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SD Series Pharma Grade Depyrogenation Ovens
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).
Key Features
- InsulationThe chamber and door(s) are externally insulated with high-density ceramic heat insulation and covered by AISI 304 stainless steel panels.
- Door GasketHermetically sealed doors with a special-profile FDA certified silicone inflatable gasket.
- Loading HandlingExternal/Internal loading cart in AISI 316L stainless-steel, equipped with guides for shelves positioning.
- Air Cooling SystemThe air cooling system inside the chamber is carried out by heat exchanger running by chilled or softened water. Water return system for recovery softener water loop available as option.
- Remote AssistanceThe on-board VPN router communicates on the local network with the PLC and the HMI, and allows remote connection from a computer, tablet, or smartphone without going on-site, drastically reducing support costs and improving machine uptime.
- Easy MaintenanceThe machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- cGMP
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- Eudralex
- ASME BPE
- PDA Technical Report
- European and US Pharmacopeia
- ISPE Guidelines
- UL and CSA (on demand)
Chamber Volume
from 330 litres / 11.7 cu ft
to 10.000 litres / 353 cu ft
Custom dimensions available upon request
Overall Dimensions
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.
Additional Products
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.
Thanks to a long experience within the pharmaceutical, nutraceutical, cosmetic, and food industries, Steelco offers a wide range of hot air static dryers to meet the most challenging market requirements.
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.
The DHP Series of Grade Decontamination air Lock is manufactured to provide a complete turnkey solution for the bio-decontamination of heat-sensitive equipment.
The AGS Series of sterilizers using Ethylene Oxide represents the best relationship between engineering and quality price, operating running costs, and, most important, the safety of the system and operators.