UA-44035381-1

Testing and Validation Labs

Production at mdi is supported by highly developed test laboratories. These labs are equipped with latest instrumentation and run by highly skilled personnel.

This is used to establish limits of conditions of use of filters and the operation limit of filters

This is used to check physical parameters of various filters.

This is used for characterization of filters with regards to extractables, TOC, conductivity, pH, particulate retention, particle/fiber release etc.

This is used for quality control of Nucleic Acid Purification Kits, Transfer Membranes and filters with regard to critical functional parameters such as yield, purity, binding capacity of proteins etc.

This is used for quality control of membranes and other materials for diagnostics.

The microbiology lab include separate areas for bacterial retention testing, sterility testing, microbial limit testing, bacterial endotoxin testing, and culture lab with independent HVAC systems for each, to ensure highest level of controls. These labs are fitted with latest biosafety cabinets and vertical laminar flow benches and dynamic pass boxes and have state of the art, in-house developed test jigs for filter pre-treatment and bacterial challenge testing with online controls.

Since customers often require filter validations with specific drug products, mdi has set up a dedicated laboratory to provide 'Asertain' Filter Validation Services. The laboratory has the facilities to handle customer samples, including oncology drugs and simulate customer processes related to filter use and report the results as per the requirements of PDA Technical Report 26.