Your Trusted Partner in Ensuring Regulatory Compliance
Since 2008, mdi has been a trusted partner to the pharmaceutical and biopharma industries, providing asertain® validation services that support the regulatory approval of drug products. Our extensive experience spans a wide range of formulations, including conventional injectables, ophthalmic drugs, oncological treatments, emulsions, and novel drug delivery systems (NDDS) such as liposomal and depot formulations (solvent phase). We also specialize in validating plasma proteins and recombinant proteins, including insulin, GCSF, monoclonal antibodies (mAbs), and more.
asertain® Validation Services for Filters & Single Use Systems
mdi’s asertain® validation services are tailored to meet specific customer requirements while ensuring alignment with regulatory expectations. These services are critical for the validation of sterilizing grade filters as well as any single use components in contact with process fluids such as media, buffers, and drug substance–drug product (DS–DP) solutions.
asertain® Filter Validation Services
Microbial Retention Studies
Extractables Study
Product-Wetted Filter Integrity
AdsorptionTest
Physicochemical Compatibility
Throughput Study
asertain® Single Use Systems Validation Services
Physicochemical Compatibility
Adsorption Studies
Extractable & Leachable Studies
Advanced E&L Studies
Toxicological Assessment
Tailored Tech Support for Pharma/Biopharma Clients
Team MDI brings a wealth of experience in addressing the unique challenges of the pharma and biopharma industries and offers holistic support, ranging from product design and development to troubleshooting. This ensures that our customers receive end- to-end solutions that are reliable and compliant with regulatory standards.
Why Choose MDI as Your Validation Partner
Aligned with Global Regulatory and Industry Standards
mdi asertain® validation services are fully compliant with key global regulatory and industry guidelines. Our processes are designed to meet the most stringent expectations for sterilizing-grade filter validation and single-use component assessment in pharmaceutical and biopharmaceutical manufacturing.
Compliance Includes:
- USFDA – Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
- European Union – Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1 (2022)
- EMA – Guideline on the Sterilization of the Medicinal Product, Active Substance, Excipient and Primary Container (EMA/CHMP/CVMP/QWP/850374/2015)
- ISO 13408-2 – Aseptic Processing of Healthcare Products – Part 2: Sterilizing Filtration PDA Technical Report No. 26 – Sterilizing Filtration of Liquids
- BioPhorum – Best Practices Guide for Extractable Testing of Polymeric Single-Use Components in Biopharmaceutical Manufacturing
- USP <665> – Plastic Components and Systems Used to Manufacture Pharmaceutical and Biopharmaceutical Drug Substances and Products
These guidelines provide comprehensive direction on the validation of sterilizing-grade filters and the qualification of components to ensure sterility, safety, and regulatory readiness throughout the drug manufacturing process.