A level sensor installed in the chamber drain connection detects build up of water in the piping system, and indication of blockage or excessive condensation (which should not occur in normal operation). The sensor initiates an alarm condition in the control system.

A secondary temperature sensor is installed adjacent to the control sensor in the drain piping system. The temperature is displayed on the fascia control panel. This sensor is independent of the control system and may be used to check / confirm the temperature indicated by the control system.

In some locations, direct-operating pressure gauges (independent of power supply or control system) are a mandatory requirement, for operator safety. To avoid the creation of a "dead-leg" in the capillary piping connecting the gauge to the chamber, all Getinge cGMP autoclaves (including GE P, GE Q and most GEV and GEC Terminal sterilizers) utilize an oil filled membrane system to isolate the gauge system from the chamber while maintaining the mandatory direct acting design.

Air admitted to an autoclave, either post sterilization for non-liquid loads or during cooling of liquid loads, must be sterile to avoid recontamination. As standard, Getinge provides a sterilizing grade air inlet filter installed in the autoclave piping system. Periodically (e.g. after filter change or maintenance), it is necessary to sterilize the filter housing and sterile piping system. This is performed by a separate program in the control system in combination with valves and temperature sensors in the air filter system. Also know as "In Situ Filter Sterilization program", this system is provided as standard on all Getinge cGMP autoclaves (including GE P, GE Q and most GEV Terminal sterilizers).

In addition to this filter sterilization, Getinge also offer an optional automatic in-place integrity test of the air filter system. Based on the Water Intrusion Test (WIT) system, this method is superior to manual / offline test system as it also confirms the integrity of the installed filter, housing and piping system. Additionally, as it is a fully automatic system initiated in the sterilizer PLC system, it eliminates the manual work in performing the test manually (which involves removing and remounting the filter as well as the test itself. Both the sterilization and integrity test are documented by the PLC system.

Accordingly, the GE P is configured with cGMP features such as:

• Condensate level sensor in the chamber drain
• Independent secondary drain temperature sensor
• Membrane isolated  chamber pressure gauges
• Automatic sterilization in place of air filter program (and Integrity Test (WIT) option)
  

cGMP Construction features
The sterilizer is constructed with sanitary 316L stainless steel piping, fabricated to eliminate dead-legs (>6D) and sloping to drain (>2%) to ensure complete drainage (and sterilization) of the process system. Process valves are sanitary diaphragm type as standard. All gaskets / elastomers are PTFE, EPDM or similar FDA approved material. Full weld and material certification is provided for the process system.