FDA Approved FKM / FFKM / EPDM RUBBER Seals
Manufacturer of standard and custom FDA approved seals. Types include solid rubber o-rings, PTFE o-rings, silicone o-rings, Viton/ FKM o-rings, buna o-rings, EPDM o-rings and o-ring kits. Seals are available in fluorosilicone rubber, hydrogenated nitrile, highly saturated nitrile, carboxylated nitrile, butyl rubber, styrene-butadiene rubber, chloroprene rubber/neoprene, polyurethane, polyacrylate, epichlorohydrin, natural rubber and ethylene/acrylic.
Food Grade Rubber Seals
Walle sealing factory understands the exacting requirements sealing materials must meet in the food and dairy sectors. We specialise in chemically resistant food grade rubber seals for use with aggressive media seen in Clean in Place (CIP) and Steam in Place (SIP) practices and high temperature steam sterilisation.
Walle's food and dairy material grades have been specially developed to provide high performance food grade seals with excellent mechanical capabilities and chemical resistance. Elastomer materials are available in several grades compliant with the requirements of the Food and Drug Administration (FDA), United States Pharmacopeia (USP Class VI), 3-A Sanitary Standards (3-A) and EC Regulation 1935/2004.
Walle's food grade rubber components for the Food and Dairy industry include; standard and non-standard sized O-rings, gaskets, specialist inflatable seals and custom rubber molded seals.
Manufacturers of process equipment can extend the operating capability of their original equipment without expensive component redesigns. Lower overall cost of ownership can be achieved through a combination of increased seal life and reduced process downtime.
Potable water seals
In addition to food grade elastomers, Walle also offers a range of certified potable water materials which meet international standards for use in drinking water systems.
Walle has over 20 years experience in food grade rubber manufacturing to the European Hygienic Equipment Design Group (EHEDG) guidelines. These guidelines look beyond the seal material and consider the seal in its operating environment. PPE routinely uses Finite Element Analysis (FEA) simulation techniques to develop hygienic seals which do not pose a contamination risk through their potential to 'trap' particles or bacteria.
We offer a full range of FFKM /FKM sealing compounds for pharamacuetical and bio-analytical industries where both mechanical and chemical properties are crucial, and hygience sealing capability is critical.
Our pharmaceutical material grades have been specially developed to withstand steam-in-place (SIP) and clean-in-place (CIP) procedures within pipe work and vessels.
In addition, many of these materials are compliant with the requirements of the Food and Drug Administration (FDA).
Our FFKM seals provide the ultimate in thermal and chemical resistance and many manufacturers of process equipment have been able to:
extend the operating capability of original equipment without expensive valve and pump redesigns
Lower overall cost of ownership
increased seal life
reduced process downtime
Our FFKM/FKM compounds for the Pharmaceutical industry include:
Standard & Non-Standard Sizes O-Rings
Gaskets
Butterfly Valve Seats
Inflatable Seals for ball segment valves
Hygiene Sanitary Seals
FDA Compliant FFKM Butterfly Valve Seals
FDA Complaint FDA Buck Valve Seals
FDA/USP Class VI FFKM Hygiene Sanitary Compounds
For Hygiene gasket seals, we do offer in FDA & USP Class VI compliant FFKM/FKM compounds which is specificicallly designed to meet the needs of pipe coupling in food, beverage and pharmaceutical process lines.
This parts are engineered to deliver optimal chemical resistance to meet the requirements of aseptic conditions CIP (clean-in-place) and SIP (sterilization-in-place) processes, our hygience FFKM seals provide excellent long-term sealing performance, therefore extending planned maintenance intervals and minimizing downtime.
Hygiene seals are manufactured to several clamp size standards (BS4825, ISO2852 and DIN32676 as lipped or unlipped gaskets) and are supplied with full manufacturing batch traceability and certifcates of conformity on request. All seals manufactured meet international approvals and conformance requirements, including: FDA-compliant with CFR 21.177.2600 (paragraphs a-f: "Rubber articles intended for repeated use"), 3-A Sanitary Standard No. 18-03 Class 1 & USP Class VI compliant
FDA Food Contact Notification (FCN) FFKM Compliant Seals
The Food and Drug Administration (FDA) has regulatory oversight for substances added to food, including monitoring their safe use. Section 309 of the Food and Drug Administration Modernisation Act (FDAMA) of 1997 now also establishes a Food Contact Notification (FCN) process as the primary method by which the FDA regulates substances that are classed as 'food contact substances' (FCS). A FCS is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food, but is not an additive within the food.
During the FCN process, the sealing material and its individual constituent ingredients undergo a significant amount of research, testing and analysis to evaluate the potential for food contamination.Successful completion of the FCN process allows our FFKM material grades to be used in a variety of food contact applications under the Food Contact Notification number FCN000402.
The Food and Drug Administration Modernisation Act of 1997 provides a system whereby a manufacturer or supplier of food-contact material may submit an Food Contact Notification (FCN) to FDA regarding the identity and use of the new food contact substance, together with necessary data to demonstrate that the substance is safe for its intended use. FCN is a formal acceptance of a material by the FDA, so it is fundamentally different to self-certification to FDA CFR21.177.2600
Contact information:
Dongguan Walle Sealing Technology Development Co., Ltd
Tel: 86-769-33291139 / 22762051
Mobile: 13620011767
Fax: 86-769-22762052
URL: walleseals.en.made-in-china.com