Washing machines, depyrogenation tunnels, filling and sealing machines, freeze dryers, sterilizers and CIP or SIP skids.
Washing, sterilising, filling and freeze drying for injectable and sterile products. The aseptic boundary is kept simple, and cleaning and sterilising paths are planned to be verifiable from the design stage.
A rotary washer that treats the inside and outside of each container in a fixed sequence. Pressure and time at every nozzle are recorded, so a washing history remains.
| Output | 6,000 ~ 24,000 vials/h |
|---|---|
| Container range | 2 mL ~ 100 mL |
| Wash steps | recycled water, PW, WFI, clean air |
| Residue limit | meets particle and endotoxin limits |
| Integration | direct coupling to the sterilising tunnel |
| Materials | STS 316L with silicone and PTFE seals |
Drying, sterilising and cooling zones joined under one laminar flow. Differential pressure and the temperature profile of each zone are monitored continuously to reproduce endotoxin reduction.
| Sterilising temperature | 250 °C ~ 350 °C |
|---|---|
| Endotoxin reduction | 3 log or more |
| Conveyor | stainless mesh belt, variable speed |
| Air supply | HEPA H14 laminar flow in every zone |
| Qualification | heat distribution and penetration tests included |
| Installation | through wall, separating classified areas |
Filling, stoppering and capping inside a single aseptic boundary. In process weight checking is linked to reject handling, which holds fill accuracy over the run.
| Output | 3,000 ~ 24,000 vials/h |
|---|---|
| Fill accuracy | within ± 0.5 % |
| Filling system | peristaltic, rotary piston, time pressure |
| Barrier | RABS or isolator |
| Weight check | 100 % or statistical |
| Monitoring | continuous particle and pressure monitoring |
Shelf temperature and chamber vacuum are controlled together to produce a repeatable drying curve. Chamber and condenser can be sterilised with pure steam.
| Shelf area | 0.5 m² ~ 60 m² |
|---|---|
| Shelf range | -55 °C ~ +70 °C |
| Condenser capacity | per batch |
| Vacuum | down to 0.01 mbar |
| Sterilisation | pure steam SIP at 121 °C |
| Options | automatic loading and unloading, isolation valve |
Cycles matched to the load are supplied as standard, and every run is kept as an electronic record. The double door layout separates the clean side from the general side.
| Chamber volume | 100 L ~ 6,000 L |
|---|---|
| Cycles | saturated steam, air mixture, liquid load |
| Temperature | 105 °C ~ 138 °C |
| Doors | single or interlocked double door |
| Records | electronic batch record with audit trail |
| Codes | pressure vessel codes and CE conformity |
Clean in place and steam in place skids that manage concentration, flow, temperature and time as a recipe. Return paths are kept short to cut water consumption.
| Tanks | 1 to 4 vessels, 200 L to 5,000 L |
|---|---|
| Supply flow | 5 ~ 60 m³/h |
| Temperature | up to 95 °C wash, 121 °C sterilise |
| Monitoring | conductivity, flow, temperature, pressure |
| Piping | minimised dead legs, full drainability |
| Records | cycle report per recipe |
