Rubber stoppers for freeze-dried preparations from Datwyler Pharma Packaging are high-quality primary packaging solutions. The lyo stoppers are manufactured in accordance with the applicable GMP guidelines (DIN EN ISO 15378) under specified and certified process conditions. They are available in diameters of 13 mm, 20 mm and 32 mm in Datwyler compounds FM140 (chlorobutyl), FM257, FM259, FM457 or FM460 (bromobutyl), among others. Also available are freeze drying stoppers with OmniFlex™-coating or diagnostic stoppers with a diameter of 18 mm in the rubber formulation FM140 red and FM257 gray.
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Manufacturer: Datwyler Pharma Packaging
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Diameter lyo stoppers: 13 mm, 20 mm, 32 mm
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Diameter diagnostic stoppers: 18 mm
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GMP (DIN EN ISO 15378) certified production according to European Pharmacopoeia, USP and JP
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Chlorobutyl, Bromobutyl
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Blowback and standard versions
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Lyo stopper including Drug Master File (DMF)
| Ø: | Design: | Compound: | Coating: | Finish: | Color: |
| 13 mm | HPP002 | FM457/0 | FLCO | gray | |
| HPP079 | FM259/0 | OmniFlex™ Plus | FLCO | gray | |
| HPP079 | FM457/0 | OmniFlex™ 3G | FLCO | gray | |
| V9250 | FM157/1 | ISAF1 | gray | ||
| V9250 | FM257/2 | ISAF1 | gray | ||
| V9250 | FM460/0 | ISAF1 | gray | ||
| V9402 | FM457/0 | OmniFlex™ 3G | FLCO | gray | |
| V9543 | FM457/0 | OmniFlex™ 3G | FLCO | gray | |
| 20 mm | V9120 | FM140/0 | ISAF1 | gray | |
| V9120 | FM257/2 | ISAF1 | gray | ||
| V9120 | FM257/5 | ISAF1 | gray | ||
| V9154 | FM257/2 | ISAF1 | gray | ||
| V9154 | FM259/0 | OmniFlex™ Plus | FLCO | gray | |
| V9172 | FM259/0 | OmniFlex™ Plus | FLCO | gray | |
| V9355 | FM140/6 | ISAF1 | gray | ||
| V9355 | FM157/1 | SAF1 | gray | ||
| V9355 | FM157/1 | RTU | gray | ||
| V9355 | FM257/2 | SAF1 | gray | ||
| V9396 | FM457/0 | OmniFlex™ 3G | FLCO | gray | |
| V9397 | FM457/0 | OmniFlex™ 3G | FLCO | gray | |
| 32 mm | V9262 | FM157/2 | ISAF1 | gray |
Diagnostic plug:
| Ø: | Design: | Compound: | Coating: | Finish: | Color: |
| 18 mm | V9241 | FM140/1 | SAF1 | red | |
| 18 mm | V9241 | FM257/2 | SAF1 | gray |
Drawings / data sheets of the stopper designs and rubber formulations or other helpful specifications and documentation can be supplied on request.
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