Pharma Engineering Insights

Architettura di controllo di una linea di riempimento asettico: macchina in barriera, pannello operatore, quadro elettrico e percorsi dati luminosi

Automation, Alarms and Data Integrity in Asepti...

Not everything the PLC produces is a GMP record, and not every GMP record originates in the PLC. How to classify the data of an aseptic filling line, and what...

Automation, Alarms and Data Integrity in Asepti...

Not everything the PLC produces is a GMP record, and not every GMP record originates in the PLC. How to classify the data of an aseptic filling line, and what...

Linea di riempimento asettico in barriera chiusa con glove port, flusso unidirezionale visualizzato e interfaccia di carico verso una camera di liofilizzazione

Aseptic Process Simulation / Media Fill: How to...

A non-representative APS never fails: what is not simulated cannot contaminate. How to build the simulated scope, the intervention list and a documented worst case, between Annex 1 and FDA...

Aseptic Process Simulation / Media Fill: How to...

A non-representative APS never fails: what is not simulated cannot contaminate. How to build the simulated scope, the intervention list and a documented worst case, between Annex 1 and FDA...

Confronto fra un RABS con pannelli trasparenti e glove port e un isolatore sigillato con rapid transfer port su due linee di riempimento identiche

RABS vs Isolators in Aseptic Fill-Finish: How t...

How to build a defensible barrier strategy for aseptic fill-finish: open RABS, closed RABS and isolator distinguished, a twelve-criterion decision matrix naming the deciding function, and the choice placed in...

RABS vs Isolators in Aseptic Fill-Finish: How t...

How to build a defensible barrier strategy for aseptic fill-finish: open RABS, closed RABS and isolator distinguished, a twelve-criterion decision matrix naming the deciding function, and the choice placed in...

Sezione di una linea di fill-finish asettico in barriera che evidenzia il punto in cui il trasporto attraversa la parete dell'involucro

How to Select an Aseptic Fill-Finish, RABS or I...

When the filling line and the barrier come from different suppliers, the interface ends up with no owner. How to build a comparable tender from URS to RFP, evaluate the...

How to Select an Aseptic Fill-Finish, RABS or I...

When the filling line and the barrier come from different suppliers, the interface ends up with no owner. How to build a comparable tender from URS to RFP, evaluate the...

Stazione di riempimento asettico con needle in acciaio, manifold di tubing single-use e testa di dosaggio sopra vial vuoti in barriera

Filling Technologies and the Sterile Product Pa...

Peristaltic, time-pressure, piston or rolling diaphragm: no dosing technology is universally better. How to select the filling principle and design the sterile product path from product characteristics, across aseptic connections,...

Filling Technologies and the Sterile Product Pa...

Peristaltic, time-pressure, piston or rolling diaphragm: no dosing technology is universally better. How to select the filling principle and design the sterile product path from product characteristics, across aseptic connections,...

Linea di riempimento asettico in isolatore con needle, vial e rapid transfer port, sovrapposta a una griglia astratta di tracciabilita dei requisiti

URS for Aseptic Fill-Finish & Barrier Systems: ...

A requirement left out of the URS is never quoted, never verified in DQ, and resurfaces as a PQ deviation. How to structure the URS for an aseptic line and...

URS for Aseptic Fill-Finish & Barrier Systems: ...

A requirement left out of the URS is never quoted, never verified in DQ, and resurfaces as a PQ deviation. How to structure the URS for an aseptic line and...