The plant
Its Own Building. Its Own Systems.
HiMedic is a standalone facility with dedicated cleanroom suites, independent air handling, a separate QC lab, and packaging lines that run only cephalosporins.
Segregation by design
Every system runs independently.
The HVAC, purified water, and WFI loops serve only the cephalosporin lines. Personnel enter through dedicated gowning rooms and change areas. Nothing is shared with another production facility.
Pictured: the controlled corridor linking HiMedic production rooms. Utility infrastructure and production equipment are shown below.
Facility at a glance
What's in the building.
Dedicated HVAC
Dedicated air handling units that serve only the cephalosporin production areas.
Independent water systems
Purified water and WFI loops that run only to cephalosporin production.
Separate personnel flow
Gowning rooms and change areas for production staff working only in the cephalosporin areas.
Certifications
Certifications.
ISO 9001 certified and cGMP compliant. Full audit records and documentation are available for review once a partnership inquiry is initiated.
What's covered
Validation, stability, and transparency.
We believe in complete transparency with our partners. Comprehensive quality documentation, including process validation reports, stability data, cleaning validation, and vendor qualification records, is available upon request.
The full Site Master File and current audit history are shared under NDA once a partnership inquiry is initiated.
Documentation on request
Available under NDA.
- Site Master File
- Process validation reports
- Stability data
- Vendor qualification records
Start a conversation
Schedule a facility audit.
Submit the inquiry form to request a facility audit or walkthrough. Our team responds within two business days.
Request a Manufacturing Quote