Product Details

Steam-Air Sterilizer

Steam-Air Terminal sterilizers are designed primarily for sterilizing products with flexible and delicate packaging that requires counter pressure throughout the sterilization phase. Another significant advantage is that the product is dry and ready for further handling immediately after the unloading.
In a steam sterilizer, the temperature and pressure relationship is always pre-defined. In steam-Air sterilizers, a separate medium is used for heating (steam) and pressurizing (air) and thus the relation can be varied. Due to this, we can achieve a chamber pressure that is higher or lower than the corresponding steam pressure for a given temperature. Hence this system helps to overcome the drawbacks associated with conventional steam sterilization systems.
For plastic containers or pre-filled syringes, the internal pressure must be balanced such that there is no net pressure differential across the container and/or closure or else there is a risk of compromising the container and/ or disrupting the closure e.g. excessive stopper movement in a pre-filled syringe An intelligent control system constantly adapts the pressure in the chamber to the pressure in the containers. This protects sensitive material to be sterilized against deformation. Steam and Air have different densities and will “stratify” if not mechanically mixed. (i.e., the heavier air will sink to the bottom). Here a fan and ducting is used to create a circulation pattern and maintain a homogenous environment.

Categories
Tech Specification

Injectable / Sterile Unit Autoclaves

All MACHINFABRIK Sterilizers are designed to comply with ASME Pressure Vessel codes, current GMP norms, EN 285, USFDA, EU, PIC etc. The system will be provided with DQ, IQ, OQ documents.
The Steam Air Sterilizer uses a mixture of steam and air to create a sterilizing medium, which allows processing at a higher and lower pressure than steam pressures prevalent in conventional sterilization systems.
The Steam Air Sterilizer can be used for processing a wide range of products, Ampoules, Vials, Glass bottles, BFS containers, Soft bag, Pre-filled syringes, Ointment tubes, Blister packed products.
The SS 316L Main Chamber, pressure vessel, houses the Inner Chamber. At the top of the Inner Chamber, there is a suction plate for the Circulation Turbine which ensures a uniform flow of the sterilization medium.
The 6mm thick Outer chamber is fabricated with SS316L with high-quality inert gas argon welding and is provided with round corners for easy cleaning and a 2% slope for full draining of the condensate.
The chamber is also provided with a safety valve and compound gauge (on both sides), RTD sensors, pressure switch and pressure transmitter.
The sterilizer is provided with one/two automatic sliding SS316L door reinforced with SS 304/mild steel. Mineral wool insulation is provided which is held in place by a stainless steel outer cover.
CNC machined groove for superior performance and excellent sealing of the door gasket can be provided.
The door is automatically moved vertically / horizontally via a pneumatic cylinder to ensure the safety of the operator and the equipment during the entire operation.
Compound gauges for gasket pressure, with door status indications are provided on both Loading & Unloading sides.
The sterilizer chamber is insulated with 50-mm thick mineral wool, which is held in place by an outer cover of SS304.
The chamber and doors are finished to a surface finish better than 8 micron Ra value. All other non-contact parts are polished to a surface finish better that 180 grit.
A SS316L Circulation Turbine is provided at the top of the Sterilizer and in the annular space between the Main Chamber and Inner Chamber. The Circulation Turbine is driven by an electric motor and is provided with a special high temperature mechanical seal for leak proof operation.
The mechanical seal is provided with a seal cooling system comprising of a tank, chilled water coil and circulation pump.
In the annular space of the Main Chamber and Inner Chamber a SS316L finned tube heat exchanger is located.
The Cabinet Enclosure houses the pressure vessel, piping system, electrical systems and SS 304 facia panels of the unit. Service doors are provided on the sides for maintenance and cleaning.
A cross-contamination seal is provided at the clean side for double door units to separate the clean and unclean sides. The system is designed to minimize the flow of the air from the clean area.
All process piping in contact with the chamber is fabricated from SS 316L with argon welding. All connections and fittings used are sanitary tri-clamp with silicone seals.
The process valves in contact with the chamber have SS 316L contact parts with Teflon seat and tri-clamp connections. All other valves have threaded connections.
For periodic validation and testing of the system, Validation Ports with tri-clamp connections are provided.
The chamber can be provided with SS 316L carriage with removable racks and boxes for loading. Each carriage is provided with four concave shaped wheels with sealed bearings impregnable to the steam.
Floor trolley is fabricated from SS 304 sturdy tubular members welded together with castor wheels.
The chamber is provided with SS 316L railing with circular cross-section. The rails can be easily removed for cleaning the chamber.
The functioning of the Sterilizer is automatic and is controlled by a PLC. The PLC is operated with the help of a color, touch screen HMI with user-friendly features.
The PLC, instrumentation and electrical switchgear are housed in a SS304 panel installed on the skid.
The control cabinet is provided with a main isolator for the three-phase supply and a separate switch for the control supply.
To ensure flexibility, accuracy, highly reliable performance and compliance to regulatory requirements the Hot Water Spray Sterilizer is provided with up to 6 Sterilization Programs.
A Six-Channel Strip Chart Recorder for recording temperature at 5 points and pressure at 1 point is provided as a watchdog-recording device.
For on-line process recording a data printer is provided in the control panel.
For ease of operation and safety of the operator all critical and non-critical alarms are displayed on the HMI as a text message and audio signal is provided via an audio buzzer.
Optionally, the following features can be provided in the system based on URS:- CE Marking, vacuum pump with mechanical seal and vent filter, Vacuum Pump with Recirculation and Cooling System, Process Air / Compressed Air Filter with SIP Facility, Sanitary PRV for Chamber Steam, Black Steam PRV for Jacket Steam, fittings and tubing to carry out steam quality testing, manual diaphragm valves for sampling of inlet Pure Steam to the Chamber and the steam condensate from the chamber, UPS supply, PID control valves, Pure steam by pass arrangement, drain condenser, sanitary accessories, level switch in drain line, utility monitoring system.
The system can be optionally provided with Industrial PC (IPC) or PC with 21CFR Part 11 Compliant System.
Optionally we can provide a 21CFR Part 11 compliant Chartless Recorder with a 4” LCD display.
After manufacturing and in-house testing customer inspection and testing can be performed as per in-house FAT protocol at our manufacturing facility.