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| Why to consider FDA Complaint Sanitary Gaskets? |
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Gaskets are a small component in any system, but generally play a major role of sealing. However with the increasing stringent quality norms adopted in the pharmaceutical segment, selection of a gasket for a given application has gained more importance.
The 3 main goals for considering FDA complaint gaskets are:
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To protect products from contamination, spalling, particulates and TOCs resulting from the use of improper sanitary hygienic seal material. |
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To protect facilities from unnecessary downtime associated with sanitary hygienic seal failure and replacement from use of improper hygienic seal material. |
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To provide a standard of consistency of sanitary seal selection between multiple facilities. |
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| In determining correct sanitary gasket, the following criteria are used: |
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U.S. Pharmacopeia Class Vl Certification |
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Cytotoxicity Criteria |
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CFR Title 21 Section 177.1550 & 2600 |
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Traceability: Lot and Batch |
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USDA Standards |
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3-A Sanitary Standards |
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| Typical Gaskets used in the Pharma Segment are: |
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| STEAMING VALIDATION GASKETS |
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Steaming validation gasket comprises of a spore strip gasket wherein the spore challenge strip could be inserted (held in place) prior to start up of the steaming of the equipment. On completion of the steam sterilization the spore strip could be retrieved without dismantling any component in the system. |
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A single smart gasket helps validating sterility in a high-purity pharmaceutical system viz Thermal mapping, meter fluids in your process system or withdraw samples. |
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Biological Gasket permits either top loading or inline positioning of a self- contained biological indicator and/or a temperature probe Results are easily obtained in only 48 hours and without problematic laboratory transfer. |
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| HIGH TEMPERATURE GASKETS |
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The Gasket's contact surface is a layer of PTFE unitized to an EPDM rubber inner core. This totally bonded construction provides with the mechanical characteristics, including memory, of an elastomer gasket. Helps one to achieve higher performance under SIP / CIP conditions. |
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PTFE and Stainless Steel 316L fused gasket are ideal for sanitary steam pipe connections in extreme temperatures ranging from - 100ºF to 500ºF. The superior strength of the gasket eliminates cold flow and creep to prevent maintenance problems and system downtime. |
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The Controlled Compression Gasket (CCG) cannot be overtightened! The non-compressible ring controls clamp compression to exactly the correct amount, allowing the properly positioned gasket to make a perfect surface I.D. seal with the ferrules. |
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Special Gaskets like Orifice Plate gaskets for flow balancing, Screen Gaskets as a prefilter to critical membrane filters, diffuser gaskets for diffusing various types of gases and Laser engraved gaskets (traceability) are also made use of. M/s Rubberfab Inc, USA manufactures these FDA complaint sanitary gaskets and is available locally with M/s Neela India Pvt Ltd. Products Division. |
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| WHY TO CONSIDER FDA COMPLAINT SANITARY HOSES? |
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Flexible hoses helps one to transfer a liquid (cold or hot), viscous products like cream, solvents, powders, raw material and finished products or even steam. The conveying could be under pressure or vacuum depending on the product and application.
Depending on the product to be transferred and the area of application the sanitary flexible hoses has to comply with (any or all): |
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Desired Temperature range |
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Meet 21CFR177 2600, BgVV Type-ll, USP Class Vl, USP |
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Physiochemical 661, Cytotoxity, Hemolysis, Europeenne 3.1.9. |
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Have High Flexibility and Small bending radius. |
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Suitable for CIP, Steam, Autoclave. |
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Typically in a Pharma segment the sanitary flexible hoses have an application in the manufacturing process of API, Formulation, Injectables, Biotechnology, Blood Plasma and Purified water and WFI.
The flexible sanitary hoses can be briefly categorized based on the material of construction which comes in contact with the product as |
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Silicone Platinum Cured |
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Rubber – EPDM |
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Thermoplastic PTFE, PFA. |
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These sanitary hoses are generally provided with reinforcement viz textile ply or galvanized SS wire submerged in suitable material or SS braided or a combination of above to suit the application. Most importantly a suitable outer cover is provided to meet the various duty conditions. The duty conditions of these hoses can be for use in sterile atmosphere, corrosive atmosphere or for repeatability like in a filling line.
The end connection considered must be sanitary in nature. Typically the connections are Swaged / Crimped which is a use and throw type or reusable type.
M/s GECI Tech, France manufactures these FDA complaint sanitary hoses and is available locally with M/s Neela India Pvt Ltd. Products Division. |
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| For more information, Please contact: |
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Tel. : +91 22 2878 2611 / 12 / 13
Email : products@neelaindia corn
URL : www.neelaindia.corn |
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