M pharmacy

1. INSTITUTE OF
PHARMACEUTICAL SCIENCE
KURUKSHETRA UNIVERSITY
SUBMITTED TO : MR BALRAM SIR. SUBMITTED BY: VISHNU KUMAR
(PROFESSOR) M PHARMA 1 SEM (QA)
.

2. MEDICAL DEVICE PACKING
• WHAT IS MEDICAL DEVICE ?
• AN INSTRUMENT, APPARATUS , IMPLEMENT,MACHINE ,IMPLANT,INVITRO,
REAGENTS OR OTHER SIMILARLY OR RELATED ARTICLE INCLUDING A
COMPONENT PART OR ACCESSORY WHICH IS :1.RECOGNISE IN THE FORMULARY
OR THE PHARMACOPOEIA
2.INTENDED FOR USE IN THE DIAGNOSIS OF DISEASES OR OTHER CONDITIONS ,OR
IN THE CURE , TREATMENT, PREVENTION OF DISEASES,IN MAN OR OTHER
ANIMALS.
3.INTENDED TO AFFECT :THE STRUCTURE OR ANY FUNCTION OF THE BODY OF
MAN OR OTHER ANIMALS.

3. MEDICAL DEVICE PACKING
• SELECTION OF PACKING STYLE CAN IMPACT PACKAGE INTEGRITY .
• PARAMETER FOR SELECTION OF PACKAGING MATERIALS;
1.CRITICAL PRODUCT CHARACTERISTICS
2 TYPE OF PROTECTION REQUIRE ( PHYSICAL ,UV ,LIGHT ,OXYGEN , W
TRANSMISSION ETC .
3. TYPE OF STERILIZATION PROCESS
4.WHERE & HOW THE PRODUCT IS GOING TO BE DISPENSED (OTC, SU
5. GLASS OR METAL CONTAINER WERE USE TO LESSERE EXTENT

4. PACKAGE TYPE USE IN MEDICAL PACKING
• THERMOFORM TRAYS
• FLEXIBLE FORMED POUCHES
• FLEXIBLE NON FORMED POUCHES

5. THERMOFORM TRAYS( SEMIRIGID)
• THERE ARE 2 TYPES OF THERMOFORM TRAY
• SEMIRIGID & FLEXIBLE
• THE MOST IMPORTANT DIFFERENCE IS THAT SEMIRIGID TRAYS ARE
STRUCTURALLY SELF SUPPORTING
• THEY CAN PROVIDE GOOD PHYSICAL PROTECTION
• THEY ARE STABLE FOR MULTICOMPONENT APPLICATION

6. ADVANTAGES OF THERMOFORM TRAYS
• EASE OF FORMING
• HEAT RESISTANT
• STERILIZATION COMPATIBILITY
• COST EFFECTIVE

7. FLEXIBLE NON FORMED POUCHES
• THIS TYPE OF POUCHES ARE USE FOR SINGLE USE DISPOSABLE ITEMS SUCH AS
GLOVES, CATHETER,TUBING , ADHESIVE BANDAGES, DRESSING,SYRINGE,ETC
• FLEXIBLE PACKAGES TEND TO PROVIDE LESS PHYSICAL PROTECTION THEN THE
RIGID ONE (10)& ARE A PREFERRED CHOICE FOR HIGH VOLUME LOW COST
DEVICE

8. CHARACTERISTICS
• GOOD VISIBILITY OF PRODUCT
• EASE OF FORMING
• RELATIVELY LOWER HEAT RESISTANT
• LIMITED VARIETY OF MATERIAL AVAILABLE

9. FLEXIBLE FORMED POUCHES
• FLEXIBLE MATERIAL IS DRAWN BY THE THERMOFORM PROCESS INTO A FLEXIBLE TRAY
• PACKAGE ARE GENERALLY NOT SELF SUPPORTING
• CHARACTERISTICS:
• GOOD VISIBILITY OF PRODUCT
• RELATIVELY LOWER HEAT RESISTANT
• OFFER LITTLE STRUCTURAL PROTECTION
• CAN NOT BE PERFORMED

10. REFERENCE
• MEDICAL DEVICE PACKAGING BY LAURA BIX
• TEXTBOOK THEORY & PRACTICE OF INDUSTRIAL PHARMACY