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 classification (WHO TRS 961 / 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)
Airborne particle limits (at rest, per m³ · ≥0.5 µm / ≥5.0 µm)
- Grade A
- 3 520 / 20
- Grade B
- 3 520 / 29
- Grade C
- 352 000 / 2 900
- Grade D
- 3 520 000 / 29 000
Recommended microbial limits (in operation · air CFU/m³ · settle 90 mm CFU/4h · contact 55 mm · glove 5 fingers)
- Grade A
- < 1 / < 1 / < 1 / < 1
- Grade B
- 10 / 5 / 5 / 5
- Grade C
- 100 / 50 / 25 / —
- Grade D
- 200 / 100 / 50 / —
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).
Classification vocabulary and limits follow WHO TRS 961 Annex 6 (aligned with EU GMP Annex 1). Figures are illustrative of the facility standard, not a specific site certification.