ISO Class 5 & 7 Depyrogenation Ovens

cGMP dyprogenation ovens are capable of performing ISO 14644-1 Class 5 up to 280°C and class 7 up to 300 °C throughout the entire cycle without the need for temperature ramping. This is made possible by a double-sealed chamber construction and unique filter suspension system. BMT USA depyrogenation ovens are environmentally safe and do not produce any pollution or waste. Both class 5 and class 7 ovens can be customized to meet your company’s specific chamber size and capacity requirements.

Dry Heat Sterilization and Depyrogenation

Dry heat sterilization and depyrogenation provide complete destruction of microorganisms by means of dry heat for a controlled period of time. BMT USA depyrogenation ovens are designed for the depyrogenation and dry heat sterilization of empty glass containers, including ampoules, injection bottles, vials and stainless steel equipment. Additional applications include sterilization of closed bottles with low aqueous liquids and powder medicaments.

Class 5 Depyrogenation Ovens

ISO 14644-1 Class 5 up to 280 °C without ramping

Complete destruction of microorganisms in compliance with ISO 14644-1, class 5 (100) up to 280°C during the entire cycle.

Class 7 Depyrogenation Ovens

ISO 14644-1 Class 7 up to 300 °C without ramping

Complete destruction of microorganisms in compliance with ISO 14644-1, class 7 (10,000) up to 300°C during the entire cycle.

Depyrogenation Oven FAQs

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 pyrogens, which are fever-inducing contaminants, ensuring the containers meet stringent safety and quality standards for drug manufacturing.

BMT USA depyrogenation ovens are primarily used to sterilize 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 medicaments.

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.

Yes, the chamber can be custom designed and built to to meet your specific capacity requirements. Please contact us to discuss your size requirements.

Yes, BMT USA offers custom stainless steel transfer trollesy, mobile racks, wire trays and cassettes to compliment any of our depyrogenation oven models.

Mobile racks are available with fixed or removable tray supports, and the height between the tray supports can be adjusted to match your load configuration. The mobile racks are also equipped with specialized wheels to withstand high temperatures without the need for lubrication.

Yes, BMT USA depyrogenation Ovens include a standard 1-year warranty on parts and labor. An extended warranty for parts and labor is also available as an option.

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