Steelco designs and manufactures a wide range of Class 100 static depyrogenation sterilizers (ISO 14644-1 class 5) to meet the most challenging pharmaceutical requirements. The SD series is used to sterilize and depyrogenate of heat resistant materials, including bottles, vials, glass containers, metal trays, and production equipment, laboratory glassware and instruments, materials sensitive to humidity, thermostable basic pharmaceutical products, chemical compounds, and non-aqueous liquid materials such as oils, glycerine, etc.
The depyrogenation process aims to reduce the level of pyrogens, with the use of hot air in temperature which ranges from 220°C up to 280°C for a controlled period of time. The high-performance Class 100 oven solution ensures an even distribution of hot air for the entire cycle, including large loads, with the installed HEPA filters preventing cross-contamination.
Available in single or double door pass-through hinged door version, the devices feature chamber volumes from 330 to 10.000 liters (11.7 to 353 cu ft). On request and previous Steelco approval shall be possible to require customized chamber dimensions.
Steelco’s GMP depyrogenation ovens and dry heat sterilizers are designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customer compliance with current Good Manufacturing Practices (cGMPs).