What is bubble point integrity test?

What is bubble point integrity test?

A forward bubble point integrity test is a procedure which measures the pressure needed to be applied to the upstream side of a filter causing bulk or open pore flow through the largest pores of a wetted filter. The bubble point is indicated by vigorous bubbling from the tubing.

How do you check filter integrity?

There are three primary nondestructive integrity test methods that can be used both before and after filtration:

  1. Forward flow (diffusion) test.
  2. Bubble point test.
  3. Pressure hold test.

How do you check the integrity of a HEPA filter?

The HEPA filter integrity test is typically performed on supply air or exhaust air HEPA filters using a photometer to scan the filter surface for pinhole leaks that could allow the transmission of contaminant particles that would be unacceptable in a critical application.

When should a filter integrity test for a 0.2 micron filter be completed?

Table 1. The integrity test of a sterilizing grade filter has to be and most commonly is performed after the filtration process (post-use). Some filter users test the integrity before the filtration process and before the filter is sterilized.

What is filter integrity in pharma?

Integrity testing sterilizing filters is a fundamental requirement of critical process filtration applications in the pharmaceutical industry. FDA Guidelines require integrity testing of filters used in the processing of sterile solutions such as large volume paren terals (LVPs) and small volume parenterals (SVPs).

What is bubble point of filter?

Bubble point is a function of pore size, filter medium wettability, surface tension and angle of contact. The filter membrane is wetted and a gradual increasing gas pressure is applied. The bubble starts forming from the largest pore first. The gas pressure at this time is the bubble point for the membrane.

How many types of filter integrity are there?

There are three standard ways to test filter integrity given the conditions and specifications of the filter. In order to understand the right test for a particular situation you need to know there are two main types of filters; hydrophilic (water attractive) and hydrophobic (water repulsive).

What is the principle of filter integrity?

By performing a filter integrity test it’s proved that the filter is fully functional and that no unwanted components did pass. In practice, there are destructive and non-destructive tests.

What is integrity of HEPA filter?

Typically, HEPA filters capture up to 99.97% of particles as small as 0.3 microns. The dispersed oil particulate (DOP) scan testing, also known as filter integrity testing, or leak testing, is one of the most quoted methods by industry standards.

Why is filter integrity test required?

Integrity testing sterilizing filters after a batch has been filtered can detect if the integrity of the filter has been compromised during the process. The stringent requirements of the pharmaceutical industry dictate that non-destructive filter integrity testing must be performed in each sterilizing application.

What is water intrusion test?

The Water Intrusion Test (WIT) measures the volumetric flow rate of water that intrudes into a hydrophobic media /membrane of the cartridge at an applied pressure per 10 minutes. The pores of hydrophobic filters will resist the passage of water up to a certain pressure.

What is minimum bubble point?

This bubble point specification is defined as the value at the low end of the filter membrane production limit. This value is thebubble point specification for all Durapore sterilizing grade membranes. No filter device is released from manufacturing with bubble points below this value.

What is the bubble point test for filters?

The most widely used non-destructive filter integrity test is the bubble point test. The bubble point test exploits the fact that liquid is held in the pores of a filter by surface tension and capillary forces. The minimum pressure required to force liquid out of the pores is a measure of the pore diameter.

How to test the non-destructive integrity of a gas filter?

One of the best ways to test the non-destructive integrity test is the bubble point test. Under this process, the fluid is held in the pores of the filter by capillary forces and surface tension.

How do you test the integrity of a sterilising filter?

The ultimate filter integrity test and most reliable measure of a sterilising filter’s performance is bacterial retention. The most widely used non-destructive filter integrity test is the bubble point test. The bubble point test exploits the fact that liquid is held in the pores of a filter by surface tension and capillary forces.

What does it mean if my filter is bubbling?

If bubbling appears at a lower pressure than the set pressure, the test is considered a fail. The pressure at which bubbling occurs downstream of the filter is its Bubble Point. Possible reasons for failure: Incorrect installation of the filter inside the housing

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