GMP construction (SS 316 + SS 304) Double door for sterile - non sterile area application Sliding door or Radial locking door as per customer selection Design temp 121/134 and pressure 15/30 psi 0.2 micron filter and SIP intergrity test Steam generator, Vacuum Pump, Trolley, Carriage, Strip chart recorder PLC with HMI / IPC 21 CFR part 11 compliance
Qualification - Bowie dick test, HPHV cycle / Gament Cycle, PLT, VLT, Standard Cycle
DQ, FAT, IQ, OQ, SAT and support during thirdy party validation PQ