Steelco_SD_乾熱滅菌機(製藥級)

SD系列的乾熱滅菌機由義大利廠Steelco製作，符合PICS cGMP, BPE規範。

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 depyrogenation process is aimed at the reduction in the level of pyrogens, with the use of hot air in temperature which range from 250°C up to 300°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.

Steelco’s GMP 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 (cGMP's).

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 us oils, glycerines, etc.

STANDARDS & GUIDELINES

In addition to having a certified Quality System as per ISO 9001 (and ISO 13485 applicable to our Medical Division), our products are subject to rigorous quality control system and inspection.

Steelco machines comply with latest international requirements and guidelines, as well as local standards as applicable and particularly:

Pharmaceutical regulation

European Standards (CEN and CENELEC)

MACHINE FEATURES

Please contact UTEK for further information.

• Hinged door left or right only

• Technical area: right / left solution

• The SD series features connection ports on the front-loading side for validation testing.

• Machines equipped with special product holding trays and handling trolleys, can be also interfaced with the isolation technology.