Infrastructure & Manufacturing

A purpose-built cephalosporin injectable facility in Baddi, Himachal Pradesh — designed around WHO-GMP and revised Schedule M expectations.

Facility Overview

Built for sterile injectables from the ground up.

Every block, line and utility is laid out to support single-product campaigns, batch traceability and regulatory audit readiness.

Sterile dry powder injection vial filling line in a classified clean room

DPI

Dry Powder Injection (DPI) Filling Line

The DPI line handles sterile filling of cephalosporin powders into vials. Vials are washed, depyrogenated, filled under classified conditions and sealed in a controlled environment with in-process fill-weight and seal-integrity checks.

Vial washing, depyrogenation and sterilisation tunnel
Sterile powder filling under LAF / isolator conditions
In-process fill-weight and seal-integrity checks
250 mg, 500 mg and 1 g presentations

Automated Form-Fill-Seal line producing sterile diluent ampoules in a cleanroom

FFS

Form-Fill-Seal (FFS) Diluent Line

The Form-Fill-Seal line produces sterile Water for Injection and sodium chloride 0.9% diluent ampoules, enabling Kolash to supply a complete vial-plus-diluent pack to partners and institutions.

Sterile Water for Injection ampoules
Sodium Chloride 0.9% diluents
Single integrated vial + diluent pack supply
Automated forming, filling and sealing cycle

Facility Systems

Cleanrooms, utilities and quality systems.

The supporting infrastructure that keeps every batch reproducible and traceable.

Classified Cleanrooms

Operations run in Grade A/B/C environments with validated HEPA filtration, pressure cascades and continuous environmental monitoring.

In-House QC Laboratory

Raw material and finished product testing, including sterility, endotoxin, assay and particulate matter, supported by documented SOPs.

Purified Utilities

Purified Water, Water for Injection, clean steam and compressed air systems are qualified and maintained under preventive maintenance schedules.

Controlled Storage & Traceability

Temperature-mapped raw material and finished goods stores with full batch traceability from API receipt to dispatch.

Schedule a facility discussion

Ask about line capacity, campaign scheduling and quality documentation.