4 services found
Advanced Microdevices Pvt. Ltd. (mdi) Services
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Product Specific Filter Integrity Test Services
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 ...
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Filter Fluid Interaction Services
Filter fluid interaction studies involve physico-chemical compatibility, extractable and adsorption ...
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Microbial Retention Studies Services
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 ...
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Process Dev. and Optimization 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 ...