Automatic cleaning sterilization filling Diagnostic reagent preparation system
This system is specially designed for diagnostic reagent preparation, ensuring the highest standards of hygiene and accuracy.
1. Strict Sterility Guarantee
Adopts closed tanks, aseptic connectors, and disposable technologies. Equipped with Online Sterilization (SIP) and 0.22μm sterilizing grade filtration to meet EU GMP requirements.
2. High-Precision Formulation
Dual control of weighing and flow via high-precision modules and mass flowmeters. Real-time online monitoring of pH, conductivity, and temperature.
3. Compliant Design
Parts in contact with materials use 316L stainless steel (USP Class VI). Fully compliant with FDA 21 CFR Part 11 and ALCOA+ principles.
4. Automation & Intelligence
PLC/SCADA control for automated formula execution. Features remote monitoring, predictive maintenance, and automatic electronic record generation.
Specifications
Details
Application
Pharmaceutical, Biotechnology, Healthcare
Capacity
Customized
Process Type
Liquid Preparation System
Main Product & Profile
We are a leading pharmaceutical equipment manufacturer, providing energy-efficient pharmaceutical water and liquid preparation solutions. Our expertise spans biopharmaceuticals, medical devices, and aesthetics across China, Japan, Africa, and Southeast Asia. We deliver solutions compliant with FDA, cGMP, and QS standards, including full validation documentation (URS, FAT, SAT, DQ, IQ, OQ, PQ).
• Professional Qualifications: High-tech enterprise with GC2 special equipment installation qualifications.
• Technological Excellence: Core products use 316L stainless steel and automated control for maximum efficiency.
• Rich Experience: Trusted by industry leaders in medical devices and biopharmaceuticals globally.
• Full Lifecycle Support: 24-hour rapid response, technical training, and GMP certification assistance.
Our Services
Certificate & Shipping
Frequently Asked Questions
Q1: Are your systems compliant with international standards?Yes, all equipment is designed and manufactured in strict accordance with GMP, FDA, and WHO requirements specific to your region.
Q2: What is the typical lead time for a customized system?Standard products take 4-6 weeks. For highly customized diagnostic reagent systems, the timeline is 6-12 weeks depending on technical complexity.
Q3: How do you handle installation and technical support?We provide 24/7 remote support via video calls and email. Our engineers are also available for on-site installation and technical training globally.
Q4: What kind of warranty and spare parts service is provided?We offer a 12-month manufacturing warranty. Critical spare parts are stocked and can be shipped worldwide within 3-7 days.
Q5: Can the system be integrated into existing production lines?Yes, our systems feature modular designs and PLC/SCADA control interfaces that allow for seamless integration with other pharmaceutical equipment.