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1. Strict Sterility Guarantee
Adopts closed tanks, aseptic connectors, and disposable technologies to meet EU GMP Annex 1. Features Online Sterilization (SIP) and 0.22μm aseptic filtration.
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2. High-Precision Formulation
Dual control of weighing and flow via high-precision modules. Real-time monitoring of pH, conductivity, and temperature with automated formula management software.
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3. Regulatory Compliance
Materials comply with USP Class VI (316L stainless steel). Data integrity follows FDA 21 CFR Part 11 and ALCOA+ principles with complete audit trails.
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4. Automation and Intelligence
PLC/SCADA control for automated execution. Supports IoT-based remote monitoring, predictive maintenance, and automatic electronic record generation.
About Our System Solutions
We are a leading pharmaceutical equipment manufacturer, specializing in providing energy-efficient and high-performance pharmaceutical water and liquid preparation system solutions. Our products are widely used in biopharmaceuticals, pharmaceutical chemicals, medical devices, medical aesthetics, food and beverage, and electronics industries.
Leveraging a top-tier technical team and international strategic partners, we deliver advanced solutions that comply with FDA, cGMP, and QS standards. Our main products include pharmaceutical water systems and aseptic liquid preparation systems. We provide a full set of validation documents (URS, FAT, SAT, DQ, OQ, IQ, PQ).
Core Advantages
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Professional Qualifications: High-tech enterprise with ISO9001, CE, and GC2 certifications. All installations comply with GMP standards.
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Modular Design: Core products feature modular automated control and 316L stainless steel for maximum corrosion resistance and efficiency.
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Industry Recognition: Trusted by global leaders in medical devices and biopharmaceuticals, handling large-scale international projects.
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Full Lifecycle Support: 24-hour rapid response, maintenance plans, and assistance with global GMP certification documents.
Frequently Asked Questions
❓ Q1: Where is your manufacturing base located?
Our headquarters and factory are based in China, serving customers worldwide with professional engineering.
❓ Q2: Is your equipment in accordance with GMP, FDA, and WHO standards?
Yes, we design and manufacture the equipment according to the specific requirements of GMP, FDA, and WHO standards applicable to your region.
❓ Q3: What is your typical production lead time?
Standard products typically take 4-6 weeks. For customized systems, the lead time is 6-12 weeks depending on the complexity of the design.
❓ Q4: What kind of warranty do you offer?
Most products come with a 12-month warranty against manufacturing defects. Extended warranties and preventive maintenance plans are also available.
❓ Q5: How do I get technical support or spare parts after purchase?
Our 24/7 customer service team supports you via email or video call. Spare parts are available for all systems and can be shipped worldwide within 3-7 days.
❓ Q6: What if there is a problem with the product after delivery?
Contact us immediately with details and photos. We provide remote troubleshooting first; if required, our engineers can arrange on-site visits for technical resolution.
Medvok Medical
