Validation gaskets are used in pharmaceutical systems in order to obtain measurements. The gaskets, which are installed with standard tri-clamp fittings, feature one to four molded ports for holding various accessories, including sampling/injection tubes or temperature probes. As a result, the gaskets can be used permanently or temporarily without the need to use customized thermowells or costly bespoke fittings. You can use the gaskets to scale up to several system sites and they can be applied more than one time.
As a result, the gaskets that are used improve factory acceptance testing (FAT) and calibration of process-type equipment in the pharmaceutical sector by precisely and securely measuring temperature, pressure, and flow. Again, gaskets can be easily installed between two regular tri-clamp flanges using a thermocouple clamp for securing the flanges. Examples of materials used for the gasket include (extremely durable synthetic rubber) EPDM or platinum-cured silicone.
How Validation Gaskets Are Used
Smart Gaskets are used to obtain the crucial mapping details needed during any validation process. The gasket, as noted, offers one to four internal ports for accepting thermocouple accessories or samples. These accessories can include a short or long temperature probe. A sample device is also included that uses regular luer lock fittings. Meter liquids in the processing system employ a peristaltic pump or extract samples using a luer lock sampler and luer syringe or valve.
What Is Creep Resistance?
When a gasket is used, you want to make sure that it also features creep resistance. Creep resistance is the accessory’s ability to resist any unwanted deformity when the gasket is being deployed. Therefore, a gasket must be designed to minimise leakage. A gasket material that features more creep resistance ensures the sealing performance of a flanged connection.
Because contamination may occur during any part of the manufacturing process, you need to make sure that your flanges and gaskets meet the highest standards when it comes to purity and quality. Therefore, make sure that you select gasketing products and sealing solutions that are contact compliant.
Safety and Processing Are Priorities
The biopharmaceutical industry is highly regulated. That is why safety and processing are priorities. That is also why you need to rely on technology-driven components that are made for contamination control and the utmost in efficiency.
Other Biopharmaceutical Devices
Naturally, when it comes to pharmaceutical processing, patient safety is mandatory. That is why it is important to use the right gasketing products. Besides gasketing items, biopharmaceutical processes also include other important devices. These items take the form of protein capture devices, freeze-drying trays, grade vent filters, pump tubing, and moulded assemblies.
What to Look for in Gasketing Items
When choosing gasketing components, make sure that the sealing performance is first-rate for the applications that are required. That means they should offer the proper tightness for emissions control, creep and cold flow resistance, and the dimensional stability needed for excessive pressures and temperatures.
As you can see, the parts that you use to process biopharmaceuticals must be as sturdy as they are dependable. That is why you need to rely on a company that features the best products of this type in the industry. Make patient safety a priority by choosing premium solutions for validation, sealing, and similar processing.