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Trusted Stable GMP Compliant Auto Control Steam Type Sterilizer for Ampoule Processing
US$20,000.00-70,000.00
1 Piece

Product profile

Customization

Available

Theory

Pressure Steam

Type

Pressure Steam Sterilization Equipments

Model NO.

AZQH

Electric Tension

380V

LCD Display

With LCD Display

Ultra High Temperature Alarm

Ultra High Temperature Alarm

Sterilization Information Recording and Printing

Sterilization Information Recording and Printing

Material

AISI316L/304 for Option

Name

Superheated Water Cascade Sterilizer

Application

Liquid Injection, Glass/PP Ampoule, Bfs Container

Control System

PLC+HMI/PC

Loading System

Ampoule Cassette, Loading Cart, Trolley

Door Type

Hinged Door

Transport Package

Wooden Box Marine Transport

Specification

Customized

Trademark

ZPAE

Origin

China

Key features

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.

Company profile

ZPAE Automation Equipment Co.,Ltd
R&D CapabilitiesQuality AssuranceRaw-Materials TraceabilityManagement Certification
CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: Foreign trade business has just begun CertifiedNearest Port: QingdaoAverage Response Time: ≤0.03h

About Our Factory & Business Background

Address1-402-1 Zhihui Building,No.1356 Yingxiu Road Jinan Shandong
Plant Area18274.81 square meters
Number of Employees93
Registered Capital20,000,000 RMB
Terms of PaymentLC, T/T, D/P, PayPal, Western Union, Small-amount payment
International Commercial Terms(Incoterms)FOB, CIF, CFR, EXW
Average Lead TimePeak Season Lead Time: one month Off Season Lead Time: within 15 workdays
Minimum Order Quantity1 set
Supply Chain Partners460

Our Production Capability & Technical Expertise

Main ProductsAutoclave, Steam Sterilizer, High Pressure Washer, Steam Quality Detector, Steam Generator
Production Lines10
Production MachinesLaser cutting machine, Welding robot, Large penetration welding machine, Long seam welding machine, Circular seam welding machine, X-ray flaw detection room, Bending machine, Polishing machine, Pressing testing system, Rolling machine, Pressing machine, Gantry milling machine, Gantry drilling machine, Drilling machine, Tapping machine, Wire cutting machine, CNC machining machine, Terminal SMT machine, Wire stripping machine, Assembly line, Debugging system, Lathe, Horizontal milling machine
QA/QC inspectors9 people
Inspection Type for Finished Products100% inspection(Visual inspection & Function inspection)
Inspection Method for Finished ProductsHave instructions and uniformly followed
R&D Engineers22 people
Traceability of Raw MaterialsYes

Our Industry Experience & Global Business Record

Year of Establishment2011-11-15
Main MarketsDomestic
Repeat Buyers Choice50%~80%
Number of Foreign Trading Staff4
Overseas Agent/BranchNo
New Products Launched in Last yearYes

Our Certifications, Standards & Industry Recognition

Management System CertificationISO9001:2015
Cooperated with Fortune 500No

Product Q&A

Q:Are you a manufacturer?
A:
Yes, we are a professional manufacturer of pharmaceutical and laboratory sterilizers, integrating R&D, production, and international trade. We warmly welcome on-site factory visits and remote video factory inspections, so you can verify our production capacity and quality control system.
Q:Do your sterilizers comply with GMP and FDA requirements?
A:
Yes. Our sterilizers are designed and manufactured following GMP guidelines, FDA 21 CFR Part 11 (electronic records & signatures), and other global pharmaceutical regulatory requirements. They are fully suitable for use in GMP-compliant production environments in pharmaceutical factories and laboratories.
Q:Can you provide the required validation documents for our project?
A:
Absolutely. We provide complete, audit-ready documentation packages in accordance with pharmaceutical industry practices and GAMP 5 guidelines, including but not limited to design documents, validation documents, SOPs, FAT, SAT, IQ/OQ/PQ, material certificates, calibration records, and other supporting documents. This documentation fully supports your regulatory audits for pharmaceutical and laboratory applications.
Q:What types of packaging can this sterilizer handle?
A:
The AZQA series is designed for ampoules, vials, tubular glass bottles, injectable packages, and oral liquid products, performing both sterilization and leak detection.
Q:Is customization available for this equipment?
A:
Yes, we offer flexible customization including custom brand selection for pumps and valves, custom loading racks, and customizable procedures to meet different process requirements.

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