12-PACKAGING MATERIAL PPT SDK

SEMINAR ON PACKAGING MATERIAL USED IN PARENTERALS : 

SEMINAR ON PACKAGING MATERIAL USED IN PARENTERALS SANGLE SHRADHA M PHARM Ist SEM DEPARTMENT OF PHARMACEUTICS SND COLLEGE OF PHARMACY BABULGAON, YEOLA 1

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CONTENTS INTRODUCTION IMPORTANCE CLASSIFICATION APPLICATION REFERENCES 2

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INTRODUCTION PACKAGING MATERIAL : An economical means of providing - Protection - Presentation -Convenience -Information -Identification : 3

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IMPORTANCE OF PACKAGING Protect against all adverse external influences that can alter the properties of the product. Protect against biological contamination. Protect against physical damage. Carry the correct information and identification of the product. Tamper evident / Child resistance 4

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CLASSIFICATION Primary packaging material: E g: Bottles, Ampoules, Vials, Syringes Catridges and Bags Secondary packaging material: E g: Labels, Cartons etc . 5

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On the basis of material of construction packaging material may be divided as: Glass Plastics Rubber Paper 6

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Economical Excellent resistance to chemical interaction Can be handled at high speed Easily cleaned Inert Provides good product presentation due to transperent nature Is softend by heat, capable of being fashioned in mould, can be reheated & remoulded into another shape Are rigid, strong , and dimensionally stable and sterilized easily GLASS CONTAINER 7

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Composition of glass Fused silica Tetrahedron Also it contains three types of oxides: 1.oxides involving monovalent cations: eg: Na + 2.oxides involving divalent cations: eg: Cao, Mgo 3.oxides involving multivalent cations: eg:B 2 O 3,, Al 2 O 3 8

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Types of glass Type Description uses 1. Highly resistance borosilicate glass Laboratory apparatus 2. Treated soda lime glass Containers for Eye drops & other dropper bottles 3. Soda lime glass Non-aq. Parenteral products & powder for injection 4. Non parentral glass (general purpose) Material other than parenteral preparation 9

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TYPES AS PER USP GLASSWARES CAN CLASSIFIED AS Chemical – 1. Type I- Highly resistant borosilicate glass 2. Type II- Treated soda lime glass 3. Type III- Soda lime glass 4. Type NF –General purpose soda lime glass Physical 1. Light protection 2. Permeation 3. Capacity 10

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FORMING AND PROCESSING BLOWN CONTAINER TUBING-MADE CONTAINERS 11

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EVALUATION TEST Water attack test: Powdered glass test: Thermal shock test Leakage test 12

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DEMERITS Fragility Heavy weight (this increase transpotation cost) 13

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Plastic material Material of construction Types Tests for quality determination Merits Demerits 14

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Material of construction 15 Materials Properties Demerits Uses HDPE Translucent,semirigid stress cracking Poor barrier against oxygen & other gases but good against moisture For disposable syringes PP Translucent,semirigid but no stress cracking Lack of clarity Packaging of dialysis fluid Polycarbonate Transparent,rigid Merit: not going under degradation at time of sterilization Disposable Syringe’s

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16 Polystyrene Transparent, rigid Has a high water vapour transmission, & high oxygen permiability For disposable syringe Flexible PVC Transparent,flexible Above 250 degree starts to degrade & PVC yellow when expose to U.V. or heat For packaging I.V. injection Also other materials are there: Teflon – Transparent, rigid PA(Polyamide)- Translucent, rigid LDPE- Translucent, flexible

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TYPES OF PLASTICS Thermoplastics- a. Polyethylenes - (PE) LDPE (low density polyethylens) HDPE (high density polyetylens) b. Ethylene vinyl acetate(EVA) c. Polypropylene(PP) d. Cyclic olefin copolymer(COCs) e. Polyvinyle chloride (PVP) f. Polystrene (PS) 2. Thermosets a. Melamine b. Phenol formaldehyde c. Urea formaldehyde 17

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18 Test Leakage test Acidity & alkalinity test Light absorption Test for Reducing substances Transparancy

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19 Merits Light weight Inexpensive Non-breakable Demerits Leaching of plastic additives into product may lead to change in pH,discoloration,degradation etc. Sorption of active ingradients.

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20 Rubber closure: Advantages Material of construction Types of rubber Tests

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21 Advantages Rubber is soft so that needle easily can be inserted & remove Product sterility is maintained after insertion & removal of needle because of resilience

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22 Contents of Rubber Polymer Vulcanizing agent eg: sulpher Accelerator eg: 2 marcapto benzothiazole Activator eg: ZnO, Zn stearate, stearic acid Filler eg: carbon black,limestone,Talc, CaCO 3 Antioxidants Softener eg:mineral oil Lubricant eg:Zn stearate,talc Pigments/colors eg:coal,tar dye

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23 Types and shapes of Rubber Natural: polyisoprene latex of free Hevea braziliensis Synthetic : 1.Gray butyl 2 .Nitrile rubber 3. Chloroprene (Neoprene) 4.Silicon rubber Shapes of rubber closures: 1.Flanged type 2.Slottted type 3.Plunger type Butyl rubber closure

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24 Evaluation test Penetrability Self sealability Fragmentation test Closure for injection

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25 PAPER Composition Wood fibers, contains: 50% cellulose 30% lignin 20% carbohydrate and resin, tannins, gums Types of wood fibers -Soft wood fibers -Hard wood fibers

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26 Types of paper Glassine & greaseproof paper Parchment paper Coated paper Waxed paper Chipboards Container board Plastic paper etc.

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27 Carton drop test A vibration tester An incline impact test Bursting test Puncture resistance test Water vapour transmission test Porosity (Gurley densometer) Compression or crushing Evaluation test

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28 Tensile strength Moisture content Tester

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29 Protection Convenience Information Identification Child resistant clousers PET Bottles Applications

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30 Refrences Indian pharmacopoeia 2007, Ministry of Health and Family Welfare, Fourth edition vol. 1, pg no. 599-616 Herbert A. Liberman and Leon Lachman Pharmaceuticals Dosage Forms: Parenteral Medications volume I second edition Reviced and expanded Edited by Kenneth E. Avis Page no.361-384, 387-443 Remington The Science and Practice Of Pharmacy volume I 21 st edition page no 810,1036,10501-055

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H. Lochart And F. A. Paine Pakaging Of Pharmaceutical ande Healthcare products Blackie acedemic and professionals page no. 1-11, 99-137 D. A. Dean, E. R Evans , I . H . Hall Pharmaceutical Packaging Technology page no. 210-263, 264-365 31

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THANK YOU 32