Purified water and WFI systems, clean steam generators, isolators, cleanrooms and HVAC.
Plant utilities including process water, clean steam, air handling and barrier systems. The same team designs them as designs the process equipment, so interfaces and qualification documents line up.
Pre treatment, reverse osmosis and electrodeionisation on a single skid. Water quality is monitored continuously and the unit returns to recirculation automatically if a limit is exceeded.
| Capacity | 0.5 ~ 20 m³/h |
|---|---|
| Water quality | KP and USP purified water |
| Conductivity | below 1.3 µS/cm at 25 °C |
| Microbial | controlled below 100 CFU/mL |
| Monitoring | conductivity, TOC, flow, temperature |
| Qualification | IQ, OQ and PQ documents supplied |
Keeps water for injection circulating at a set temperature to hold back microbial growth. Piping with minimal dead legs and full drainability keeps the loop sanitary.
| Tank volume | 500 L ~ 30,000 L |
|---|---|
| Loop temperature | above 80 °C or ambient with ozone |
| Return velocity | 1.0 m/s or more |
| Surface finish | electropolished to Ra 0.4 or better |
| Monitoring | TOC, conductivity, temperature, pressure |
| Sanitisation | pure steam SIP |
Supplies clean steam for sterilising and steam in place with a stable pressure. Condensate quality is managed against water for injection limits.
| Steam output | 100 ~ 3,000 kg/h |
|---|---|
| Supply pressure | 1 ~ 6 bar |
| Condensate | meets WFI limits |
| Non condensable gas | below 3.5 % |
| Materials | STS 316L, electropolished |
| Codes | pressure vessel codes, HTM 2031 reference |
Puts a physical barrier between operator and product to hold aseptic conditions. Hydrogen peroxide decontamination cycles and pressure management are provided together.
| Classification | ISO 5 inside, ISO 7 or 8 background |
|---|---|
| Pressure | plus 20 to plus 60 Pa, negative option |
| Decontamination | vaporised hydrogen peroxide, 6 log reduction |
| Access | glove ports, half suit, rapid transfer port |
| Monitoring | particles, pressure and air velocity monitored |
| Integration | couples to fillers and freeze dryers |
Panels, air handling, pressure cascade and environmental monitoring delivered under one responsibility. Zone classification and airflow direction are fixed at the design stage.
| Cleanliness | ISO 5 ~ ISO 8 (GMP A ~ D) |
|---|---|
| Air changes | 20 to 600 per hour |
| Filtration | pre, medium and HEPA H14, three stages |
| Pressure cascade | 10 to 15 Pa between zones |
| Monitoring | temperature, humidity, pressure and particles logged |
| Qualification | airflow, pressure, cleanliness and recovery tests |
