Masterflex Single-Use Custom Assembly FAQs

SAL 10-6, >25 kGy

The validated Sterility Assurance Level ensures that your tubing assemblies are consistently sterilized to the proper level to ensure a 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. The Certificate of compliance documentation is sent separately as no paper/documentation will be in the product box. This certificate includes the lot number, manufacturing date, and expiration date (where applicable). 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 the amount of detail recorded in the assembly documentation for sterile assemblies. 

Both sterile and gamma irradiated(sterilized/microbial controlled) assemblies are assembled in a clean 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 Cleenrooms (or sometimes called Class 10,000) also have the following credentials:  ISO-9001, cGMP compliant.

Masterflex facility will perform Particle Monitoring, HEPA Filter Integrity Testing and Air Changes Rate every 6 months, and we will test air pressure differentials, humidity and temperature on a daily basis. Microbiological Monitoring will be performed quarterly. These tests are done to ensure our desired quality standards are met.

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.