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Brasilian customers bought pharmacy syringes filling capping labeling line with IPC system
Published by: PENGLAI INDUSTRIAL CORPORATION
Date:2019-05-14 10:02:30

Our customers from Brasil (South America) placed the new order on one(1*) whole line of syringe filling capping labeling with IPC+Codes printing system;
For all the machines purchased it is clear to confirm all the information on the products so we often ask our customers to freight the samples to test and commission the machines in order that the machines and customer's products gains the best compatibility and adaptability.
After getting the confirmation &samples of the product in sizes and drawing for manufacturing the filling sealing labeling printing machines
we spent only KSA7 working days finishing everything and made the machines ready after testing them in a satisfactory feedback.
Recently our customers sent us the positive commentar on the machines which keep running very well in their factory ever since the machines arrived their factory.
The machines was shipped via Ocean to  . The documentaries certificated with ISO&CO&CE together with other files necessory are sent via DHL to customer for assisting customers to clear the custom.

As below there listed the basic information on the successful transaction between PENGLAI and their American counterpart:

Purchased order issued from Brasilian customer:

PO for labeling filling capping printing machinery.jpg

Samples sent from customers in South-America

10ML syringes drawing.jpg

20ml drawing.jpg

specification.jpg

specification.jpg

samples sent from Brasilian customers (1).jpg

samples sent from Brasilian customers (2).JPG

labels samples (2).JPG

syringes samples.jpg

syringes samples.jpg

labeling with printing samples.JPG

samples sent from Brasilian customers (3).JPG
Bank copy of Down&balance payment for purchasing filling sealing line model YX-PSF06

syringe filler liquid line.jpg

HSBC Receipt Rafael syringe filling machinery .jpg

Balance paymnet for syringes filler.jpg

Balance payment for syringes machinery.jpg
Testing videos on Model YX-PSF06 Syringes filling sealing machinery:

Wooden case packing of filling closing labeling printing line model YX-PSF06
foam wrapping machinery wooden case for shipping.jpg

wooden case for syringes filling machinery (1).jpg

wooden case for syringes filling machinery (2).jpg

wooden case for syringes filling machinery (6).jpg

wooden case for syringes filling machinery (8).jpg

wooden case for syringes filling machinery (9).jpg
As follow there given the description on the machines purchased respectively:

The whole syringes filling sealing labeling line is specially manufactured for our Brasilian customer.
The product is Normal Saline in Pharmacy use.  The whole line includes the part such as :
Syringes lifting feeding system;
Filling sealing part model YX-PSF06;
Connection part;
Horizontal labeling machine Model YX-BS200;
IPC system; Laminar Flow Class 5;

Before being shipped to Brasil the machine was approved and verified by the FAT whose details are given as below:

Factory Acceptance Testing – FAT
Automated disposable syringe filler

Main parts of the Equipment
2    Fluid Loading Station : Fluid loading station must be able to handle different reservoir sizes ranging from 1L to 100L, compatible with 0,9% Saline Solution viscosity and pH.
2    Syringe Loading Station: Loading Station for 10mL AND 20mL assembled syringes   
2    Loading Station for luer lock caps
2    Filling Station   
2     Labelling station    
Good Manufacturing Practices
4.1.4    The equipment surfaces shall be stainless steel minimum grade 304 and shall be finished to give a uniform smooth finish
4.1.5    Equipment parts that will have contact to the Solution to be filled shall be stainless steel minimum grade 316L and shall be finished to give a uniform smooth finish, polished
4.1.8    Plastic parts should be constructed preferred in Delrin
4.1.9    Gaskets and or rubber parts should be made on medical grade silicone
4.1.10    Equipment should be supplied with Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols
Dimensional Requirements
5.1.2
5.2.1    Cleanroom internal doors are 1800mm x 2000mm equipment or its parts should be able to clear pass these doors.
Equipment height should be lower than 2000 mm
6.1.1
6.1.2    General electrical power supply:    
1 x 220 V (60Hz) or
3 x 380 V+P+N (60 Hz)
All the electrical equipment must be designed for a 60 Hz frequency
No 110-120V available in the facility

6.1.3    Compressed air supply:        Pressure range 7 – 10 bar
7.1    Equipment shall be labelled
7.2    In/Out cables of the control system be label and comply with the drawings.
8.1    Equipment shall be packed in proper manner for ocean shipments, such as wooden case.
8.2    Minimum warranty of one year after installation, excluding normal wearable parts, accidents or misuse
Documentation and Manuals
9.1.2
9.1.3
9.1.4    User guideline and manuals, process descriptions
9.1.5
9.1.6
9.1.7
9.1.8    Drawings, PIDs, Electrical diagrams, Components list and components documentation
9.1.9    Maintenance guide and procedures
9.1.10    IQ/OQ/PQ Protocols
9.1.11
9.1.12    Calibration procedures and Certificates
SECTION II – SYRINGE FILLING STATION
10.1.1    Production Capacity Output, minimum 1,000 syringes per hour
10.2.1
10.3.1    Filling volume shall be adjustable and capable to deal with volumes varying from 3 – 60 mL with accuracy of +-3%
10.4.1
10.4.2
10.4.3    Equipment shall be supplied with automatic syringe feeder
Equipment shall be supplied with customs tooling for ISO 7886:2005 10mL AND 20mL luer lock plastic syringe according to samples supplied
10.5.1    Equipment shall be supplied with automatic feeder for luer caps
10.5.2    Equipment shall screw the cap in the syringe after filling
10.5.3    Screw torque or number of turns shall be adjustable
10.6.1
10.6.2
10.6.3
10.6.4    Filling lines shall be flexible and possible to use sterile and disposable tubing
Hard parts in filling lines should be reduced as far as possible
Fluid container shall be compatible with standard IV bags of 500mL or 1L
10.7.2    Equipment shall be equipment with laminar flow in the filling area with class 100 (ISO class 5) to avoid particle contamination compliant with EN 14644.
10.7.3    Equipment shall be equipped with variable air flow system and controlled by PLC
10.7.4    Filter specification shall be detailed in the equipment documentation for maintenance and change proposal
10.8.1    Syringe Output from the filling and capping station to the labelling equipment shall be done by an automatic transfer system
SECTION III – LABELLING EQUIPMENT
11.1    Labelling Capacity
11.2    Label Specification
11.3    Printing Software
Installation and Commissioning
12.1.1    Supplier to detail any special service or installation requirements.
12.1.7    Equipment must support  21 CFR Part 11 requirements for electronic records.
12.1.8    Hardware/software back-ups should be available in case of systems failure
12.1.9    Procedures should be provided for system recovery
 

The machine model YX-PSF06 Medical gel syringe filling plugging sealing pharmaceutical packaging equipment is suitable for liquid &rubber plugging on glass or plastic syringes. other types of syringe are also up to custom made. 

6 nozzles are for filling simultaneously .plugging can be either by pressing down or screwing ways.

Plugging is done parallelly with filling .multi points inspection with optical fiber sensors. neither filling nor plugging when syringe is missed.

All product contact parts are of AISI316L and medical silicon.

Actual working status can be displayed on touch screen with multi languages.

Rotating plunger pumps are driven with servo motor. Precision adjustment can be made on touch screen without any tools. each plunger pump can be adjustable slightly

Working flow from Brasilian-purchased filling capping labeling syringes machinery model YX-PSF06:
1. Syringe elevator feeding empty syringes
2. Syringes fall down to slide track guidef to turntable 3.Rotary one syringe to pressing mechanism position,empty the air inside syringe.
4.Rotate syringes in position& six heads filler heads start filling
5. Vibrating bowl feeding caps and deliver to capper, finish capping.6. Rotating turntable to discharge the filled sealed syringe. 7. Worker monitor the completed product.
8. Robot hand picks up the syringe and deliver to labeling station.
9. Syringe in position and finished labeling process.
10. Robot hand discharge the product on the conveyor

Application of syringe for filling plugging capping sealing labeling line:

SYRINGE FILLING sealing labeling line (2).jpg

SYRINGE FILLING sealing labeling line (1).jpg

Pre-filled syringes have emerged as one of the fastest-growing choices for unit dose medication as the pharmaceutical industry seeks new and more convenient drug delivery methods. Pharmaceutical companies are able to minimize drug waste and increase product life span, while patients are able to self-administer injectable drugs at their home instead of the hospital.
The market has expanded and is exploring all options outside of the traditional process. In the past, glass syringes dominated the market, but there has been a movement toward plastic and disposable syringes. Pre-filled syringes have also been utilized across a wide range of therapeutic sectors, such as vaccines, blood stimulants, and therapeutic proteins.
Eliminating dosing errors and ease of use are two of the greatest advantages of pre-filled syringes. However, there are a number of challenges that manufacturers face, such as the interaction between the pre-filled syringes and the drug, stability concerns, and quality control.

caliberator syringes.jpg

syringes samples von EU.jpg

touch screen controlling.jpg

Machine drawing model YX-PSF06 Fill-seal printing set

PSF samples.jpg

Drawing of model YX-PSF06.jpg

Dimension of syringe filler.jpg

Syringes filler.jpg

Basic parameter of pre-sterilized syringe filling plugging capping machine:

capping part sealing.jpg

filling capping machinery drawing.jpg

touch screen parameter (3).jpg

Model YX-PSF06

Filling volume

0.5ml-100ml

Number of filling head

6sets

Capacity

1800-3600 syringes/hour

Sealing method

Pressure or screw

Compressed air

6kg/cm2,0.15m3/min

Supply

3P 380V/220V 50-60Hz 2.0Kw

Dimension

1800*800*1700mm (L*W*H)

Net weight

750Kg

Details pictures for machines syringe filling capping equipment:

syringe filling capper.jpg

plugging filling for EU customers.jpg

filling part.jpg

capping part sealing.jpg

output PSF.jpg

Parts for syringe pre-filled injector loading system

storage tank stainless for gel.jpg

LIFTING FOR syringe.jpg

bowl caps feeding.jpg

Component origin

electronics board.jpg

NO

NAME

QTY

ORIGIN

REMARK

1

Filling needle

1

Self-produce          

316L,mirror polish

2

Ceramic pump

1

Jiangsu

 

3

Ceramic valve

1

Jiangsu

 

4

Transmission motor

1

Jiangsu.Deli

0.75KW

5

Servo Motor

4

Taiwan,Delta

400W

6

Touch screen

1

Taiwan,Eview

7 inches

7

PLC

1

Taiwan,Delta

 

8

Air-break switch

6

Zhejiang,CHNT

 

9

Lead screw

4

Taiwan,Sheheng Jaan

Ball screw (high resolution)

10

Linear guide way

6

Japan,IKD

 

11

Solenoid valve

12

Japan SMC

 

12

Cylinder

12

Tawiwan Airtac

 

13

Optical fiber

3

Japan Panasonic

 

14

Pressure controller

4

JAPAN SMC

 

15

The isolation glass

6

ACRYLIC

8mm thickness

 

Syringe filling -capping-labeling line for our USA customer:

drawing of filling capping.jpg

Pre-syringe filling sealing line for Turkey customers:

automatic gel filling equipment.jpg

CE test declaration(part)&CE report(part)

CE report.jpg

CE test report.jpg

Samples&Final product output

specification.jpg

syringe samples.jpg

PSF final product.jpg

Wooden case packing for pre-syringe filling line

packaging wooden case machine capping.jpg

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