Sterile filter integrity, liquid permeability, and membrane testing for biotech and biologics — 21 CFR Part 11 ready FIA and supporting analyzers.
At M19 Labs, we support biotech and biologics manufacturers with precision instruments for membrane characterization, liquid permeability, surface area analysis, and filter validation in modern bioprocess environments.
Biotech teams need repeatable, audit-ready data across single-use assemblies and stainless systems. M19 deploys custom-configured instruments with secure records so membrane and filtration performance can be validated with confidence.
Filter Integrity Analyzer (FIA), Liquid Permeability Analyzer (LPA), Micropore Analyzer (MPA), Nanopore Analyzer (NPA), Density/Porosity Analyzer (DA/PA), Surface Area Analyzer (SAA), and Bubble Point Tester (BPT) for membrane and porous-media characterization in bioprocess environments.
Yes. Tamper-proof audit trails, secure user levels, and PDF/CSV export support validated workflows aligned with 21 CFR Part 11 expectations.
Yes. Instruments characterize membranes and filters used in single-use bioprocess assemblies with repeatable, traceable lab data.
Yes. M19 provides on-site installation, operator training, and domestic service with a 2-year extended warranty.