PRESENTATIONON

PHARMACEUTICAL PACKAGING MATERIALS

MD: SHARIFUL ISLAM SOUTH EAST UNIVERSITY

INTRODUCTION:

PACKAGING IS THE SCIENCE, ART AND TECHNOLOGY OF ENCLOSING OR PROTECTING PRODUCTS FOR DISTRIBUTION, STORAGE, SALE, AND USE.

PACKAGING MAY ALSO BE DEfiNED AS THE COLLECTION OF DIFFERENT COMPONENTS (E.G. BOTTLE, VIAL, CLOSURE, CAP, AMPOULE, BLISTER) WHICH SURROUND THE PHARMACEUTICAL PRODUCT FROM THE TIME OF PRODUCTION UNTIL ITS USE.

FUNCTIONS OF PACKAGING: PRODUCT IDENTIFICATION PRODUCT PROTECTION FACILITATING THE USE OF PRODUCT PRODUCT PROMOTION

USES OF PACKAGING:

PHYSICAL PROTECTION

INFORMATION TRANSMISSION

MARKETING

CONVENIENCE

BARRIER PROTECTION

SECURITY

PACKAGING IS A BRIDGE

CHARACTERISTICS OF PACKAGING MATERIAL:

THE MATERIAL SELECTED MUST HAVE THE FOLLOWING CHARACTERISTICS:•MUST MEET TAMPER-RESISTANCE REQUIREMENTS

•MUST BE FDA APPROVED

•MUST BE NON-TOXIC

•MUST NOT IMPART ODOR/TASTE TO THE PRODUCT

•MUST NOT REACTIVE WITH THE PRODUCT

•THEY MUST PROTECT THE PREPARATION FROM ENVIRONMENTAL CONDITIONS

TYPES OF PACKAGING

PRIMARY PACKAGING: IT IS IMMEDIATE CONTAINER IN DIRECT CONTRACT WITH THE PHARMACEUTICAL

PRODUCT. EXAMPLES: AMPOULES,VIALS ,CONTAINERS ,DOSING DROPPER ,CLOSURES (PLASTIC, METAL) ,SYRINGE ,STRIP PACKAGE, BLISTER PACKAGING, PVC OR ALU-ALU BLISTER.

SECONDARY PACKAGING

IS OUTSIDE THE PRIMARY PACKAGING PERHAPS USED TO GROUP PRIMARY PACKAGE TOGETHER.EXAMPLE: PAPER AND BOARDS, CARTONS ,CORRUGATED FIBERS ,BOX.

TERTIARY PACKAGINGUSED FOR BULK HANDLING , WAREHOUSE STORAGE AND TRANSPORT SHIPPING. THE MOST COMMON FORM IS A PALLETIZED UNIT LOAD THAT PACKS TIGHTLY INTO CONTAINERS.

EXAMPLE: BARREL, CONTAINER, EDGE PROTECTOR.

THE CHOICE OF PACKAGING MATERIAL WILL DEPEND UPON:• THE DEGREE OF PROTECTION REQUIRED• COMPATIBILITY WITH THE DOSAGE FORM• CUSTOMER CONVENIENCE E.G. SIZE, WEIGHT OF DOSAGE FORM,• FILLING METHOD• STERILIZATION METHOD TO BE EMPLOYED AND COSTPACKAGE TESTING:

• DROP TEST

• VIBRATION TEST

• SHOCK TEST

• INCLINED IMPACT TEST

• REVOLVING DRUM TEST

TYPES OF PACKAGING MATERIALS USED FOR PHARMACEUTICAL PACKAGING

Glass Metals Rubbers

Plastics Fibrous material Films, Foils and laminates

SYMBOLS USED ON PACKAGES AND LABELSMANY TYPES OF SYMBOLS FOR PACKAGE LABELING ARE NATIONALLY AND INTERNATIONALLY STANDARDIZED. FOR PRODUCT CERTIFICATIONS, TRADEMARKS, PROOF OF PURCHASE, ETC. IDENTIFICATION CODE .