Laboratory sterilizer SD

for sterilization servicesfor the pharmaceutical industryfor cleanrooms

Overview
The SD Series is a hot-air sterilizer and depyrogenation oven designed for depyrogenation in aseptic pharmaceutical processes using controlled hot, dry air. It reduces endotoxin levels under Class 100 / ISO Class 5 conditions. Controlled airflow and temperature ensure uniform results across different load sizes and include contamination-control features to protect product and process.

Typical loads

• Moisture-sensitive materials resistant to heat
• Vials, bottles, laboratory glassware
• Metal trays and instruments
• Thermostable basic products
• Chemical compounds
• Non-aqueous liquid materials such as oils and 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 minimise particle levels and 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 applications 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 include EN 10204 traceability and USP Class VI compliant elastomers.

Features

• Filtration system designed to keep particle levels low throughout the cycle; filter housings minimise thermal bridge points and mechanical stress
• Uniform air distribution via differentially perforated walls promoting consistent unidirectional airflow across chamber and load
• Class 100 / ISO Class 5 stationary airflow with HEPA filtration to prevent cross-contamination during circulation
• Manufactured using proven, globally available, industry-standard (non-proprietary) components
• Integrated automation ready to connect with Siemens, Rockwell and Proficy iFix environments; developed in accordance with GAMP 5 to support data integrity and compliance

Technical specifications

• Product type: Hot-air sterilizer, depyrogenation oven
• Cleanliness class: Class 100 / ISO 14644-1 Class 5
• Chamber volume: 15 standard chamber sizes from 330 L to 10,000 L
• Heating: Electrical heating elements with recirculation fans for uniform temperature
• Filtration: Pre-filters plus HEPA filtration on inlet, exhaust and chamber recirculation; DOP-testable filter housings
• Monitoring: Differential pressure monitoring
• Cooling: Controlled air cooling via heat exchanger using chilled or softened water
• Construction materials: 316L stainless steel process-contact surfaces; welds ground flush; fully drainable, non-retentive surfaces
• Materials traceability & compliance: EN 10204 traceability for process-contact materials; USP Class VI compliant elastomers
• Quality & regulatory: Designed and manufactured according to cGMP principles within an ISO 9001 quality system; developed to meet applicable international pharmaceutical regulations (FDA, EU GMP) and relevant electrical, EMC and safety requirements
• Components: Uses industry-standard, non-proprietary components to facilitate spare-parts sourcing