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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).
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
from 330 litres / 11.7 cu ft
to 10.000 litres / 353 cu ft
Custom dimensions available upon request
The overall dimensions may vary according to machine configuration and customer’s requirements. Electrical cabinet may be installed remotely from the machine depending on space and operational requirements.
Fully compatible with the strict standards of the pharmaceutical industry, the unit is provided with electrical heating elements and air recycling fan(s) positioned on top of the chamber. Pre-filters and preventing cross-contamination. The sterility of the air recycling in chamber is guaranteed by a set of HEPA filters installed in the air duct on the chamber side. Monitoring of chamber pressure and HEPA filters efficiency by differential pressure transmitters. Absolute filters' housing provided with accessories necessary for the DOP test. The air cooling is carried out by an heat exchanger running by chilled or softened water.
Differentially perforated walls, air speed and temperature control ensure an extremely air drying quality process. Tri-clamp connections for air quality monitoring and validation activities installed on fascia. As standard, one temperature product probe in chamber is provided for temperature monitoring. Upon request, additional temperature probes are provided.
Chamber, machine body, and aeraulic system made of AISI 316 stainless steel. Polish finish chamber with rectangular cross-section and rounded internal angels. Chamber bottom fitted with guides for moving the product holding carts. Fast-closing swing-out doors are equipped with an interlock system by pneumatic device that prevents the door to be open during the cycle.
Steelco AV Series Pharmaceutical Grade Saturated Steam Sterilizers are a fundamental part of the process used to render an object free from viable infectious agents, including viruses and bacterial spores.
The AVD Series combines all the features of a Pharma Grade Saturated steam sterilizer with the capability of performing bio-decontamination cycles using VH2O2.
The AMS Series of Pharmaceutical Grade Steam-Air Mixture sterilizers is a range of autoclaves designed for terminal sterilization using steam air mixture technology.
Steelco’s range of autoclaves using superheated water are for the terminal sterilization of injectable solutions.
Sterile continuity is the vision. The SPE Series is ideal for treating closures for containers normally used in the pharmaceutical industry, where continuous sterility has to be maintained between different phases.