International Pharmacopoeia Standards Aseptic Liquid Preparation System

• Customization: Available
• Application: Pharmaceutical Industry
• Main Material: 316L Stainless Steel
• Model NO.: Aseptic liquid preparation system
• Power Source: Electric
• Safety Features: Emergency Stop Button, Overload Protection, Safety Interlock
• Warranty: 1 Year
• Precision: High Precision
• Computerized: Computerized
• Condition: New
• Transport Package: Wooden Package
• Specification: Customized
• Trademark: TianSure
• Origin: China
• HS Code: 8421219990
• Production Capacity: 5000sets Per Year

Product Description

Product Introduction

International Pharmacopoeia standards Aseptic liquid preparation system

There are three types of aseptic liquid preparation: small volume injection preparation system, large volume injection preparation system, large volume infusion preparation system.

 

1. Strict sterility guarantee to reduce the risk of contamination
The system adopts closed tanks, aseptic connectors and disposable technologies (such as disposable bag reactors) to avoid environmental exposure and meets the requirements of aseptic processes in EU GMP Annex 1.
Online Sterilization (SIP) function: Supports high-temperature steam or hydrogen peroxide sterilization to ensure the inner surface of the equipment is sterile without the need for disassembly treatment.
Aseptic filtration integration: Equipped with a 0.22μm sterilizing grade filter to filter the liquid medicine at the terminal.
2. High-precision formulation ensures product quality
Dual control of weighing and flow: The high-precision weighing module is linked with the mass flowmeter to ensure the accuracy of material feeding.
pH/ conductivity/temperature online monitoring: Real-time feedback and automatic adjustment of parameters to reduce manual intervention errors.
Formula management software: It can store multiple sets of formulas, with hierarchical permission management to prevent operational errors.
 

3. Compliant design, meeting global regulatory requirements
Material compliance: The parts in contact with materials are made of 316L stainless steel or disposable materials that comply with USP Class VI, with no risk of leaching.
Data integrity: Complies with FDA 21 CFR Part 11 and ALCOA+ principles, with complete audit trail and electronic signature functions.
4. Automation and Intelligence
PLC/SCADA control: Automate the execution of formula steps (such as feeding, stirring, and temperature adjustment) to reduce the risk of human contamination.
Remote monitoring and predictive maintenance: Through IoT technology, real-time analysis of equipment status (such as motor vibration, filter element pressure difference) is conducted to issue early warnings of faults.
Automatic record generation: Automatically record process parameters (such as mixing time and temperature curves), and support electronic record export.

Application	Biopharmaceuticals, Chemotherapeutic drugs, Hospital preparation, Basic infusion production
Capacity	Customized
Process Type	liquid preparation system
Specification	Customized

 

Main Product

Company Profile

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. With a broad global market presence, our business have spaned China, Japan, Africa, the Middle East, Southeast Asia and etc.
Leveraging a top-tier technical team and international strategic partners (such as DOW, METTLER TOLEDO), we are committed to delivering advanced solutions that comply with FDA, cGMP, and QS standards. Our main products include pharmaceutical water systems (covering pure water systems, water for injection systems, and pure steam generators) and liquid preparation systems (covering aseptic preparation systems, oral liquid preparation systems, and topical preparation systems). We also provide a full set of validation documents (including URS, FAT, SAT, DQ, OQ, IQ, PQ).
Backed by a rigorous quality management system, precise engineering, and professional installation support, we ensure our customers receive highly efficient and compliant turnkey solutions. At TianSure, we remain committed to innovation, sustainability, and long-term partnerships, and we dedicate our full expertise to delivering premium machinery and services to customers worldwide!

Company Advantages

1.Professional Qualifications and Certifications
The company has a number of authoritative qualifications, including high-tech enterprise certificates, ISO9001 and CE certifications, GC2 pressure-bearing special equipment installation qualifications, etc. Production and installation comply with GMP standards to ensure the compliance and safety of equipment in high-standard industries such as pharmaceuticals and food.
2.High-quality products and technological advantages
Core products (such as pharmaceutical purified water equipment, liquid preparation systems, stainless steel pressure vessels, etc.) adopt modular design and automated control to improve production efficiency and product quality. Equipment materials (such as 316L stainless steel) are highly corrosion-resistant, meet high-standard process requirements, and provide customized services.
3.Rich industry experience and customer recognition
Serving many well-known companies (such as Kangyuan, Getein Biotech, Mindray Medical, etc.), covering pharmaceuticals, medical devices, electronic new energy and other fields. Multiple large-scale purchases in customer cases (such as a single order of 1.2 million US dollars in 2023) reflect market trust.
4.Complete after-sales service and support
Provide 24-hour rapid response maintenance services, regular maintenance plans and technical training to ensure long-term stable operation of equipment. Assist customers to complete GMP certification and document preparation, and provide full-process quality management support.

Our Services

Our Certificate and Exhibition

Package and Shipping

FAQ

Q1: Where is your company located? A: Our headquarters and factory are based in Nanjing, China.
Q2: Is your equipment in accordance with GMP, FDA, WHO? Yes, we will design and manufacture the equipment according to the requirement of GMP/FDA/WHO in your country.
Q3: What is your typical production lead time? A: For standard products: 4-6 weeks. For customized orders: 6-12 weeks, depending on complexity. We'll confirm the exact timeline in your quote.
Q4: What warranty do you offer? A: Most products come with a 12-month warranty against manufacturing defects. Extended warranties and maintenance plans are available for an additional fee.
Q5: How do I get technical support or spare parts after purchase? A: Our 24/7 customer service team supports you via email, phone, or video call. Spare parts are available for all products, and we can ship them worldwide within 3-7 days.
Q6: What if there's a problem with the product after delivery? A: Contact us immediately with details and photos/videos of the issue. We'll troubleshoot remotely first; if needed, our engineers can arrange on-site visits (fees apply based on location).