Single-use assemblies

Fill/finish single-use assemblies

Overview

Fill/finish single-use assemblies

WMArchitectTM fill/finish single-use assemblies safeguard your therapeutic during the filling process with a wide range of sterility-assured assembly configurations.

Fill/finish single-use assemblies are custom manufactured, pre-assembled and packaged in Watson-Marlow ISO 14644-1 Class 7 cleanrooms. They consist of a large suite of components, all lot traceable and carry an ISO 11137 sterility assurance claim.

Representative assemblies are routinely tested for bioburden, particulates and endotoxin. Where further assurance is needed, our validation experts can provide lot release testing to meet your quality requirements.

Features and benefits

  • Complete confidence in product quality
  • Designed to reduce your validation burden
  • Support of internal validation protocols
  • Product quality assurance with 10-6 SAL (sterility assurance level)
  • Flexible integration with an open architecture approach
  • Use in conjunction with Watson-Marlow peristaltic pumps or Flexicon filling systems for an end-to-end fluid management solution
  • Supply security with Watson-Marlow’s global manufacturing and supply network

Technical summary

CertificationADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
SterilitySterile (10-6 SAL) 

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

Specifications

Technical specifications

Fill/finish for Flexicon - PF7+Fill/finish for Flexicon - PF7+ with BagFill/finish for Flexicon - QC12/QC14Fill/finish for Flexicon - QC12/QC14 with Bag
CertificationADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
SterilitySterile (10-6 SAL) Sterile (10-6 SAL) Sterile (10-6 SAL) Sterile (10-6 SAL) 

Literature

Brochures

  1. WMArchitect Brochure (US).pdf
    PDF - 1.1mb

Datasheet

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