Validated Autoclave Solutions
Steam Sterilizers
Validated Autoclave Solutions for GMP Pharmaceutical Manufacturing
Steam sterilizer
Overview
Validated autoclave solutions with real-time F₀ monitoring, single and dual-door configurations and a complete IQ/OQ/PQ package for GMP manufacturing.
ASMEPED 2014/68/EUEN 285ISO 17665
Detailed PDF datasheet available on request.
Technical Specifications
Engineered to exact tolerances
- Chamber Volume
- 50 L – 10,000 L
- Operating Temp.
- 121°C – 135°C | ±0.5°C
- Operating Pressure
- Up to 3 bar (absolute)
- F₀ Calculation
- Real-time monitoring & trending
- Door Configuration
- Single-door or dual-door pass-through
- Standards
- ASME · PED 2014/68/EU · EN 285 · ISO 17665
Applications
Where it is used
- Gravity displacement — standard wrapped goods
- Pre-vacuum — porous loads & hollow instruments
- Liquid cycle — bulk solutions & media
- Bio-decontamination — waste treatment loads
Key Benefits
Why it stands out
- Full IQ/OQ/PQ package
- FAT/SAT protocols
- Calibration certificates
- Risk assessment & URS traceability matrix
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