Cleanroom & weighing zones
4,500 m² · ISO 7 / Class 10,000; separate ISO 5 / Class 100 weighing booths.
DEMOAn editable demonstration of the Shenzhen campus, process infrastructure and equipment schedule.
The configuration and quantities below are sample planning data. They are not a verified inventory of installed Biocia equipment.
Illustrative cleanroom area
Sample main cleanroom class
Sample weighing zone class
4,500 m² · ISO 7 / Class 10,000; separate ISO 5 / Class 100 weighing booths.
DEMOIllustrative configuration: dedicated supply and exhaust, three-stage filtration and H14 HEPA terminal filtration.
DEMOIllustrative WFI loop with continuous hot circulation at +80 °C. USP / EP / ChP water specifications shown as dossier placeholders.
DEMOSample equipment names and quantities, ready to replace with the approved facility inventory.
| Process stage | Illustrative system | Demo quantity / scale | Record required |
|---|---|---|---|
| Automated solid-phase synthesis | CSBio CS936X + microwave batch reactors | 16 synthesis systems · DEMO | Equipment qualification & batch records |
| Preparative chromatography | High-pressure preparative HPLC / DAC columns | 12 systems · Ø 150–300 mm · DEMO | Equipment qualification & batch records |
| Lyophilisation & closure | Tofflon lyophilisers / dry-nitrogen closure | 4 units · 40 m² shelf area · DEMO | Equipment qualification & batch records |
| Analytical HPLC | Waters e2695 / Agilent 1260 Infinity II | Instrument configuration · DEMO | Equipment qualification & batch records |
| Mass spectrometry | Shimadzu LC-MS analytical system | Instrument configuration · DEMO | Equipment qualification & batch records |
Define sequence identity, synthesis strategy and process controls.
Document separation fractions and the analytical release method.
Record drying cycle, packaging specification and closure parameters.
Associate source reports, product identity and batch traceability.