Single-use assemblies
Asepticsu single-use fluid path assemblies
Overview
Single-use fluid paths - asepticsu™
asepticsu™ is a sterile, pre-assembled single-use fluid path perfected for aseptic filling.
The combination of asepticsu™ and Flexicon peristaltic filling technology lowers your risk in high purity, high accuracy filling applications.
Offering precision filling from less than 0.5 ml to over 50 ml, asepticsu delivers rapid product change-over, no line-cleaning, no cross-contamination, simplified validation and less inventory management.
Features and benefits
- Huge validation savings – faster to market
- Contamination – eliminated
- Small batch production – easy and efficient
- Costly overfilling – prevented
Technical summary
| Certification | ADCF, EMEA 410/01, FDA 21CFR177.2600, ISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-5, ISO 10993-6, USP Class VI |
| Sterility | Gamma irradiated to 10-6 SAL |
Technical Summary table lists features available within the range. See ‘Specifications’ tab for model specific information.
Specifications
Technical specifications
| Asepticsu | |
|---|---|
| Certification | ADCF, EMEA 410/01, FDA 21CFR177.2600, ISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-5, ISO 10993-6, USP Class VI |
| Sterility | Gamma irradiated to 10-6 SAL |
Validation
About the asepticsu validation guides
asepticsu™ is a single-use, sterile filling assembly, available in a variety of configurations for use in Flexicon’s filling and dispensing equipment.Quality is an integral part of this product.
The primary purpose of this validation guide is to provide assurance that the whole product and each of its components meet the stringent requirements for aseptic filling applications.
Validation summary guide
The summary guide summarises the validation/qualification testing that has been carried out on asepticsu.
View asepticsu summary guide - 593.3kbLiterature
Brochures
Bioprocessing (EN).pdf
PDF - 3.5mbasepticsu brochure (EN).pdf
PDF - 412.2kb
Datasheet
Videos
asepticsu™Single-use fluid path for aseptic filling
Order Information
Product codes
| asepticsu description | Part number | pcs |
|---|---|---|
| Filter | ||
| 0.2μm with Ø6ID Accusil tubing and MPC connector | 80F.0002.A01 | 10 |
| Configuration A | ||
| Ø0.8ID Accusil tubing and PEI nozzle | 8PA.0008.A02 | 10 |
| Ø1.2ID Accusil tubing and PEI nozzle | 8PA.0012.A03 | 10 |
| Ø1.6ID Accusil tubing and PEI nozzle | 8PA.0016.A04 | 10 |
| Ø3.2ID Accusil tubing and PEI nozzle | 8PA.0032.A05 | 10 |
| Ø4.8ID Accusil tubing and PEI nozzle | 8PA.0048.A06 | 5 |
| Ø6.0ID Accusil tubing and PEI nozzle | 8PA.0060.A07 | 5 |
| Configuration B | ||
| 1L - Ø0.8ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0108.A30 | 5 |
| 1L - Ø1.2ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0112.A31 | 5 |
| 1L - Ø1.6ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0116.A32 | 5 |
| 1L - Ø3.2ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0132.A33 | 5 |
| 5L - Ø0.8ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0508.A34 | 5 |
| 5L - Ø1.2ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0512.A35 | 5 |
| 5L - Ø1.6ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0516.A36 | 5 |
| 5L - Ø3.2ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0532.A37 | 5 |
| 5L - Ø4.8ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0548.A38 | 5 |
| 5L - Ø6.0ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.0560.A39 | 5 |
| 10L - Ø1.6ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.1016.A44 | 5 |
| 10L - Ø3.2ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.1032.A45 | 5 |
| 10L - Ø4.8ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.1048.A46 | 5 |
| 10L - Ø6.0ID Accusil tubing, MPC connector and PEI filling nozzle | 8PB.1060.A47 | 5 |
| Configuration C | ||
| 5L - Ø0.8ID Accusil tubing, MPC connector and 2 PEI filling nozzles | 8PC.0508.A40 | 5 |
| 5L - Ø1.2ID Accusil tubing, MPC connector and 2 PEI filling nozzles | 8PC.0512.A41 | 5 |
| 5L - Ø1.6ID Accusil tubing, MPC connector and 2 PEI filling nozzles | 8PC.0516.A42 | 5 |
| 5L - Ø3.2ID Accusil tubing, MPC connector and 2 PEI filling nozzles | 8PC.0532.A43 | 5 |
| 10L - Ø1.6ID Accusil tubing, MPC connector and 2 PEI filling nozzles | 8PC.1016.A48 | 5 |
| 10L - Ø3.2ID Accusil tubing, MPC connector and 2 PEI filling nozzles | 8PC.1032.A49 | 5 |
| 10L - Ø4.8ID Accusil tubing, MPC connector and 2 PEI filling nozzles | 8PC.1048.A50 | 5 |
| 10L - Ø6.0ID Accusil tubing, MPC connector and 2 PEI filling nozzles | 8PC.1060.A51 | 5 |
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Single-use assemblies
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