Custom Masterflex® single-use bioprocess assemblies

Customized for your needs

Trusted configurations that meet the highest quality in assembly and sterilization

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What was once a multistep process of ordering, assembling, sterilizing and validating now requires just one call to us. As a respected supplier of nearly every component in the bio disposables market, we offer the widest selection of brands for truly custom fluid handling solutions.

Masterflex single-use custom disposable sterile assemblies

  1. Validated brands
    We custom configure, validate and package according to your specification from thousands of trusted brands.
  2. Reduced downtime
    Stop clearing and revalidating your system. We manage your inventory and send assemblies according to your schedule.
  3. Assured quality
    Our single-use assemblies are available gamma-irradiated and validated to a 10-6 sterility assurance level.

Ordering your custom assemblies is easy

Our ordering process makes it easier to get your assembly quickly and efficiently. Decrease paperwork by ordering just one custom item number. Reduce your purchasing, receiving and storage costs and eliminate wasteful downtime due to late product deliveries by letting us manage your inventory and deliver assemblies according to your schedule.

1Map your assembly

We work with you to map the assembly and make recommendations on tubing, fitting and filter components. Our experts review and confirm each step to ensure you receive the product you need.

2Quote & schematic

You will receive a quote and drawing with the details of your assembly. Upon your approval of the design, we will send a sample of the assembly for your final approval.

3Delivery schedule

We work with you to establish a manufacturing and delivery schedule. We stock many fluid handing components such as tubing, fittings, filters and bags, so they are available when needed.

Examples of assembly schematics

Sterile components

Masterflex single-use custom assembly FAQs

The validated sterility assurance level (SAL) ensures that your tubing assemblies are consistently sterilized to the proper level to ensure safe operation every time. There is no need to worry that an assembly, packaging or processing variation will ruin important work or contaminate product.

Yes, full lot traceability is assured with every Masterflex® single-use order. Files are maintained at the production facility and Masterflex headquarters.

A Certificate of Conformance is included with every Masterflex single-use custom assembly order that is shipped.  Additionally, a Certificate of Gamma Irradiation Processing confirming the dosage, processing date and lot number is completed for every order that is gamma irradiated. It is filed at both the production facility and Masterflex headquarters.

The major difference between sterile assemblies and gamma-irradiated assemblies is gamma irradiated does not include testing verifying the SAL 10-6 certification. There is also a higher degree of pre-assembly component cleaning, and more details are recorded in the assembly documentation for sterile assemblies.

Both sterile and gamma-irradiated (sterilized/microbial controlled) assemblies are assembled in a cleanroom environment by gloved and gowned, trained technicians using similar packaging materials and methods. Both types of assemblies are exposed to the same amount of gamma irradiation.

No, the assembly is processed and exposed to gamma irradiation based upon direction from the customer and how the assembly will be used.

Our ISO Class 7 cleanrooms (or sometimes called Class 10,000) also have the following credentials: ISO-9001, cGMP compliant.

Yes, we invite customers and prospects to visit our facilities and meet with our production and quality team. They are prepared to answer all questions and concerns.

Start your custom assembly today

Our experts will help you design your custom bioprocess assembly with the brands, components, and validation you need.

Get started here