BFS Machine Aseptic Blow-Fill-Seal System

Details:

  1. Main advantages of BFS plastic ampoule comparing with the old style glass ampoule.
  2. No needle extract medicine liquid.
  3. Finger won’t be injure or stab wounds.
  4. There are no glass debris,bacteria or plastic granule in medicine liquid.

Description

Application

Shanghai Huiheng Pharmaceutical Aseptic BFS Filling Machine for plastic ampoule (BFS machine for short) is an advanced technology that integrates molding, filling, and sealing under complete control, which enables liquid to be packaged in polypropylene/high-density & low-density polyethylene plastic bottle, and the whole production process automatically completes the followings in a controlled environment (aseptic environment):

1. Extrude plastic particles into plastic perform at high temperature.

2. Then the preform is blown into a container by sterilized and filtered air.

3. Filling liquid that has been sterilized and filtered.

4. Tight sealing of containers after filling.

5. BFS machine is suitable for liquid filling in pharmaceutical, chemical, and food industries with aseptic or non-aseptic packaging in plastic containers.

Feature

Characteristics

1.The design, MOC, manufacturing, assembly, and debugging of the Pharmaceutical Aseptic Blow Fill Seal BFS system meet the requirements of the new GMP standards for drug production.

2.Advanced equipment, unique and reasonable structure, stable and reliable performance.

3.Applicable Specification: 0.2ml-1000ml plastic bottle (as per user’s requirements).

4.Production Capacity: 1000-18000BPH for Pharmaceutical Aseptic Blow Fill Seal BFS system

5.The number of bottles made each time: 1-30 bottles/mold, can be selected based on production capacity.

6.Filling Accuracy: ≤ ±1% (according to drug characteristics)

7.The BFS machine is integrated with bottle-making, filling, and sealing, with compact structure and occupies a small area, which reduces clean workshop area and saves energy consumption of air conditioning unit, as well as investment and use cost.

8.The plastic particles are plasticized by a low-speed long screw extruder driven by a specially designed servo motor, which can effectively reduce thermal stress of the material and accurately control the size of bottle preforms.

9.Each working cycle of the equipment can be compared and controlled automatically, with real-time feedback.

10.Stainless steel 304 hopper at extrusion station of the equipment is equipped with a level switch and linked with feeding device; when the material level is getting lowered, the alarm information of “lack of material” will be displayed on the man-machine interface.

11.High production efficiency, stable product performance, simple and reliable operation, and beautiful appearance.

12.For large capacity products, the container thickness is controlled at 100 points by an advanced thickness controller, and the precision servo motor controls the gap between mold core and mold cup.

13.The filling system is accurately calculated by time pressure method with high filling precision, which can meet the filling range of 0.2ml-2000ml to ensure production speed.

14.The equipment has black and white sections, the moving parts are isolated in non-clean are(black area), and only the basic components and operations are kept in the clean area(white area), which reduces the area of cleanroom and the number of particles in cleanroom.

15.Automatic in-place cleaning / in-place sterilization function (CIP/SIP) can be realized.

16.Configurable on-line monitoring system for dust particles and plankton bacteria.

17.In the process of bottle transfer, the inner surface of the interface is not in contact with parts, which eliminates the production of visible foreign matter.

18.To realize fully automatic control and monitor of the production process, high precision color touch screen operation monitoring, PLC automatic control, automatic protection, host frequency conversion speed regulation, and other control technology is used.

19.The products can be customized according to the actual demand of customers.

Technical Parameters

No. Item Parameters Remarks
1. Product Parameters
1.1 Product type
1.2 Raw material PP or LDPE Choose one
1.3 Volume 0.4ml~20ml
1.4 Product shape Customized
1.5 Products to be filled Water-like solution Max temperature 25°C, max viscosity. 100 mpaxs, no sedimentation. no foaming
2. Mold Parameters
2.1 Number of parison 1
2.2 Tube diameter of parison 110mm
2.3 Number of containers from one parison Decided by the diameter of the container
2.4 Mold shape Single-row mold
2.5 Number of mold 1
2.6 Number of mold cavity Parison quantity × Number of containers from one parison
2.7 Service life of mold About one hundred thousand running hours Not damaged mechanically or by man
3. Technical Parameters
3.1 Each cavity output capacity
Recommend bottle type
0.4~1ml 2500±10% pcs/h Eye drops 10 pcs/cavity, bottle width 11.5 mm
0.4~1ml 2060±10% pcs/h Eye drops 8 pcs/cavity, bottle width 11.7 mm
2ml 2060±10% pcs/h Ampoule 8 pcs/cavity, bottle width 11.7 mm
2ml 1520±10% pcs/h Ampoule 6 pcs/cavity, bottle width 12.5 mm
5~20ml 1250±10% pcs/h Ampoule 5 pcs/cavity, bottle width 18.3 mm
3.2 Production capability
Recommend bottle type
Each cavity output capacity
×Mold chamber quantity
Actual output capacity depends on the dimension of product and plastic particles
0.4~1ml 2600±10% pcs/h Eye drops 10 pcs/cavity, bottle width 11.5 mm
0.4~1ml 2060±10% pcs/h Eye drops 8 pcs/cavity, bottle width 11.7 mm
2ml 2060±10% pcs/h Ampoule 8 pcs/ pcs/cavity, bottle width 11.7 mm
2ml 1520±10% pcs/h Ampoule 6 pcs/ pcs/cavity, bottle width 12.5 mm
5~20ml 1250±10% pcs/h Ampoule 5 pcs/ pcs/cavity, bottle width 18.3 mm
3.3 Filling error range Compliant with pharmacopoeia
3.4 Weight error range ±0.3g Raw material of same batch
3.5 Container thickness error ±0.1mm
3.6 Product qualification rate ≧98%
3.7 Product quality Compliant with relevant quality standard Transparency, sealing, strength, appearance

4. Utilities Supply

4.1 Power supply 380V ±10%, 50HZ ±1HZ 3-phase AC
4.2 Installed capacity 35 kVA
4.3 Operating power approx. 25 kWh
4.4 Compressed air min. 6 bar~max.8 bar Oil-free
4.5 Main machine compressed air consumption 200L/min
4.6 Punching machine air consumption 400L/min
4.7 Normal temperature water 30L/min P≥ 2bar,T= 20°C ~25°C
4.8 Cooling water 20L/min P≥ 2bar,T= 12°C
4.9 Saturated steam 20kg/h min.1.6 bar~max.4 bar adjustable
4.10 Cleaning water for drug liquid loop 1m3/h 2.5bar,approx. 15min
4.11 Cleaning water for mold vacuum loop 0.5m3/h 2.5bar,max. 60℃
5. Environmental Parameters
5.1 Room Temperature min. 25°C / max. 30°C
5.2 Room Humidity max. 60%
5.3 Equipment Noise about 80 dB Depending on the final installation and adjustment
5.4 Equipment Size 2.0m×4.3m×3.1m L×W×H, including the punching device size
5.5 Equipment Weight 5.0T Subject to the final layout drawing
5.6 Room Size 4m×7.5m×3.6m The recommended smallest room

Tablet Example

Video

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Our professional team will reply to you as soon as possible.

Email

kevinpharmachinery@gmail.com

WhatsApp/Phone/Wechat

008613166139318

Company name

Shanghai Huiheng Pharmaceutical Machinery Co., Ltd.