PRODUCTION FACILITY | LEADING PHARMACEUTICAL PACKAGING
▶ WASHING
Two washing lines are located into Clean Room Class C
▶ STERILIZATION AND DEPYROGENATION
Into static oven or through tunnel, from ISO 7 to ISO 5 – Class A
▶ ASEPTIC PACKAGING ZONE UNDER LAF
Into Clean Room Class A, surrounding Class B
▶ SECONDARY PACKAGING ZONE
Into Clean Room Class C
▶ W.F.I. PRODUCTION
by Thermocompression Distiller
PHARMACEUTICAL CONTROL | FINAL PRODUCT
Sterility test on production samples by steritest regarding sterility, bacterial endotoxins and subvisible particles as iso 21882 (2019).
Analysis of the rinsing water on a sample of sterilized vials.
▶ SUBVISIBLE PARTICLES
▶ BACTERIAL ENDOTOXIN TEST (L.A.L.)
▶ T.O.C. (TOTAL ORGANIC CARBON)
▶ CONDUCTIVITY
IN PROCESS CONTROL
CLEAN ROOMS MONITORING
▶ Overpressures
▶ Temperatures
▶ RH
▶ Particle Counting – during all packaging process
▶ Microbiological Tests – Sampling Air System, surface and contact and sedimentation Petri dishes
WFI LOOP AUTOMATIC MONITORING
▶ T.O.C. On Line | Temperature | Conductivity | Water Speed | Periodic water checks basedon Pharmacopoeia regulations: continuous validation
LABORATORY TEST ON WFI (if required)
▶ BIOBURDEN (Milliflex)
▶ L.A.L. (PTS)
