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  8. The Big Time-Saver: Custom Single-Use Bioprocess Assemblies

The Big Time-Saver: Custom Single-Use Bioprocess Assemblies

From pharmaceuticals to food and beverage to aerospace to manufacturing, custom single-use assemblies are providing process solutions that work.

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A diagnostics and life sciences laboratory uses preassembled color-coded non-sterile tubing kits with attached valves. Already put together, the assemblies are ready to fill with the four types of media in their production batches. When a run ends, it’s easy to replace assemblies within minutes.

A biosimilars producer experiences a rush need for gamma irradiated assemblies for buffer filtration. Because time is critical, the assemblies are designed and approved in less than eight weeks. The assemblies containing Masterflex® tubing, sanitary adapters, and gaskets are now helping the company deliver on its commitments.

A pharmaceutical manufacturer required presterilized molded assemblies in their pilot-scale project for GMP production. The molded assemblies give them assurance there will be no leaks from nonsecure connections or contamination via ingress areas. While reducing the possibility of significant loss in production, the molded assemblies also supply consistent quality.

Why preassembled?

Putting together bioprocess assemblies once required ordering various components, assembling, sterilizing, and validating them. For single use, this process was repeated every time. In many facilities, this absorbed significant time from researchers and scientists—time that could be spent more effectively on the research.

With the burgeoning need for greater efficiency, laboratories began looking at other options. Custom single-use sterile bioprocess assemblies offered a time-saving solution. With a single order, labs could seamlessly integrate the systems into their process, streamline production, and reduce the hassle.

They could also eliminate the hours of downtime between product runs spent cleaning the production system. There was no longer any need to validate the sterilizing and cleaning steps.

Cost savings was within reach as they no longer needed to purchase separate materials and equipment for self-sterilization.

Why choose Masterflex® Single-Use Service Service?

With Masterflex Single-Use, you get custom assemblies arriving gamma-sterilized (if needed) and can be discarded after one use. You can keep your favorite brand of components and the units are assembled to precise specifications.

Components include:

  • Filtration
  • Bio-Bags
  • Tubing
  • Fittings
  • Sampling and Injection

What types of assemblies are available?

Three customer-specified assemblies include sterile assemblies, microbial-controlled (gamma irradiated) assemblies, and non-sterile assemblies. The non-sterile assembly is available with or without an isopropyl alcohol rinse. You can choose to conduct your own sterilization.

The non-sterile options offer greater economical savings if you do not need to comply with stringent sterility requirements.

Bioprocess solutions arrive assembled (and sterilized, if needed) with full traceability. Masterflex Single-Use assemblies are made in an ISO Class 7 cleanroom. The assembly facility is ISO-13485 certified, cGMP compliant, and FDA registered.

Masterflex Single-Use offers gamma irradiation sterilization with a 10—6 SAL (Sterility Assurance Level)—with only a one in one million chance of microbial contamination. Full lot traceability identifies the production site, manufacturing date, and origin of the components.

All required documentation (certificates of conformance and sterility) is included. The certificate of conformance includes the lot number, manufacturing date, and expiration date, where applicable. Each assembly has an approved Device History File (DHF), a Control Document and Device Master Record (DMR). If the assembly has received gamma irradiation, a Certificate of Gamma Irradiation Processing confirms the dosage, processing date, and lot number for the production facility

Masterflex Single-Use custom bioprocess assemblies are compliant with United States Food and Drug Administration (FDA) Quality System regulations as well as ISO 13485, ANSI, and AAMI standards.

Masterflex Single-Use technical specialists work with you to determine a custom assembly that satisfies your sterilization, validation, and supply chain requirements. If requested, we will ship your product to you sterilized, complete with multilevel packaging for aseptic delivery. Contact us at 1-866-802-0579 for more information.