Class 7 Depyrogenation Oven

ISO Class 7 up to 300°C over the full duration of the cycle

BMT USA Class 5 Depyrogenation ovens protect against contamination through the complete elimination of pyrogens from pharmaceutical packaging and equipment, including glass containers, injection bottles, and stainless steel. BMT USA depyrogenation ovens achieve ISO 14644-1, Class 7 (formerly class 10,000) up to 300°C during the full duration of the cycle without temperature ramping.

Built to ensure the complete destruction of pyrogens

cGMP Design

As standard, BMT USA depyrogenation ovens are constructed with AISI 304 or 316L stainless steel inside and out, with additional grades of stainless steel available to meet your specific requirements.

The water-cooling element is constructed of AISI 316L stainless steel and is a continuous welded unit without any connections inside the cabinet. The water-cooling element is pressure tested to ensure reliable operation over the entire lifespan of the oven.

The chamber is fully welded inside to ensure no leakage to the insulation can occur and for improved ease of cleaning. All welds are visible and can be inspected. The inside chamber is fully welded and assembled to the outside cabinet without the use of screws or rivets, eliminating hidden crevices where particles and bacteria could grow.

Semi-Automatic Chamber Doors

The chamber door is flush-mounted, creating a completely flat surface across the face of the oven, and automatically closes and locks with just a gentle push.

Pass-through oven models are equipped with an automatic door interlock system to prevent operation failure or contamination through the chamber, even in the event of a power outage. Additionally, both doors can never be opened simultaneously during normal operation. The door(s) is also designed to interface with an isolator.

Temperature Distribution

Forced air convection rapidly transfers heat to the load, while air distribution plates, combined with the shape and position of the electrical heating element, ensure a consistent temperature distribution throughout the chamber.

Temperature distribution is preset and tested before delivery and does not require adjustments over the lifetime of the oven–eliminating the need for future re-validation and machine downtime. The precise temperature uniformity allows for configuring the setpoint temperature very close to the minimum required temperature for the specific load.

Chamber Sealing

To obtain ISO Class 7 during the entire cycle, it is critical for the chamber to be fully sealed. BMT USA depyrogenation ovens are standard equipped with FDA approved double door gaskets to prevent leakage between the chamber and the outside environment. The double door gasket design also minimizes the surface temperature of the sterilizer and eliminates undesired air flow into the sterile area. Additionally, the inlet air and exhaust are equipped with HEPA filters.

Documentation

With regulatory requirements increasing for quality documentation, emphasis has been placed on providing thorough IQ/OQ qualification and validation documents as standard with the order of any depyrogenation oven. Each oven also includes a comprehensive operation and maintenance manual. Optional QA-documentation is also offered.

GAMP
A complete package of qualification and validation documentation based on GAMP5 (Good Automated Manufacturing Practice) is available as an option to help save time and costs during the validation process.

FDA
For clients with production facilities requiring FDA approval, BMT USA depyrogenation ovens are designed and built in compliance with FDA guidelines and pass inspection.

Control System

BMT USA depyrogenation ovens are equipped with Allen-Bradley or Siemens PLCs and touch screen operator interfaces. The control system provides fully automated cycles and is engineered to comply with the requirements for control of critical production units within the pharmaceutical industry. The control system can also be connected to a local factory network and configured to support multi-user password authentication in compliance with FDA 21 CFR part 11 for secure electronic data storage.

Key Features

ISO Class 7

ISO Class 7 compliance over the full duration of the depyrogenation cycle, tested and documented before delivery of every oven.

Temperature Uniformity

Even temperature distribution inside the chamber without adjustment. No temperature ramping needed during the heating and cooling phases, significantly reducing cycle duration.

Reliable Performance

Our use of high quality stainless steel, fully welded chambers with no screws or rivets, industrial-grade PLC control systems, and rigorous quality testing ensures reliable performance while reducing downtime and maintenance costs.

Warranty

Standard 24-month warranty on every unit for peace of mind and assurance that any service issues will be handled quickly and effectively.

Operation Overview

BMT USA depyrogenation ovens feature a unique chamber construction and filter suspension system that work together to achieve ISO Class 7, while allowing for full speed heating and cooling without the risk of generating particles.

Automatic Depyrogenation Cycles

Our depyrogenation cycles are fully automatic and have been developed to optimize energy savings without compromising performance to ensure the complete destruction of pyrogens from pharmaceutical packaging and equipment.

Heating & Drying

The cycle starts with the drying phase. During this phase, the damper on the exhaust is open to ensure all moisture is removed from the chamber.

Each oven is equipped with a powerful heating element to reduce heating time. Due to specialized filtration suspension system, ramping is not required during the heating and cooling phases, reducing the cycle time while maintaining ISO Class 7 conditions.

Sterilizing

After the drying phase completes, the damper will close and the temperature will quickly rise to the sterilizing temperature. The damper remains closed during the entire sterilization phase.

The sterilizing timer can be started either by delay timer or load sensors. If load sensors are chosen, the sterilizing timer will only run if all load sensors are within an acceptable range from the sterilizing setpoint.

Cooling

Forced air cooling or water cooling is available to deliver rapid cooling for applications that require reduced cycle durations.

Accessories

We offer a range of customizable accessories, including transfer trolleys, mobile racks, wire trays and cassettes:

Transfer Trolleys

The transfer trolley allows for transporting the mobile rack outside the chamber. The transfer trolley is locked to the chamber during loading to ease operation.

Mobile Racks

The mobile rack is available with fixed or removable tray supports. The height between the tray supports can be adjusted to suit customer load configurations. Additionally, the mobile rack is equipped with a smooth running wheel that can also withstand temperatures as high as 300 °C, without requiring lubricant.

Cassettes

The Cassettes can also be customized and are available in a perforated design. All mobile rack wire trays and cassettes are constructed with AISI 316L stainless steel.

Chamber Volume

4.03m³

Class 7 Depyrogenation Oven

ISO Class 7 up to 300°C over the full duration of the cycle

Built to ensure the complete destruction of pyrogens

cGMP Design

Key Features

ISO Class 7

Temperature Uniformity

Reliable Performance

Warranty

Operation Overview

Automatic Depyrogenation Cycles

Heating & Drying

Sterilizing

Cooling

Accessories

Transfer Trolleys

Mobile Racks

Cassettes

Chamber Sizes

Model

Chamber Dimensions

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Chamber Volume

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Chamber Dimensions

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Chamber Dimensions

External Dimensions

Chamber Volume

Chamber Dimensions

External Dimensions

Chamber Volume

Chamber Dimensions

External Dimensions

Chamber Volume

Chamber Dimensions

External Dimensions

Chamber Volume

Chamber Dimensions

External Dimensions

Chamber Volume

Chamber Dimensions

External Dimensions

Chamber Volume

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