Single-use assemblies

Fill/finish single-use assemblies

Overview

Fill/finish single-use assemblies

<p>WMArchitect<sup>TM</sup> fill/finish single-use assemblies safeguard your therapeutic during the filling process with a wide range of sterility-assured assembly configurations.</p>
<p>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.</p>
<p>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.</p>

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 ‘Technical 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 (EN).pdf
    PDF - 1.3mb

Datasheet

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