Glass as a packaging material in pharmaceutical packaging

transcript

GLASS AS A PACKAGING MATERIAL IN PHARMACEUTICAL PACKAGING Prepared by: Shweta Sambhaji ShelkeM. Pharm (Q. A.)

INTRODUCTION

The packaging can be defined as an economical means of providing presentation, protection, identification information, containment, convenience and compliance for a product during storage, carriage, display and until the product is consumed.

Glass is an amorphous solid material which is usually brittle and optically transparent.

Glass is a uniform material of arguable phase , produced when the viscous molten material cools rapidly to below its glass transition temperature, without sufficient time for a regular crystal lattice to form.

COMPOSITION OF GLASS Glass is composed of sand, soda ash, cullet,

silicon, aluminum, boron, potassium, zinc etc. Most glasses contain about 70-72% by

weight of silicon dioxide (SiO2)

ADVANTAGES OF GLASSES

They are transparent. They are available in various shapes and sizes. They can withstand the variation in temperature and

pressure during sterilization. They are economical and easily available. They can protect the photosensitive medicaments from

light during their storage. They are neutral after proper treatment. They are impermeable to atmospheric gases and moisture. They have good protection power. They do not deteriorate with age. They can be easily labelled. They can be sealed hermetically or by removable closures.

TYPES OF GLASSES Type4

Type 3

Type 1

TYPE 1 : BOROSILICATE GLASS .

COMPOSITION : Highly resistance glass, a substantial part of

the alkali and earth cations are replaced by boron and/or aluminum and zinc.

SiO-80%,Al2O3-95%,Na2O-7%,K2O-0.5%,B2O2-12%,CaO-1%

SUITABILITY: Parenteral usage ,Chemical glassware

container for alkali sensitive preparation.

PROPERTIES: Alkalinity is removed by using boric oxide to

neutralize the oxides of Potassium and sodium.

The addition of about 6% boron to form borosilicate glass reduces the leaching action, so that only 0.5 ppm is dissolved in a year.

Borosillicte glass melt at a higher temperature than ordinary Sillicate glass .

It has very low thermal expansion coefficeint ,about 1/3 rd of ordinary glass.

PROPERTIES CONTINUE…. This reduces material resistant to breaking .

This glass begin to soften at 821ºc More resistant to thermal shock than other

types of glass, borosillicate glass can still crack or shatter when subjected to the uneven temperature variation.

TYPE 2- TREATED SODA LIME GLASS INTRODUCTION: Type 2 is a soda glass which has a surface

treatment by sulphating or sulphuring forming a coating of sodium sulfate, which is neutralize by excessive surface alkalinity.

COMPOSITION : SiO-80%,Al2O3-95%,K2O-0.5%,B2O2-12%,CaO-1%

SUITABILITY: Parentral use, alkali sensitive preparations for

blood, plasma and infusion fluids.

PROPERTIES: Glasses are being given different treatments in

order to improve their surface lubricity, increasing impact resistance and aesthetic appearance

It has a very low coefficient of thermal expansion

Softer than borosilicate

Easy to mould

Cheaper than Borosillicate

TYPE 3:SODA LIME GLASS INTRODUCTION: Type 3 glass is a regular soda lime glass in which the

containers are untreated and have an average chemical resistance

COMPOSITION: SiO-75%, Al2O3-2%, K2O-0.5%, B2O2-3%, CaO-12%

SUITABILITY:• Only for non aqueous preparation • Not recommended for Parentral preparations until

and unless indicated• Not for alkali sensitive preparation

PROPERTIES OF TYPE 3 GLASS It is an alkaline glass having high per cent of

lime and soda and no boric oxide as compare to Type 1 glass

Moderate hydrolytic resistance ( Limited alkalinity)

Easy alkali to water flakes separated out loss of brilliance

Cheapest glass

TYPE 4:NON PARENTRAL (N. P.) GLASS

Lead free glass Coloured glass Silicone treated

COLORED GLASS INTRODUCTION: In addition to glass composition metal salts

carbon and sulphur or iron and mangnese for amber color

SUITABILITY/USE:• Used for light sensitive product • Do not use for parentral unless specified

PROPERTIES:• It does not allow the UV rays to pass through

LEAD FREE GLASS USE: • Used for liquid preparations • Used when preparation meant for lead

poisoning e.g. Na E.D.T.A

DISADVANTAGE:• As lead monoxide is used in manufacturing of

glass cause lead poisoning

SILICONE TREATED GLASS Its surface is treated with dimethyl siloxone As it is hydrophobic in nature not welled so

product do not cling to surface

GENERAL TESTS

Critical dimensions Capacity and height

Wall thicknessThermal shock testLimit of alkalinity

VerticalityAnnealing testVisual defects

Air bubble Bottle thickness

Neck thin

QUALITY CONTROL TESTS AS PER U. S. P.

Powder glass test

Water attack test

Hydrolytic resistance

POWDER GLASS TEST Preparation of specimen of powdered glass test.

Rinse 6 or more containers

Dry them

Divide 100gm of coarsely crushed glass into 3 equal parts

Place 1 portion in mortarCrush further by shrinking ¾ blows with hammer

Nest the sieves

Empty the mortar into 20#sieve

Crush into fragments

Continue preparation of specimen for powder glass test

Shake the sieve & then remove the glass from 20 & 40#

Crush & sieve again as above

Transfer the retained portion on 50#, which should weigh excess of 10gm

Spread the specimen on glazed paper & remove iron particle with help of a magnet

Wash with six 30ml portions of acetone & decant acetone

Dry the contents for 20 min at 140ºC

Transfer to weighing bottle and cool in desiccators

Final specimen to be used in powdered glass test

POWDER GLASS TEST (AS PER U. S. P.)

Transfer 10.0g of prepared specimen in 250ml conical flask digested previously with high purity water in bath at 90ºC Add to conical flask containing 50ml of high purity water

Cap all the flask

Autoclave (continue heating for 10min )

Close vent cock

Adjust temp to121ºC

Hold the temp (121ºC ±221ºC for 30min)

Powder glass test continue….Reduce the heat & wait for autoclave to cool

Cool the flask in running water

Decant water Wash the residual glass (4 times with 15ml high purity

water)Add the decanted washing to main portion

Add 5 drops of methyl red solution

Titrate immediately with 0.02N sulphuric acid

Record the volume of 0.02N sulphuric acid

Volume doesn’t exceed the limit

WATER ATTACK TEST AT 121ºC The water attack test at 121ºC is performed

on intact containers The containers are filled up to 90% of their

overflow capacity Containers are autoclaved for 60 min Then content of container are cooled & from

cooled content 100ml of the solution is titrate as in case of powdered glass test

WATER ATTACK TEST…Rinse 3 or more containers with high purity water

Fill each container to 90%of its overflow capacity

Cap all the flasks, autoclave for 60 min

Empty the contents & cool the contents in 250ml conical flask to a volume of 100ml

Add five drops of methyl red solution

Record the volume consumed

Titrate with 0.02N Sulphuric acid while warm

Volume should not exceed limits

TYPES OF GLASS & THEIR LIMITS Types

of glass

General description of

Types of test

Limits size ml

Limits (ml of 0.20N)

1 Highly resistant borosilicate glass

Powdered glass

All 1.0

2 Treated soda lime glass

Water attack

100 or less

Over 100 0.2

3 Soda –lime glass Powdered glass

All 8.5

4 General –purpose soda lime glass

Powdered glass

All 15.0

HYDROLYTIC RESISTANCE This test is done for detecting the type of

glass Type of container Test to be done

Type 1 & type 2 glass containers to distinguish from type 3 glass containers

Test 1 (surface test)

Type 1 & type 2 glass containers where it is necessary to determine whether the high hydrolytic resistance is due to the chemical composition or the surface treatment

Test 1 & 2

HYDROLYTIC RESISTANCE TEST Test 1 -Surface glass test

Wash containers with carbon dioxide free water

Fill the containers with CO2 free water (90%)

Close with aluminum foil

Autoclave at 100º-120ºC for 20 min

Maintain at 120ºC for 1 hr

At lower temp for 40 min

Remove containers & cool

HYDROLYTIC RESISTANCE TEST (TEST 1)CONT…

Titrate it within 1 hour

Titrate with 0.01 M HCL (end point colourless)

Repeat with same volume of CO2 free water

VOLUME OF TEST SOLUTION TO BE USED

Sr. no.

Nominal capacity of

container (ml)

No. of containers to

be used

Volume of test solution to be

used (ml)

1 Up to 3 At least 20 25.0

2 5 or less At least 50.0

3 6 to 30 At least 50.0

4 More than 30 At least 100.0

VOLUME OF 0.01M HCL REQUIRED BY TEST SOLUTION

Capacity of container (corresponding to 90% avg over

flow volume ml)

Volume of 0.01M HCl for 100 ml of test solution Type 1 or 2 glass (ml)

Type 3 glass (ml)

Not more than 1 2.0 20.0More than 1 but not more than 2 1.8 17.6More than 2 but not more than 5 1.3 13.2More than 5 but not more than 10 1.0 10.2More than 10 but not more than 20 0.80 8.1More than 20 but not more than 50 0.60 6.1More than 50 but not more than 100

0.50 4.8

More than 100 but not more than 200

0.40 3.8

More than 200 but not more than 500

0.30 2.9

More than 500 0.20 2.2

HYDROLYTIC RESISTANCE TEST Test 2Rinse container twice with water and with 4%volume

solution of HF

Allow to stand for 10min

Empty the container

Rinse 5 times with water

Carry out test similar test 1

ARSENIC TEST Inner & outer surfaces are washed 5 times with freshly

prepared distilled water

Prepare 50ml using adequate number of test solution

Pipette out 10 ml of test solution from combined content of ampoule into flask

Add 10ml of HNO3

Evaporate to dryness on water-bath

Add the residue in an oven @ 130 C for 30 min

ARSENIC TEST CONTINUE…Cool ,add to hydrazine molybdate reagent to dissolve

Heat under reflux on water bath for 20 min

Cool to room temperature

Determine the absorbance of resulting solution at maximum of about 840 nm using hydrazine molybdate

reagent as a blank

Limit :0.1ml of arsenic std

DEFECTS Care should be taken to avoid unwanted

defects in packaging. It includes cracked /chipped bottle , fracture

in body, missing liner in closures ,stones or air bubbles in glass bottle ,small dents or scratches ,etc.

These are categories as follows: Class A –Critical defects Class B – Major defects Class C – Minor defects

DEFECTS IN GLASS CONTAINER Sr.no. Critical defects Major defects Minor defects1 These defects

which prevent container or package from protecting the contents are referred as critical defects .

These defects have bottle like dysfunction .it reduces the identity by virtue of graphic defects .

These defects that damage the appearance but not the function of package are called minor defects

2 Examples--Cracks & penetrating checks -Light side walls broken /chip finish contaminations with insects

Examples- - Nonfunctioning stretching bead liner in excess of 1/8 inch on each side

Examples--Stones & heavy appearance followed by rough molding lines & uneven outer surface

3 Acceptance criteria is subjective matter.

Acceptance criteria has demerits of 3 points

Acceptance criteria has demerits of 2 points

CONCLUSION: A number of glass containers used in

pharmaceutical industry include ampoules, bottles, vials, etc.

Due to their advantages glass has served the pharmaceutical industry as one of the good packaging material for pharmaceutical preparations.

REFERENCES: Phrmaceutical packaging handbook, Edward

Baur ,page no 189-198

USP 36,Physical tests /<663> containers Glass -1

International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701, Vol. 4 (4) Oct – Dec 2013

REFERENCES … Lachaman and Libermann, Theory and practice of

Industrial pharmacy, Verghese pub.723-731

Lockhart H and Paine FA. Packaging of pharmaceuticals and healthcare Products, Blackie Academic and Professional pub. P-1, 98-99

“Selection and Evaluation of Pharmaceutical Packaging Materials, Containers and Closures”by Hemant Rathod, Natasha Sharma.

THANK YOU

Glass as a packaging material in pharmaceutical packaging

Health & Medicine