Sterile Formulations

 Ø sterile formulations of

Ø  Vials

Ø  Ampoules

Ø  Pre-Fill Syringes

Ø  Blow Fill syringes

Ø  Ophthalmic

Ø  Infusions (Bag FFS)

INDEX

 

1.      Introduction

2.      Process Flow Charts

3.      Checklist

i.            Compounding,

ii.            Filling

iii.            Autoclave

iv.            Washing & Tunnel

v.            Filling

vi.            Sealing

vii.            Terminal Sterilizer

viii.            Lyophilizer

ix.            Packing

4.      Process Flow

i.            CIP

ii.            SIP

iii.            Autoclave

iv.            Washing

v.            Tunnel

vi.            Filling

vii.            Sealing

viii.            Lyophilization

ix.            Terminal Sterilization

x.            Packing

5.      Validation

i.            Area qualification

ii.            CIP

iii.              SIP

iv.            Autoclave &Terminal Sterilization

v.            Tunnel

vi.            Washing

vii.            Filling machine

viii.            Sealing machine

ix.            Lyophilizer

x.            Compressed air & nitrogen

6.      Media fills

7.      Engineering Assurance

i.            Water System

ii.            HVAC

iii.            Utilities

iv.            Instrumentation

8.      Investigation Report

9.      Change Management

10.  Vendor Qualification, Re-Qualification & Dis-Qualification