A 30,000 sq ft sterile manufacturing facility at MEPZ-SEZ Tambaram, Chennai — designed end-to-end for biosimilar fill-finish across vials, pre-filled syringes and cartridges.
Inside the facility
From corridor to combi line.
A walkthrough of the sterile manufacturing suites, fill lines, formulation vessels and quality labs that sit behind every Regenix batch.
01 · Sterile Fill Line
Combi machine in operation under Grade A air
02 · Formulation
Process vessels
03 · Quality Control
Analytical & microbiology labs
04 · Cleanroom
Service corridor & airlocks
05 · MEPZ-SEZ Chennai
Facility exterior
Facility walkthrough
A guided tour, on-site.
A short walkthrough recorded inside the facility — through the cleanrooms, formulation suites and fill-finish lines.
3 min 37 sec · MEPZ-SEZ, Chennai
Core capabilities
Eight manufacturing strengths.
Aseptic processing through cold-chain logistics — every step on one campus, governed by one quality system.
Aseptic Processing
Grade A/B cleanrooms per ISO 14644-1 with isolator-based filling under EU GMP Annex 1. Continuous viable and non-viable particulate monitoring across classified zones.
Formulation
50 L and 350 L jacketed SS316L process vessels with magnetic-coupled and low-shear vibro-mixer drives for sensitive proteins. WFI loop and pure-steam at point of use.
Vial Filling
3 mL, 5 mL and 10 mL Type I borosilicate vials — automated bromobutyl stoppering and aluminum flip-off crimping on the combi line for insulins and biosimilars.
Pre-Filled Syringes
20 / 40 / 60 / 80 mg PFS lines for enoxaparin — automated vacuum stoppering, plunger placement and in-line visual inspection per USP <790> for particulate matter.
Cartridge Filling
3 mL insulin and GLP-1 cartridges on a combi line with rapid SKU changeover between vial, PFS and cartridge. CIP/SIP cycles validated per ISPE Baseline Guide.
Visual Inspection
Automated and semi-automated inspection stations — particulate, cosmetic defect and fill-volume verification per USP <790> and <1790> before secondary packaging.
QC & Microbiology
HPLC, GC and Karl Fischer for chemistry; sterility (USP <71>), bacterial endotoxin (USP <85>), particulate matter (USP <788>) and container-closure integrity testing for microbiology.
Cold Chain Logistics
Validated 2°C–8°C chain from finished-goods cold rooms through international air-freight. Real-time temperature logging and qualified shippers per WHO TRS 961 Annex 9.
Schedule a facility visit or virtual tour.
Distributors, licensing partners and regulatory teams welcome on-site or via virtual walkthrough. Drop us a note — we'll arrange a date that works.
