Single-use assemblies

Asepticsu single-use fluid path assemblies

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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

CertificationADCF, EMEA 410/01, FDA 21CFR177.2600, ISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-5, ISO 10993-6, USP Class VI 
SterilityGamma irradiated to 10-6 SAL 

Technical Summary table lists features available within the range. See ‘Technical specifications’ tab for model specific information.

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Specifications

Technical specifications

CertificationADCF, EMEA 410/01, FDA 21CFR177.2600, ISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-5, ISO 10993-6, USP Class VI 
SterilityGamma 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 - 593.3kb

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Disclaimer: You hereby agree the provided validation guide is for private use only to assist in the qualification of the products listed within the validation guide.

You also agree that you will not copy, redistribute, transmit, assign, sell, broadcast, rent, share, lend, modify, adapt, edit or transfer the validation guide to any other party without prior consent from WMFTG.

Literature

Brochures

  1. Bioprocessing industry (US).pdf
    PDF - 2.9mb
  2. asepticsu brochure (US).pdf
    PDF - 1.1mb

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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Related Products

  1. Accusil tubing

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    Tubing for accurate filling with excellent dispensing accuracy ± 0.5 %. Eight sizes available.

    Single-use assemblies

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