SD Series
Hot-air sterilizer, depyrogenation oven
The SD Series supports depyrogenation in aseptic processes, using controlled hot, dry air to reduce endotoxin levels under Class 100 / ISO Class 5 conditions. Airflow and temperature control are designed for uniform results across different load sizes, with contamination-control features to protect product and process.
Typical loads
Suitable for sterilization or depyrogenation of a wide range of items, including:
- Moisture sensitive materials resistant to heat
- Vials, bottles, vials, laboratory glassware
- Metal trays and instruments,
- Thermostable basic products
- Chemical compounds
- Non-aqueous liquid materials such as oils, glycerin
Hot air sterilization process
- Electrical heating elements with top-mounted recirculation fans for uniform chamber temperature
- Pre-filters and HEPA filtration on inlet, exhaust, and chamber-side recirculation to help prevent cross-contamination
- Differential pressure monitoring and DOP-testable filter housings
- Controlled air cooling via a heat exchanger using chilled or softened water
Sanitary GMP construction
Built for sanitary application in regulated environments: fully drainable designs, non-retentive surfaces and 316L stainless steel with a smooth finish. Welds are ground flush and fabrication can be documented in a complete logbook. Process-contact materials with EN 10204 traceability and USP Class VI compliant elastomers.
Features
Filtration system
The filtration system is designed to keep particle levels low in the chamber throughout the cycle and meet pharmaceutical requirements. The filter housing minimizes thermal bridge points and mechanical stress.
Uniform air distribution
Differentially perforated walls promote uniform unidirectional airflow across the chamber and load. This supports consistent results across varied load types and geometries.
Class 100 / ISO Class 5
Class 100 stationary airflow supports clean conditions around the load, with HEPA filtration assuring prevention of cross-contamination during air circulation.
Non-proprietary components
The equipment is manufactured with proven, globally available, industry-standard components rather than proprietary parts. Original spare parts can be sourced through SteelcoBelimed with appropriate documentation and traceability or directly from original manufacturers.
Services
Integrated automation – ready for your architecture
SteelcoBelimed automation can integrate into Siemens, Rockwell and Proficy iFix environments. The platform combines modern technologies with tested, validated solutions developed in accordance with GAMP 5, supporting data integrity and compliance expectations.
SteelcoBelimed equipment for pharmaceutical applications is designed and manufactured in accordance with cGMP principles and within an ISO 9001–certified quality system. All systems are developed to meet applicable international pharmaceutical regulations (FDA, EU GMP), as well as relevant electrical, EMC and safety requirements.
Chamber Volume
15 standard chamber sizes: 330 to 10,000 L / 12 to 353 cu ft
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