Saturday, November 29, 2014
Siliconization

Unless otherwise specified,  Helvoet Pharma rubber closures are siliconized to enhance machineability and prevent agglomeration during storage.

In a proprietary process, closures are siliconized by means of a high viscosity (30,000 cSt) silicone oil which meets the requirements of the USP and other Pharmacopoeia.

Using high-viscosity silicone oil instead of low-viscosity oil or emulsions has the following advantages:

  • Much lower release of visible and especially subvisible particles.
  • More reproducible siliconization levels for constant reliable machineability.
  • Stable siliconization levels over storage time.
The following are our siliconization target ranges  (in µg silicone oil per cm² rubber surface):
  • (I)SAF 1   :  10 - 25 µg
  • (I)SAF 2   :  15 - 35 µg
The prefix  ISAF is used in the case of Ready-for-Sterilization or Ready-for-Use rubber closures.

 

Unless otherwise specified,  Helvoet Pharma rubber closures are siliconized to enhance machineability and prevent agglomeration during storage.

In a proprietary process, closures are siliconized by means of a high viscosity (30,000 cSt) silicone oil which meets the requirements of the USP and other Pharmacopoeia.

Using high-viscosity silicone oil instead of low-viscosity oil or emulsions has the following advantages:

  • Much lower release of visible and especially subvisible particles.
  • More reproducible siliconization levels for constant reliable machineability.
  • Stable siliconization levels over storage time.
The following are our siliconization target ranges  (in µg silicone oil per cm² rubber surface):
  • (I)SAF 1   :  10 - 25 µg
  • (I)SAF 2   :  15 - 35 µg
The prefix  ISAF is used in the case of Ready-for-Sterilization or Ready-for-Use rubber closures.

 



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