Glass Containers for Pharmaceutical Packaging

A. A. Joshi.

GLASS AS A PACKAGING MEDIA

GLASS BOTTLE - CONTAINER OF CHOICE FOR PACKAGING. IMPERVIOUS TO MOISTURE & GASES. INERT. PROVIDES GOOD PROTECTION.

GLASS CONTAINERS
RAW MATERIALS
TYPE I FLINT SAND ALUMINA SODIUM OXIDE BORIC OXIDE CALCIUM OXIDE 68% 5.5 10 10 1 AMBER 65% 6 9.5 10 0.5 TYPE III FLINT AMBER 72.5% 2 14 0.5 11.5

Glass container making

15-30% cullets- broken glass are added which helps in melting the glass in the furnace. Colorless glass is obtained by using decolorizers like selenium or cobalt oxide. Reducing Iron content to below 0.3% can limit green tinge to acceptable level. Amber colour glass is obtained by adding iron & manganese oxide.

Glass container making process

Glass container making has 4 stages 1. Glass gathering 2. Parison Forming 3. Transfer 4. Blowing

DEFECTS IN GLASS BOTTLES

BOTTLE MANUFACTURING INVOLVES HIGH TEMPERATURE - 1400 C. BOTTLES COMING OUT OF MOULD AT HIGH TEMPERATURE ARE EXPOSED TO ROOM TEMPERATURE AND ARE THUS SUBJECTED TO THERMAL SHOCK, SETTING STRESSES WITHIN ITS BODY.

Annealing to release stresses

Glass containers receive a thermal shock as it comes out of the mould & placed on a conveyor which is at room temperature, as inner side is hot while outer side is exposed to room temp. To release the stresses built in the container body, it is passed though a tunnel called Annealing lehr which gradually reduces the temp. from about 550 C at the beginning of the tunnel to near room temp. at the other end of the long tunnel.

Glass container defects

Mould Design- cavity wears out due to fluctuation in Temperatures bet 450-600 C as red hot glass drops in to the mould which is at near room temp. & then parison is transferred to another mould for blowing This results in bottle capacity variation & other defects

 GLASS IS ONLY AS STRONG AS ITS SURFACE. SCRATCHING, BRUISING CAUSE SIGNIFICANT REDUCTION IN THE STRENGTH OF CONTAINER. BREAKAGE IS REDUCED TO LESS THAN 1% BY SHRINK PACKAGING FROM OVER 2% WITH CFB PACKAGING IN ONE CO.

COATNGS ON GLASS BOTTLES

COLD END / HOT END COATINGS TO IMPROVE DURABILITY.

 Glass is preferred as packing material in pharmaceutical industry mainly because:

Importance of Glass

1. Glass is chemically inert and this property enables us to pack the products without any risk of reaction or spoilage. 2. Compatible with majority products. 3. Not allow gases, moisture and other odour to penetrate through its walls.

Importance of Glass ...cont

4.Transparent nature allows visual inspection of filled products. 5. Can be made in any shape and size as desired. 6.The basic raw materials for making glass are silica sand, soda ash and lime, which are readily available in India as a natural source. So procurement of materials is not a problem.

Importance of Glass..

cont

7. It is ideal for running on high speed automatic packing lines. 8. It can be made pilfer proof by using cap seals.

9. 100% Recycling is possible hence environment friendly.

Types of Glass Containers

All bottles used in liquid packing are normally of soda lime glass of USP Type III. However, if high resistance glass is required for the product, for example, injectables and transfusions, Borosilicate USP Type I glass is being used. USP Type II is same as the Type III but inside of the glass is coated, which reduces the alkalinity level.

TYPE OF CONTAINERS

I - NEUTRAL / BOROSILICATE
II - INNER SURFACE COATED III - LIMITED ALKALINITY

Type II Surface coated glass

Glass bottles type III are treated in Annealing lehr by adding Amonium sulphate tablet in each bottle or injecting sulpher dioxide. By this treatment excess surface alkalinity is neutralized.

Glass container selection for a pharmaceutical product will depend mainly on the product properties and container availability. The product properties to be taken into account will be such as 1) Nature of product

Selection of a Container

i.e. acidic /neutral /alkaline.

Selection of a Container...cont
2)Frothing, effervescent, releasing gases on storage, requiring inert atmosphere.

Selection of a Container..cont
3) The processes the container will undergo such as washing sterilization, hot or cold filling, method of sealing & type of closure.

Selection of a Container...cont
3) Frothing, effervescent, releasing gases on storage, requiring inert atmosphere. 4) Physical properties such as specific gravity, density. 5) Light and heat sensitive ingredients.
6) Shelf life - After filling, storage, exposure to heat, cold, moisture, and light exposure.

Selection of a Container..cont
7) The processes the container will undergo such as washing sterilization, hot or cold filling, method of sealing & type of closure. 8) Container size and shape, design, narrow mouth OR wide mouth, Tall OR short in height.

Selection of a Container..cont
9) Colour - Amber or Flint. 10) Chemical Durability. 11) Types of machinery used for washing, filling, sealing labeling etc.

PACKAGING OF LIQUIDS.
PACKAGING MACHINES 1) PRODUCT FILLING. 2) CONTAINER CLOSING / SEALING. 3) CONTAINER LABELLING. 4) OVERPRINTING / CODING. CARTONING / SHRINK PACKAGING. PACKAGING IN SHIPPER (CASE PACKER.)

The products such as expectorant, cough formulas, drops and such other products have been filled into conventional type of bottles but with varying capacity. These types of containers are mainly in 22 mm and 25 mm pp (pilfer proof) neck.

Standard Containers

Standard Containers ..cont

In selection of these packs the quantum of off take is another factor. In large volume products selection of a simple type of bottle help in packing of the product. This type of bottles can be filled, sealed and labeled with machinery readily available

The different size and shape containers are selected mainly for the products, which an organization wants to be identified in the market place OR a brand image needs to be established. These are either a unique type or fancy shape containers that attract the consumer. These types of products fall under the category of multi vitamins, tonics, food supplements and nutraceuticals. e.g. Santivani of Novartis, RB tone of Medley etc.

Non standard containers

Various Parts of Container

Bore Finish Neck Bead or Collar

Finish:- This is the top of the container above the neck Shoulder ring parting line . It includes : Sealing surface, Bore, Bead or collar. The sealing device is in the finish, also the bore or mouth for filling and emptying. The bead or collar s used to assist o transferring the parison into the blow mold. Neck:- The part which extends from the parting line Contact point to the curve at the base of the neck.
In Sweep Push Up extends from the base of the neck Shoulder:- This

to the straight part of the body. Bottom

Heel

Body:- The main part of the container which holds the product.

GLASS BOTTLE SHAPE.

SHAPE OF THE BOTTLE AFFECTS BOTTLE PERFORMANCE. 1) LONG NECK BOTTLES ARE DIFFICULT TO FILL. 2) TALL BOTTLES ARE UNSTABLE ON HIGH SPEED MACHINE. 3) CYLENDRICAL BOTTLES ARE STRONGER & GOOD FOR STACKING.

BOTTLE DIMENSIONS.
IMPORTANT DIMENSIONS ARE 1) BODY DIAMETER. 2) NECK DIMENSIONS. 3) HEIGHT. BOTTLE CAPACITY.

TOLERENCES IN GLASS BOTTLE.

TOTAL HEIGHT - +/- O.6 = 1.0 MM. DIAMETER - +/- 0.5 = 1.0 MM. VERTICALITY - 0.3 + 0.01 HEIGHT. CAPACITY - +/- 5 ML FOR 500ML & ABOVE.

10% REJECTION IN BOTTLE MFG. IS NORMAL.

Siliconised vials
To prevent powders sticking to the side walls, vials are silicon coated & dried in the oven.

COLOURED BOTTLES.
COLOUR OF BOTTLE INFLUENCE PRODUCT PROTECTION. 1) TRANSPERENT ARE GOOD FOR EASY INSPECTION. 2) AMBER COLOUR FILTERS CERTAIN LIGHT RADIATIONS & HELPS PREVENT PRODUCT DEGRADATION.

PRINTED GLASS BOTTLES

IT IS POSSIBLE TO PRINT GLASS CONTAINERS WITH CERAMIC INKS . THIS MAY REDUCE THE LABELLING OPERATION AND ITS COST. PRINTING OF MULTICOLOUR GRAPHICS IS ALSO POSSIBLE.

IMPORTANT TESTS
The glass bottles manufacturer and user pharmaceutical organization normally have a common understanding about the Accepted Quality Levels (AQL). The defects are categorized as Critical, Major and Minor.

AVERAGE QUALITY LEVEL (AQL)

CRITICLE DEFECTS - CONTAMINTES PRODUCT WITH LOSE GLASS PARTICLES - 0.4%. MAJOR DEFECTS - WHICH CAUSE LOSS OF PRODUCTION - 0.6 TO 1 % . MINOR DEFECTS - NO FUNCTIONAL PROBLEM BUT POOR APPEARANCE - 4%.

IMPORTANT TESTS
1. Critical dimensions (height, diameter, neck finish etc.) 2. Capacity and weight. 3. Wall thickness. 4. Thermal shock test 5. Limit of alkalinity. 6. Verticality test. 7. Annealing test. 8. Visual defects.

TESTS FOR GLASS

ANNEALING RELEASES THE STRAIN IN GLASS. 1) ANNEALING TEST - TESTED BY PASSING POLARISED LIGHT THROUGH GLASS AND VIEWING THROUGH POLARISCOPE - SHOULD NOT SHOW PLAY OF COLOURS - STANDARD DISC NO.1 TO 5 USED. OPTICAL GLASS TO PASS WITH DISC NO.1.

 FOR COMMERCIAL GLASS - DISC NO.3 PASSING IS OK. 2) RING SECTION ANALYSIS IS DONE TO TEST HOMOGENITY OF GLASS DONE BY CUTTING 1 CM HIGH RING FROM THE CONTAINER AND VIEWING THROUGH MICRO POLARISCOPE.

3) THERMAL SHOCK TEST -

FOR TESTING, HOT AND COLD WATER IS USED.

FOR TYPE I, THERMAL SHOCK OF 60OC. IS GIVEN. FOR OTHER TYPES, THERMAL SHOCK OF 45OC IS GIVEN.

 THIN WALLED CONTAINERS HAVE BETTER RESISTANCE . BOROSILICATE GLASS HAS BETTER THERMAL SHOCK RESISTANCE THAN SODA GLASS. 4) PRESSURE TEST DONE FOR BOTTLES USED FOR LIQUOR, SODA WATER, ETC.

 PRESSURE IS APPLIED IN THE CONTAINER FOR 1 MINUTE. AT HIGHER TEMPERATURE PRESSURE RESISTANCE IS REDUCED i.e. PR. REST. AT 30OC > PR 60OC.

5) IMPACT TEST -

FOR CONTAINER UNDERGOING MULTIPLE HANDLING e.g. MILK & BEVERAGE BOTTLES.
STEEL BALL OF 400 GMS IS DROPPED FROM THE HEIGHT OF 10 CMS. FOR MILK BOTTLE, THE BALL IS DROPPED 3 TIMES ON THE SAME SPOT AND BOTTLE SHOULD NOT BREAK.

6) DENSITY TEST USES MIXT. OF MONOCHLOROBENZENE AND XYLENE OF 2.5 DENSITY. TEST AND CONTROL (REFERENCE) SAMPLES ARE DROPPED IN THE TEST TUBE WITH THE MIXT. AND HEATED IN A WATER BATH. BOTH THE PIECES TO SINK SIMULTANEOUSLY.

7)Alkalinity- Type of Glass-USP

By titrating extracts of distilled water with N/50, H2SO4 Type I 1ml Type II 0.2 ml for up to 100 ml bottle Type III 8.5 ml Type IV 15 ml

REDUCED BREAKAGE OF GLASS CONTAINERS

THE GLASS INDUSTRY IS INCREASINGLY ADOPTING SHRINK/STRETCH WRAPPING TECHNIQUES FOR PACKAGING OF EMPTY GLASS VIALS/BOTTLES. THIS HELPS IN REDUCED BREAKAGES IN TRANSIT AND ALSO AVOIDS CONTAMINATION DURING STORAGE.

CLEAN GLASS CONTAINERS

EARLIER OWING TO CONTAMINATION DURING STORAGE AND TRANSPORTATION, GLASS BOTTLE USERS WERE REQUIRED TO WASH THE BOTTLES BEFORE USE. OWING TO IMPROVED HOUSE-KEEPING AND (SHRINK) PACKAGING, THE USER INDUSTRY CAN USE BOTTLES FOR PRODUCT FILLING DIRECTLY.

LIGHT WEIGHT GLASS CONTAINERS

LIGHT WEIGHT GLASS -- WITH IMPROVEMENT IN GLASS CONTAINER TECHNOLOGY, UNIFORM DISTRIBUTION OF GLASS IN THE CONTAINER IS POSSIBLE.

THIS HAS RESULTED IN REDUCING THE WEIGHT OF THE GLASS BOTTLES WITHOUT SACRIFICING THE STRENGTH.

COST SAVING
REDUCE NECK SIZE - PARTICULARLY FOR LIQUID PRODUCTS, IT IS SUGGESTED TO REDUCE THE NECK SIZE FROM 25 MM OR MORE TO SAY 22 MM. THOUGH THIS DOES NOT REDUCE THE COST OF BOTTLE, IT HELPS IN REDUCING THE SIZE OF CAP AND MEASURING CUP ETC. WHICH MAY RESULT IN COST SAVING.

BOTTLE CLOSURE.
1) METAL CAP -ALUMINIUM / TINPLATE( FOR PILFER-PROOOFING). 2)WADING - CORK / EXPANDED POLYETHYLENE.(FOR GOOD SEALING). 3) LINERS - LDPE / PVC. ( PREVENT CONTAMINATION FROM WADDING).

CHILD RESISTANT CLOSURES

FOR SOME PRODUCTS, IT IS DESIRABLE TO HAVE A CHILD RESISTANT CLOSURE.
IN SOME COUNTRIES IT IS MANDATORY FOR SOME OF THE SCHEDULED DRUGS.

SENIOR CITIZEN FRIENDLY CLOSURES

THERE IS A TREND TO USE CLOSURES WHICH ARE RELATIVELY SIMPLE & EASY TO OPEN PARTICULARLY FOR PRODUCTS MEANT FOR SENIOR CITIZENS.

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Thank You.

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Thank You.