Description

RC-100 High-Speed Aseptic Monoblock for Sterile Saline Solution in PE Infusion Bottles

GMP & FDA-Compliant Design for Global Pharmaceutical Markets.

Designed for Reliability in Sterile IV Fluid Production.

• Aseptic Guarantee: ISO 14644-1 Class 5 (Grade A) protection zone with HEPA filtration throughout the filling and capping process.

• Integrated GMP Design: 316L stainless steel construction, CIP/SIP capabilities, and polished surfaces for full cleanability and compliance.

• High-Precision Filling: Peristaltic or piston filler ensures volumetric accuracy of ±1% for critical pharmaceuticals.

• Global Validation Support: Documentation and support packages available to meet international regulatory requirements.

Aseptic Packaging Integrity for Critical Pharmaceuticals

In pharmaceutical manufacturing, especially for parenteral products like infusion fluids, maintaining sterility is non-negotiable. The RC-100 Aseptic Monoblock is engineered to provide an uncompromising barrier against contamination. It integrates the three most critical post-sterilization operations—rinsing, filling, and capping—into a single, enclosed system continuously bathed in HEPA-filtered laminar airflow (ISO Class 5 / Grade A). This eliminates exposure to non-sterile environments, safeguarding product sterility from the filling nozzle to the sealed cap.

Integrated Sterile Process: Rinsing, Filling, and Capping

1. Station 1: Sterile Rinsing: Infusion bottles are fed into the isolator and rinsed with WFI (Water for Injection) or sterile air to remove any particulates.

2. Station 2: Aseptic Filling: A precision peristaltic pump filler delivers the sterile saline solution (or other liquid) with exact volumetric accuracy, critical for dosage integrity.

3. Station 3: Sterile Capping: The machine applies a sterile closure (e.g., a screw cap or stopper) to the bottle in the same protected environment, ensuring the container remains sealed and sterile.

Technical Specifications & Validation Support

• Model: RC-100 (BootlePack)

• Type: Aseptic 3-in-1 Rotary Monoblock

• Process: Aseptic Rinsing, Filling, and Capping

• Environment: ISO 14644-1 Class 5 (Grade A) Laminar Flow Zone

• Speed: Up to 100 bottles/min (dependent on volume)

• Filling System: Peristaltic Pump (standard) or Piston Filler

  • Filling Accuracy: ≤ ±1.0%

  • Filling Volume: 50ml — 1000ml (standard for infusion bottles)

• Container Compatibility: Polyethylene (PE) and Polypropylene (PP) infusion bottles.

• Power Supply: 380V/50Hz/3Ph (standard, configurable)

• Construction Material: 316L Stainless Steel (electropolished finish), pharmaceutical-grade seals

• Cleaning: Clean-in-Place (CIP) and Sterilize-in-Place (SIP) options

• Control System: PLC with Touchscreen HMI with data logging for full process traceability

• Compliance: Designed to meet GMP, FDA 21 CFR Part 211, and EU Annex 1 requirements.

GMP & FDA-Compliant Design for Global Pharmaceutical Markets
The RC-100 is not just machinery; it’s a validation-ready system. Every aspect of its design, from the easy-to-clean 316L stainless steel with minimal dead legs to the embedded data logging capabilities, is intended to help manufacturers meet the rigorous demands of international regulatory bodies. This makes it an ideal solution for pharmaceutical companies in emerging markets looking to export to the US, EU, and other strictly regulated regions.

Designed for Reliability in Sterile IV Fluid Production

• Reduced Contamination Risk: The integrated monobloc design minimizes the number of transfer points and operator interventions, which are primary sources of contamination in aseptic processing.

• Operational Efficiency: One validated system replaces three, reducing qualification time, floor space, and overall complexity.

• Focus on Critical Applications: While ideal for saline, it is also suitable for other sterile waters, irrigation solutions, and parenteral products.

Key Features Description:
This high-speed rotary monoblock is engineered for sterile filling of infusion solutions and injectable pharmaceuticals into innovative Bootle-Pack® plastic containers. The system performs three critical operations in a single integrated platform: precise volumetric filling of sterile solutions, automatic cap orientation and feeding, and secure cap placement and sealing.

Bootle-Pack® soft plastic bottles represent a modern alternative to traditional glass infusion bottles (such as BKZ-type containers) for blood substitutes and parenteral solutions, offering enhanced safety, reduced breakage risk, and improved logistics efficiency.

The equipment features advanced aseptic processing capabilities with ISO Class 5 (Grade A) environmental protection, making it suitable for pharmaceutical manufacturers requiring compliant sterile filling solutions for injectable products.

Technical Specifications & Advantages:

• Aseptic Processing Technology: Maintains ISO 14644-1 Class 5 environment throughout filling and capping operations

• High-Speed Production: Capable of processing up to XX bottles/minute (configurable based on container size)

• Precision Filling System: Volumetric accuracy within ±1% for critical pharmaceutical applications

• Automatic Cap Handling: Integrated cap orienter and feeding system for continuous operation

• Container Compatibility: Specifically designed for Bootle-Pack® plastic containers of various sizes

• GMP Compliance: Manufactured according to pharmaceutical standards with 316L stainless steel contact parts

• Changeover Flexibility: Quick adjustment capabilities for different container volumes and cap types

Applications:

• Sterile infusion solutions (saline, glucose, electrolytes)

• Blood substitutes and plasma expanders

• Injectable pharmaceuticals

• Parenteral nutrition solutions

• Irrigation solutions

RC-100 Aseptic Monoblock for infusion bottles, showing the stainless steel interior with laminar airflow HEPA filters and the integrated filling and capping stations.

Rotary Aseptic Monoblock for Sterile Filling of Infusion Solutions into Bootle-Pack® Plastic Bottles.

Aseptic Packaging Integrity for Critical Pharmaceuticals.

Integrated Sterile Process: Rinsing, Filling, and Capping in an Isolated Environment.

📜 Schedule virtual airflow visualization test.

💡 Mention your: Target market (EU/US/Global South), Active ingredient, Required throughput.

🔬 Schedule virtual factory acceptance test with our engineers.

🏷️ Request Compliance Audit: Free gap analysis with throughput simulation.

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