Validation studies

Due to regulatory requirements, the pharmaceutical industry must provide a high level of assurance that sterile drugs produced under aseptic conditions possess the identity, consistency, quality and purity that they should have or are claimed to possess. (Ref. USFDA 21CFR 211.100(a)).

Consequently, it has become increasingly critical to establish and quantify the impact that contact with the various process components has on the drug under different operating conditions.

Sterilising-grade filters are key components of aseptic processes, as they ensure the sterility of the filtered drug and, furthermore, as they maintain a large surface area in contact with it, they can have a significant impact on other parameters such as purity or consistency.

Mdi offers a wide range of validation studies to establish the functionality, reproducibility and compatibility of sterilising-grade filters with the drug.