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:

Samples sent from customers in South-America

Bank copy of Down&balance payment for purchasing filling sealing line model YX-PSF06

Testing videos on Model YX-PSF06 Syringes filling sealing machinery:

Wooden case packing of filling closing labeling printing line model YX-PSF06

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