PACKAGING MATERIALS

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PRESENTED By S.VYNIKA(12DU1S0315) M-PHARM(PHARMACEUTICS) PACKAGING MATERIALS

CONTENTS:

CONTENTS INTRODUCTION GLASS PLASTIC CLOSURES TAMPER RESISTANT PACKAGING FDA REGULATIONS

INTRODUCTION:

INTRODUCTION Packaging materials are materials meant to enclose the materials to be packed or to hold them together. The materials selected must have the following properties. They must protect the preparation/formulation from environmental conditions. They must not be reactive with the product. They must not impart any taste or odor to the product. They must be nontoxic. They must be FDA approved. They must meet applicable tamper resistant requirements. Examples are Glass, Plastic, Aluminium, Copper, Cardboard.

GLASS:

GLASS Glass is commonly used in pharmaceutical packaging. Composition of Glass Sand Soda ash Lime stone Cullet Common cations (Silicon, luminium,Boran,Sodium ) Anions (Oxygen)

Types of Glass:

Types of Glass Borosilicate Glass(Type I) Treated Soda lime Glass(Type II) Regular Soda lime Glass(Type III) General Purpose Soda lime Glass Borosilicate Glass Highly resistant glass In is type of glass with the main constituents are Silica and Boron oxide. It has strong hydrolytic resistance because of Boric oxide Resist to thermal shock It can able to withstand stress and not react with other substances or parentral products Mainly used to pack parentral products and Aerosols

Treated Soda lime Glass:

Treated Soda lime Glass Used for oral dosage forms, aqueous, acid, neutral solutions It cannot be recycled Not used for packing parentral products It is not recommended for sulfur treatment. Regular Soda lime Glass It has moderate and vulnerable hydrolytic resistance Used for packing solid dosage forms or oily products or oil dosage forms Containers are untreated and made of commercial Soda lime glass General Purpose Soda lime Glass Containers supplied for non parentral products intended for oral or topical use

Evaluation of Glass:

Evaluation of Glass Hydrolytic resistance Test Fill the solution in glass tubes and place it in autoclave , increase the temperature from 100 0 c to 121 0 c ↓ At 121 0 c keep it for 20 min ↓ Decrease the temperature from 121 0 c to 100 0 c for 40 min ↓ Then cool the container and the solution is collected in flask ↓ Add 0.15ml Methyl red and titrate against 0.01M Hydrochloric acid ↓ The end point is appearance of color

Test 2:

Test 2 4% V/V of Hydrochloric acid is filled in the container ↓ Allow it to stand for 10 min ↓ After 10 min empty the container and wash it for 3 to 5 min ↓ After washing carry out Test 1 ↓ Test 1 will give the result of Test 2 in 4% Hydrochloric acid

Arsenic Test:

Arsenic Test 10 ml of test solution + 10 ml of Nitric acid ↓ Keep it in water bath until it dry ↓ Dried residues are collected and further dried in oven at 130 0 c for 30 min and cooled ↓ Then 10ml of Hydrazine – Moly Lead is added ↓ Keep it in Reflux condenser for 20min ↓ Note the absorbance at 840nm and compare with Hydrazine Moly Lead blank ↓ If Arsenic concentration exceeds 0.1 ml(10ppm) of Arsenic ↓ Arsenic Limit is allowed in glass

Powder Glass Test:

Powder Glass Test Wash the glass containers with purified water and crush ↓ 3 parts of 100 gm each in the glass is taken ↓ The glass particles has to be passed through 10 mesh ↓ Using magnet remove Iron , Aluminium or other impurities ↓ Transfer this 100 ml into 250 ml conical flask ↓ Wash it with Acetone ↓ Dry it for 20 min at 140 0 c and cooled

Test 2:

Test 2 Take 10gm from 250ml conical flask +50ml of purified water ↓ Take it into 250ml conical flask with Borosilicate beaker ↓ Place it in autoclave at 121 0 c ↓ Increase the temperature from 100 to 121 0 c for 19 t0 23 min ↓ 121 0 c must be hold for 30 min ↓ It has to be reduced from 121 to 100 0 c in 38 to 42min ,cool ↓ Add 5 drops of Methyl red and titrate against 0.02N Sulfuric acid

Water Attack Test:

Water Attack Test Water is taken into glass and autoclaved, watch it whether it undergoes Weathering. PLASTIC Plastic is synthetic polymer or long chain of high molecular polymers. Constituents of Plastic Polymer Residues associated with polymerisation process Additives Processing aids Antioxidants Antistatic agents Coloring agents Impact Modifiers Lubricants Plasticizers Stabilizers

Types of Plastic:

Types of Plastic Thermoplastic - This type of plastic gets softened to viscous fluid on heating and hardens again on cooling. The hardness after cooling is influenced by the degree of cross linkage (or) intramolecular attrition between the long chain molecules. Thermosetting – This type of plastic may become flexible but does not become fluid on heating. They are generally hard and brittle at room temperature because of a high degree of cross linking. Polyethylene Polypropylene Polyvinylchloride Polystyrene Polymethylene Polycarbonate

Polyethylene:

Polyethylene High density polyethylene is used in pharmaceutical industry. It is good barrier against moisture, most solvents don’t attack on polyethylene and is unaffected by strong acids and alkalies. Polypropylene It does not stress, crack except for hot aromatic (or) halogenated solvents which soften it. It is resistant to all types of chemicals, strong acids, alkalies and most of organic materials. Excellent gas (or) vapour barrier. Used for foil packages and for sterilizable products because it has high melting point.

Polyvinyl Chloride:

Polyvinyl Chloride It is crystal clear, stiff but has poor impact resistance at low temperature. PVC turns yellow when exposed to UV so add a stabilizer along with resin supplies. Excellent barrier for oil, both volatile and fixed alcohols and petroleum solvents. Causes liver cancer in persons exposed to vinyl chloride polymers. Polystyrene Rigid , crystal clear plastic. It has high water vapor transmission and high oxygen permeability Resistant to acids except strong oxidizing acids and alkalies . Used to pack dry products only because it is cracked by many chemicals

Drug-Plastic Considerations:

Drug-Plastic Considerations Permeation P ermeation of water through plastic wall into drug creates problem to dosage form if it is sensitive to hydrolysis and oxidation. Temperature, humidity influence permeability of oxygen and water through plastic Leaching This problem arises in colored plastics. Coloring agents migrate into ophthalmic (or) parentral solution cause toxic effect cause drug contamination. Sorption This process is removal of constituents from the drug product by the packaging material.

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This effects the therapeutic efficacy of the preparation. Sorption of low concentration preservatives causes microbial growth . Chemical Reactivity Certain ingredients in plastic formulation react with drug components chemically. At times ingredients in formulation react with plastic. This alter the appearance of plastic (or) drug product. Modification The physical and chemical alteration of packaging material by drug product is modification. Closures A closure must prevent the contents from escaping and allow no substance to enter the container.

Types of Closures:

Types of Closures Screw –on, threaded (or) lug closure Crimp –on (Crowns) Press –on (Snap) Roll –on Friction Screw Cap A Screw closure is a mechanical device which is screwed on and off of a threaded “finish” on a container. Either continuous threads (or) lugs are used. Metal caps can be either performed (or) in some instances, rolled on after application.

Crown Cap:

Crown Cap Beverage bottles are frequently closed with crown beverage caps. These are shallow metal caps that are crimped into locking position around the head of the bottle. Snap On Some closures snap on. For opening, the top is designed to pry off (or) break off (or) have a built in dispenser. Roll on Closures It has aluminum (or) light gauge metal. Resealable, non resealable and pilferproof types of roll on closures are used for both glass and plastic.

Pilfer proof Closures:

Pilfer proof Closures This extends below the threaded portion to form a bank fastened to basic cap by a series of narrow metal bridges. Friction Fit Some containers have a loose lid for a closure. Laboratory glassware often has ground glass joints that allow the pieces to be fitted together easily. An interference fit (or) friction fit requires some force to close and open, providing additional security. Paint cans often have a friction fit plug.

Tamper Resistant Packaging:

Tamper Resistant Packaging FDA defined Tamper resistant package is one having an indicator (or) barrier to entry which if breached (or) missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. Film Wrapper It is for products requiring package integrity (or) environmental protection. End Folded Wrapper Formed by pushing the product the into sheet of overlapping film which forms the film around the product and folds the edges in a gift wrap fashion.

Fin Seal Wrapper:

Fin Seal Wrapper The seals are formed by crimping the film together and sealing together, the two inside surfaces of film producing a “fin” seal. Shrink Wrapper In this shrink film is used in roll form with centre fold the sheet into which product is inserted. An L-Shaped sealer seals the overwrap and trims extra film. Blister Package It is formed by heat softening a sheet of thermoplastic resin and vacuum drawing the softened sheet of plastic into a contoured mold.

Strip Package:

Strip Package It is formed by feeding two cubes of heat sealable flexible film through either a heated crimping roller (or) a heated reciprocating plate. Bubble Pack Formed by sand witching the product between a thermo formable, extensible (or) heat shrinkable plastic film and a rigid backing material. If heat shrinkable material is used pass through heated tunnel this shrinks the film into bubble (or) skin over the product.

Shrink Banding:

Shrink Banding It uses heat shrinking polymer like pvc. It is manufactured as oriented tube with larger cap and neck ring of the bottle is to be sealed. Foil, paper (or) Plastic Pouches In VERTICAL OPERATION a web of film is drawn over a metal collar and around a vertical filling tube through which product is dropped into formed package. Horizontal System It is for small volume products in this web of film is folded upon itself rather than tube.

Bottle Seals:

Bottle Seals The inner seal is inserted in the bottle cap and held in over the permanent cap lines by friction fit into the cap (or) a application of wax, this temporarily adheres the seal to cap liner. Tape Seals Involves the application of glue (or) Pressure sensitive tape (or) label over Closure package. The paper used must be high density light weight paper. Breakable Caps The cap blank is held on the bottle Under pressure while rollers crimp and Contour the bottle thread into cap blank. The bottom portion of cap is rolled around.

Sealed Tubes:

Sealed Tubes Tubes are made of polypropylene (or) polyethylene. For high barrier packaging metal (or) laminated tubes are used. Aerosol Containers A hydrocarbon propellant in its cooled liquid phase is added to container along with product and a spray nozzle contained in a gasketed Metal ferrule is crimped over the opening of aerosol container. Sealed Cartons The closure of folding cartons is accomplished by many ways by use of “tuck end” design.

FDA Regulations:

FDA Regulations It evaluates that specific drug preserve drug’s efficacy as well as it’s purity, identity, strength and quality for its entire life. Under Federal Food, Drug and Cosmetic Act it is responsible of manufacturer to get approval of packaging material safety before using it. A list of substances “Generally Recognized As Safe “ (GRAS) has been published by the FDA. The drug manufacturer must include data on container and package components in contact with pharmaceutical product in its “New Drug Application “ (NDA). If FDA determine drug is safe and effective then that package is suitable it approves drug and package.

References:

References The Theory and Practice of Industrial Pharmacy – LACHMAN Pharmaceutical Dosage Forms – AULTON Packaging materials - Wikipedia

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