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Application
The primary settings are pharmaceutical manufacturing plants, high-volume compounding pharmacies, and biotechnology facilities that perform terminal sterilization of liquid products. These units are typically installed as large, floor-standing, pass-through autoclaves within a cleanroom environment. They are used to sterilize critical loads like large batches of IV solutions, sealed injection vials, and eye drops. The precise control over the cooling profile (temperature and counter-pressure) allows for faster cycle times compared to passive cooling, significantly increasing production throughput while ensuring product quality. AOP is an essential process step for any manufacturer relying on terminal sterilization rather than aseptic filling, offering a higher degree of sterility assurance for sealed products.
Transaction Details
AOP sterilizers are major capital purchases. Payment terms involve a Letter of Credit (L/C) or structured T/T payments tied to design approval, manufacturing milestones, and final Factory Acceptance Testing (FAT). Shipping is via specialized heavy-duty freight under CIF/DDP terms. The price includes the complex air compression system and the full IQ/OQ/PQ validation package. Lead times are the longest for all categories (up to 6 months) due to design, manufacturing, and regulatory compliance requirements. Buyers must provide detailed utility specifications, including the required compressed air purity. The warranty covers the pressure vessel and the sophisticated control system. We require a mandatory site inspection before installation to ensure the facility meets the strict requirements for this complex equipment.
