This document provides an overview of prefilled syringes and the qualification process for a prefilled syringe filling machine. It describes that a prefilled syringe is a single-dose packet of medication that has a needle fixed by the manufacturer. The document outlines benefits of prefilled syringes such as reduced dosing errors and costs. It then details the objective to qualify a specific prefilled syringe filling and stoppering machine. The qualification approach and specifications for the PFS-A-10 filling machine are presented.

1. INSTITUTION GUIDE:-
DR. NAZMA INAMDAR
DEPARTMENT 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 MISHRA
QA HEAD, BSVL.

2. 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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3. BENEFITS FOR PREFILLED SYRINGES
 Healthcare benefits:
• Potential to minimize microbial
contamination
• Potential to reduce medication dosing
errors
• Enhanced convenience and ease of use
 Market 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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4. 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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5. QUALIFICATION APPROACH
User/Engineering/QA Manufacturing Installation Commissioning Test Run
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Change Control
URS
DQ
FAT
IQ
OQ
PQ

6. PRE-FILL SYRINGE FILLING MACHINE
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7. PFS SYSTEM SPECIFICATION
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Model Name PFS-A-10
1 No. Of Heads 10
2 Output Syringe/Hour 5000 to 6000
3 Filling Volume & Accuracy 0.2 to 10ml ± 0.2ml with the
help of change parts
4 MOC Non-contacts parts- S.S 304
Contacts parts- S.S 316L
5 Pneumatic Festo and SMC
6 Servo Motor & Drive Fuji (Japan )
7 PLC/HMI Fuji (Japan)
8 Overall dimensions 1500(L) x 1000(W) x 1200 (H)

8. REFERENCE
 Stephen 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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9. Thank You !
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