QUALIFICATION OF PRE-FILL SYRINGE FILLING

AND STOPPERING MACHINE

INSTITUTION GUIDE:-DR. NAZMA INAMDARDEPARTMENT OF Q.A.T

PRESENTED BY:-ANWAR MUNJEWAR

M.PHARMACY (SEM-III)M.C.E SOCIETY’S ALLANA COLLEGE OF

PHARMACY, PUNE-01

INDUSTRIAL GUIDE:-SANJEEB MISHRAQA HEAD, BSVL.

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PREFILLED SYRINGES

A prefilled syringe is a single-dose packet of parental drug to which a needle has been fixed by the manufacturer.

The pre-fillable syringe system has a Polypropylene barrel, a rubber plunger stopper(halobutyl elastomer), a polypropylene plunger and a needle cover made with natural rubber. The plunger stopper and the metal needle are siliconized.

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BENEFITS FOR PREFILLED SYRINGES

Healthcare benefits:• Potential to minimize microbial

contamination• Potential to reduce medication

dosing errors• Enhanced convenience and ease

of useMarket benefits:• Reduced therapy and injection

costs• Increasing product life span.• Minimizing drug waste; 20% API

savings vs. vial filling• Increased market preference

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OBJECTIVE

The objective of study is to perform the Qualification of the Pre-fill syringes filling & stoppering machine. Further the study will also include the qualification cycle of this equipment.

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QUALIFICATION APPROACH

User/Engineering/QA

Manufacturing Installation Commissioni

ng Test Run

Change Control

URS

DQ

FAT

IQ

OQ

PQ

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PRE-FILL SYRINGE FILLING MACHINE

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PFS SYSTEM SPECIFICATIONModel Name PFS-A-10

1 No. Of Heads 102 Output Syringe/Hour 5000 to 60003 Filling Volume & Accuracy 0.2 to 10ml ± 0.2ml with

the help of change parts4 MOC Non-contacts parts- S.S

304Contacts parts- S.S 316L

5 Pneumatic Festo and SMC6 Servo Motor & Drive Fuji (Japan )7 PLC/HMI Fuji (Japan)8 Overall dimensions 1500(L) x 1000(W) x 1200

(H)

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REFERENCEStephen A. Unilife – Developing prefilled products of

choice. Cedar cottage, New timber Place Lane, West Sussex, BN6 9BU United Kingdom: ON drug delivery Ltd; 2010.

Pre-Filled Syringes: World Industry and Market Prospects 2014-2024, www.visongain.com.

Makwana S, Basu B, Makasana Y & Dharamsi A. Prefilled syringes: An innovation in parenteral packaging, Department of Pharmaceutics, Atmiya Institute of Pharmacy, Gujrat.

Mudhar P. Asian Hospital and Healthcare Management. Vol. 23. Secunderabad, Andhra Pradesh, India: Ochre Media Pvt Ltd; 2011. Are Pre-Filled Syringes the Future?

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Thank You !