Used machines for sale
 Filter Integrity Test
Main brands:
Merk, Millipore
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| Filter Integrity Test |
Filter integrity testing is a common practice in the injectables industry and is performed to ensure the effectiveness of filters used in the manufacturing process, especially in the pharmaceutical and biotechnology sectors. These filters play a critical role in removing unwanted particles and microorganisms from the final product, ensuring its quality and safety.
What is it for:
Quality Assurance: Filter integrity testing is crucial to ensure the filter is functioning as designed and that there are no flaws that allow contaminants to pass through.
Regulatory Compliance: Highly regulated industries, such as pharmaceuticals, are required to meet rigorous quality and safety standards. Filter integrity testing is often required by regulatory agencies to ensure compliance.
Contamination Prevention: The integrity of the filter is essential to avoid microbiological contamination and the presence of unwanted particles in injectable products.
How it works:
Filter integrity testing generally involves methods that simulate filter operating conditions during the manufacturing process. Some common methods include:
Bubble Test: This method involves immersing the filter in a liquid and applying a differential pressure. If there is a filter failure, air bubbles may be observed on the surface, indicating a possible lack of integrity.
Gas Diffusion Test: This method uses gas detection to assess filter integrity. Gases of a specific size are introduced at a differential pressure, and the presence of gas on the opposite side indicates possible filter failure.
Filtration Integrity Test: In this method, a liquid containing microorganisms or challenging particles is passed through the filter, and the retention efficiency is evaluated. If the filter is intact, it should efficiently trap challenging particles.
Differential Pressure Test: Measures the differential pressure across the filter under specific conditions. The change in pressure is monitored over time, and variations outside of expectations may indicate a possible filter failure.
It is important to note that the choice of method depends on the type of filter and product specifications. Testing is generally performed as an integral part of quality control during the manufacturing of injectable products to ensure safety, efficacy and regulatory compliance. |
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