Glass as a packaging material in pharmaceutical packaging

This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.

1. Glass as a packaging material in pharmaceutical packaging Prepared by: Shweta Sambhaji Shelke M. Pharm (Q . A.) 1

2. 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. 2

3. 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 (SiO 2 ) 3

4. 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. 4

5. Types of Glasses 5

6. 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%,Al 2 O3-95%,Na2O-7%,K 2 O-0.5%,B 2 O 2 -12%,CaO-1% SUITABILITY: Parenteral usage ,Chemical glassware container for alkali sensitive preparation. 6

7. 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. 7

8. 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. 8

9. 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 %,Al 2 O3-95%,K 2 O-0.5%,B 2 O 2 -12%,CaO-1% SUITABILITY: Parentral use, alkali sensitive preparations for blood, plasma and infusion fluids. 9

10. 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 10

11. 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%, Al 2 O 3 -2%, K 2 O-0.5%, B 2 O 2 -3%, CaO-12 % SUITABILITY: Only for non aqueous preparation Not recommended for Parentral preparations until and unless indicated Not for alkali sensitive preparation 11

12. 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 12

13. Type 4:Non parentral ( n . p.) glass 13

14. 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 it 14

15. 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 15

16. 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 16

17. General tests 17

18. Quality control tests as per u . s. p. 18

19. 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 mortar Crush further by shrinking ¾ blows with hammer Nest the sieves Empty the mortar into 20#sieve Crush into fragments 19

20. 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 20

21. 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 ±2 21 ºC for 30min) 21

22. 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 22

23. 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 c ooled & from cooled content 100ml of the solution is titrate as in case of powdered glass test 23

24. 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 24

25. Types of glass & their limits Types of glass General description of glass 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 0.7 Over 100 0.2 3 Soda –lime glass Powdered glass All 8.5 4 General –purpose soda lime glass Powdered glass All 15.0 25

26. 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 26

27. Hydrolytic resistance test Test 1 -Surface glass test Wash containers with carbon dioxide free water Fill the containers with CO 2 free water ( 90%) Close with aluminum foil Autoclave at 100º-120ºC for 20 min Maintain at 120º C for 1 hr At lower temp for 40 min Remove containers & cool 27

28. 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 CO 2 free water 28

29. 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 29

30. 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 20.0 More than 1 but not more than 2 1.8 17.6 More than 2 but not more than 5 1.3 13.2 More than 5 but not more than 10 1.0 10.2 More than 10 but not more than 20 0.80 8.1 More than 20 but not more than 50 0.60 6.1 More 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 30

31. Hydrolytic resistance test Test 2 31

32. Arsenic test 32

33. Arsenic test continue… 33

34. 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 34

35. Defects in glass container Sr.no . Critical defects Major defects Minor defects 1 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 35

36. Conclusion: A number of glass containers u sed 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. 36

37. 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 37

38. 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. 38

39. Thank you 39