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)

Share

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 (EN).pdf
    PDF - 1,3mb

Datasheet

Recommended Products

  1. 530 process pumps

    530 process pumps

    Flow rates to 3.5 L/min (55 USGPH) and pressures up to 7 bar (100 psi). Precise 2,200:1 speed control range.

    Pumps - cased pumps

Related Products

  1. Single-use assemblies

    Single-use assemblies

    Optimise your process with WMArchitectTM single-use assemblies, custom-designed to meet your specific requirements.

    Single-use assemblies

  2. Fill/finish single-use assemblies

    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.

    Single-use assemblies