High-Capacity Automatic Sterile Diagnostic Reagent Preparation System

Customization: Available
Application: Pharmaceutical Industry
Main Material: 316L Stainless Steel

Product Description

📊Basic Info
Model NO.Diagnostic reagent preparation system
Power SourceElectric
Safety FeaturesEmergency Stop Button, Overload Protection, Safety Interlock
Warranty1 Year
PrecisionHigh Precision
ComputerizedComputerized
ConditionNew
Monitoring SystemEquipped
Transport PackageExporting Wooden Package
SpecificationCustomized
OriginChina
Production Capacity2000 sets Per Year
🔬Product Introduction
High-Capacity Automatic Sterile Diagnostic Reagent Preparation System

High-Capacity Automatic Sterile Diagnostic reagent preparation system
This system is specially designed for diagnostic reagent preparation.

1. Strict Sterility Guarantee

Closed tanks, aseptic connectors, and disposable technologies avoid environmental exposure. Meets EU GMP Annex 1. Supports Online Sterilization (SIP) and integration of 0.22μm filters.

2. High-Precision Formulation

Dual control of weighing and flow via mass flowmeters. Real-time online monitoring of pH, conductivity, and temperature. Advanced formula management software with hierarchical permissions.

3. Compliant Design

Material parts are 316L stainless steel or USP Class VI disposable materials. Complies with FDA 21 CFR Part 11 and ALCOA+ principles for data integrity.

4. Automation & Intelligence

PLC/SCADA control for automated execution of formula steps. IoT-based remote monitoring and predictive maintenance. Automatic electronic record generation.

ApplicationPharmaceutical, Biotechnology, Healthcare
CapacityCustomized
Process TypeLiquid preparation system
SpecificationCustomized
📦Main Product
🏢Profile Overview

A leading pharmaceutical equipment manufacturer, specializing in energy-efficient and high-performance pharmaceutical water and liquid preparation system solutions. Widely used in biopharmaceuticals, medical devices, medical aesthetics, food and beverage, and electronics industries.

Committed to delivering solutions that comply with FDA, cGMP, and QS standards. Products include pure water systems, water for injection systems, aseptic preparation systems, and oral liquid systems. Full validation documentation sets (URS, FAT, SAT, DQ, OQ, IQ, PQ) are provided.

Key Advantages
Professional Qualifications

ISO9001 and CE certifications, pressure-bearing equipment installation qualifications. Production complies with high-standard GMP requirements.

Modular & Automated Design

316L stainless steel construction with automated control to improve production efficiency and ensure corrosion resistance.

Comprehensive After-Sales

24-hour rapid response, regular maintenance plans, and technical training. Support for GMP certification and document preparation.

🛠️Our Services
📜Certificates & Exhibitions
🚢Package & Shipping
Frequently Asked Questions
Q1: Does your equipment comply with international standards like GMP or FDA?

Yes, all equipment is designed and manufactured in accordance with GMP, FDA, and WHO requirements specific to your region.

Q2: What is the typical production lead time?

Standard products typically take 4-6 weeks. For customized systems, the lead time is 6-12 weeks depending on the technical complexity.

Q3: What kind of warranty do you provide?

We offer a 12-month warranty against manufacturing defects. Extended warranties and comprehensive maintenance plans are also available.

Q4: How is technical support handled after the purchase?

Our 24/7 service team provides support via email, phone, or video call. Global spare parts shipping is available within 3-7 days.

Q5: What happens if there is a technical issue after delivery?

We provide remote troubleshooting first. If required, specialized engineers can be deployed for on-site visits to resolve complex issues.

Q6: Can you assist with equipment validation?

Yes, we provide a full set of validation documents including URS, FAT, SAT, DQ, OQ, IQ, and PQ to help you meet regulatory requirements.

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