Marya Automatic Pfs Filling Sealing Line 0.1-20ml CIP/SIP GMP Validation

Product Description

Marya Automatic Pre-Filled Syringe Filling and Sealing Machine with CIP/SIP system 0.1-20ml for Vaccine Biological Product Saline Flush
 

 The Pre-Filled Syringe Filling Line is an automated production system specifically designed for manufacturing sterile medical consumables such as prefilled plastic syringes and disposable catheter flushers. We have established a fully closed-loop aseptic control system throughout the entire manufacturing process, balancing regulatory compliance, operational stability, and production efficiency. We provide pharmaceutical companies with standardized, verifiable aseptic manufacturing solutions, helping them produce high-quality sterile medical consumables that meet industry standards. 
 

Application Scenarios:

This filling line is widely used in core fields such as pharmaceutical manufacturing and medical consumable production. It is particularly suitable for manufacturers of prefilled plastic syringes and disposable catheter flushers. The line can be employed for filling products that demand extremely high aseptic conditions, including clinical catheter flush solutions, vaccines, biological products, and aesthetic skin booster injections.

Performance Features:
 

1. Compliance & Traceability: Meets GMP Validation Requirements:
 

• The machine is equipped with a PLC-based intelligent control system, enabling real-time monitoring and full traceability of all production parameters, including cleanliness, flushing pressure, and filling volume. It can automatically generate production reports, assisting enterprises in completing the full validation process of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). This helps ensure successful compliance with pharmaceutical industry regulations and mitigates production compliance risks.
• The machine features a modular design with a compact structure, facilitating CIP (Clean-in-Place) and SIP (Sterilize-in-Place). It supports the production of various pharmaceutical liquids such as vaccines, biological products, and sterile flush solutions. The machine allows quick changeover between different models of syringes/catheters, meeting the requirements of pharmaceutical enterprises for large-scale, standardized aseptic production. We uphold the essential standards of aseptic compliance, improve production efficiency, reduce operational and maintenance costs, assist manufacturers in producing high-quality sterile medical consumables that meet industry standards, and strengthen their core market competitiveness.

2. Full-Process Aseptic Closed-Loop: Eliminates Secondary Contamination:
 

• Aseptic Filling: The system adopts an isolated closed filling design, ensuring no exposure during liquid transfer. Equipped with a rotary ceramic pump and servo control system, the filling accuracy is controlled within ±1%. It is compatible with prefilled syringes of various volumes ranging from 0.1 to 20 mL, minimizing liquid waste and dosage deviation.
• Integrated Automatic Operation: The machine integrates filling, stoppering, and sealing into a fully automated process with no manual intervention. An online seal integrity detection system ensures leak detection accuracy ≤ 0.01 mL, and non-conforming products are automatically rejected, ensuring that every finished product meets aseptic standards.
• Flexible Adaptability: The modular design offers a compact structure, easy cleaning, maintenance, and upgrade. It supports rapid changeover between different sizes of catheters and multiple types of liquid (e.g., vaccines, insulin, sodium chloride flush solution). Parameters can be customized according to enterprise requirements, accommodating both large-scale batch production and small-batch custom orders.

3.  Intelligent Control

• Equipped with an intuitive human-machine interface (HMI), the system enables real-time monitoring of equipment operating status, aseptic environmental parameters, and filling accuracy. Parameters can be stored and retrieved, ensuring full production traceability, facilitating quality control and compliance audits, and reducing operational, maintenance, and training costs.

4.  Material Compliance: Meets Medical-Grade Biocompatibility Standards

• All components that come into contact with the liquid are made of medical-grade stainless steel 316L (in compliance with GB/T 1220-2019), with a surface roughness Ra ≤ 0.4 μm. The surfaces are electropolished to provide resistance to acids, alkalis, and chemical corrosion, with no leaching of harmful substances. The materials are validated to ISO 10993 for biocompatibility of medical devices, eliminating the risk of liquid contamination originating from the material itself, thereby meeting the strict material compliance requirements for the production of sterile medical consumables.

Product Parameters
 

Filling Range	0.1ml-20ml
Filling Mode	Customized (metal pump, peristaltic pump, ceramic pump)
Filling Accuracy	±1%
Silicone Oil Spraying Accuracy	0.5mg-2mg
Production Capacity	2000-30000 pcs/hour
Pass Rate	≥99.5%
Equipment Noise	≤70db
Power Supply and Power Rating	380V 50HZ

 

 

 

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