Products / Depyrogenation Ovens / Lytzen Class 7 (10,000) Depyrogenation Ovens
Overview
Dry heat sterilization and depyrogenation provide complete destruction of microorganisms by means of dry heat for a controlled period of time. Lytzen ISO Class 7 Depyrogenation Ovens are designed for critical depyrogenation applications in clean room areas, including the sterilization of empty glass and metal ampoules, injection bottles, vials, and stainless steel equipment. Lytzen depyrogenation ovens conform to ISO 14644-1, class 7 (formerly class 10,000) up to 300°C during the entire cycle.
Key Features:
- Even temperature distribution without adjustments.
- Manufactured in a ISO 9001 certified facility.
- ISO class 7 compliance throughout the cycle – tested and documented before delivery of every sterilizer.
- No temperature ramping needed during the heating or cooling phases of the cycle, significantly reducing overall cycle times.
- High quality performance with low maintenance cost and reliable production.
- Standard 24-months warranty on every unit.


ISO Class 7 up to 300°C
The Lytzen ISO Class 7 (10,000) depyrogenation ovens are equipped with HEPA filters on the air inlet and exhuast, but does not include internal HEPA filters. Due to the chamber construction and double door gasket sealing, ISO class 7 classification can be achieved throughout the entire cycle without the need or internal HEPA filters. The absence of these interal filters also works to significantly reduce the overall cost of the ovens.
Doors
Temperature Distribution
Chamber Sealing
Documentation
Control System
Doors
Lytzen depyrogenation ovens are equipped with a semi-automatic door. The flush-door design is automatically closed and locked by the control unit when you gently push the door into the opening.
For pass-through models, the doors are equipped with an automatic door interlock system to prevent operation failure or contamination through the chamber, even during a power outage. Both doors can never be open at the same time during normal operation. The flush-door is also designed to interface with an isolator.
For pass-through models, the doors are equipped with an automatic door interlock system to prevent operation failure or contamination through the chamber, even during a power outage. Both doors can never be open at the same time during normal operation. The flush-door is also designed to interface with an isolator.
Temperature Distribution
The ovens utilize forced air convection to rapidly transfer heat to the load. The air distribution plates, combined with the shape and position of the electrical heating element, ensures a consistent temperature distribution inside the chamber.
Temperature distribution is preset and tested before delivery and does not require any adjustments over the lifetime of the oven, eliminating the need for future re-validation and machine downtime.
Temperature distribution is preset and tested before delivery and does not require any adjustments over the lifetime of the oven, eliminating the need for future re-validation and machine downtime.
Chamber Sealing
To obtain ISO Class 7 during the entire cycle, it is important that the chamber is properly sealed. To achieve this, Lytzen depyrogenation ovens are equipped with double door gaskets (FDA-approved) as standard. The double door gaskets ensure there is no leakage between the chamber and the outside environment, while also minimizing the surface temperature of the sterilizer and eliminating any undesired air flow into the sterile area.
Documentation
With regulatory requirements for quality documentation increasing, emphasis has been placed on providing thorough IQ/OQ qualification and validation documents as standard with the order of any Lytzen depyrogenation oven. Each oven also includes a comprehensive operation and maintenance manual. 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 clients save on time and costs during the validation process.
FDA
For clients with production facilities requiring FDA approval, Lyzten depyrogenation ovens are designed and built to meet all FDA guidelines and pass inspection. Lytzen continuously ensures their products are compliant with the latest FDA requirements, and their depyrogenation ovens have never caused a production facility to fail an inspection.
GAMP
A complete package of qualification and validation documentation based on GAMP5 (Good Automated Manufacturing Practice) is available as an option to help clients save on time and costs during the validation process.
FDA
For clients with production facilities requiring FDA approval, Lyzten depyrogenation ovens are designed and built to meet all FDA guidelines and pass inspection. Lytzen continuously ensures their products are compliant with the latest FDA requirements, and their depyrogenation ovens have never caused a production facility to fail an inspection.
Control System
Lytzen’s Lytcon control systems utilize Allen-Bradley or Siemens PLCs and touch screen operator interfaces. The systems provide fully automated cycles and are constructed to comply with the requirements for control of critical production units within the pharmaceutical industry.
All Lytcon control systems can be connected to a local factory network and have secure password authentication to comply with FDA 21 CFR part 11 for secure electronic data storage.
Optimized Automatic Cycle
Lytzen Depyrogenation oven cycles are fully automatic and have been optimized to save energy.
Drying
The cycle starts with the drying phase where the damper on the exhaust is open, ensuring any moisture will be removed from the chamber.
Heating
Once the user-selected set-point temperature is reached, the damper will close and the temperature will quickly rise to the sterilizing set-point temperature. The damper will also stay closed during sterilization.
Each Lytzen oven is equipped with a powerful heating element to reduce heating time. Due to a superior filtration suspension system, the oven doesn’t need to ramp during heating and cooling phases, and can run at full speed to shorten the cycle time, while maintaining ISO class 5 conditions.
Each Lytzen oven is equipped with a powerful heating element to reduce heating time. Due to a superior filtration suspension system, the oven doesn’t need to ramp during heating and cooling phases, and can run at full speed to shorten the cycle time, while maintaining ISO class 5 conditions.
Sterilizing
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 set-point.
Cooling
For applications where a reduced cycle time is necessary, forced air cooling or water cooling is available for rapid cooling times.
The cycle starts with the drying phase where the damper on the exhaust is open, ensuring any moisture will be removed from the chamber.

cGMP Design
As standard, Lytzen depyrogenation ovens are constructed with AISI 304 or 316L stainless steel inside and out, with different types of stainless steel also available to meet your specific requirements.
The oven’s 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 also pressure tested to ensure reliable operation over the entire lifetime of the oven.
The chamber is fully welded inside to ensure no leakage to the insulation can occur and to simplify chamber cleaning. All welds are visible and can be inspected. The inside chamber is fully welded and assembled to the outside cabinet without use of screws and rivets, eliminating hidden crevices where particles and bacteria could generate and grow.
The oven’s 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 also pressure tested to ensure reliable operation over the entire lifetime of the oven.
The chamber is fully welded inside to ensure no leakage to the insulation can occur and to simplify chamber cleaning. All welds are visible and can be inspected. The inside chamber is fully welded and assembled to the outside cabinet without use of screws and rivets, eliminating hidden crevices where particles and bacteria could generate and grow.
Accessories
Lytzen Depyrogenation ovens can be ordered with a range of accessories, including transfer trolley, mobile rack, 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.

ISO Class 7 Depyrogenation Oven Chamber Sizes
Lytzen depyrogenation ovens can be designed to meet your specific needs with flexible chamber size and capacity options. The listed models below are just a sample of the available standard sizes.
Model
Chamber Dimensions
(W X H X D)
External Dimensions
(W X H X D)
Chamber Volume
(m³)
LDF-590
Chamber Dimensions
700 x 800 x 1050 mm
External Dimensions
2205 x 1300 x 2405 mm
Chamber Volume
0.59m³
LDF-760
Chamber Dimensions
900 x 800 x 1050 mm
External Dimensions
2405 x 1300 x 2405 mm
Chamber Volume
0.76m³
LDF-920
Chamber Dimensions
800 x 800 x 1440 mm
External Dimensions
2305 x 1300 x 2795 mm
Chamber Volume
0.92m³
LDF-1540
Chamber Dimensions
100 x 1070 x 1440 mm
External Dimensions
2505 x 1570 x 2795 mm
Chamber Volume
1.54m³
LDF-2020
Chamber Dimensions
1000 x 1400 x 1440 mm
External Dimensions
2505 x 1900 x 2795 mm
Chamber Volume
2.02m³
LDF-2390
Chamber Dimensions
1000 x 1450 x 1650 mm
External Dimensions
2505 x 1950 x 3005 mm
Chamber Volume
2.39m³
LDF-2680
Chamber Dimensions
900 x 2070 x 1440 mm
External Dimensions
2405 x 2570 x 2795 mm
Chamber Volume
2.68m³
LDF-3190
Chamber Dimensions
900 x 2150 x 1650 mm
External Dimensions
2405 x 2650 x 3005 mm
Chamber Volume
3.19m³
LDF-3480
Chamber Dimensions
900 x 2150 x 1800 mm
External Dimensions
2405 x 2650 x 3155 mm
Chamber Volume
3.48m³