Validation and packaging

The Masterflex^® single-use advantage: Managing the quality and risk of your single-use systems

Supporting quality and risk management programs

Masterflex^® supports a quality and risk management program that 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 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 non-sterile or gamma-sterilized. All assemblies have full lot traceability and are manufactured in an ISO Class 7 (Class 10000) cleanroom. The manufacturing facility is ISO 13485 certified and cGMP compliant.

Sterility validation you can rely on

With Masterflex, 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 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 10000) cleanroom

Masterflex^® single-use assemblies are manufactured in an ISO Class 7 (Class 10000) cleanroom.

Certified, compliant & registered

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

Gamma irradiation

We offer gamma irradiation sterilization with a 10—6 SAL (Sterility Assurance Level).

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.

Packaged for safety and ease

Validated packaging
Masterflex 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.

Shelf-stable
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 single-use assemblies seamlessly into your procurement system. The detailed label will contain the information you have specified to ensure the assemblies can be received quickly without requesting more information.