Integrity testing systems are used to assess the integrity and quality of filtration membranes and other critical components involved in bioprocessing, such as bioprocessing containers. These systems are critical at the clarification, sterilization, and purification stages of biopharmaceutical products. The integrity test of sterilized filters is essential for critical process filtration applications in the pharmaceutical industry. Various regulatory guidance requires integrity testing of filters used in the processing of aseptic solutions and also requires corresponding testing documentation to be included with batch product records.
Integrity testing is categorized as either destructive or non-destructive. Destructive testing methods may involve subjecting test targets to extreme conditions such as high pressure, high temperature, or stress beyond the expected operating limits. The objective is to determine the point of failure or integrity compromise of the component. This type of testing can determine the maximum loads, failure modes, or weak points of a component to understand its performance capabilities and limitations. Common destructive testing methods include burst testing, tensile testing, compression testing, and chemical resistance testing, which are used to measure the maximum pressure, the ultimate tensile strength, the compressive loads, and the suitability for specific applications and environments, respectively. Non-Destructive Testing (NDT) is the inspection and evaluation of the integrity, quality, and performance of a component or material without causing damage or altering its function. NDT methods commonly include visual inspection, ultrasonic testing, radiographic testing, magnetic particle testing, liquid penetrant testing, and pressure decay testing to check the condition and integrity of the instrument.
The most widely used NDT method is the bubble point test, which is utilized to evaluate the integrity and pore size of filter membranes or porous materials. During a bubble point test, a pressurized gas or liquid is applied to one side of the membrane while the other side is open to atmospheric pressure. The pressure is gradually increased until bubbles begin to emerge from the pores of the membrane. The critical pressure at which the first bubble appears is called the bubble point, which represents the minimum pressure that overcomes the capillary forces within the membrane pores and initiates gas flow through the membrane pores. The bubble point is directly related to the size of the smallest pore in the membrane because smaller pores require higher pressure to overcome surface tension and initiate bubble formation.
Pressure-hold testing is another common NDT method. By pressurizing the fluid to a certain level, the system is allowed to stabilize for a period of time under the applied pressure. During this process, the system is checked for any visible signs of leakage and whether the pressure remains stable. Pressure-hold testing provides valuable information about a system's ability to withstand pressure. This NDT method verifies the integrity of equipment and systems such as vessels, tanks, piping, or other critical components of a bioprocessing facility, and it helps identify leaks, weak points, or other integrity issues in a bioprocessing system, which can help ensure the reliability, efficiency, and safety of bioprocessing operations.
Amerigo Scientific offers integrity testing systems with different testing methods to determine the integrity of filter membranes, bioprocessing containers, and other components to ensure the efficiency and safety of the research and manufacturing processes.
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