GMP Nitrogen for API & Sterile Packaging

GMP-compliant nitrogen for API protection, lyophilization, and sterile packaging. Full audit trail and data logging.

GMP Compliance Requirements

21 CFR Part 11 requires electronic records with audit trails. Our PLC logs purity, flow, pressure every 60 seconds with tamper-proof storage.

All wetted parts certified. 316L stainless steel with surface finish <0.8 um Ra. Full material certificates provided.

IQ/OQ/PQ documentation package included. Factory acceptance test (FAT) and site acceptance test (SAT) protocols.

20-60 Nm3/h99.99%

GMP-compliant N2 for vial purging and blister packing. Full data logging.

20-60 Nm3/h99.999%

Add downstream purifier for lyophilization and API blanketing.

GMP-compliant configurations.

For UHP API applications.

Food and other related sectors.

GMP validation documentation.