- Depyrogenation Oven

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Lytzen - Depyrogenation Oven

The Depyrogenation oven for depyrogenation and dry heat sterilization provides complete destruction of micro-organisms by means of a controlled temperature for a controlled period of time. The sterilizing effect is calculated by the PLC (F-calculation). The depyrogenation and dry heat sterilization is environmentally safe and causes no waste problems for surroundings an personnel.

Sterile production

Lytzen depyrogenation oven / Dry heat sterilizer

It is Lytzen policy to deliver high quality cGMP-design in every aspect of the depyrogenation oven and to be in com­pliance with all major di­rectives within the pharma­ceutical industry.

We have specialized within the field of dry heat sterilizers for sterile production since the late seventies and can proudly say that the current design is a result of always trying to apply to the highest demands of our customers.

We understand production in sterile areas.

ISO Class 5 (Class 100)

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ISO 14644-1 Class 5 up to 280 °C.

Lytzen depyrogenation ovens are capable of performing ISO 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.

Lytzen first to maintain class 100 during an entire cycle

Lytzen was the first company to be in compliance with the U.S. Federal standard for class 100 during an entire cycle (heating, sterilizing, and cool­ing).

  • 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.

ISO Class 7 (Class 10,000)

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ISO Class 7 up to 350° C.

The Lytzen class 10,000 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 class 10,000 is obtained without use of internal HEPA-filters throughout the complete cycle. As it can be seen from the adjacent particle report, Lytzen is actu­ally far below the class 10,000 limit. The absence of internal filters reduces the overall price for the depyrogenation oven considerably.

cGMP - In every detail

The Lytzen depyrogenation oven is of course in stainless steel inside and outside. Stainless steel AISI 304 or 316 L is standard.

The Lytzen depyrogenation oven is in stainless steel inside and outside. Stainless steel AISI 304 or 316 L is standard.

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 to the outside cabinet, eliminating hidden hollows caused by cover panels where particles and bacteria can hide. We only use stainless steel for the reinforcement in the insulation.

The water cooling element 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.

Chamber Sealing

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

Door gasket
As standard, Lytzen sterilizers 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 pat­ented air seal.

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

Doors

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The Lytzen dry heat sterilizers can be supplied with two door types; semi-automatic or for manual opera­tion.

Both door types are sealed with double door gaskets for maximum protection of the chamber and to secure the lowest surface temperature on the outside. Low sur­face temperature is very important to avoid undesired air-flow on especially the sterile side.

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.

Semi automatic operation
The door is in a flush-door design. The door is auto­matically closed and locked by the PLC when you gently push the door into the opening. This version is especially well designed to interface with an isolator.

Manual operated box door

Manual operation
The door is automatically locked by the PLC, but the operator has to close the door manually by using door handles.

Flexible Design

The production facilities at Lytzen are designed to customize our depyrogenation ovens. Lytzen is very flexible regarding chamber sizes.

Different types of stainless steel are available.

Lytzen is also very flexible regarding the control system and the documentation. We have two brands of PLC (Siemens and Allen-Bradley) as standard.

Temperatur Distribution

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Superior air control - Guarantee for complete sterilization

Lytzen depyrogenation 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 computer calculated 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 life time of the oven, accordingly no down time for re-validation of 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 sterilization.

Cycle Description

Optimized cycle
The cycle of a Lytzen Depyrogenation oven is of course fully automatic.

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 power-ful heating element to shorten the heating time

Because of our superior filter sus­pension system we do not need to ramp during heating and cooling, but can go with full speed to shorten the cycle time.

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.

Control System

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

The hardware for Lytcon can either be Siemens or Allen-Bradley. These brands are chosen to secure minimum hardware fail­ure and to ensure that all our customers can get support locally, to minimize down time if any hardware problems should occur. The system itself is built as a menu-operated system making it very easy to operate the sterilizer.

The password system is according to FDA 21CFR part 11.

The Lytcon control system can of course be con­nected to external SCADA systems.

A chart recorder or printer connected to the control system, is available.

Five of the advantages of the Lytcon control system (standard and part 11) are:

1) Capacity for more than 50 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.

FDA 21 CFR Part 11

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The latest version of the Lytzen control system Lytcon 2 is designed for facilities which have to be compliant with FDA 21 CFR part 11. The system is based on brands known world-wide (Siemens/Allen-Bradley & Eurotherm). The system provides a password protec­tion and an audit trail as required by part 11. The system can easily be connected to a SCADA-system and Lytzen provides the software for handling the data on PC.

Documentation

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As the demands from the regulatory authorities regarding documentation have become 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.

Gamp4
As an option Lytzen can offer a complete package of qualification and validation documentation based on GAMP4 (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 can of course offer assistance for completion of the GAMP documents.

FDA-approval
A lot of our customers have production facili­ties, needed to be approved 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 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.

Applications

The Lytzen depyrogenation oven is mainly used for sterilization and depyrogenation of glassware and metal such as:

  • Ampoules
  • Vials
  • Injection bottles
  • Infusion bottles
  • Tanks / Containers
  • Production equipment
  • Products with low moisture content

Datasheet

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LYTZEN A/S
LYTZEN A/S
Dynamovej 9
Herlev DK-2730

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