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Neelam - Pre Filled Syringe Filling & Stoppering Machine
Compact machine / Dosing of syringes in nests from 0.2 to 20 ml. Ready-to-use disposable syringes offer ease of use, security, hygiene and dosing accuracy for medical injections.
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- Our line allows a combination of filling closing for processing ready-to-use disposable syringes and vials in nests.
- Ready-to-use disposable syringes are supplied sterilized and ready to-fill into trays called “Nest”.
- The equipment is designed to be used in sterile room applications, in accordance with regulations of the cGMP and USFDA.
- Machine adjusted automatically and are associated to each format of syringe or vial processing.
- The formats can be recalled from the control panel, re-establishing automatically the ideal predetermined settings.
- New programs can be created easily and quickly by the user.
- The changeover to a different size is carried out quickly, easily and without tools, by exchanging complete sets of format parts.
- To work under sterile room applications we offer different laminar flow units enclosures adapted to each size of machine.
- These optionals guarantee to work under ISO 5 Class.
- The unit can be designed to be installed into an isolator when production requirements recommend its use.
In Compliance with :
- cGMP
- GAMP
- 21 CFR PART 11
Machine sequence of operations :
- Manual or automatic insertion and manual or automatic removal of “Nest”, depending on the machine model.
- Dosing through valveless rotary piston pumps or through peristaltic pumps.
- Automatic infeed and automatic positioning of plunger stoppers / stoppers.
All production parameters are stored in the PLC data memory, through “formats”.Therefore, parameters such as :
- Dose volume.
- Programmable Kinematics of the filling process.
- Positioning depth of the plunger stoppers / stoppers.
- Output speed.
- Robotic Tyvek Removal System.
- Semi-Automatic & Fully Automatic Machines Option Available.