Saturated Steam Pharmaceutical Autoclave (FOF)
The FOF type of pharmaceutical autoclave enables saturated steam sterilisation. Its flexibility and its many possibilities (vacuum, counterpressure, water flow, fans ...) makes it perfectly suited to moist heat sterilisation for many loads:
Complex solid equipment and various assemblies
- Porous materials, either packaged or overpackaged
- Filled ampoules with air-tightness test
- Filled ampoules and vials, with spray cooling using air under counterpressure
The steam autoclave has all the features and qualities of Fedegari pharmaceutical autoclaves (see process information). The FOF pharmaceutical autoclaves have a cylindrical or quadrangular chamber and rectangular doors.
FOF Pharmaceutical Autoclaves are controlled by the Thema 4 system, which allows the user to create programs tailored to the size of the loads to be sterilised, in full conformity with CFR 21 part 11 and cGMP.
FOF pharmaceutical autoclaves with a volume capacity of up to 35 m3 can be fitted with various different features:
- Rotating loads, by means of a magnetically driven drum
- Automated loading system
- Loading at ground level
- Stopper treatment, including washing, rinsing, siliconing, sterilisation, drying and automatic unloading into a sterile area.
- Treatment of High Pathogen materials, requiring special procedures to avoid any risk of external contamination
All moist heat sterilisation pharmaceutical autoclaves are equipped with a water ring vacuum pump which operates in each step of the moist heat sterilisation process:
- The initial evacuation of air trapped in the chamber and heat pulses,
- The continuous removal of condensates that form in the dynamic steam chamber
- Treatment at a temperature below 100 ° C
- The final drying of sterilised loads under vacuum
An important feature of these pharmaceutical autoclaves lies in the fact that control is maintained by using the pressure of the chamber, not the temperature. Simultaneously but independently, the control system checks the temperature in the chamber and that of the load, so as to ensure the correspondence between pressure and temperature, thereby demonstrating that the pharmaceutical steriliser is functioning correctly. This technique achieves a much better level of temperature uniformity than that which is normally required (± 0.5 ° C).