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Inflatable seal silicone FDA compliant

Inflatable seal silicone FDA compliant

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Silicone rubber since its discovery has been used for a wide range of applications.One such sector in which it has been extensively used is in manufacture of inflatable seal for Pharmaceuticals. Because of its chemical inertness, Food grade properties and its transparency, It became on of the favorite choices in selection of polymeric raw materials.Some of the main unit processes in the production cycle of any pharmaceutical industry include granulation, blending, Drying, coating etc.

In the process of Drying these companies use machines called as Fluidized Bed Dryers(Also known as Fluidized Bed Equipment acronym: FBE) or more commonly known as FBDs.Coating processes make use of the Machines called Coaters.

These machines have chambers, which have to be cleaned to start another batch, change filter bag or sometimes just for maintenance shut down. Hence these machines are never in one piece but generally have openings. The thing about these openings is that even when they are in operation they create contamination by bringing in the outside atmospheric air.One thing common about all of these machines is that they need to be 100% contamination free. That implies, no atmospheric substance including air can come in contact with the product being processed.

Silicone inflatable seal was developed to solve this sealing problem.

Silicone inflatable seal because of their unique FDA properties that made them different than regular seals. These seals can inflate and seal all nooks and corners perfectly. Therefore this provides 100 percent sealing. Platinum Cured Transparent silicone inflatable seals are manufactured for use in fluid bed dryer ( FBD, FBP, FBE)  machines of capacities from 25 kg to 1500 kg.  Hence we have  inflatable seals for ACG, Tapasya, Anish Pharma, Ganson, Alliance engineering, Glatt, Bectochem machines are available ex stock.

 

These Silicone Inflatable seal are classified into

1) Based on machine design

  • Top Gasket
  • Filter Bag gasket
  • Bottom Gasket

2) Based on Nozzle placement on gasket

  • Nozzle on Inside( on ID ) of gasket
  • On the outside (on OD) of gasket
  • Nozzle on the top of gasket
  • On the Bottom of gasket

 

Advantages Of Using Our Silicone Inflatable seals.

  • Wacker® and Dow Corning® grade silicone
  • 1 year warranty on Leakage from the joint or nozzle
  • We have over a decade of experience in making these inflatable seal, hence we only give you the best
  • Our seals go under rigorous quality testing before dispatch
  • We provide all relevant data and certifications needed by our client
  • We manufacture and provide these inflatable seals to all top OEM machine manufacturers in India.
  • Assist clients to improve their sealing and polymer technologies to avoid FDA compliance related problems.
  • Above all our superior service and on time delivery are the qualities that have differentiated from our competitors

 

Certifications for silicone inflatable seal.

 Drug Master File  (DMF) Number 29046. 

  • Food contact status and FDA regulations : FDA 21CFR177.2600
  • Silicon Rubber Oxidation Resistance Data
  •  Rubber Tear strength data
  •  steam resistance data
  •  fungus resistance data
  • USP-28 Toxicology Test report
  • BSE/TSE certificate
  • Silicon Rubber Tested on Dak System Inc. U.T.M.
  • Pressure Test Certificates
  • Rheometer rubber compound Graphs.

For further technical details or any other guidance in polymer technologies kindly write to us. Will be more than willing to help you.

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