The integrity of the sanitary manufacturing application is essential for full compliance with the validation process.
The potential for contamination increases with the introduction of peripheral components, such as filtration and temperature and pressure measuring instrumentation required to ensure process parameters remain within acceptable limits. As a result, these inline devices must themselves meet standards set by governing agencies to ensure there are no weak links in the sanitary chain.
Organizations providing sanitary requirements
There are many organizations that outline the standards needed to adhere to the sanitary requirements in a validated environment. The following organizations offer guidelines: 3A—3A Sanitary Standards, Inc. (3A SSI), USP Class IV, FDA Compliant, cGMP—current Good Manufacturing Practices, and EHEDG-Certified—The European Hygienic Engineering & Design Group.
Sanitary connections must meet USDA or FDA requirements, or meet 3A sanitary standards, for a process system to be eligible for validation. The standards make recommendations on what type of process connection should be used. Available sanitary connections include Tri-Clover® Tri-Clamp®, Cherry-Burrell®, DIN 11851, DIN 32676, ISO 2852, Varivent®, and 4” Tank Spud, among others.
Connection materials matter
You will also need to take into consideration the type of materials the connection is made from. Austenitic stainless steel is used as the standard material for sanitary applications. The 316L stainless steel is the most common. This material provides good welding and corrosion-resistance attributes. To add to the list of considerations, the surface finish may need to be Ra<=15 µin electro polished depending on the application as the process wetted surfaces and anything that comes in contact with the media needs to be passive and free of microscopic faults to avoid buildup of pathogenic organisms and/or the formation of biofilms. The considerations when choosing a process connection does not stop here. You also need to think about the gauge casing material, instrument housing, autoclave sterilization, diaphragm seals, the list goes on and on.
With all of the different governing bodies offering advice on how to adhere to a hygienic environment and all of the different types of hygienic connections available, it might be helpful to recommend a technical resource to help you make the correct choices for hygienic process needs. Not only does Cole-Parmer offer an extensive line of hygienic and non-hygienic process connections, but also the technical knowledge to guide your decisions.Click here to read the entire sanitary instrumentation articleClick here for related articles and news
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