Fill/finish single-use assemblies

Overview

Fill/finish single-use assemblies

WMArchitect^TM 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

Certification	ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI
Sterility	Sterile (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 Bag	Fill/finish for Flexicon - QC12/QC14	Fill/finish for Flexicon - QC12/QC14 with Bag
Certification	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	ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI
Sterility	Sterile (10-6 SAL)	Sterile (10-6 SAL)	Sterile (10-6 SAL)	Sterile (10-6 SAL)