BSP Pharmaceuticals S.p.A. was glad to announce validation of its new manufacturing Sterile Department - Sterile 4 - by AIFA (Italian Medicine Agency), during its last General GMP Inspection of 11 - 13 October 2016.
The Sterile 4 suite was projected to be a unique manufacturing system specially designed for anticancer drugs, with the flexibility to manage small molecules and the complexity of ADC products.
Sterile 4 suite capabilities:
LYO SURFACE: 2x215 sqf
VIAL SIZES range from 2 ml to 100 ml
ISOLATOR AND CLOSED RABS to have the highest level of sterility assurance and containment: cRABS