BMT Products

Class 10,000 Dry Heat Ovens

  • Built to cGMP requirements
  • Industry standard non-proprietary components
  • 12” thick intake and exhaust HEPA filters for maximum air flow
  • Semi-automatic and manual doors available
  • All-welded construction – no particles can enter
  • Fully automatic cycle controlled by Allen-Bradley PLC control systems
  • Temperature range from 50 – 400°C
  • Extremely reliable operation with very limited maintenance


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 7 (10,000) Dry Heat Ovens
(Other sizes available on request)
MODEL   C E H1 H2 J1 J1D J2
INSIDE
VOLUME
ft3 30 60 57.2 114.4 95.3 89 190.7
m3 0.85 1.7 1.62 3.24 2.7 2.52 5.4
INSIDE
WIDTH inch 27.6 2 x 27.6 35.4 35.4 59 2 x 27.6 59
mm 700 2 x 700 900 900 1500 2 x 700 1500
DEPTH inch 32 32 48 95 48 48 95
mm 810 810 1200 2400 1200 1200 2400
HEIGHT inch 59 59 59 59 59 59 59
mm 1500 1500 1500 1500 1500 1500 1500
OUTSIDE
WIDTH inch 74 118 82 82 105 118 105
mm 1865 2995 2065 2065 2665 2995 2665
DEPTH inch 44 44 59 106 59 59 106
mm 1110 1110 1500 2700 1500 1500 2700
HEIGHT inch 113 113 113 113 113 113 113
mm 2855 2855 2855 2855 2855 2855 2855
EXAMPLES OF APPROXIMATE CAPACITY
AMPOLES 1 ml 40,000 80,000 80,000 160,000 120,000 120,000 240,000
5 ml 19,000 38,000 38,000 76,000 56,000 56,000 112,000
INJECTION
BOTTLES
10 ml 8,600 17,200 17,500 35,000 25,000 25,000 50,000
100 ml 1,500 3,000 3,100 6,200 4,400 4,400 8,800
INFUSION
BOTTLES
500 ml 400 900 900 1,800 1,400 1,400 2,800
1000 ml 200 400 400 800 600 600 1,200

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
Manual and semi-automatic door types are available for Lytzen ovens.  Both door types are equipped with double gaskets 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 10,000 (ISO Class 7)
Lytzen Class 10,000 depyrogenation ovens have HEPA filters on the air inlet and exhaust.  The chamber construction and the sealing of the chamber guarantee’s Class 7 without the need for internal HEPA filters which reduces the overall investment.  Lytzen Class 10,000 Dry Heat Ovens are often used for sterilization of dry product and for depyrogenation of instruments, tanks, trays, glassware and other dry goods.

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.