Product Details

Dry Heat Sterilizer

Sterilization by dry heat has become increasingly popular worldwide due to two reasons first the need to sterilize small objects, particularly ampoules, syringes and secondly for de-pyrogenation of manufacturing apparatus which is not possible in a steam sterilizer. Another advantage of this method of sterilization is that objects which are damaged by water or steam e.g. powder or ointment can be sterilized provided the heat penetrates to all parts of the substance.
The distinctive feature of these sterilizers lies in particle contamination class. We ensure a particle contamination level in the chamber that does not exceed the values prescribed by class 100: not even during transient phase, such as heating and cooling during which the filters can release considerable amounts of practices due to temperature related deformations. Special air flow technique guarantees over-pressure in the chamber throughout the cycle thereby assuring sterile integrity of the load, These sterilizers are designed to meet the stringent requirements of the pharmaceutical and medical device industry and are available in different configurations to meet specific temperature and cycle time requirements. These sterilizers represent the ideal solution for any production where the variability of products, batches and formats does not allow the use of continuous sterilizers such as tunnels.

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 Dry Heat Sterilizer is used for de-pyrogenation of glass and metallic containers / components using hot air as a sterilization medium.

The chamber is fabricated from SS316L and is provided with smooth and rounded corners for easy cleaning. All weld seams are argon welded and are ground and mechanically polished.
It consists of HEPA filters, air distribution plate, and adjustable louvers to maintain uniform air velocity over the chamber. The top of the chamber has a module for installation of the centrifugal blower and heater assembly.

The DHS is provided with two SS 316L hinged doors.

The chamber is insulated with Resin Bonded Glass Wool [150 mm thick] to reduce the heat loss to the environment and ensuring better temperature uniformity.

The Outer Enclosure of the machine is fabricated from SS304.

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 contact parts of the equipment are mechanically polished and then electro polished to a surface finish better than8 m Ra value while non-contact parts are mechanically polished to a surface finish better than 1.0 Ra.

For re-circulating the air in the chamber, a SS 316L centrifugal blower is provided at the top of the chamber, baffles are provided for uniform Air flow.

A Pressure module mounted at the top of the chamber with 5m Pre-filter, 0.3m HEPA filter, a SS 304 suction blower and damper.

A heating system mounted at the suction of the circulation blower.

The SS 304 exhaust module comprises of 0.3m HEPA filter, SS 304 suction blower and pneumatically actuated isolation damper provided at the top of the chamber is used for exhausting the water vapors during the moisture removal phase and the hot air during the cooling phase.
In a CLASS 100 DHS, for filtration of the air inside the chamber a bank of high temperature HEPA filters [0.3m, > 99.95%] is provided.

For periodic validation and testing of the system, Validation Ports with tri-clamp connections are provided. All HEPA filters are provided with upstream and downstream ports for DOP of all filters.
The chamber can be provided with SS 316L carriage with removable Shelves (perforated/wire-mesh type) 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 DHS 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.
OPERATING PROGRAM
- Heat up.
- Moisture removal.
- Heat up.
- Sterilization Hold.

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.
Magnahelic gauges are provided to measure the differential pressure across HEPA filters installed in the Pressure Module, Exhaust Module and chamber.
For very accurate temperature control in the chamber a thyristor is provided for controlling the current to the heating system.
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.
The system can be optionally provided with Industrial PC (IPC) or PC with 21CFR Part 11 Compliant System.