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Sterilization Power: Delivers high-purity, pyrogen-free steam vital for sterilizing equipment and surfaces, ensuring product safety.
No Corrosion: Prevents rust and equipment damage by being free of utility steam additives, extending lifespan and maintaining product purity.
Regulatory Ready: Built to meet GMP and pharmacopoeia standards, simplifying validation and ensuring compliance.
Process Optimization: Provides a reliable, dedicated steam source that boosts efficiency and minimizes contamination-related downtime.
Description
Introduction
A clean steam generator for pharma is a specialized piece of equipment crucial for pharmaceutical manufacturing. Unlike regular utility steam, which can contain impurities from boiler additives, a clean steam generator produces high-purity steam from purified water (like WFI or purified water). This pure steam is essential for sterilization processes (e.g., in autoclaves, sterilizing-in-place systems for tanks and piping) and for humidifying critical cleanrooms. It prevents contamination of pharmaceutical products and sensitive equipment, ensuring compliance with strict regulatory standards like Good Manufacturing Practices (GMP).
Application
1.Sterilization of Equipment (SIP - Sterilize-In-Place): This is the primary application. Clean steam is directly injected into process equipment, tanks, filters, and piping systems to sterilize them between production batches, ensuring no microbial contamination.
2.Autoclaves: Used as the sterilization medium in autoclaves for sterilizing components, vials, stoppers, tools, and garments that come into direct contact with pharmaceutical products.
3.Cleanroom Humidification: In controlled cleanroom environments, clean steam is used to maintain precise humidity levels without introducing airborne contaminants, ensuring a sterile atmosphere for sensitive manufacturing processes.
4. Washing and Drying: Used in washers and dryers for pharmaceutical components and containers, providing a clean, residue-free drying process.
5.Heating and Heat Exchangers: While not always direct contact, clean steam is often used in heat exchangers to provide heat for various processes (e.g., heating purified water) where any potential leak or cross-contamination demands the highest steam quality.
6.Lyophilizers (Freeze Dryers): Clean steam is used to sterilize the chamber of lyophilizers, ensuring a sterile environment for the freeze-drying process of sensitive pharmaceutical products.
7.Bio-Waste Deactivation (Kill Tanks): In some biotechnology or vaccine production facilities, clean steam can be used to heat and deactivate bio-hazardous waste in "kill tanks" before disposal.
8.Essentially, any application in a pharmaceutical plant where steam or its condensate might come into direct or indirect contact with the product or product-contact surfaces requires clean steam to prevent contamination and ensure product quality and patient safety.
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