Sanitary Gaskets
Ultrapharma is producing many different sanitary gaskets of very high quality. The photos below show some of our standard gaskets that are used at the production sites of bio-pharmaceutical plants. We design our tooling so they meet current international standards. We are able to design custom made parts as well, these can be made from a wide selection of validated compounds. We follow current GMP guidelines to secure a reproducible gasket, time after time.
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PEROXIDE SILICONE COMPOUND NR. CMD-1015 Colour RED, Hardness 70 Shore A Passes Cytotoxicity Testing USP <87> Passes USP Class VI-121°C <88> Meets FDA 21 CFR 177.2600 Animal Derived Ingredient Free ADIF 40MPFX-R-150 40MPX-R-150
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Peroxide EPDM COMPOUND NR. CMD-1006 Colour BLUE, Hardness 70 Shore A Passes Cytotoxicity Testing USP <87> Meets FDA 21 CFR 177.2600 1935/2004 for all, except ethanol & iso-octane Animal Derived Ingredient Free ADIF
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EPDM COMPOUND NR. CMD-1004 Colour BLACK, Hardness 70 Shore A Passes USP Class VI-121°C Passes USP <381> Passes Cytotoxicity Testing USP <87> Meets FDA 21 CFR 177.2600 EC1935/2004 for all, except ethanol & iso-octane Animal Derived Ingredient Free (ADIF) 40MPE-150 40MPFE-150
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PEROXIDE SILICONE COMPOUND NR. CMD-1027 Colour WHITE, Hardness 70 Shore A Passes Cytotoxicity Testing USP <87> & ISO 10993-5 Meets FDA 21 CFR 177.2600 Animal Derived Ingredient Free ADIF
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FKM COMPOUND NR. CMD-1010 Colour BLACK, Hardness 80 Shore A Passes USP Class VI-121°C Passes Cytotoxicity Testing USP <87> Meets FDA 21 CFR 177.2600 Meets EC 1935/2004 Animal Derived Ingredient Free (ADIF)
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PLATINUM SILICONE COMPOUND NR. CMD-1071 Colour Transparent, Hardness 70 Shore A Passes USP Class VI-121°C <88> Passes Cytotoxicity Testing USP <87> Meets FDA 21 CFR 177.2600 Meets EP 3.1.9 Animal Derived Ingredient Free (ADIF) 40RXPX-200 40RXPXF-200
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COMPOUND CMD-1019 Passes USP Class VI-121°C<88> Passes Cytotoxicity USP<87> Meets FDA 21 CFR 177.1550 USP <661> ADIF
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PLATINUM SILICONE COMPOUND NR. CMD-1012 Colour Transparent, Hardness 70 Shore A Passes USP Class VI-121°C <88> Passes Cytotoxicity Testing USP <87> Meets FDA 21 CFR 177.2600 Meets EP 3.1.9 Animal Derived Ingredient Free (ADIF) PN Example: SMS3017 (SMS3008 Pipe) UP30RXPXF-XXX (FLANGED) UP30RXPX-XXX (NON FLANGED)
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WHITE PTFE COMPOUND NR. CMD-1018 Colour WHITE, Hardness 60 Shore D Passes USP Class VI-121°C Passes Cytotoxicity Testing USP <87> Meets FDA 21 CFR 177.1550 Meets EC10/2011 Migration test Animal Derived Ingredient Free (ADIF)
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WHITE PTFE COMPOUND NR. CMD-1018 Colour WHITE, Hardness 60 Shore D Passes USP Class VI-121°C Passes Cytotoxicity Testing USP <87> Meets FDA 21 CFR 177.1550 FKM/EPDM inserts meet FDA 21 CFR 177.2600 PTFE meets EC10/2011 Migration test Animal Derived Ingredient Free (ADIF) PN Example: SMS3017 (SMS3008 pipe) UP30MPGRV-XXX UP30MPGRE-XXX
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Compounds/Material
The compounds that we use for our gaskets are carefully selected and meet current requirements for pharmaceutical use.
Popular gasket materials are:
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EPDM
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Platinum Silicone
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FKM
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PTFE
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Tri-Bond® (PTFE bonded to elastomer)
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Steam-Flon® (PTFE with stainless steel powder)
Standards
We manufacture sanitary gaskets in all standards such as:
DIN32676 series A, B, and C.
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DIN32676 (Series A)
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ISO1127 (DIN32676 Series B)
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ASME BPE (DIN32676 Series C)
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ISO2852
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SMS3017 pipe SMS3008
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ASME BPE Category I & II
Popular Partnumbers
CMD-1004 EPDM 40MPE-XXX 40MPFE-XXX
UP40MPE-XXX UP40MPFE-XX
CMD-1071 PLATINUM SILICONE 40RXPX-XXX 40RXPXF-XXX
UP40RXPX-XXX UP40RXPX-XXX
CMD-1010 FKM 40MPSFY-XXX 40MPFSFY-XXX
UP40MPSFY-XXX UP40MPFSFY-XXX