Rotary filling system for Rtu vials in pharma production

Optimize your sterile liquid and powder handling with a versatile system designed to ensure aseptic conditions and precise filling, tailored to streamline high-speed pharmaceutical production lines.

Fills, Weighs, and Decontaminates Sterile Pharmaceutical Products

The MICRO BI Rotary Filling System from Comecer is designed specifically for pharmaceutical and biologics manufacturers, offering an integrated solution for aseptic filling of both liquid and powder formulations. This system is distinguished by its ability to maintain consistent batch quality through intelligent servo-driven technology, minimizing error and enhancing efficiency. It caters to a diverse range of applications, producing biopharmaceutical vials, insulin injectables, vaccines, and radiolabeled compounds. With filling speeds of up to 200 units per minute, MICRO BI effectively eliminates bottlenecks in high-speed, continuous production settings.

The system seamlessly integrates into your existing production line, combining rotary filling capabilities with an aseptic isolator environment. Its compact design optimizes the use of production floor space, while full servo automation enhances operational precision and repeatability. Constructed with corrosion-resistant stainless steel, and equipped with H14 filters and a VPHP generator, the MICRO BI ensures compliance with Class 3 containment and ISO 10648-02 standards.

This equipment is also designed for ease of maintenance and cleaning, featuring spray balls and guns for efficient decontamination. With configurable options for filling pumps and closure types, and backed by robust automation support through Baseline Keba controls, MICRO BI offers customization to meet tailored production needs, supported by extensive documentation and validation resources.

Benefits

  • Ensures sterility and operator safety with integrated aseptic isolator, enhancing product quality.
  • Maximizes production efficiency with selectable filling speeds, minimizing bottlenecks in high-volume operations.
  • Reduces labor costs and error rates through full servo automation and intelligent control features.
  • Meets stringent industry standards with GMP-compliant designs and Class 3 containment levels.
  • Facilitates swift and thorough cleaning, minimizing downtime for maintenance and ensuring contamination-free operation.

General


Applications
Liquid formulations,Pharmaceutical powder,Radiopharmaceuticals,Pharmaceutical injectables,Biopharmaceuticals
End products
Vaccines,Biopharmaceutical vials,Insulin injectables,Radiolabeled compounds,Sterile saline solutions,Antibiotic powders
Steps before
Compounding,Aseptic Preparation,Vial Preparation
Steps after
Sterilization,Packaging,Batch Consistency Verification
Input ingredients
RTU vials,clinical and early-stage pharma production materials,liquids,powders,trayed vials,nested vials,syringes,cartridges
Output ingredients
filled vials,filled syringes,filled cartridges,stoppered vials,closed vials
Market info
Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.

Technical Specifications


Filling speed
50 or 200 units per minute
Filling method
Servo-driven design
Air flow practice
ISO 5
Containment level
Class 3,ISO 10648-02
Leak rate
,lt
1%

Operating Characteristics


Working Mechanism
Rotary filling system
Integrated Steps
Filling,closing,capping
CIP/SIP
CIP principles for cleanability
Batch vs continuous operation
Batch
Changeover Time
Optimized for quick changeover
Automation level
PLC / Servo-driven
Containment Level
Class 3,ISO 10648-02
Cleaning Method
Spray Balls and Spray guns

Material Compatibility


Cleanability
Able to accommodate aseptic conditions and easy cleaning via spray balls and guns
Corrosive resistance (e.g. acids)
Stainless steel AISI 316L
Biological compatibility
Suitable for aseptic pharmaceutical and biologics injectables

Product type Characteristics


Container Size and Shape
RTU Vials


ISO 10648-02
Class 3 containment level

Physical Characteristics


Compact footprint
Space-saving design
Control panel type
PC based touch panel screen
Discharge method
Trayed vials and/or nested vials/syringes/cartridges
Isolator walls material
Stainless steel AISI 316L with internal finish Mirror Brite
Glove ports
Independent safety barrier with Integrated Glove Integrity Tester
Doors material
12 mm thick tempered glass with inflatable gaskets
Filtration grade
H14 filters IN / OUT

Custom Options


Filling speed options
50 or 200 units per minute
Control panel type
PC based touch panel screen
Pumps type options
Peristaltic and Piston pumps
Machine configuration
Isolator ready / RABS configurations
Integration compatibility
ATS Scientific Products rotary filler with Comecer aseptic isolator