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MedQ Medical Grade Silicone

MedQTM Medical Grade Silicone          

4247M: A Step-up from 4247 USP Class VI Single-use Silicone!  A Second Option for Secure Supply!

 

Newman Sanitary Gasket is pleased to announce a new addition to our high purity compound lineup. Newman 4247M MedQTM Medical Grade Platinum-cured Liquid Silicone Rubber (LSR) for the Single-use Industry: a step up from 4247 USP Class VI Silicone (still available!).  4247M means more gasket supply options and broadens the applications of our single-use gaskets!  “M” means Medical Grade: with More choices, More certifications, and More applications!

 

  • 4247M: Fully Compliant Biomedical Grade Liquid Silicone – for high volume gaskets and O-rings!
  • 4247M: An added source of supply for Newman 4247 Single-use silicone – separate supply stream!
  • 4247M: The perfect partner for Newman 4749 Medical Grade HCR (High Consistency Rubber, used for compression molding and extrusions, not generally for high-volume parts)!

 

During the past 20 years, Newman 4247 USP Class VI Platinum-Cured Silicone LSR has become the Gold Standard material for Single-use gaskets around the world.  With unparalleled purity and performance, it has been the mainstay during the recent pandemic for vaccines and other biologics.  4247M MedQTM exceeds Newman 4247 in both certifications and its uses in the medical device industry.

 

Together with world recognized Newman 4749 Medical Grade Platinum-cured HCR, Newman 4247M MedQTM Medical Grade Platinum-cured LSR “closes the loop” to supply all your Biopharmaceutical and Medical grade sealing applications, from the smallest quantities and most complex geometries to the highest volume, simple O-ring.

 

Should silicone supply ever become an issue like it was during the pandemic, Newman 4247M MedQTM, with its separate material supply chain from Newman 4247, but using Newman designs, tooling, processes and personnel for consistency, will help ensure that your drug product or medical device has uninterrupted supply, both to your company and the patient.  Validate both 4247 and 4247M for your safety!

 

A validation package and samples are available now.  Contact us for details!



MedQTM Samples Available:  42RXPXM0075 – ¾” Mini-Clamp Gasket, 40RXPXM0150 – 1 ½” Clamp Gasket

 

Newman USP Silicone Comparisons

     
 

BioPharm

Medical

 

USP

USP/Medical

 

Compound 4247

Compound 4247M

Availability

   

Standard Gasket Sizes

Conformance

   

FDA 21CFR177.2600

USP/NF <87> (per material)

USP/NF <87> (every lot)

 

USP/NF <88> Class VI

EP 3.1.9 (Selected Tests)

 

Allergens

Allergens (ASTM F2147)

 

ADI Free - EMA/410/01 rev. 3

Antibiotic Free

Cytotoxin Free

GMO Free

Genotoxic Impurities (Ames)

 

Hormone Free

ICH Q3C

ICH Q3D

ISO 10993 Parts 3,4,5,6,10

 

3A SSI 18-03

The same expertise and experience that has made Newman proprietary formulations among the best in the world is also available to you as a Newman customer.  Newman Sanitary Gasket Company is uniquely positioned to offer its customers custom compounding designed to meet their specific needs.   Whether it is a custom color, a specific resin, or a particular balance of properties, we can help!  Our own in-house Polymer Chemist will work with you to get the specific compound you have in mind created, tested and compliant, tuned to your specific high-purity application.

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Contact our Specialists at Newman

Newman Sanitary Gasket Company’s mission is to continually grow in our ability to meet our customers’ needs and improve our capabilities. We strive for excellence in quality, service, supply, distribution, and product development and performance. You can count on Newman Sanitary Gasket Company as your number one provider for all your gasket needs.

Selecting the Right Compound

When selecting the most favorable hygienic gasket for each application, several factors should influence your decision making, including chemistry, type of fluid processed by the pipelines, process temperature and pressure, exposure limits, and regulatory specifications, such as USP and FDA.

Use the following table is a quick way to help you better select which of our compounds are right for you. The following table lists the six elastomer materials used for these gaskets, including temperature and pressure ranges, recommended applications, and performance properties.

We guarantee highest quality sanitary elastomer parts available on the market.

Quality Assurance

Quality Assurance

We monitor performance with Statistical Process Control (SPC), which drives our improvement and consistency.
Rigorous Testing

Rigorous Testing

Every batch of polymer and every lot of gaskets is tested for physical properties and optically inspected to meet tolerances.
Inspection

Inspection

Our inspectors are the gatekeepers to our inventory of high quality sanitary gaskets and elastomer parts.
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Newman Sanitary Gasket Company is a leading manufacturer of FDA and USP Class VI seals for High Purity Process applications such as the Pharmaceutical, Food & Beverage and Dairy industries. Newman Diaphragms provides world class replacement diaphragms for ITT®, Gemü®, Saunders® and Aquasyn® valves.

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Address
P.O. Box 222 Lebanon, OH 45036
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