Shanghai Marya China Supplier Pharmaceutical SIP/CIP Liquid Preparation System for Injection Line

• Customization: Available
• Application: Clinical Diagnosis, Food Safety, Forensic Science, Pharmaceutical Industry
• Disposable: No
• Model NO.: MY-01
• Injection Site: Intramuscular
• Material: Glass, Plastic, Rubber, Silicone, Stainless Steel
• Needle Gauge: 18G
• Safety Feature: Auto-Retractable Needle, Locking Mechanism, Needle Guard, Tamper-Evident Seal
• Usage: Diabetes Care, Medical, Pain Management, Vaccine Administration
• Warranty: 1 Year
• Function: Formulation
• Usage Industry: Pharmaceutical
• Size: Customized
• Voltage: 220V
• Filling: Liquid
• Transport Package: Wooden Packing
• Specification: customized
• Trademark: Marya
• Origin: China
• Production Capacity: 50000pieces/Year
• Package Size: 400.00cm * 400.00cm * 400.00cm
• Package Gross Weight: 400.000kg

Product Description

Shanghai Marya China supplier pharmaceutical SIP/CIP liquid preparation system for injection line

Characteristic

The Aseptic Liquid Formulation System is a cGMP-compliant pharmaceutical production platform engineered for precision compounding of sterile/non-sterile injectables. This integrated solution enables:

Core Functionality
• API-Solvent Integration: Accurately blends active pharmaceutical ingredients (APIs) with WFI (Water for Injection) or organic solvents
• Dynamic Process Control: Achieves target concentration (±1% tolerance) through closed-system stirring, in-line heating (20-80°C), and real-time density monitoring
• Sterility Assurance: Incorporates steam-in-place (SIP) sterilization and 0.22μm membrane filtration meeting EU Annex 1/WHO TRS 1025 standards
• Multi-Phase Compatibility: Processes solutions, suspensions, and emulsions with viscosity up to 8,000 cP

Technical Differentiation
1. Dual-use configuration: Switchable between sterile (Grade A/B) and non-sterile (ISO Class 8) production modes
2. PAT-enabled workflow: QbD-compliant with integrated HPLC monitoring for critical quality attributes (CQAs)
3. Scalable capacity: Modular design supports 50L pilot batches to 2,000L commercial-scale production
4. Data integrity: 21 CFR Part 11-compliant audit trail and electronic batch records

Application Scenarios
1.Sterile Preparations: Lyophilized powder reconstitution, monoclonal antibody formulations, mRNA-LNP encapsulation
2.Non-Sterile Liquids: Pediatric oral suspensions, topical gel matrices, sustained-release drug carriers

Certified for FDA/EMA regulatory submissions with full validation support (IQ/OQ/PQ documentation packages).

Perfomance and Advantage:

1. The system can be fully automatic, with modular design, and its follow-up installation and maintenance is convenient

2. The automatic control system of CIP and SIP can be turned on by one key, which can automatically detect the end of cleaning and sterilization, with recipe management, electronic signature, electronic records, audit tracking and other computer functions.

3. When the equipment is running, it can realize controllable production of key process parameters of drugs (such as temperature, dissolved oxygen, PH, etc.), and can automatically detect them and give an alarm when there are special conditions outside the set parameters, so as to avoid quality problems of drugs.
 

4.The system follows ASME BPE and GMP design concepts, meets 3D blind corner requirements, and allows for low residue and continuous production

5.Before manufacturing the equipment in our factory, we will carry out one-to-one three-dimensional design to rationalize the arrangement of pipelines, valves, instruments, etc. in the system to make the operation of the equipment more user-friendly.

6.We will use ANSYS fluid analysis software to simulate the real situation of the fluid in the tank, and to select suitable agitators and shears based on it, to ensure that the laboratory process can be smoothly transferred to large-scale production.

7.We will use high-precision oil & water phase transfer pumps to strictly control the mixing ratio of oil and water phase to ensure the emulsification effect.

8.If there are hazardous raw materials for the production of pharmaceuticals, we will install isolators in the feeding area of the preparation system to ensure the sterility of the API feeding process and personnel protection.

9.The mixing tanks are available in special shaped designs to achieve very low minimum mixing volumes.

10.For suspension products, we will adopt the circulating pipeline design to avoid the uneven composition of the product due to the settling of suspended particles in the pharmaceutical agent caused by long-time filling.

Including system:

Bioreactor Systems

Medium Storage Systems

Purification and Filtration Systems

Buffer Solution Storage Systems

CIP Station Cleaning System

Waste water Inactivation Systems

Buffer Solution Preparation Systems

Medium Preparation Systems

Semi-finished Product Preparation system

 

 

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