primary and secondary packaging

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SELECTION AND EVALUATION OF CONTAINERS AND CLOSURES Presented by Sunitha Pudi Y alamarty College Of Pharmacy

PACKAGING:

PACKAGING Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. It refers to the process of design, evaluation, and production of packages. Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and use. 2

OBJECTIVES OF PACKAGING:

OBJECTIVES OF PACKAGING Physical protection,eg:shock, vibration Barrier protection , eg:Oxygen,light Containment or agglomeration Security Convenience,eg . distribution,handling,sale Portion control,eg . Single dosage pack 3

TYPES OF PACKAGING:

TYPES OF PACKAGING Primary packaging is the material that first envelops the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents. 4

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Secondary packaging is outside the primary packaging – perhaps used to group primary packages together. Tertiary packaging is used for bulk handling , warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into containers. 5

CONTAINERS:

CONTAINERS A pharmaceutical container is a device that holds the pharmaceutical product and it may or may not be in direct contact with it. ADVANTAGES : It must be neutral It must not interact physically and chemically Maintain the stability against environmental factors It should be designed simply to withdraw a dose Closure of the container must be easily removable and replaceable

TYPES OF CONTAINERS:

TYPES OF CONTAINERS Well closed containers Tightly closed containers Hermatically sealed containers Light resistant containers Single dose containers Multi dose containers Aerosol containers

CLASSIFICATION OF CONTAINERS:

CLASSIFICATION OF CONTAINERS Glass/polyethylene bottles Collapsible tubes Ampoules Vials Polythene packets for i.v fluids Dosing dropper Aerosol containers 8

GLASS A glass container is very commonly used as a drug packaging material :

GLASS A glass container is very commonly used as a drug packaging material DISADVANTAGES - Leaching - Fragility - Flaking - Heavy weight - Light Transmission ADVANTAGES : Impermeable Transparent Inexpensive Withstand high temp. pressure Ease to clean

TYPES OF GLASS:

TYPES OF GLASS Type I (Boro silicate glass): It is highly resistant type. It consists of mainly silicon dioxide and boric acid etc… Suoitable for parentral products. Type II (Treated soda lime glass): I t is obtained by treating sulphur dioxide or ammonium sulphate or ammonium chloride. Suitable for parentral products. Type III: Suitable for anhydrous parentral products Type IV (NP): Suitable for oral and topical product packaging

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AMPOULES One point cut ampoules. Flat Based and Constricted Neck ampoules Flame cut ampoules. Closed ampoules Ampoules with colour break band and identification bands VIALS: Multidose injectable preparation. 11

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BOTTLES : - Used in the dispensary as either amber metric medical bottles or ribbed(fluted )oval bottles. Available in sizes from 50ml to 500ml. Amber metric medical bottles are used for packaging a wide range of oral medicines. This includes liniments, lotions, inhalations and antiseptic solutions. 12

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DROPPER BOTTLES :- Eye drop and dropper bottles for ear and nasal use are hexagonal-shaped amber glass container fluted on three sides. They are fitted with a cap, rubber teat and dropper as the closure. The bottles are used at a capacity of 10ml or 20ml. 13

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PLASTICS Used as container for the product and as secondary packaging .Two classes of plastics are used and these are known as thermosets and thermoplastics. ADVANTAGES OF PLASTICS :- Flexible and not easily broken. Low density and light in weight. Are cheap DISADVANTAGES OF PLASTICS :- They are not as chemically inert as Type -I glass. They are not as impermeable to gas and vapour as glass. They may possess an electrostatic charge which will attract particles 14

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POLY ETHYLENE : This is used as high and low density polyethylene Low density polyethylene (LDPE) is preferred plastic for squeeze bottles. High density poly ethylene (HDPE) is less permeable to gases and more resistant to oils, chemicals and solvents. It is widely used in bottles for solid dosage forms. POLYVINYLCHLORIDE (PVC):- Used as rigid packaging material and main component of intravenous bags. POLY PROPYLENE :- It has good resistance to cracking when flexed. Suitable for use in closures , tablet containers and intravenous bottles . POLYSTYRENE:- It is also used for jars 15

PLASTIC CONTAINERS:

PLASTIC CONTAINERS 16

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METALS Metals used such as tin-plated steel, mild steel, stainless steel, tin-free steel, and aluminum and its various alloys. Metal is strong, opaque, and impermeable to moisture, gases, odors, light, bacteria, etc. It is resistant to high and low temperatures TIN :- Tin is the most chemically inert of all tube metals. It offers good appearance and compatibility with a wide range of products 17

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TINPLATE:- Tinplate is basically a steel structure with a thin layer of tin deposited on either one side or both sides, gives the steel some protection from corrosion . ALUMINIUM :- Aluminium lighter in weight and can be easier to shape. The thick rigid closures are used mainly for cans or aerosol containers, while the thin flexible material is used primarily for the closure of ,bottles or thermoforms 18

CLOSURES:

CLOSURES It is a part of package which prevents the content from escaping and allow no substance to entre the container. ADVANTAGES: It prevents loss of material by spilling or volatalisation . It avoids contamination of the product. It prevents the product from environment . TYPES OF CLOSURES - Plug type - Crimp-on (crowns) - Push-fit - Screw-on - friction

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Plug Type: The closure of this type is a push-fit into neck of the container. Eg: Cork,glass stopper. Crown Cap : The cap is commonly used as crimped closure for bevarage bottles. Made of metals. Push-fit Cap: These are simple slide fit over the neck of the container.

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SCREW CLOSURES These are very commonly used.It consists of three components - Cap - Wad - Liner Cap : Made of tin plate or aluminium metal.Sometimes it is used to close the container by screwing the cap on the neck. Wad : It is a seal which prevents the contamination of the product. Should be inert. Made of rubber or silicon rubber. Liner : Made of metal foils, rubber,plastic film and paper impregnated with a suitable resin, wax or plastic.

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TAMPER RESISTANT PACKAGINGS It is provided with an indicator or barrier before entering the package. Designed to prevent accident for safe packaging. Film Wrappers Blister package Strip package Bubble package Shrink seals and bands Foils, paper or plastic pouches Bottle seals Sealed tubes Aerosol containers Sealed cartons

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BLISTER PACKAGE: Blister packs are commonly used as unit dose packaging for pharmaceutical tablets, capsules or lozenges. Blister packs consist of two principal components : 1) a formed base web creating the cavity inside which the product fits and 2) the lidding foil for dispensing the product out of the pack. There are two types of forming the cavity into a base web sheet: thermoforming and cold forming . 23

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THERMOFORMING In the case of thermoforming, a plastic film or sheet is unwound from the reel and guided through a pre-heating station on the blister line The temperature of the pre-heating plates (upper and lower plates) is such that the plastic will soften and become mouldable. 24

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COLD FORMING In the case of cold forming, an aluminum-based laminate film is simply pressed into a mould by means of a stamp. Advantage of cold form foil blisters is that the use of aluminum is offering a near complete barrier for water and oxygen, allowing an extended product expiry date. The disadvantages of cold form foil blisters are the slower speed of production compared to thermoforming and the lack of transparency of the package and the larger size of the blister card 25

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Example for cold forming method 26

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Aluminium Foils for Blister Packing Aluminium Foil suitable for blister packing of Pharmaceutical Products such as Tablet, Capsules, etc. 27

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STRIP PACKAGE:- It is commonly used for the packaging of tablets and capsules. A strip package is formed by feeding two webs of a heat sealable flexible film through a heated crimping roller .The product is dropped into the pocket formed before forming the final set of seals. A continuous strip of packets is formed which is cut to the desired number of packets in length. The materials used for strip package are cellophane, polyester, polyethylene, polypropylene, polyvinylchloride. 28

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Example for strip package 29

EVALUATION OF PRIMARY PACKAGING MATERIAL:

EVALUATION OF PRIMARY PACKAGING MATERIAL Leakage test Hydrolytic resistance Collapsibility Residue on Ignition Buffering Capacity Light Transmission Water Vapour Permeation Heavy Metals & Non Volatile Residue 30

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HYDROLYTIC RESISTANCE: Powder glass test: Rinse 6 or more containers dry them crush into fragments divide 100g of coarsely crushed glass into 3 equal parts place one portion in mortar crush further by striking 3 or 4 blows with hammer

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pass through sieve no 20 and 40 transfer the retained portion&weigh excess of 10 g spread it on glaze paper and remove iron particles with magnet wash with six 30ml acetone, decant acetone dry the contents for 20min at 140 o c transfer to dessicator final specimen to be used in powdered glass

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LEAKAGE TEST : Ten containers are filled with water,filled with the closures and are kept inverted at room temperature for 24hrs.there should be no signs of leakage from any container. COLLAPSIBILITY TEST : It is applicable to containers which are to be squeezed in order to remove the contents. By collapsing inwards during use,yield at least 90% of its normal contents at the required rate. TRANSPARENCY TEST : Five empty containers were filled to their nominal capacity suspension in each container is detectable when viewed through the containers,as compared with a container of the same type filled with water. WATER VAPOUR PERMEABILITY TEST : Five containers are filled with nominal volume of water and heat sealed with aluminium foil polyethylene laminate.Stand for 14days and weighed. Loss in weight is not more than 0.2%

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REFERENCES :- Remington.The Science and Practice of Pharmacy, 21 st ed,Vol-1;Pg:1047-10 . Indian Pharmacopiea,2007,Vol-1;Pg:599-25 Leon Lachman, Liberman AH, Kanig JL.The Theory and Practice of Industrial pharmacy,4 th ed,Pg:711-22. www.authorstream.com www.ipapharma.org 34

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THANK YOU 35 PRESENTED BY SUNITHA PUDI

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