
FPC50
Highly flexible aseptic filling system with integrated, full or partial stoppering and capping of vials.
Aseptic filling - fully automatic systems
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Our WMArchitectTM Interchangeable Parts service enables qualified, alternative component options to be agreed during assembly design to safeguard against the constraints of single-use component supply.
This versatile approach to interchangeable components avoids regulatory compliance interruptions and long lead times to establish a resilient supply of single-use assemblies.
Alongside the full WMArchitectTM single-use solutions range, Interchangeable Parts is fully supported by our experienced specialist scientists and Validation Testing team.
Our collaborative Interchangeable Parts service eliminates the disruption of reduced component stock and potential production shutdowns. It also provides a solution for the uncertainty of choosing substitute parts and the absence of clear guidance in standardised criteria. We adapt to your evolving needs with full traceability to provide fast evaluation and single-use component availability.
By putting a smoother supply process in place with our agile service, you will establish an uninterrupted manufacturing capability.
How does it work?
We adopt the BioPhorum best practice interchangeability assessment and qualification method to eliminate compatibility, performance and safety concerns.
Based on sound science and detailed process understanding, we assess form, fit and function alongside manufacturing details and validation data to find alternative components. We then advise interchangeable components during the early design phase of your assembly specification to find interchangeable parts that are right for you.
This versatility in your process ensures simplified, efficient change management giving greater confidence to regulators.
Your alternative interchangeable components are advised at the design assembly stage for a solution designed specifically for your requirements.
This technical assessment into interchangeable single-use components thoroughly examines component material characteristics, quality and regulatory requirements. The assessment parameters are led by a user requirement specification and follow the BioPhorum best practice approach.
The table below details starting components, with the option for customers to include additional components as the design process progresses.
Component type | Example alternative components |
---|---|
Tubing | Third-party silicone tubing |
Tube Fittings | Tri-clamp: BioClamp and Q-Clamp |
Pinch clamps | |
Polypropylene and PVDF Eldon James and Nordson connectors | |
Cable ties vs Oetikers | |
Filters | Vent filters |
Interchangeable parts are assessed and categorized as:
• Identical parts
• Like-for-like parts
• Functionally equivalent parts
• Functional modification (not interchangeable parts)
Highly flexible aseptic filling system with integrated, full or partial stoppering and capping of vials.
Aseptic filling - fully automatic systems
Uniquely configurable fill/finish system. Innovative design with a wide variety of options to suit all requirements.
Aseptic filling - fully automatic systems
Tabletop aseptic filling machine for <0.2 ml to >250 ml. Accuracy of ±0.5 % on most volumes prevents costly overfilling.
Aseptic filling - benchtop fillers
Optimize your process with WMArchitectTM single-use assemblies, custom-designed to meet your specific requirements.
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
WMArchitectTM single-use fluid transfer assemblies optimize fluid transfer between equipment and process steps.
Single-use assemblies
The WMArchitectTM single-use solutions range is fully supported by our experienced validation testing specialists.
Single-use assemblies