We validate filters in sterile pharmaceutical manufacturing. By filter validation we ensure the filter is working properly and sterilizing the material or air.
There are eight elements that constitute the process of filter validation:
Fit for use
Sterilization
Stability
Compatibility
Extractables / Leachables
Retention
Integrity testing
Filter compatibility assessment is the first phase of a validation study. This test evaluates the integrity of the filter media and seals after exposure to the product under the worst-case process conditions. The membrane filters are tested for bubble point, tensile strength and porometry before and after exposure to the product.
Bacterial challenge testing is performed at an independent, FDA approved laboratory. The objective of bacterial retention is to demonstrate the ability of a filter to produce sterile product in a specific pharmaceutical process.
The non-volatile residue (NVR) analysis is performed in accordance with USP <661> </661>in order to quantify the amount of extractables released by the filter system. If there are sufficient extractables, following NVR analysis, these are analysed by FTIR spectroscopy.
The level of adsorption by the filter should be minimised to ensure that after filtration, the product contains all of the ingredients within specification.
Integrity testing of sterilizing grade filters pre- and postuse is essential to guarantee the sterility of a product. In some cases, it is more convenient to use the product instead of the reference liquid (usually water or IPA water) as a wetting fluid for integrity testing. The product-wetted integrity studies are performed by comparing the integrity test results using the product as the wetting agent and the reference wetting fluid on the same filters. The product-wetted parameters can be determined as: minimum bubble point, test pressure and maximum allowable diffusive flow. The study is performed using at least three filter samples from different batch numbers. The integrity test parameters are influenced by the surface tension and temperature of the product.
We create innovate custom solutions for your each of your filtration needs
with our wide range of knowledge and experience.
No business is the same, each business needs custom creative
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With more than 80 years of experience we provide quality services in not only
checking of the filters
We have a leading range of industry standard filters curated for the most demanding applications in select industries.
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We Offer a highly skilled professional service with a touch of fun
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