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Help CenterBFS Three-in-one Bottlepack Blow/ Fill/Seal Packaging System
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Bottlepack
Specifications
2.Frequency variable speeds.
3.Plastic Bottle Forming, Filling and Sealing 3 in 1
4.Meet cGMP.
Definition:
BFS is the abbreviation for blow-fill-seal, This technology accomplished the plastic ampoule forming, liquid filling and the plastic ampoule sealing through the process of continuous operation of a device. All of these processes in aseptic
condition are completed in one time, the cycle time is 12-14 seconds.
BFS technology has been used for about 40 years in the world. The pollution rate by verification can reach 0.1%. According to the summary and analysis of the medium filling data, the pollution rate of
BFS system is 0.001%.
Characteristics:
The biggest advantage of BFS is reduce outer pollution —human contamination, environment pollution and material pollution, which can be sure product safety .
Package
The process is versatile and a wide variety of containers of different sizes can be made on the
machine. The size may range from 0.2ml to 13 litres. For convenience, the sizes of containers are
classified in the following three categories:
-Small Volume Packaging: For containers from 0.2ml up to volume of 50ml.
-Large Volume Packaging: For containers from 50ml up to 500ml.
-Very Large Volume Packaging : For containers above 2500ml.
Structure
There are two structure type of BFS machine ,black/white zoning and without black/white zoning.
1. BFS machine conforms to Black/White zoning configuration and this module configuration separates filling(white zone)
from auxiliary device zone(black zone). All particles source are placed into auxiliary device zone
(black zone). Auxiliary device
zone to filling zone(white zone) keeps negative pressure, so the clean room space decreases greatly.
2. BFS machine conforms to without Black/White zoning configuration and this configuration is to be
the entire device placed
in the C class zone. This structure occupied clean area is relatively large , but the overall size of the
device is relatively small.
Development Tendency
From the development trend of the pharmaceutical industry, the traditional open type aseptic
production environment and over a number of personnel to participate can not meet the growing
demand for the production of sterile preparations. The BFS technology which can achieve automation and isolate will be the future development direction of sterile preparations.
The process of BFS is not only with the requirements of GMP, but also is the development trend of
sterile drug products in China. The BFS technology which will replace glass ampoules and glass
bottle infusion will become the mainstream of sterile drug products .
Blow-fill-seal Process
1. The mould is transferred to blowing/filling station quickly. The blowing/filling/sealing
mandrels are protected against contamination by sterile air in the aseptic air chamber. The
blowing /filling nozzle is lowered into the parison until it forms a seal with the neck
of the mold. The plastic material is now formed into a container as determined by the design of the
mould by vacuum and /or sterile air pressure.
2. The container is immediately filled with a metered volume of the solution, displacing the
sterile air. Both the air and the solution are filtered through bacteria retaining filters
immediately before entry into the forming, or formed container. Pipe contacting with
solution can realize CIP and SIP before filling, so that it ensures drug solution safety.
3. After filling, the tube parison between top of plastic mould and the holding jaws
remains semi-melting condition, and then sealed mould closes and forms the top of
container and keeps the containers sealed.
4. After sealed, the plastic mould is opened. The container is totally formed,
filled, sealed and is ready to out feed and then starts next cycle.
Capacity
It is mainly used for small volume injection, eye drops, and oral liquid and ear drops with the range of 0.2ml~20ml.Each device could product 4800~9000 per hour, which depends on filling volume, raw
material and number of chambers in mould.
NO. | Chamber NO. | Volume max.(ml) | Section (mm) | ΦMax (mm) | Design capacity approx. pieces/h |
1 | 30 | 0.2 | 12 | 10 | 9000 |
2 | 30 | 0.4 | 12 | 10 | 9000 |
3 | 30 | 0.8 | 12 | 10 | 9000 |
4 | 30 | 2 | 12 | 10 | 9000 |
5 | 24 | 5 | 16 | 14 | 7200 |
6 | 20 | 10 | 20 | 15 | 6000 |
7 | 20 | 15 | 25 | 15 | 6000 |
8 | 20 | 20 | 25 | 18 | 6000 |
The Main Structure
The main frame include: filling system, Class A Air Flushing device , The mold carriage and carriage assembly , CIP / SIP system,
particulate removal device, hot cutter ,sealing clamp system, mould, HMI and other components.
Equipment Layout
1. BFS system is made up of BFS mainframe and cutting edge machine.
2. The mainframe is designed black/white zone.The main frame and filling zone are placed in the
white zone and other equipment is placed in a black zone. This layout greatly reduces the pollution sources of Class C zone and the space of Class C zone .
3. The main device is constructed with a modular structure, which include with 4 independent modules: the main structure, Extruder structure, electric control cabinet and auxiliary equipment.
QA-File System
-The complete file system
-Strict quality assurance procedure
-Comply with GMP authentication scheme
-Escort the whole equipment manufacturing process
-Ensure the product quality is stable and reliable
About SPM
Shanghai Pharmaceutical Machinery Co. Ltd. (SPM) is recognized as a major pharmacy equipment manufacturer and supplier. Our company is founded in Shanghai, China, with a base of 20 years
of prior experience in the pharmaceutical industry. This has allowed us to expand our business in a
well-planned manner. We now offer a comprehensive line of quality pharmaceutical machines at
competitive prices. In addition, we can undertake turnkey projects for conceptual design, process
design, water treatment solutions, cleanroom design, etc.
SPM Products
Our products fall into four categories, which are solid preparation machinery,iquid-injection processing
machinery, pharmaceutical packaging machinery, and laboratory instruments. Some of our primary products
are pulverizers, blenders, granulators, sterilizing machines, blister packing machines, encasing machines, air
compressors, and tablet testing instruments. Our solid preparation equipment and liquid processing equipmen,which are corrosion resistant, highly effective, safe, and easy to use, are utilized in countless applications.
For example, our rotary tablet press presses granular materials into tablets, our capsule filling machine is
suitable for filling powdered or granular materials into capsules, and our freeze drying machine is mainly
used for the cryodrying of blood products, vaccines, antibiotics, and biological products. For more product
applications, please see our product page to find a complete list of our pharmaceutical machinery.
Projects
Customer Service
Our excellent customer service also includes the installation of our machines. To ensure smooth
performance, we also provide a one year warranty, and a spare set of wearing parts to our customers.
If any difficulty occurs, we will supply free spare parts and even on-site service, upon request.
Please contact us to help you with your particular spare parts of pharmaceutical equipment.
Industries Served
At SPM, we focus on fabricating efficient and technically sound pharmaceutical machines that meet or exceed our customers' expectations. Our vast product selection caters to numerous industries, worldwide. Some of the areas we serve are
- Food Industry
- Pharmaceutical Industry
- Chemical Industry
- Electronic Industry
- Ceramic Industry
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