Advanced Microdevices Pvt. Ltd. (mdi) services

mdi since its inception, has been in close interaction with discerning scientists and process owners in critical biopharmaceutical and pharmaceutical applications; as well as the rapid immunoassay industry. Our ability to comprehend user requirements along with the experience gathered over 4 decades, has helped us bring together a large intellectual pool dedicated towards providing customized solutions to facilitate process development and improve process efficiencies.

Our microbial retention studies qualify the filter under test to repeatedly produce a sterile filtrate with the drug product under simulated worst case process conditions in accordance to: USFDA CDER guidance document on Sterile Drug Products Produced by Aseptic Processing. PDA Technical Report No. 26, Revised 2008 on Sterilizing Filtration of Liquids.

We comprehend and value the critical importance of establishing drug product wetted integrity test specifications to ensure filter efficiency. The drug product / process fluid, due to different components, may have different surface tension than the filter manufacturer specified wetting fluid, impacting the drug – filter interface and consequently the integrity test values exhibited by the filter.

Filter fluid interaction studies involve physico-chemical compatibility, extractable and adsorption studies.