressure connection, pressure vessel, three valves and the test filter housing must be available see figure, simplified representation.
The laboratory must also have a sterile workbench as well as an autoclave and an incubator. 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.
During this, v838-83 of the sterile filter to be tested, a filter with a pore size of 0. The test bacteria B. For this purpose, different dilutions 10 -3 — 10 -5 of bacterial suspension have to be prepared and plated as a defined quantity 0. This is done with Gram staining that has to be evaluated microscopically.
Preparing the device The entire device must be prepared according astj the defined requirements explained in the following paragraph to perform the test method. 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.
Sterilizing Grade Membranes ASTM F and What You Need to Know! — C Cubed Biotech
Conducting the test For the test performance, a negative control has to be prepared in advance. The same applies if bacteria colonies on the negative control are found. 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. 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.
Identification of the filter type of filter, manufacturer, batch number, pore size, etc. 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. What is method validation? The cultivation of B. The PDA 26 report additionally includes a positive control.
After that, the real test can be performed. Here is a link to the article and I hope you find a wealth of information there:. Bacteria of this size are considered to be very small and should be retained by a sterile filter with a pore size of 0.
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.
Information from the filter supplier Filter validation: First, a microbial strain from the ATCC culture needs to be cultivated. This also applies to all tubes and connecting pieces.