Pre-Filled Syringe Filler (FDA&GMP Approved)

FDA&cGMP Approved Prefilled Syringes filling machine.

Design and Manufacturing According to FDA&cGMP Standard

Specifications  

1,Filling

A---

Flush nitrogen before & after filling.

Note:If filling liquid like clear water, anti-drip set is no need.                

         If filling special liquid, anti-drip set is optional.

2,Vacuum Plugging

B---

After filling, the syringe is delivered to the vacuum chamber manually. When the vacuum chamber is closed following operation to be performed: vacuum sucking-nitrogen flush –vacuum sucking- nitrogen flush, then plug the stopper inside the syringe .The vacuum degree can be displayed digitally, and adjustable according to the filling volume.

3, Isolation Technique

C---

 Work area must be under Laminar Air Flow .Class 100 with isolation technique with sanitary gloves.

4, Cleaning

D---

 The machine shall be designed to have easy accessibility to all parts to ensure cleaning and changeover.

The equipment shall be easily accessible for manual cleaning of the surfaces.

All the contact parts i.e. filling pumps, filling nozzles, the transferring hoses, Nitrogen flushing tubes and accessories shall be removable and sterilizable.

5, Instrumentation

E---

At least the following measurements shall be measured automatically (on-line, continuously shown on MMI:

Run indicator light

All alarms and possible remedy.

Low pressure notification for Nitrogen, Compressed air and vacuum.

6,Utility Failure & Alarms

F----

The control system must annunciate an alarm in case of lower limit of utilities(such as electricity, compressed air .Nitrogen, Vacuum etc.)before going to process shut down.

PLC and MMI programs must retain on electric power failure .system recovery after power failure must be possible for operator via MMI and without any programming.

7,Material Specification

G----

All contact parts shall be made of stainless steel AISI 316L or compatible. Stainless steel AISI 304 or equivalent shall be in surfaces that are not in contact with the produce.

All non-metallic materials used in the equipment must withstand cleaning with ethanol 70% and detergents .Hoses in contact with the produce shall be food grade quality.

8, Print-out of process parameters, original data is stored.

9,Nitrogen flush protect

  

Technique Date:

Filling volume	0.5-3ml BD-Hypac pre-fill syringe If change filling system, it can be up to 20ml
Number of filling head	5 sets
Capacity	2400-3600 Pcs/h 1ml 3000Pcs/h;  0.5ml 3600Pcs/h 100Pcs/tray
Filling accuracy	±1%
X travel distance	80mm
Y travel distance	300mm
Printer	Hot-sensible printing paper width 56mm, max.20 letters per line
Vacuum	-95KPa~0 (-720mmHg~0), can be set up
Nitrogen	1-3kg/cm2, 0.2m3/min, 0.25μm
Compressed air	6kg/cm2, 0.20m3/min
Power supply (including vacuum pump)	3P 380V/200V 50-60Hz 4.0kw

Pre-Filled Syringe Filler (FDA&GMP Approved)