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

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.

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

Request full validation guide

Thank you for requesting our validation documentation. We have received your request and will respond within 48 hours.

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 WMFTS.

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 WMFTS.

Literature

Brochures

  1. asepticsu brochure (EN).pdf
    PDF - 412.2kb

Datasheet

Videos

asepticsu Single-use fluid path for aseptic filling

 

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