Page 2 - FAR 222 Laboratory Manual V2 2019

Contents

1 COURSE & PRACTICAL OUTLINE ............................................................................ 1
PRACTICAL CLASSES & TUTORIALS ................................................................... 1

ASSESSMENT ........................................................................................................ 1
2 INTRODUCTION TO STERILE PHARMACEUTICAL AND MEDICAL PRODUCTS ... 2

INJECTIONS ........................................................................................................... 2
OPHTHALMIC PREPARATIONS ............................................................................ 5
3 CONTAINERS, CLOSURES AND PACKAGING ........................................................ 8
CONTAINMENT ...................................................................................................... 8

PROTECTION ......................................................................................................... 9
4 LABELLING OF STERILE PRODUCTS .................................................................... 10

LABELLING REQUIREMENTS ............................................................................. 10
GENERAL LABEL FOR INJECTIONS ................................................................... 11
GENERAL LABEL FOR EYE DROPS ................................................................... 13
5 THE PRODUCTION OF STERILE PRODUCTS ........................................................ 15

STERILISATION METHODS ................................................................................. 16
GENERAL PROCEDURE OF THE PRODUCTION OF STERILE PRODUCTS IN
COMPOUNDING LABORATORY ......................................................................... 17
6 STERILITY TEST ...................................................................................................... 20

REFERENCES .......................................................................................................... 22
APPENDICES ........................................................................................................... 23
LIST OF INFUSION SALTS .................................................................................. 23

OVERAGE FOR AMPOULE .................................................................................. 24
COMMON BUFFERS ............................................................................................ 25
COMMONLY USED ISOTONIC VEHICLES FOR OPHTHALMIC PRODUCTS..... 26

SODIUM CHLORIDE EQUIVALENTS, FREEZING POINT DEPRESSIONS AND
HOMOLYTIC EFFECT OF CERTAIN MEDICINALS IN AQUEOUS SOLUTION ... 28