ISO Class 5 (100) Depyrogenation Oven

Depyrogenation protects against contamination through the complete elimination of pyrogens from pharmaceutical and laboratory materials and equipment, including glass containers, such as ampoules and injection bottles, as well as stainless steel. BMT USA depyrogenation ovens achieve ISO 14644-1, class 5 (formerly class 100) up to 280°C during the entire cycle without ramping.

ISO Class 5 up to 280 °C without ramping

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.

Class 5 Testing

The critical phases for maintaining ISO class 5 are the heating and cooling phases due to the expansion and contracting of the frames around the filters. Particle counting during an entire cycle is therefore required over only counting during sterilizing 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.

Semi-Automatic Chamber 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.

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. The precise temperature uniformity in the chamber allows for configuring the set-point temperature very close to the specific sterilization application’s minimum required temperature.

Chamber Sealing

To obtain ISO Class 5 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.

Inlet air and exhaust are equipped with HEPA filters. The internal HEPA-filters inside the cabinet are equipped with a suspension system, solving the particle problem during heating and cooling.

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.

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.

Key Features

ISO Class 5

ISO class 5 compliance throughout the cycle – tested and documented before delivery of every sterilizer.

Temperature Uniformity

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

Quality Performance

High quality performance with low maintenance costs and reliable production.

Warranty

Standard 24-month warranty on every unit.

Operation Overview

BMT USA depyrogenation ovens feature a unique chamber construction and filter suspension system that work together to achieve ISO 14644-1 Class 5 up to 280 °C during the entire cycle, while allowing for full speed heating and cooling without the risk of generating particles.

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.

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.

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.

Chamber Volume

4.03m³

ISO Class 5 (100) Depyrogenation Oven

ISO Class 5 up to 280 °C without ramping

cGMP Design

Key Features

ISO Class 5

Temperature Uniformity

Quality Performance

Warranty

Operation Overview

Optimized Automatic Cycle

Drying

Heating

Sterilizing

Cooling

Accessories

Transfer Trolleys

Mobile Racks

Cassettes

Chamber Sizes

Model

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

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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