Transcript
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 .
top related