Smashing, conveying, mixing, weighing, segregating and Subpackaging system of aseptic raw materials

Smashing, conveying, mixing, weighing, segregating and Subpackaging system of aseptic raw materials

The system is used for the post-drying treatment process of the aseptic bulk drug, and the whole system is the equipment integration which can manage the processes of discharging, conveying, smashing (granulating), re-transporting, mixing, weighing and Subpackaging and so on of the dry aseptic raw materials. The operation is completely in a closed state, which minimizes the probability of contact between personnel and materials, and can effectively reduce the risk of contamination of the product by particles and microorganisms. The modified system meets the new GMP requirements. The material turnover and treatment of the entire process are carried out under the effective protection of a closed environment or a dynamic A-level environment.

● Reference process

Freeze-dried dry material process

 Solvent drying and discharging process

Schematic diagram of material mixing and buffer mixing process

Single cone mixer, parameter list:

Loading coefficient: 0.7-0.85

Effective volume: 200-2000L

Dimensions: H=2300-4000MM, diameter=1100-2100MM

Power: Main shaft: 3-22KW, swing arm: 0.5-2.2KW

Speed: Spindle: 5-12rpm, Swing arm: 22-60rpm

Lifting mixer, parameter list:

Loading coefficient: 0.5-0.8

Dimensions: 2400*1400*3000MM

Working area: 2400*2500MM

Power: 5.5KW

Mixing speed: 8-12rpm

Mixing barrel series: 100L 200L 300L 500L 600L 800L 1000L 2000L

● Material Subpackaging and weighing system

● RABS(Restricted Access Barrier Systems) Subpackaging system

Positive pressure / negative pressure system

Online pressure monitoring system

▲ Main composition: 316L stainless steel

▲ Cleaning spray gun (CIP)

▲ RTP (fast delivery interface)

▲ drainage system

▲ sewage system

▲ FFU ventilation filter unit system

▲ Environmental Monitoring System

▲ transmission door interlock

▲ glove box

▲ Illumination 500-700Lux

Optional component

▲ temperature control

▲ humidity control

▲ Wind speed online monitoring

▲ On-line monitoring of dust particles

▲ On-line monitoring of microorganisms

Each functional section of the ORABS/CRABS Subpackaging system has independent air supply and exhaust system. The transmission door between the functional sections adopts pneumatic and inflatable sealing doors. The working area of each functional section is vertical laminar flow, and the wind speed is 0.36-0.54 m/s. It is positive pressure relative to the outside world.

Siemens PLC S7-200 centrally controls air volume, pressure, weighing SIP/CIP.

SMART 7-inch touch screen.

The system complies with GMP, FAD and EU-GMP requirements.

●Subpackaging & Capping station RABS protection system

It adopts vibration subpackaging or screw subpackaging form, and PLC control to realizes automatic Subpackaging.

Equipped with a dust-collecting device to effectively prevent dust from spreading.

Adopting METTLER ELECTRONICS, the maximum weighing range is 15Kg (standard), and the Subpackaging accuracy is 0-10g.

System accuracy: 5Kg +-5g, packing capacity 45-60 seconds / barrel

5Kg +-10g, packing capacity 20-35 seconds / barrel

●Rotary Capping Machine

▲ Capping adopts rotary structure

▲ Suitable for capping of various aluminum barrels

▲The capping machine is equipped with a dust suction device to prevent aluminum chips

● RABS vaporization hydrogen peroxide (VHP) sterilization program

The VHP Sterilizer can sterilize the RABS online.

Small single compartment RABS with one nozzle, large multi-compartment RABS

Configure multiple nozzles. The VHP is connected to the RABS via a return air hose.

Multi-compartment RABS can be configured with fixed connections.

VHP can also be integrated into the main body of the RABS.

● Automatic control of the system

The whole system is a chain control system. The procedures of vacuuming, sucking, pulverizing, subpackaging, weighing, wind pressure adjustment, cleaning, sterilization and drying in RABS are all completed by a PLC system. Through the touch panel operation panel on the main control cabinet, every action and function can be easily implemented.

●Cleaning, sterilization, drying system