Dry Heat Sterilizer

Dry Heat Sterilizer or ampoule vial sterilizer is suitable to sterilize washed ampoules, vials and bottles. It is made from MS heavy angles and inner wall made from Stainless Steel 316 & outer wall made from Stainless Steel 304 materials. Our double door DHS is made in accordance with the requirement of cGMP standards approved in Injectable pharmaceutical plants maintain class 100 environment. All contact parts are made from Stainless Steel 316L or FDA approved materials for cGMP compliance.

The Dry Heat Sterilizer by Adinath International can effortlessly sterilize glass ampoules, vials, and bottles, guaranteeing they are free from contaminants before filling. This equipment is essential in pharmaceutical manufacturing, providing a reliable method for sterilization and depyrogenation.

Constructed with a robust framework, the dry heat sterilizer features an inner chamber made from Stainless Steel 316 and an outer wall from Stainless Steel 304, ensuring durability and compliance with Good Manufacturing Practices (GMP). The design includes a trolley system for easy loading and unloading of containers, facilitating efficient operation.

Operational Mechanism

Containers are placed in trays and loaded onto the trolley in a non-sterile room. Then, the trolley moves into the dry heat sterilizer. Next, temperature and time are set on the digital controller to achieve the desired sterilization. An impeller mounted on the top circulates hot air horizontally over the charge, ensuring uniform heat distribution. The air is heated by elements mounted on the top, and fresh air enters the system through a HEPA filter module, maintaining the sterility of the environment.

• cGMP Compliance: Ensures adherence to Good Manufacturing Practices.
• Stainless Steel Construction: Provides durability and corrosion resistance.
• Digital Control System: Allows precise setting of temperature and time parameters.
• HEPA Filtration: Maintains sterile conditions by filtering incoming air.
• Uniform Heat Distribution: Achieved through horizontal air circulation by the impeller.

Dual Doors with Interlock: Features two doors, one opening into the sterile room and the other into the non-sterile room, both pneumatically interlocked to prevent cross-contamination.

The Ampoules / Vials placed in trays are washed in non-sterile room and loaded on the trolley. The trolley is moved to the sterilizer on a transfer trolley. Temperature and Times are set on the Digital Controller. The Impeller mounted on the top circulates the hot air horizontally over the charge. The air is heated by elements mounted on the top. Fresh air enters the system through Hepa Filter Module. The system incorporates two doors, one opening into the sterile room and the other opening in the non-sterile room. Both the doors are pneumatically interlocked. The temperature profile during sterilization cycle is recorded on a circular chart recorder, validation of the system is provided by a six-point digital temperature scanner. After the time period required for sterilizing the batch has elapsed, the heating circuit shuts of the pneumatics damper (exhaust) opens and cooling operation commences.

* Power voltage can be adjusted as per customer’s domestic power voltage requirements.
* Rights of technical improvements & modification reserved.
* Illustrations & dimensions are shown for information purpose only.

• Construction Materials: Inner chamber made from Stainless Steel 316; outer wall from Stainless Steel 304.
• Control System: Digital controller for setting temperature and time.
• Air Circulation: Impeller mounted on top circulates hot air horizontally.
• Heating Elements: Mounted on top for efficient heating.
• Air Filtration: HEPA filter module for fresh air intake.
• Door Mechanism: Pneumatically interlocked dual doors for sterile and non-sterile rooms.

Applications

The Dry Heat Sterilizer is ideal for sterilizing:

• Glass Ampoules: Ensuring sterility for injectable solutions.
• Glass Vials: Preparing containers for vaccines and other sterile pharmaceuticals.
• Glass Bottles: Used in various pharmaceutical applications.

Its ability to handle different container sizes makes it versatile for various production requirements.

Integration and Compatibility

Designed to integrate seamlessly with upstream washing machines and downstream filling lines, the dry heat sterilizer ensures a continuous, contamination-free transfer of containers, enhancing overall production efficiency.

Maintenance and Validation

The design includes provisions for easy maintenance and validation. Filter integrity sample ports and validation thermocouple ports facilitate routine checks, ensuring consistent performance and compliance with regulatory standards.

Adinath International’s Dry Heat Sterilizer offers a reliable solution for sterilizing glass containers in pharmaceutical manufacturing. Its advanced features, compliance with industry standards, and energy-efficient operation make it  a wise integration to the manufacturing unit. It’s highly appreciated for maintaining product sterility and safety.