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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Cookies make it easier for us to provide you with our services. After the incubation period, the negative control, as well as the sample, has to be checked for the growth of bacterial colonies.

The laboratory must also have a sterile workbench as well as an autoclave and an incubator. As I am actively working 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 that developed, and offers great insight on the topic.

At first the cells are counted under the microscope. Bacteria of this size are considered to be very small and should be retained by a sterile filter with a pore size of 0. After incubating the plates for 48 hours, the grown colonies are counted and the viable cell concentration is calculated. The bacteria retention rate can be calculated now, using the found number of colonies.

Identification of the filter type of filter, manufacturer, batch number, pore size, etc. You need certain materials to conduct the test. Janet Thode Trainings – Dr. Accordingly, colonies of a different color for example light red or Gram-positive bacteria mean that there has been a contamination by external germs. 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 PDA 26 report additionally includes a positive control. This filter is mounted on an agar plate for cultivating possible bacteria as well and is incubated for up to 7 days.

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: During this, instead of the sterile filter to be tested, a filter with a pore size of 0.

This is done with Gram staining that has to be evaluated microscopically. The cultivation of B. In contrast to the negative control, the filtrated solution is transferred to a second pipe by opening another valve and wets the control filter located there.

For this purpose the filter to be tested f8838-83 be mounted in the filter housing of the device and then be sterilized for example in the autoclave. Why is one filter called a “Biorburden” reduction filter and the other certified as “Sterilizing Grade”. 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.

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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. Afterwards, the testing device has to be assembled under the sterile asm. For this purpose, different dilutions 10 -3 — 10 -5 of bacterial suspension have to be prepared and plated as a defined quantity 0. Moreover, buffer solutions and nutrient media like for example SLB — saline lactose broth — or TSB – tryptic soy broth must be provided.

For the test performance, a negative control has to be prepared in advance.


Evaluating the test After the aastm period, the negative control, as well as the sample, has to be checked for the growth of bacterial colonies. 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.

Why do I need 0.

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

The same applies if astn colonies on the negative control are found. Conducting the test For the test performance, a negative control has to be prepared in advance. 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. First, a microbial strain from the ATCC culture needs to be cultivated.

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

Preparing the device The entire device must be prepared according to the defined requirements explained in the following paragraph to perform the test method. After that, the real test can be performed. This also applies to all tubes and connecting pieces. Janet Thode Michael Thode. The aim is to determine how many log-levels of bacteria the filter can reduce.

The filter is mounted in a specified device and a defined bacteria solvent is pushed through the filter.

What is the ISO ? Necessary materials You need certain materials to conduct the test. If other bacterial strains are found on the nutrient medium of the sample, the test has to be declared invalid. Operating conditions pressure, temperature, flow rate etc.