Single-use assemblies

Validation testing

Overview

Validation testing

The WMArchitectTM single-use solutions range is fully supported by our experienced validation testing specialists.

We offer bioprocessing expertise and tailored validation packages to help reduce your regulatory burden.

Our validation testing services team will design your validation studies using the most up-to-date, industry-recognised standards alongside our fully qualified testing partners. We provide a bespoke results assessment to ensure your specific quality assurance requirements are met.

Our decades of expertise in biopharmaceutical equipment manufacture ensure that your validation data analysis is rigorous and can be trusted.  

Features and benefits

  • Complete confidence in product quality
  • Designed to reduce your validation burden
  • Tailored validation packages to meet your specific needs
  • Product quality assurance with 10-6 SAL (sterility assurance level)

Specifications

Protocols can cover one-off testing or lot-release testing, and include standards such as:

• Endotoxin (USP <85>)

• Particulate (USP <788>)

• Bioburden ISO 11737

• Leak/integrity (pressure decay) ASTM F2095

• Extractable and leachable (BPOG/ USP <665>)

• Sterility (ISO 11137/ USP <71>)

• Nitrosamine (USP <1469>)

• Chemical compatibility

• Functional, for example pressure rating

• Other, tailored to your specific validation needs

Literature

Brochures

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

Datasheet

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