Is dual-sourcing of a validated Single-Use assembly possible?

Flexible Single-Use solutions for biopharma production

In modern biopharmaceutical manufacturing, flexibility, sterility, and supply security are more important than ever.
During the COVID-pandemic, manufacturers and CMDO’s were faced with supply-chain challenges.
It appeared that moving to a second supplier was possible, but not easy.
That is why Flowmeister BV proudly represents GMPTEC GmbH in the Netherlands, bringing high-quality single-use solutions to pharmaceutical, biotech, and life-science customers.

Single-use technology has become a standard in many upstream and downstream bioprocesses.
From sterile product transfer and filtration to sampling and filling applications, our disposable assemblies help manufacturers to:
– reduce cleaning validation,
– minimize contamination risks and
– improve operational flexibility.

The GMPTEC portfolio ranges from sterile off-the-shelf components to fully customized tubing and bag assemblies.
Depending on the application, assemblies can be supplied ready-to-use, gamma sterilized, or ready for autoclaving.
Typical solutions include tubing sets, filter assemblies, bottle assemblies, manifolds, and bioreactor connections. All is engineered according to your specifications.

In today’s market, availability, pricing, and product quality are increasingly important reasons for companies to consider dual-sourcing.
However, successful dual-sourcing strongly depends on the level of detail in the original specifications.
Especially in the field of validated processes, dual-sourcing is a careful operation
Material selection, tubing dimensions, connectors, sterilization methods, validation data, and packaging requirements all play a critical role.
Together with the experts of GMPtec GmbH, Flowmeister supports customers in defining these specifications clearly and practically.
We help you create robust and future-proof sourcing strategies.

A major advantage of GMPTEC is its brand-independent engineering approach.
Because the company is not tied to one specific component manufacturer, their engineers provide objective advice and select the most suitable combination of components for each process.

Where desired, assemblies can also integrate an ultrasonic single-use flowmeter for accurate, non-contact flow-measurement in demanding biopharmaceutical applications.