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1 Pharmaceutical Packaging Material By:- Dahiwal Sandesh Sanjay M.Pharm IInd Sem ( P’eutics ) Contact no: 9423338866

What is Glass?:

What is Glass? An amorphous inorganic product of fusion that has been cooled to a rigid condition without crystallizing. Not a crystalline solid, not a liquid. It is a “frozen” liquid. 2

HISTORY OF GLASS:-:

HISTORY OF GLASS :- Glass is believed to have first discovered in 3000BC. In ancient days sandcore method is employed for Sandwich preparation of packing materials. First bottle making machine, invented in 1882 by Philip Arbogart based on press and blow method. Glass has been a successful material for the long periods because it still meets the requirements of modern packaging material.

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MERITS :- Glass shows high degree of chemical inertness. Glass is impermeable to all gases,solutions,solvents. Heat resistance &high M.P make it more suitable for both moist & dry sterilisation. It is a rigid material. Neutral glass (resistant to chemical attack) are also available. They can be easily labelled .

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DEMERITS :- Glass is fragile a material. Release alkali to aqueous preparations Heavy Susceptible for mechanical breakage Unable to withstand sudden changes in temperature Leaching of Alkali Potential Hazards from glass splinters or fragments in food .

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CLASSIFICATION OF GLASS: USP classifies glass in to 4 types according to the amount of alkali released from the glass when attacked by water under specified condition. They are : Type1 glass: neutral or borosilicate glass. Type 2 glass: soda glass with a surface treatment. Type 3 glass: soda glass of limited alkalinity. Type 4 glass: European Type 4 or NP glass.

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TYPE USES Highly resistant Buffered & unbuffered borosilicate glass. aqueous solutions. Treated soda lime glass Buffered aqueous solutions with pH below 7,dry powders. Soda lime glass Dry powders. General purpose soda lime For tablets, oral solutions, glass suspensions, ointments, external liquids.

COMPOSITION & ADDITIVES USED IN GLASS::

COMPOSITION & ADDITIVES USED IN GLASS: Colourless white flint soda glass has the following composition: Silica 59-75% Calcium oxide 5-12% Sodium oxide 12-17% Alumina 0.5-3% Ferric oxide small quantity Titanium oxide small quantity Potassium small quantity Magnesium oxide small quantity

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ADDITIVES USED IN GLASS : Fluxing agent-reduce the melting point. Ex:soda ash. Stabilisers-Calcium carbonate. Decolourants- selenium or cobalt oxide. Durability enhancer-Alumina. Colourants-Glass acts as a solvent for certain oxides so colored glass may be obtained by the addition components while manufacturing.

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Glass colour colourant used Amber - carbon & sulphur or iron & Mgo. Yellow - compounds of cadmium and sulphur. Blue - cobalt oxide or cupric oxide. Green - iron oxide,manganese oxide, chromium oxide. opale - phosphates.

Glass Manufacturing:

Glass Manufacturing 11

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MANUFACTURING PROCECESS : Glass containers can be fabricated by certain basic process: blown glass : press and blow blow and blow Tubular glassware: Danner or vello process Pressed glassware-rarely used for packaging containers Annealing : All glass containers pass through an annealing lehr to relief stress and strain.

Narrow Neck Press & Blow (NNPB) :

Narrow Neck Press & Blow (NNPB) Relatively recent process Similar to press & blow process More accurately control uniformity of glass distribution Weight is reduced upto 25% 14

Annealing Process:

Annealing Process Slow cooling of the glass in order to strengthen the container. Produces a more stable product. 15 Annealing lehr (oven) 540oC Holding for 15 minutes Cooling Almost the softening point of glass

Annealing Process:

Annealing Process Heating to annealing point & then lowering the temp. gradually for releasing the residual strain in the glass Controlled heating & cooling process designed to relieve internal stress introduced in container during & immediately after glass container formation. Annealing Point: The sp. Temp. in which internal stresses build up during glass container formation. 16

Types of containers:

Types of containers Tubular glass containers Ampoules Vials Disposable syringes Aerosols 17

Special Pharmaceutical Containers:

Special Pharmaceutical Containers Glass containers broadly divided into Narrow necked (including sprinkler ) Wide necked Most specialized container names. Carboys: exist in balloon shape or cylindrical or straight side form. Cylindrical rounds, Boston rounds: Convential cylindrical bottle with near flat shoulders Winchesters: widely used in UK & covers range from 0.5fl.oz upwards. 18

Tubular glass containers :

Tubular glass containers Limited use of these containers prior to 1917, but after introduction of continuously drawing glass tube leads to greater use. Advantages: Lower weight, Thinner & more even wall control Hermitically sealed 19

Ampoules :

Ampoules T he current use of ampoule is vary static. It was one of the first unit dose container. Some std. are exist for ampoule shapes & sizes with variations on the neck & method of opening (scoring & ceramic point) These are sterilized by dry heat or steam after filling. 20

Vials :

Vials These were popular in 1920s & 1930s when first used. These are parallel side containers with a flat or concave base with variety of neck finishes in various capacities. Injection vials are obtained in either neutral or soda glass & occasionally in treated soda glass. Rubber closure with aluminium overcap used for multidose container 21

Disposable syringes :

Disposable syringes Use of glass tube with an end cap seal & movable plunger is early used for unit dose injectable in dental trade. The next stage was to combine cartridge tube and syringe thus creating glass disposable syringe. These are also available with two compartments which allow unstable parts of the pharmaceutical formulation to be kept separate and mix immediately prior to use. 22

Aerosols :

Aerosols Use of glass offers mixed comments on risk involved. Glass offers greater flexibility in design than metal cans. Breakage risk can be avoided by adequate bottle strength plus an external coating of PVC Glass bottles cost more than metal cans but offer good appearance. The valves are set in an aluminum overseal . 23

Glass Defects:

Glass Defects Due to thermal shock or impact stress Can be grouped as: Critical- hazardous to the user Major- reduced usability of the container or its contents Minor- usability of container not affected Can be classified as: Checks Seams Non-glass inclusions Dirt, dope, adhering particles or oil marks Freaks and malformations Marks 24

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Future Potential:

26 Future Potential Glass is still serves the pharmaceutical & cosmetic industry effective, attractive packs. Besides breakage risk, glass would offer best protection, hygiene, inertness, zero permeation. Under conditions of material shortage, glass is the least likely to be affected and could enjoy further success. Very thin coating (organic & inorganic origins) on the glass to improve colour range and strength, shows greatest promise.

REFERENCES::

REFERENCES: Dean D.A, Evans E. R., Hall H Pharmaceutical packaging technology,1 st ed pg:210-65. Modern pharmaceutics Fourth edition Gilbert S Banker Pg:587. Indian pharmacopiea 2007, vol-1,pg:599-25. Leon Lachman, Liberman AH, Kanig JL. The theory of practice of Industrial pharmacy 4 th ed.pg:711-22.

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Thanks for your attention. Questions?