Trusted Stable GMP Compliant Auto Control Steam Type Sterilizer for Ampoule Processing

Trusted Stable GMP Compliant Auto Control Steam Type Sterilizer for Ampoule Processing. Horizontal Sliding Door Design: Requires no front opening space, simplifying workshop layout for clean rooms. Dual Leak Detection Modes: Supports vacuum leak test and vacuum dye water leak test for accurate inspection. PLC + HMI Intelligent Control: Monitors temperature, pressure, vacuum, and F0 value with full data traceability. Uniform Temperature Distribution: Multi-angle spray system ensures even sterilization for ampoules and vials. Flexible Customization Options: Offers customization for brand, loading racks, and core components like pumps. Comprehensive Safety Interlocks: Built-in safety locks for pressure, temperature, and door status guarantee operation. GMP and FDA Compliance: Designed following GMP guidelines and FDA 21 CFR Part 11 for regulatory use. Complete Validation Documentation: Provides audit-ready packages including IQ/OQ/PQ, SOPs, and material certificates.