Every BMT USA depyrogenation oven is built around a fully welded, all-stainless steel chamber equipped with a special HEPA filter suspension system engineered to eliminate particles and protect cleanroom integrity throughout the cycle. Available in single door and pass-through configurations with custom chamber sizes to match your production requirements.
BMT USA depyrogenation ovens are constructed with AISI 304 or 316L stainless throughout.The 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, and ensuring particles from the insulation cannot enter the chamber. All welds are visible and can be inspected.
For both ISO Class 5 and ISO Class 7 ovens, the air inlet is equipped with two-stage E11 and H13 HEPA filters, while class H13 HEPA filters are installed on the exhaust.
ISO Class 5 ovens are also equipped with internal heat-resistant class H13 HEPA filters mounted in a special suspension system that prevents particle leakage between the filter and the frame.
Smooth airflow regulation further prevents particles from entering the chamber during the heating and cooling phases.
The chamber door is flush-mounted, creating a completely flat surface across the face of the oven. The door(s) automatically close and lock with just a gentle push.
Pass-through models are equipped with an automatic door interlock system to prevent both doors from opening simultaneously, even in the event of a power outage, protecting against cleanroom contamination through the chamber.
The doors can also interface with an isolator.
BMT USA depyrogenation ovens are equipped with two FDA approved silicone door gaskets on each door. The double gasket design ensures a tight door seal while also minimizing the surface temperature of the oven and eliminating any undesired air flow into clean room environments.
Forced air convection rapidly transfers heat to the load, while air distribution plates, combined with the shape and position of the electrical heating elements, 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 machine downtime for future re-validation.
The precise temperature uniformity allows for configuring the setpoint temperature very close to the minimum required temperature for the specific load, protecting load integrity and utility cost savings.
The critical phases for maintaining ISO class 5 are during heating and cooling due to the expansion and contracting of the frames around the filters. Particle counting during an entire cycle is required versus only counting during the sterilization phase or at ambient temperature.
Each depyrogenation oven is factory tested under simulated production conditions prior to shipping. A particle counter is used to test conformity with ISO Class 5 requirements. The chamber is tested for temperature distribution and pressure stability.
Documentation of the testing is provided within the owner’s manual at delivery. The kit for particle counting is also available to be ordered upon request.
BMT USA depyrogenation ovens are offered in a range of chamber sizes and volumes in both single-door and pass-through configurations. The table below contains some of our standard models; however, we can design and build a customized solution to match your exact requirements.
25 (700)
35” x 29” x 45”
900 x 732 x 1140 mm
82” x 86” x 61”
2077 x 2191 x 1540 mm
1500
53 (1500)
59” x 35” x 45”
1500 x 900 x 1140 mm
107” x 95” x 61”
2727 x 2410 x 1540 mm
71 (2000)
59” x 35” x 59”
1500 x 900 x 1500 mm
107” x 95” x 75”
2727 x 2410 x 1900 mm
3900
138 (3900)
59” x 35” x 115”
1500 x 900 x 2920 mm
120” x 95” x 131”
3052 x 2410 x 3320 mm
4500
159 (4500)
59” x 41” x 115”
1500 x 1030 x 2920 mm
120” x 100” x 131”
3052 x 2540 x 3320 mm
A depyrogenation oven is a critical piece of equipment used in the pharmaceutical and biotech industries to remove contaminates from empty glass or metal containers through exposure to intense dry heat, typically ranging from 260°C to 300°C, for a controlled duration. This process effectively deactivates and destroys endotoxins (pyrogens), which can cause adverse reactions in patients, ensuring the containers meet stringent safety and quality standards for drug manufacturing.
BMT USA depyrogenation ovens are primarily used to sterilize and depyrogenate empty glass and metal containers, including ampoules, injection bottles, vials, and stainless steel equipment. Other applications include the sterilization of closed containers with low aqueous liquids and powder pharmaceuticals.
In general, a clean room is an enclosed space with equipment that controls the amount of particulate matter in the air by using air pressure and filters. ISO 14644-1 is a classification for clean rooms regulating the maximum particulate count per m3 as specified in the air cleanliness class. BMT USA depyrogenation ovens achieve ISO 14644-1 Class 5 and Class 7 thanks to a unique chamber construction and filter suspension system.
BMT USA offers custom chamber sizes to meet your specific capacity requirements. Please contact us to discuss your size requirements.
BMT USA offers custom stainless steel transfer trolleys, mobile racks, wire trays and cassettes to compliment any of our depyrogenation oven models.
Mobile racks are available with fixed or removable tray supports with adjustable spacing to match your load configuration. The mobile racks are also equipped with specialized wheels to withstand high temperatures without the need for lubrication.
BMT USA depyrogenation ovens include a standard 1-year warranty on parts and labor. Optional extended warranties for parts and labor are also available.
Browse our full range of custom-built, non-proprietary cGMP steam sterilizers for pharmaceutical and biotech facilities.
