Pharmaceutical Non-PVC Film Bag Infusion IV Soft Bag Filling and Sealing Machine Production Line

• Customization: Available
• After-sales Service: Answers Online Within 24 Hours
• Certification: CE, GMP, ISO
• Model NO.: SSM-3000
• Condition: New
• Customized: Customized
• Voltage: 380V
• Warranty: 1 Year
• Pass Rate: Min. 99.97% (Based on The Qualified Materials and
• Core Components: Motor
• Filling Temperature: Max.85° C
• 500ml: 3000 Bags/Hour
• Filling Pressure: 0.2MPa-0.4MPa
• Filling Accuracy: +/- 1.0 %
• Power: 3phases 380V 50Hz Max.20kw
• Type: Pharmaceutical Packaging Machinery
• Finished Dosage Form: Liquid
• Precision: High Precision
• Computerized: Computerized
• Transport Package: Wooden Package
• Specification: customized
• Trademark: medigrage
• Origin: Shanghai
• HS Code: 8422301090
• Production Capacity: 30sets/Year

Product Description

Machine parameter

Equipments specification		Length (Max.  Mm)			Width (Max.  Mm)		Heigth (Max.  Mm)	Remark
SSM2000		6600 (including roller's length )			2000		1800	3bags/group
SSM3000		5200 (including roller's length )			2000		1800	2 bags/group
Layout		For ,SSM2000 type equipment, pls refer to Figure 1 attached.
Equipments capability
type		SSM2000  (2 bags/group)		SSM3000 (13bags/group)		Remark
500ml		2200 bags/hour		3000 bags/hour		The data needs to meet the following conditions : Filing pressure 0.40Mpa ;Conpressed air 0.75Mpa
Filling
Filling pressure	0.2Mpa-0.4Mpa
Filling tempreture	Max.85° C
Filling accuracy	+/- 1.0 %
Product connection	50.5 standard Tri-Clamp
Online disinfection	Standard equipment only provides the disinfection for pipeline interface components.
Pass Rate
Pass Rate			Min. 99.97% (based on the qualified materials and non error operation) Leakage rate Max.0.01%
Waste edge remove rate			99.99%,there are collection container
Energy demand
Power			3Phases 380V 50Hz SSM3000  Max.20kw SSM2000 Max. 15kw
Conpressed Air			0.5Mpa~0.75Mpa, oilfree dry compressed air SSM3000 2500L/min SSM2000 1800L/min
Cooling Water			Null(Cooling module can be increased according to customer requirements)
Nitrogen			Be increased according to customer requirements
Working Environment
Room Tempreture			20 °C - 24 °C
Air Humidity			45%-65% Max.85%
Other Parameters
Temperature Control Accuracy			Stable Running Tempreture Control Accuracy +/- 0.5° C The Start-Stop control accuracy +/- 1.5° C (Bag-making molds/ Port welding molds/ Port preheating molds)
Noise			Max. 75dB
Operator			Fixed operator : 1 person Auxiliary operator : 1~2 persons (to replace production materials)
Language			Chinese&English

SSM2


Equipment function
1.An overview of the
The machine is designed for pharmaceutical use according to the GMP and FDA guidelines. It is designed for forming, filling and sealing bags.
The machine is designed as a single-track linear system with a motor actuated film transfer control. In the machine, the film will be transported through grippers.
According to its required capacity, the machine is either equipped with one working stations.
The machine's framework consist of stainless steel AISI 304, especially suitable for pharmaceutical use.
All components coming in touch with the product are made of stainless steel AISI 316 L quality.
The safety doors and windows mounted on the framework are made of polycarbonate. Thus they correspond to the health and safety regulations and ensure at the same time an optical supervisory control.
The machine is equipped with a switch cabinet and a control unit. The control units are interconnected via a bus system.
Two operators are necessary to operate the machine (1 permanent, second operator only necessary for film change).
The machine consists of the following components:
-01- Unwinding station
-02- Printing station
-03-Film transfer station
-04-Contour welding and cutting station
-05-Port Cutting
-06-Port pre heating station
-07-Port welding station
-08-Waste ejector station
-09-Filling station
-10-Cap station
-11-Bag outfeed with transport belt
 

1. Station Instructions

2.1 Unwinding station

The film is fed into the machine via a motor controlled unwinding device. The film roll is pneumatically cramped onto the reception bolt. In order to ensure a constant film transfer speed, the film is temporarily stored on a castoring wheel. Thus, the changing film roll diameter is compensated.
The motor to unwind the film will be started as soon as the castoring wheel releases a sensor.
Membrane-free alarm,alarm can be exhausted in the membrane.*
2.2 Printing station
The 'Full-Face' print is printed on the bag film using a hot film printing unit.
Variable manufacturing data, such as the production number, the best-before date, the batch number, etc. are adapted by exchanging the separate reception vises which are especially designed for this purpose.
Printing temperature, printing time and printing pressure are adjustable.
The automatic printing film supervisory unit (odometer to determine the film feed) ensures a machine stop in case the printing film has run out or teared off, and thus ensures a constant bag printing.
The printing film reception rolls are equipped with a pneumatic, hand-operated clamping. So the printing film can be exchanged very easily and without any special tool, the time required for service purposes is reduced to a minimum.
In order to ensure that the bag film does not adhere to the printing film subsequent to the printing process, the bag film is held down by pneumatic film clips.
For changing the printing block, only two clamps have to be released. The block reception must not be removed if you have to change the characters of the production and best-before date, the batch number, etc.
2.3 Film transfer station
Film transfer with film opener.
The film transfer is performed by an electric motor driven linear gear unit. During the transfer, the film is held by pneumatic film clips. When the film is fed in, the two film layers are opened with a fixed opener taper key in the front area, where the next step, i.e. the port insertion, will be carried out.
2.4 Contour welding and cutting station
This station is used for welding the outer contour of the bag, for adhering the ports to the bag film and for cutting the outer contour of the bags. The welding is done by exchangeable welding tools provided with heating cartridges to produce the required welding temperature.
Welding time, pressure and temperature are adjustable.
The welding temperature is verified within a defined min./max. range by the PLC control unit and temperature sensor, in order to ensure a permanently correct welding process.

In case the welding temperature remains under or exceeds - for any reason whatsoever - the defined  min. / max. range, the machine will stop. Simultaneously, an error message is displayed in the control panel.
Using the unique design of the heating plate and mold separation, replacement of mold is extremely simple.
2.5 Tube cutting
The cylinder drives the cutter to cut the hose with fixed length, and sends the cut hose to the equipment fixture.

2.6 Tube pre heating station
This station serves for pre-heating the ports up to a certain temperature before they arrive between the two bag film layers of the contour welding station, and thus it ensures an optimal welding of port and bag film. For this, two pre-heating tools which are pre-heated to a certain temperature and having the same contour as the ports, are brought together on the port. Pre-heating temperature and time can be adjusted via the control panel.

2.7 Port welding station
This station is used for welding ports and bag film.
For this, two welding tools which are preheated up to a certain temperature are brought together on the bag head contour.
Welding time and temperature are adjustable via control panel.
Using the unique design of the heating plate and mold separation, replacement of mold is extremely simple.
High-precision processing technology, perfect welding.
2.9 Filling station
Filling method uses a double while filling hose
No bags are not filling, not filling inaccurate positioning
2-year life of fixture
The amount of each batch of the filling can be automatically recorded
2.10 Cap station
Sealing plug with a separate feed hopper control
No bags not filling not sealed
2.11 Bag outfeed with transport belt
The finished bags are taken out by gripper system and leave the machine to the outfeed conveyor belt.
3,CIP/SIP
consisting of automatic function of CIP / SIP including steaming bar and drain pipes for condensate water. The outlet valves of drain and steam are to open manually.
CIP
 
After the rinsing process has been started from the filling station control panel by manual operating, the filling nozzle will move downward into the cleaning and steaming bar. The filling nozzle at the different filling locations are sealed with a silicone gasket in the cleaning and steaming bar. The cleaning fluid flows from the product connection through the surge tank into the product distributor. From here, the cleaning fluid flows into the different filling locations, through the mass flow, the product tube and through the filling valve into the cleaning and steaming bar. From here, the cleaning fluid flows through two outlet tubes into a drainpipe beneath the filling station. After cleaning, the filling nozzle returns to its original position.

After the cleaning of the machine the steaming process will begin at a temperature of about 125 °C. After the steaming process has been started from the filling station control panel by manual operating, the filling nozzle will move downwards into the cleaning and steaming bar. The filling nozzle at the different filling locations are sealed with a silicone gasket in the cleaning and steaming bar. The filling valves are opened and the superheated steam moves from the product connection trough the surge tank into the product distributor. From here the superheated steam moves into the different filling locations, through the mass flow, the product tube and through the filling valve into the cleaning and steaming bar. Inside the cleaning and steaming bar, two side-mounted temperature probes (PT - 100) monitor the temperature during the cleaning process. From here, the superheated steam moves through two outlet tubes into the drainpipe beneath the filling station. Two stop valves are located on the left and on the right hand side of the drainpipe. Beneath stop valve a approx.1 mm diameter aperture is located. Through this gooseneck the superheated steam condenses into water. This condensate is finally let out through a drainpipe. At the end of SIP process the filling nozzles will stay in the sterile steaming bar and wait for set up or next production to ensure sterile conditions of the whole filling system.


Other descriptions:
The customer chooses the double tube non-PVC soft bag, which follows the form of PVC soft bag in Europe and America, and is more in line with the use habits of medical staff. However, the tube non-PVC soft bag has the disadvantages of high leakage rate at the root of the tube (3 ‰) and high comprehensive cost.
After the introduction of non-PVC soft bags in China, to solve these two problems, soft bags with hard tubes began to be used
The double hard tube soft bag retains the structural characteristics of the two tubes of the flexible bag, and uses PP hard interface to replace the soft tube. The cost reduction was accompanied by a significant reduction in the leakage rate (below 1 in 10,000).

Comparison is as follows:

Item		soft tube soft bag	Hard tube soft bag
appearance
material	film	Non-PVC multilayer co-extruded film	Non-PVC multilayer co-extruded film
	interface	Non-PVCmultilayer co-extruded film	PP Medical interface
	sealing plug	PP Twist off plug PC sealing plug + isoprene rubber plug	PP Cap+Bromobutyl rubber plug for injection

 

If you are interested in this, please contact me: Nana Zhang
Shanghai Medigrade Industry Co.,Ltd
Waigaoqiao Free Trade Zone, Shanghai,China. 200137
 
 
 
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