BMT Products

Class 100 Depryogenation Ovens

 Breakthrough in Class 100 Technology
Lytzen Class 100 Dry Heat Sterilizers offer dramatically reduced cycle times with specially designed HEPA filters able to withstand temperatures up to 280°C. Lytzen’s patented filters, filter suspension system and air shaft seal preclude the introduction of particles. This eliminates the need for temperature ramping while exceeding ISO 14644-1(Part 1) Class 5, Classification of Air Cleanliness* conditions throughout the depyrogenation cycle. This is true even during the critical heating and cooling phases when the filters are expanding and contracting the most.

Applications
Dry heat sterilization and depyrogenation ensures complete destruction of micro-organisms by means of dry heat over a controlled period of time. The process is environmentally safe and, therefore, ideal for treatment of empty ampoules, injection bottles, infusion bottles and production equipment. It is also suitable for sterilization of liquids with low moisture content or powder medications.

 

 

Capacities of Lytzen ISO Class 5 (100) Dry Heat Ovens  
(Other sizes available on request) 
MODEL   CF 1020 CF 1300 CF 1650 H1F 1300 H1F 1650 H1F 2000
INSIDE
VOLUME		 ft3 19.8 25.1 31.8 57.9 73.4 88.6
m3 0.56 0.71 0.9 1.64 2.08 2.52
INSIDE
WIDTH inch 27 27 27 35.4 35.4 35.4
mm 685 685 685 900 900 900
DEPTH inch 31.5 31.5 31.5 55 55 55
mm 800 800 800 1400 1400 1400
HEIGHT inch 40.2 51.2 65 51.2 65 78.7
mm 1020 1300 1650 1300 1650 2000
OUTSIDE
WIDTH inch 87 87 87 95 95 95
mm 2190 2190 2190 2405 2405 2405
DEPTH inch 44 44 44 67 67 67
mm 1100 1100 1100 1700 1700 1700
HEIGHT inch 94 105 120 105 120 132
mm 2375 2655 3055 2655 3055 3355
EXAMPLES OF APPROXIMATE CAPACITY
AMPOLES 1 ml 26,000 45,000 64,000 80,000 105,000 164,160
5 ml 10,000 18,000 26,000 32,000 45,000 67,860

INJECTION
BOTTLES

 10 ml 9,000 10,000 16,000 26,000 36,000 35,190
100 ml 800 1,485 1,900 2,500 3,600 5,625
INFUSION
BOTTLES		 500 ml 280 350 490 800 1,120 1,440
1000 ml  144  192  288  416  624  728

 

Capacities of Lytzen ISO Class 5 (100) Dry Heat Ovens 
(Other sizes available on request)
MODEL   H2F 1300 H2F 1650 H2F 2000 2H1F 1650 2H1F 2000
INSIDE
VOLUME		 ft3 92.2 112.6 169.5 147.2 178
m3 2.61 3.19 4.8 4.17 5.04
INSIDE
WIDTH inch 35.4 35.4 35.4 2 x 35.4 3 x 35.4
mm 1500 900 900 2 x 900 3 x 900
DEPTH inch 84.6 84.6 104.9 55 55
mm 2150 2150 2665 1400 1400
HEIGHT inch 53 65 78.7 65 78.7
mm 1300 1650 2000 1650 2000
OUTSIDE
WIDTH inch 95 95 95 170 170
mm 2405 2405 2405 4325 4325
DEPTH inch 95 95 117 67 67
mm 2405 2405 2965 1700 1700
HEIGHT inch 105 120 132 120 132
mm 2655 3055 3355 3055 3355
EXAMPLES OF APPROXIMATE CAPACITY
AMPOLES 1 ml 170,000  180,000  250,000  210,000  280,000
5 ml 70,000  80,000  104,000  90,000  130,000

INJECTION
BOTTLES

 10 ml 39,200  47,900  86,000  72,000  80,000
100 ml 5,800  6,400  8,000  7,200  9,750
INFUSION
BOTTLES		 500 ml 1,600  1,820  2,620  2,240  2,400
1000 ml  900  1,050  1,300  1,100  1,456

cGMP Construction
Lytzen Depyrogenation ovens are constructed completely of stainless steel inside and out.   The chamber is full welded from the inside to the outside fascia panel, ensuring that no particles can migrate from the insulation into the chamber or into your clean room.  All welds are visible and can be inspected. There are no hidden hollows for bacteria or particles to hide which makes the unit easy to clean.

Doors
The doors are recessed and are locked automatically when closed.  Due to the clean design the doors are suitable for use with isolators.  Each door is equipped with a double gasket sealing on two separate surfaces to ensure an extremely tight seal and enables a low surface temperature.  Double door pass-through units are equipped with an interlock door system preventing operation failure and contamination through the chamber.

Guaranteed Temperature Distribution
Lytzen depyrogenation ovens utilize the forced convection principle for fast transmission of the heat to the load.  Together with the shape and position of the heating element and the computer designed air distribution plates, we can achieve very tight temperature distribution across the load.  The temperature distribution is tested before delivery and guaranteed without the need for adjustments once it arrives at your site.

Class 100 (ISO Class 5)
Lytzen was the first company to be in compliance with the U.S. Federal Standard for maintaining class 100 conditions throughout an entire cycle (heating, sterilizing and cooling).

Today we are now conforming to ISO 146644-1 (former class 100 according to US Federal Standard 209E) up to temperatures of 280 C, during the entire cycle.

The critical phases for maintaining ISO class 5 are the heating and cooling phase due to the expansion and contracting of the filter frames.  Particle counting during an entire cycle is therefore a necessity.  Lytzen performs particle tests for all depyrogenation ovens, and the test results are provided to every customer before delivery.

Cooling
Both forced air cooling and water cooling are available for Lytzen ovens, with water cooling being the most efficient especially for larger models.  Due to the unique design of Lytzen ovens, the units can be heated and cooled at full speed without the need of ramping while maintaining a very low particle count.

Energy Savings
The exhaust is equipped with a motorized damper controlling the air exchange during the cycle.  The damper will be closed during the heating and sterilization step to save heat loss and energy.

Lytcon 2 Control System
The Lytcon 2 control system is designed to comply with the requirements for control of critical production.  The system is available with Allen Bradley or Siemens Industrial Grade PLC and utilizes touch screen operator interfaces.  The system can be delivered for storing process data on electronic media, ready to be integrated into a production complying with FDA 21 CFR, part 11.

Documentation
As the demands from the regulatory authorities have become more stringent, a high level of documentation has become a requirement.  As standard, Lytzen provides the highest level of documentation which includes a comprehensive Operation and Maintenance manual together with Installation Qualification and Operational Qualification documents.

GAMP
Lytzen’s industrial grade PLC control systems are programmed utilizing the latest “Good Automated Manufacturing Practices” to ensure ease in validation of the software.  As an option we will provide the GAMP documentation along with your Lytzen Depyrogenation purchase. 

Accessories
The accessories are specially designed for the rigorous temperature changes inside a depyrogenation oven and the special cGMP requirements within the pharmaceutical industry.  The full package of accessories includes transfer trolleys, mobile racks, wire trays and cassettes.  For storage, the transfer trolleys are provided with a unique space saving feature.

Service and Parts
Each Lytzen oven is backed up with BMT USA’s highly trained service personnel and parts supply.  Only high quality, non-proprietary parts that are available locally or through BMT USA are utilized.  BMT’s service offices are located throughout North America for fast, efficient service response.