Masterflex Single-Use Advantage

The Masterflex Single-Use program allows customers in the biopharmaceuticals industry to purchase disposable, custom-designed bioprocess assemblies, eliminating the need for these manufacturers to track inventory or self-validate.

The multistep process of ordering, assembling, sterilizing and validating bioprocess systems now requires just one call to us. Select from a wide range of brand-name tubing, fittings, filters, and container systems. Order assemblies nonsterile or gamma sterilized. All assemblies have full lot traceability and are manufactured in a ISO Class 7 (Class 10,000) cleanroom. The manufacturing facility is ISO-13485-certified, cGMP-compliant, and FDA-registered!

Sterilization Validation you can rely on

With Masterflex Single-Use, you will no longer have to validate the cleaning and sterilizing of your bioprocess assemblies. The purchase of a preassembled, sterilized, and validated system shifts the principal burden of validation to the supplier. That is why it is important to be sure your supplier uses only the most reliable brand name products and adheres to strict, well-established protocols in the sterilization process.

ISO Class 7 (Class 10,000) cleanroom

Masterflex Single-Use assemblies are manufactured in an ISO Class 7 (Class 10,000) cleanroom.

Certified, Compliant, & Registered

The assembly facility is ISO-13485 certified, cGMP compliant and FDA registered.

Gamma Irradiation

We offer gamma irradiation sterilization with a 10—6 SAL (Sterility Assurance Level), a one millionth probability of microbial survival.

Lot traceability

We offer full lot traceability; identifying the production site, manufacturing date and origin of components. We provide and maintain all required documentation, including complete validation documents and certificates of conformance and sterility.
Masterflex Single-Use packaging

Packaging— We've thought of every detail

Validated packaging

Masterflex Single-Use packaging has been tested and validated to stringent guidelines, to ensure that the assemblies will withstand the rigors of shipping to arrive sterile at your facility.  


stable shelf-life

Once they are in your facility, we have tested that the packaging will keep the product sterile to allow flexibility to choose when you want to use the assemblies – use them immediately or use them 2 years later – either way our validated package testing can attest to the sterility level of the assemblies.  


Detailed labelling

When the product arrives at your facility you will experience the ease of integrating Masterflex Single-Use assemblies seamlessly into your procurement system. The detailed label will contain the information you’ve specified to ensure the assemblies can be received quickly without requesting more information.  


Easy open bag

When opening the assembly bag, you’ll find that the easy-open feature on the bag makes integration quick and simple. The Masterflex Single-Use bags have a special tear-notch feature that eliminates excess pull or scissors to open. Just one more way that Masterflex Single-Use assemblies streamline your processes!  


Inventory Management— Deliveries on your schedule

Right on time

Eliminate wasteful downtime due to late product deliveries – We manage inventory and deliver assemblies according to your schedule.

Gain efficiencies

Avoid the time and hassle of purchasing, receiving and storing multiple item numbers. Masterflex Single-Use allows you to order your bioprocess assembly under one item number.