100% Integrity Tested

Each Single Use System is tested for integrity to comply with validated acceptable integrity test specifications.

Pressure, Temperature Endurance

SUS are validated to endure operating pressure and wide temperature conditions that may be encountered during use.

These systems are also validated for burst pressure with liquid to ensure user as well as product safety in case of inadvertent pressure build-up.

Extractables

MDI has strong analytical abilities with in-house state of the art analytical instrumentation such as HS-GCMS, GCMS, LCMS, TOC Analyzer along with well qualified andtrained manpower to deeply characterize different SUS components for volatile, semi-volatile and non-volatile extractables with multiple extraction media under differentconditions of time and temperature.

Sterilization

MDI SUS are sterilized by gamma irradiation to provide a sterility assurance level of 10-6. The sterilization process has been validated as per ISO 11137-2 which includes dose verification, dose mapping and quarterly dose audits.

The sterilization dose of 25 kGy has been substantiated through careful definition of the test samples, bio-burden testing of multiple lots of the selected test samples, calculation of verification dose and sterility testing

Endotoxin Testing

Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test

Biosafety

Passes Biological Reactivity test, In-Vivo, as per USP <88> for Class VI plastics

Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87>