Tag Archives: FDA

The Rise of Metal Detectable O-Rings

Food Safety Modernization Act (FSMA)

Every year, nearly 1 in 6 people in the U.S. get sick (~48 million people), 100,000+ are hospitalized, and 3,000 die from foodborne illnesses or diseases, according to data from the CDC. Though this is largely a preventable problem, it still poses a significant public health burden.

The FDA Food Safety Modernization Act (FSMA), enacted by Congress in 2011, is “transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it.”

Although one might think the relevancy of the FSMA isPastries on a Conveyor Belt more geared towards the food or beverage product itself, this act is actually vital to the processing operations in food, beverage, and pharmaceutical industry.

Over time, exposure to continuous vibration, volatile temperatures, and corrosive chemicals can cause O-rings in processing operations to become worn and eventually fail. When this occurs, particles of rubber from seals and gaskets can shear-off and migrate through sanitary systems, piping mechanisms, or by other means, eventually entering the product stream.

In some cases when a problem is discovered, equipment must be shut down and visual inspections conducted to find the source of contamination. This leads to downtime, lost production, and lost revenue. If the contaminant ends up in the supply chain, even more risk is assumed due to recalls or litigation.

Enter the metal detectable O-ring.

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FDA Compliant PUR-GARD™ Bearing Isolator

PUR-GARD™ Bearing IsolatorsPUR-GARD™ bearing isolators offer the ultimate rotating equipment sealing solutions for the food processing industry. Manufactured with materials that are FDA compliant, metal detectable and x-ray inspectable while utilizing a patented IP66 design, Garlock PUR-GARD™ is a revolutionary seal that combines improved safety and overall process purity with cost savings through extended equipment and bearing life.

Features & Benefits

  • Patented labyrinth design provides bearing protection even in the most challenging environments, extending the life of rotating equipment
  • Unitized construction will not come apart during installation
  • IP66 in most common design configurations
  • Non-contacting design reduces shaft drag and energy consumption
  • Available in a broad range of configurations
  • Substantially reduced installation time – NO ARBOR PRESS NEEDED
  • No metal-to-metal contact
  • Metal detectable and x-ray inspectable

Typical Applications

Rotating equipment (pumps, motors, gearboxes) exposed to heavy wash down and/or zone 1 and 2 applications.

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FDA Standards Key to Proper Gasket Selection

Food and beverage producers rely on a wide array of equipment to ensure their products are safe and free of contamination. Sealing devices such as gaskets are key components in this equipment, yet do not receive the attention they warrant given the critical importance of their function.

Gasket Selection - PTFE
PTFE (Polytetrafluoroethylene) Molecule

PTFE-based and elastomeric seals have for decades been the products of choice for food and beverage applications. The two most commonly referenced Food and Drug Administration (FDA) standards for sealing products are found in the Code of Federal Regulations under Title 21 (Food and Drugs), part 177 (Indirect Food Additives: Polymers). Section 177.1550 focuses on perfluorocarbons such as PTFE- based products, and Section 177.2600 deals with rubber articles intended for repeated use.

These two standards specify which ingredients used in the production of sealing products are acceptable for applications where contact with food products can occur, as well as how much of the approved ingredients can be released from the polymer/elastomer when extracted with specific media — i.e. water, hexane, etc. — under specified testing conditions.

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Proven Seal Design, New Materials

The Freudenberg Simmerring has been a successful product for about 85 years. It seals rotating shafts reliably, and is used in millions of applications and machines in many industries. The Simmerring is flexible, highly loadable, and very dependable. Freudenberg Sealing Technologies has now further developed Simmerrings for use in the process industry – and they are made of food-grade materials.

At high rotational speeds and pressures, traditional PTFE shaft seal rings quickly reach their limits. Seal malfunctions and leaks are the result. Moreover, it has not been possible to use Simmerrings in the food industry to this point because their PTFE materials have not been approved for food-related applications. That’s why experts at Freudenberg Sealing Technologies have developed two new materials – from which tried-and-tested Simmerrings are manufactured – especially to meet the process industry’s requirements.

Maximum Performance even under Extreme Pressure: B2PT

Food-Grade SimmerringsSimmerrings with the B2PT design can be stressed with pressures of up to 10 bar. The B2PT consists of a newly developed material, Quantum® PTFE F18245, and a housing made of 1.4571 (V4a) stainless steel. The PTFE used here has been conceived especially for direct contact with foods. The still-required approvals under FDA 21 CFR §177.1550 und EC 10/2011 are in preparation. This Simmerring design is thus superbly suited for the food and pharmaceutical industries. The design of the B2PT can also be adapted for customer-specific, individualized applications.

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New Sealing Material HiFluor® FB

Article re-posted with permission from Parker Hannifin Sealing & Shielding Team.
Original content can be found on Parker’s Blog.


New Sealing Material HiFluor® FB for Hygienically Sensitive Applications

HiFluor® FB - Hygienically Sensitive Sealing MaterialBe it in the production of food, pharmaceuticals and cosmetics or medical devices coming into contact with the human body, excellent purity and media resistance combined with a wide range of robust properties is always required of the materials used for the components in the manufacturing processes. Specifically for these challenging applications, Parker has developed a new sealing compound with very good mechanical properties and excellent permanent elasticity: HiFluor® FB V8991.

Fluoroelastomeric materials have proven their viability in chemical and food processing, cosmetics, pharmaceutical and life science applications involving non-polar solvents, aliphatic compounds, greases, oils and aromatic substances whenever the resistance of standard materials such as hydrogenated nitrile butadiene rubber (HNBR) and ethylene propylene rubber (EPDM) is no longer sufficient.

Innovative “Pure” Sealing Solution HiFluor® FB V8991

As a compound and seal manufacturer, Parker Prädifa, in the light of the growing demands made on sealing elements in the aforementioned markets, has developed a HiFluor® FB compound with very good mechanical properties and excellent permanent elasticity.

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Sealing Materials for Food Applications

Article re-posted with permission from Parker Hannifin Sealing & Shielding Team.
Original content can be found on Parker’s Blog.


A Guide to Selecting the Proper Sealing Material for Food Applications

Food ApplicationsThe substances used in the food and in the chemical process industries are identical in many cases, whether they are of natural origin or synthetically produced.  Irrespective of their type and occurrence – be it in process media, in raw materials for products or in finished products – the materials for seals and engineered components used in production equipment coming into contact with diverse chemical substances have to meet specific purity requirements and be resistant to chemicals under the given process conditions. Purity and stability are therefore basic prerequisites for materials in the chemical process industry and the food industry. The challenge lies in selecting the proper sealing material for an application.

Top Priorities: Consumer Health and Safety

Consumer health and safety are of paramount importance in food, beverage and pharmaceutical production processes. Therefore, the materials have to comply with specific legal requirements and standards, depending on their application. The harmlessness of the materials for the intended uses, such as applications involving contact with foodstuffs and drinking water, must have been certified by relevant approvals and conformities. Equally important to consumer safety is that the materials are free of polycyclic aromatic hydrocarbons (PAH), phthalates, mineral oil based plasticizers and animal derived ingredients (ADI).

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Why Use Food Grade Silicone?

There are a plethora of choices when it comes to gasketing material.  But if you are in the food processing, it is crucial that every item that makes contact with the gasket is left unaffected.  And although silicone is inherently non-toxic, only a specially formulated food grade silicone is fit for use with consumables.

Food Grade Silicone - FDA ApprovedSilicone is an ideal elastomer to use if you require FDA-approved rubber.  Since there is an emphasis on rubbers being suitable for repeated use in the food processing industry, silicone is ideal being that the material is not susceptible to harmful microbial agents or other contaminants.  Food grade gaskets and seals should be able to function for long periods of time without falling prey to harmful contamination, or degradation.

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