Question 1

What pharmaceutical testing instruments does M19 Labs provide?

Accepted Answer

M19 Labs provides a full range of material-characterization and filtration instruments for pharma — Filter Integrity Analyzer — with 21 CFR Part 11-ready software.

Question 2

Are M19 instruments compliant with 21 CFR Part 11 and GMP?

Accepted Answer

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.

Question 3

Which standards do the pharmaceutical instruments follow?

Accepted Answer

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.

Question 4

Can M19 instruments integrate with our existing lab systems (LIMS)?

Accepted Answer

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.

Question 5

Do you offer local service and support in India?

Accepted Answer

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.