Silicone RXPX series gaskets
USP Class VI compliant and animal derived component free (ADCF). Compliant with FDA regulations CFR 21 177.2600.
Fluid path - gaskets
Fluid path - gaskets
Silicone 5000 series gaskets
Overview
High purity platinum-cured silicone gaskets – 5000 series
Manufactured and packed within an ISO 14644-1 Class 7 cleanroom, these high purity silicone gaskets are ideally suited for bioprocessing fluid paths. Demonstrating comprehensive knowledge of the materials involved in packaging components, the 5000 series gaskets have a low extractable profile. They are also gamma stable for irradiation up to 50 kGY, and autoclavable.
Product validation performed on post gamma-irradiated gaskets.
Extractable studies have been performed using a multi-solvent approach to BPOG guidelines.
Features and benefits
- Laser etched lot numbering for full material traceability (non laser-etched version also available)
- Designed in accordance with ASME-BPE standards
- USP Class VI compliant and animal derived component free (ADCF)
- Compliant with FDA regulations CFR 21 177.2600
- Gamma stable and autoclavable
- Low extractable profile
- Double-bagged and heat-sealed
Technical summary
| Gasket type | Unflanged |
| Certification and compliance | ADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <85>, USP <87>, USP Class VI |
| Shelf life | 5 years |
| Gamma stability | Max 50 kGy |
Technical Summary table lists features available within the range. See ‘Specifications’ tab for model specific information.
Specifications
Technical specifications
| Small Silicone 5000 Gaskets | Standard Silicone 5000 Gaskets | |
|---|---|---|
| Gasket type | Unflanged | Unflanged |
| Internal diameter | 10.9 - 16 mm (0.43 - 0.63 in) | 22.9 - 147.8 mm (0.9 - 5.82 in) |
| External diameter | 21.6 mm (0.85 in) | 50.3 - 165.4 mm (1.98 - 6.51 in) |
| Size | 0.5, 0.75 in | 1, 1.5, 2, 2.5, 3, 4, 6 in |
| Quantity | 25 PCS | 25 PCS |
| Certification and compliance | ADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <85>, USP <87>, USP Class VI | ADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <85>, USP <87>, USP Class VI |
| Operating temperature | -55 °C to 210 °C (-67 °F to 410 °F) | -55 °C to 210 °C (-67 °F to 410 °F) |
| Shelf life | 5 years | 5 years |
| Gamma stability | Max 50 kGy | Max 50 kGy |
Materials of construction
| Material | Platinum-cured silicone |
Documentation
Brochures
-
BioPure overview (EN).pdf
PDF - 636.9kb
Datasheets
-
Small Silicone 5000 Gaskets datasheet (EN).pdf
PDF - 451.3kb -
Standard Silicone 5000 Gaskets datasheet (EN).pdf
PDF - 458.4kb
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