Depyrogenation Ovens

First manufacturer to comply with ISO Class 5

Lytzen was the first company to comply with U.S Federal standard for Class 100 (equivalent to ISO class 5 standard) during the entire cycle, heating sterilizing and cooling.

ISO Class 5 up to 280 °C
Our depyrogenation ovens are capable of performing ISO 14644-1 Class 5 up to 280 ° C during the entire cycle. We have achieved this, due to our unique chamber construction and filter suspension system, and our never ending work for further improvements.

Documentation for ISO Class 5 before delivery
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 a necessity. Particle counting only during sterilization is meaningless.
Lytzen is performing particle tests for all ISO Class 5 depyrogenation ovens and the test result is available to the customer before delivery of the oven.

Lytzen welcomes and recommends that the customer attends FAT before shipment to see the tests and the oven.

The particle counting kit is available from Lytzen.

Full compliance with ISO Class 7

The Lytzen depyrogenation oven complies with the ISO 14644-1 Class 7 up to 300 °C. The ISO Class 7 is equivalent to the U.S. Federal Standard 209E Class 10,000.

A depyrogenation oven with no internal filters needed
The Lytzen ISO Class 7 depyrogenation oven is without internal filters.

Only filters on the air inlet and exhaust are necessary. The chamber construction and the sealing of the chamber guarantee, that ISO Class 7 is obtained without use of internal HEPA-filters throughout the entire cycle. The absence of internal filters reduces the overall price for the depyrogenation oven considerably.

Flexible cGMP-design in every detail

The production facilities at Lytzen are designed to customize our depyrogenation ovens on your company’s specific needs. Lytzen is very flexible regarding chamber sizes enabling many capacity requirements.

Stainless steel in different types
The Lytzen depyrogenation oven is in stainless steel inside and outside. Stainless steel AISI 304 or 316 L is standard. Different types of stainless steel are available. The water-cooling element in AISI 316L is a continuous welded unit without any connections inside the cabinet boundary. It is pressure tested and is expected to last the lifetime of the oven.

Tight and clean design based on cGMP
The chamber is fully welded inside, no leakage to the insulation can occur and the chamber is very easy to clean. All welds are visible and can be inspected. Due to our unique design, our inside chamber is fully welded and assembled to the outside cabinet, without use of screws and rivets, eliminating hidden hollows. We only use stainless steel for the reinforcement in the insulation.

In order to obtain ISO Class 5 during the entire cycle, it is important that the chamber is sealed.

Door gasket
As standard, Lytzen depyrogenation ovens are equipped with double door gaskets (FDA-approved). The purpose of double door gasket is to render maximum security, allowing no leakage between the chamber and the outside. Furthermore, the double gasket minimizes the surface temperature of the sterilizer and any undesired air flow in the sterile area.

Fan shaft seal
The fan shaft connecting the fan motor with the circulation wheel through the insulation is a potential problem area for particles penetrating the chamber. Lytzen has solved this problem by the Lytzen air seal.

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

The Lytzen dry heat sterilizers are supplied 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.

Door Interlock
The doors are equipped with an automatic door interlock system, which prevents improper or accidental door operation even during power failure. Both doors can never be open at the same time during normal operation. The flush-door design is especially well designed to for interface with an isolator.

SUPERIOR AIR CONTROL
The Lytzen Depyrogenation oven offers superior air control guaranteed throughout the entire sterilization.

Unique air distribution ensures sterilization

Principle of air circulation
The ovens operate in accordance with the forced convection principle with fast air circulation securing a rapid heat transmission to the load. Together with the shape and position of the electrical heating element, the air distribution plates ensure a unique temperature distribution in the sterilization chamber.

The temperature distribution is tested and fixed before delivery and does not require any adjustments in the lifetime of the oven, accordingly no down time for re-validation is needed. The uniform temperature in the chamber makes it possible to fix the set-point temperature very close to the required minimum temperature for the specific sterilization

Optimized cycle

The cycle of a Lytzen Depyrogenation oven is fully automatic, and is optimized to save energy.

Drying
The cycle starts with the drying phase where the damper on the exhaust is open ensuring, that any moisture will be removed from the chamber.

Heating
At a set-point temperature decided by the customer, the damper will close and the temperature will rise to the sterilizing set-point temperature as fast as possible. The damper will also stay closed during sterilization. Lytzen ovens are always equipped with a powerful heating element to shorten the heating time.
Due to our superior filter suspension system, we do not need to ramp during heating and cooling but can run with full speed to shorten the cycle time and still keep the ISO class 5 condition.

Sterilizing
The sterilizing timer can be started either by delay timer or/and load sensors. If load sensors are chosen, the sterilizing timer will only be running if all the load sensors are within an acceptable range from the sterilizing set-point.

Cooling
If the cycle time is important, forced air cooling or water cooling is available for rapid cooling.

Well-proven control system

The unique Lytzen control system is called Lytcon. The basic layout has been used since 1996. All improvements from this point are based on this layout. Accordingly, the system is very well proven.

Six of the advantages of the Lytcon control system (standard and FDA 21 CFR part 11) are:

1. Capacity for practical unlimited pre-stored recipes.
2. Extended maintenance menu with check of I/O signals and software calibration.
3. Password system according to FDA 21 CFR part 11.
4. Complete cycle information.
5. More than 50 different alarm messages for easy troubleshooting
6. Communication with customer Scada systems

The Lytzen control system, Lytcon with touch screens, provides a fully automatic cycle. Lytcon is constructed to comply with the requirements for control of critical production units within the pharmaceutical industry. The system is available with Siemens or Allen-Bradley PLC, making it easy to get local support all over the world in case of hardware failure.

All Lytcon control systems have password structures complying with FDA 21 CFR part 11.

Lytcon can be connected to local factory network.

Documentation included

As the demands from the regulatory authorities regarding documentation is becoming increasingly extended, the requirement for first class qualification & validation documentation is a necessity.
Along with the comprehensive operation and maintenance manual, IQ/OQ qualification documents are standard when buying the Lytzen depyrogenation oven. Lytzen also offers QA-documentation.

GAMP
As an option Lytzen can offer a complete package of qualification and validation documentation based on GAMP5 (Good Automated Manufacturing Practice).
An easy access to validation can save a lot of money and, not to forget, a lot of time. 1 week more for validation means 1 week less for production. Lytzen offers assistance for completion of the GAMP documents.

FDA-approval
A lot of our customers have production facilities demanding approval by FDA, accordingly we put a special emphasis in making depyrogenation ovens that ensure that the customer will get a very smooth inspection by FDA. We are keeping ourselves continuously updated on the newest directives from FDA and no production facilities have ever been turned down by FDA because of our products.

Lytzen accessories are specially designed to fit the specific depyrogenation oven and to satisfy the special cGMP requirements within the pharmaceutical industry.

Full accessory package
The full package of accessories for the Lytzen sterilizer comprises transfer trolley, mobile rack, wire trays and cassettes. The transfer trolley is for transporting the mobile rack outside the chamber. The transfer trolley is locked to the chamber when the mobile rack is pushed into the chamber making the operation very easy.

Trolley and tray support
For storage, the trolley is provided with a unique floor saving feature. The mobile rack is available with fixed or removable tray supports. The height between the tray supports can be adjusted to suit customer load configuration.

The mobile rack is equipped with the special Lytzen wheel that runs very easily and at the same time can stand a very high temperature (300 °C), without any need for lubrications.

Cassettes are customized and are also available in perforated design. Mobile rack wire trays and cassettes are always in stainless steel AISI 316.

Worldwide service and spare parts

Through our world-covering net of representatives and Lytzen’s own service technicians, we can offer service anywhere in the world.

As our products are very reliable, emergency assistance is a rarity but through our world covering net of representatives and Lytzen’s own service technicians, we can provide assistance with short notice. Normally our high skilled engineer can solve the problem on the phone or by e-mail. Lytzen ovens are now as standard with a “Secomea box” allowing for long distance support of the control system and oven through an encrypted line and secure line.

Access to spare parts nearby
As Lytzen uses only high quality world-wide known brands whenever possible, it is very easy for the customer to have access to most spare parts local. It also allows for assistance from locally representatives of Lytzen sub-suppliers in case of hardware problems with equipment on the dry heat sterilizer.