Manufacturing
Sterile fill and oral solid dose, packaged in-house
Two production streams — sterile injectables and oral solids — feed a single serialised packaging line. Classified cleanrooms, qualified equipment and continuous environmental monitoring sit behind every monograph in the register.
A classified facility with segregated streams for sterile injectables and oral solids, built around Grade A–D cleanrooms and a Water-for-Injection loop.
Cleanroom grades (EU GMP Annex 1)
- Grade A — filling & aseptic connections
- ISO 4.8 · unidirectional 0.36–0.54 m/s
- Grade B — aseptic background
- ISO 5 (at rest)
- Grade C — preparation
- ISO 7 / ISO 8
- Grade D — support
- ISO 8 (at rest)
HVAC & air handling
- Supply air
- HEPA-filtered (H14, ≥ 99.995%)
- Grade A airflow
- Unidirectional, 0.36–0.54 m/s
- Pressure cascade
- Positive, ~10–15 Pa between grades
- Air changes (Grade B)
- ≥ 20 per hour
- Recovery
- Cleanroom recovery time verified at requalification
Water systems
- Purified Water (PW)
- Ph. Eur. grade, circulating loop
- Water-for-Injection (WFI)
- Distillation; hot circulation ≥ 70 °C
- Monitoring
- Conductivity, TOC, bioburden, endotoxin
- Endotoxin (WFI)
- ≤ 0.25 EU/ml (USP <85>)
Environmental monitoring
- Non-viable particle counts (≥ 0.5 µm and ≥ 5.0 µm) at defined locations.
- Viable air sampling, settle plates and contact plates on a risk-based schedule.
- Personnel monitoring (glove and gown) after aseptic interventions.
- Continuous differential-pressure, temperature and humidity logging with alarms.
Personnel & flow
- Segregated personnel and material airlocks into each grade.
- Qualified aseptic gowning with periodic gown re-qualification.
- Unidirectional material flow from dispensing through to packing.
- Aseptic process simulations (media fills) qualify the filling operation.
Utilities
Purified Water and Water-for-Injection are generated and distributed through monitored loops; HVAC maintains classified pressure cascades. All critical utilities and equipment are commissioned through Installation, Operational and Performance Qualification (IQ/OQ/PQ).
Particle and viable limits are given in full on the Cleanroom & CCS tab, following EU GMP Annex 1 (2022 revision) and ISO 14644-1:2015. Figures are illustrative of the facility standard, not a specific site certification.