Pumpsil tubing
Platinum-cured silicone tubing with ultra smooth bore and excellent flow stability. -20 ºC to 80 ºC (-4 ºF to 176 ºF).
Tubing - peristaltic
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
| 垫片的类型 | Unflanged |
| Certification | ADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <95>, USP <97>, 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
| Silicone 5000 series gaskets | |
|---|---|
| 垫片的类型 | Unflanged |
| Internal diameter | 10.9 - 147.8 mm |
| Internal diameter | 0.43 - 5.82 in |
| External diameter | 21.6 - 165.4 mm |
| External diameter | 0.85 - 6.51 in |
| Size | 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6 in |
| Quantity | 25 PCS |
| Certification | ADCF, ISO 10993, ISO Class 7, Ph. Eur. 3.1.9, USP <788>, USP <95>, USP <97>, USP Class VI |
| Operating temperature range | -55 to 210 °C |
| Operating temperature range | -67 to 410 °F |
| Shelf life | 5 years |
| Gamma stability | Max 50 kGy |
Materials of construction
| Material | Platinum-cured silicone |
Validation
About the Platinum-cured silicone gaskets validation guides
The 5000 series platinum-cured silicone gaskets and its raw materials have been tested under a range of pharmacopoeial and non pharmacopoeial standards. These include:
USP Biocompatibility in vivo and in vitro
European Pharmacopoeia, 3.1.9
ISO 10993
Additional testing carried out includes extractables testing. For a summary of the validation/qualification testing that has been carried out on the 5000 series silicone gaskets, please download the high purity gasket validation summary guide.
The full validation guide including additional information regarding test methods and actual test reports is available on request by submitting a validation request form.
BioPure high purity gaskets (5000 series silicone only), its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances can be found in the compliance guide and is available on request by filling in the validation request form.
Validation summary guide
The summary guide summarises the validation/qualification testing that has been carried out on Platinum-cured silicone gaskets.
View Silicone gaskets summary guide - 393.3kbliterature
Brochures
BioPure overview (EN).pdf
PDF - 863.8kb
Datasheet
Silicone 5000 Gaskets datasheet (EN).pdf
PDF - 385.2kb
Order Information
Product codes
| BioPure High Purity Platinum-Cured Silicone Gasket—Laser Etched | ||||
|---|---|---|---|---|
| Part number | Size inch | O.D inch (A) | I.D inch (B) | Quantity |
| 5001.0050.025 | 1/2 | 0.85 (21.6) | 0.43 (10.9) | 25 |
| 5001.0075.025 | 3/4 | 0.85 (21.6) | 0.63 (16.0) | 25 |
| 5001.0100.025 | 1 | 1.98 (50.3) | 0.90 (22.9) | 25 |
| 5001.0150.025 | 1 1/2 | 1.98 (50.3) | 1.40 (35.6) | 25 |
| 5001.0200.025 | 2 | 2.52 (64.0) | 1.90 (48.3) | 25 |
| 5001.0250.025 | 2 1/2 | 3.05 (77.5) | 2.40 (61.0) | 25 |
| 5001.0300.025 | 3 | 3.58 (90.9) | 2.90 (73.7) | 25 |
| 5001.0400.025 | 4 | 4.68 (118.9) | 3.87 (98.3) | 25 |
| 5001.0600.025 | 6 | 6.51 (165.4) | 5.82 (147.8) | 25 |
| BioPure High Purity Platinum-Cured Silicone Gasket | ||||
|---|---|---|---|---|
| Part number | Size inch | O.D inch (A) | I.D inch (B) | Quantity |
| 5201.0050.025 | 1/2 | 0.85 (21.6) | 0.43 (10.9) | 25 |
| 5201.0075.025 | 3/4 | 0.85 (21.6) | 0.63 (16.0) | 25 |
| 5201.0100.025 | 1 | 1.98 (50.3) | 0.90 (22.9) | 25 |
| 5201.0150.025 | 1 1/2 | 1.98 (50.3) | 1.40 (35.6) | 25 |
| 5201.0200.025 | 2 | 2.52 (64.0) | 1.90 (48.3) | 25 |
| 5201.0250.025 | 2 1/2 | 3.05 (77.5) | 2.40 (61.0) | 25 |
| 5201.0300.025 | 3 | 3.58 (90.9) | 2.90 (73.7) | 25 |
| 5201.0400.025 | 4 | 4.68 (118.9) | 3.87 (98.3) | 25 |
| 5201.0600.025 | 6 | 6.51 (165.4) | 5.82 (147.8) | 25 |
Recommended Products
Related Products
-
![EPDM gaskets]()
EPDM gaskets
Achieves a smooth bore, contamination free fluid path under clamping compression. Superior Steam-in-Place (SIP) stability.
Fluid path - gaskets
-
![PolySteel gaskets]()
PolySteel gaskets
PTFE/stainess steel composite gasket. Minimal cold flow and creep compared to solid PTFE.
Fluid path - gaskets
-
![PTFE gaskets]()
PTFE gaskets
Solid PTFE gasket for ultimate chemical resistance and purity. Precision engineered.
Fluid path - gaskets
-
![Silicone RXPX series gaskets]()
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
-
![Viton® gaskets]()
Viton® gaskets
Provide improved heat, acid and chemical resistance. Manufactured in accordance with ASME-BPE standards.
Fluid path - gaskets
