What pharmaceutical testing instruments does M19 Labs provide?
M19 Labs provides a full range of material-characterization and filtration instruments for pharma — Filter Integrity Analyzer — with 21 CFR Part 11-ready software.
Pharma Filtration & Material Testing | M19
FIA filter integrity, DA/PA density and porosity, PFEA filtration efficiency, and BPT bubble point testing for pharma — USP <1207>, 21 CFR Part 11, GMP-ready.
Instruments for Pharma
Frequently asked questions
Are M19 instruments compliant with 21 CFR Part 11 and GMP?
Yes. Every instrument ships with electronic signatures, tamper-proof audit trails, four-level access control and validation-ready documentation (IQ/OQ/PQ), supporting US FDA, EU GMP and WHO GMP requirements.
Which standards do the pharmaceutical instruments follow?
Depending on the instrument, testing follows ASTM F316, EN 1822, ISO 29463, ISO 16890, ISO 9277, USP <699> and ISO 7231:2023, among others. Each product page lists its specific reference standards.
Can M19 instruments integrate with our existing lab systems (LIMS)?
Yes. USB, Ethernet, Wireless LAN and PLC/SCADA connectivity plus PDF export let results flow directly into LIMS, batch records and validation files. Suitable with the company’s internal domain.
Do you offer local service and support in India?
Yes. M19 instruments are manufactured domestically in India and the USA, giving faster service response, ready spare-parts availability, lower cost of ownership and a 2-year extended warranty.