Saturated steam sterilizer for bio-pharma applications
In the bio-pharmaceutical industry, maintaining sterile conditions is crucial for product safety and regulatory compliance. Traditional methods often struggle to effectively sterilize a variety of sealed and unsealed containers, filters, machine parts, tools, and garments, leading to potential contamination risks and operational inefficiencies.
Ensure comprehensive sterilization with customizable solutions
The FOF Saturated Steam Sterilizer by Fedegari is designed to address the diverse sterilization needs of the bio-pharmaceutical industry. This sterilizer leverages saturated steam to effectively sterilize a wide range of loads, including sealed and unsealed containers, filters, machine parts, tools, wrapped tools, and garments. The system features a 316Ti stainless steel chamber, available in both circular and square sections, with sizes ranging from 200 to 6,800 liters, which can be fully customized to meet specific requirements. The chamber’s internal surface is polished to a roughness Ra <0.4 μm, complying with stringent pharmaceutical standards. The sterilizer is equipped with one or two doors available in automatic sliding or semi-automatic hinged versions. Four RTD PT100 temperature probes per chamber ensure precise temperature monitoring. Fedegari's exclusive patented door gaskets assure complete tightness, contributing to the sterilizer's efficiency and reliability. It is suitable for various processes, including tyndallization, pasteurization, and inactivation. Pre-validated Thema4 process controller facilitates integration and validation.
Benefits
- High precision with control through pressure variations under 0.5 °C
- Comprehensive monitoring with up to 200 alarms and messages
- Custom-designed chambers to meet specific needs
- Cost-effectiveness through smart maintenance and process optimization
- Compliance with FDA, GMP, GAMP5, and other international standards