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High-Performance Modular Benchtop Sterilizer
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DCS20 Control & 316L Stainless Steel Autoclave
Fedegari Benchtop Lab Sterilizers
Safety and reliability are central to the design, featuring a unique, patented pneumatic gasket seal for the door system which guarantees absolute airtight integrity and enhanced operator safety. Beyond mechanical security, the machine incorporates a fully validated and documented DCS20 control system, adhering to GAMP5 guidelines and facilitating compliance with data management requirements such as 21 CFR Part 11, vital for regulated laboratory operations.
Efficiency is optimized through intelligent engineering, notably the inclusion of a heat exchanger recovery system. This feature is strategically installed outside the sterilization chamber to capture and reuse the heat generated by condensate, pre-heating the water before steam generation. This sophisticated approach directly contributes to significant energy savings and overall lower operational costs, a key advantage in high-throughput lab environments.
The need for high-level process reproducibility and audit trail integrity is addressed by the sophisticated DCS20 Controller. This validated system offers 30 configurable cycles, providing the essential precision required for treating sensitive loads such as culture media or large volume parenterals. Its fully documented life cycle management complies rigorously with current GMP standards, alleviating the administrative burden of validation and ensuring that every sterilization run is traceable and defensible for regulatory scrutiny.
Laboratories frequently struggle with escalating running costs due to high water and power consumption. The integrated Energy saving system counters this operational challenge by employing a heat exchanger recovery mechanism positioned externally to the main chamber. This intelligent design reclaims residual heat from the steam condensate, utilizing it to efficiently pre-heat incoming water, thus drastically reducing the overall thermal energy needed for steam generation and minimizing long-term utility expenditure.
Maintaining sterility across barriers in classified environments often presents a technical headache, requiring cumbersome installation solutions. This sterilizer resolves that by offering configurations with double hinged Doors, facilitating pass-through functionality between different contamination zones. This option, combined with the patented pneumatic gasket seal, ensures that the absolute containment integrity is maintained, preventing cross-contamination and simplifying workflow in cGMP-compliant facilities.
Premature equipment failure and complex repair procedures due to inaccessible components contribute significantly to downtime. The thoughtful mechanical Design of the unit ensures wide and easy access to the entire technical area for maintenance personnel. This focus on serviceability, combined with the use of robust, sanitary-grade 316L stainless steel and electropolished finishing for all wetted components, minimizes corrosion risk and accelerates routine maintenance, maximizing machine uptime.
Ensuring the complete absence of leaks, which compromises a sterilization cycle, is a perpetual concern. The unique, patented pneumatic Gasket seal system provides an unparalleled level of airtight integrity. Unlike conventional seals, this system dynamically pressurizes to guarantee a perfect seal during the cycle, maximizing reliability and operator safety while ensuring successful sterilization outcomes, thereby reducing the need for costly and time-consuming cycle re-runs.
In laboratories with varied sterilization needs, the limitation of a fixed chamber size can restrict processing capabilities. The Capacity of this line addresses diverse load requirements, offering four distinct chamber volumes (45, 75, 90, and 122 liters). This modular approach allows research and quality control labs to select the optimal size for processing anything from small batches of tools and glassware to larger loads like machine parts and garments, optimizing space utilization and processing efficiency.
Regulatory compliance, especially in global markets, demands adherence to a complex web of standards. This sterilizer is certified to a comprehensive range of directives and standards, including PED 2014/68/UE and the ASME U & S Stamp for the US market, confirming its global Compliance. This extensive documentation and certified manufacturing process eliminate the user's burden of proving equipment suitability across different geographical jurisdictions for highly regulated products.
Data integrity and security for electronic records are non-negotiable in pharmaceutical and biotech settings, often requiring expensive third-party systems. The DCS20 control system is designed to comply with 21 CFR Part 11 data management Protocol requirements, offering native capabilities for secure record-keeping and data archiving. Options for remote monitoring and full interaction via Ethernet further enhance process control and data security, centralizing data management within a fully validated platform.
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