quality control test for containers, closures and secondary packing materials.pptx

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1. Quality control test for containers, closure and secondary packaging materials Vani.ch Vani.CH I/II M PHARM Y17MPH0554

2. Introduction: What is packag ? It is art and science of preparing articles for transport, storage, display and use. The selection of a package therefore begins with a determination of the product’s physical and chemical characteristics, its protective needs, and its marketing requirements. 2

3. Objectives of packaging Marketing potential and presentation of packaging. Identification , information, protection. Preserves integrity of product. Convenience, compliance and containment during storage. Brand identity. 3

4. Selection of type of pack depends upon its : Content stability Content reactivity with packaging material(drug compatibility). Accessibility of pack to user. Packaging process. Regularity ,legal, quality issues. 4

5. TYPES OF PACKAGING : Primary packaging is the material that envelopes 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. Primary packaging : 5

6. Secondary packaging Is outside the primary packaging-perhaps used to group primary packages together. 6

7. Tertiary packages: I s used for bulk handling, warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into the container. 7

8. Containers and closures Types of containers 8

9. CLOSURE: A closure is the part of the package which prevent the contents from escaping and allow no substance to enter the container. Closures are available in five basic designs Screw on, threaded or lug Crimp on(crowns) Press on(snap) Roll on and Friction 9

10. CLOSURE LINERS: A liner may be defined as any material that inserted in a cap to effect a seal between the closure and the container. It is of two types: Homogeneous liners These are one piece liners available as disk or a ring of rubber or plastic. It can be withstand high temperature sterilization. Heterogeneous liners These are composed of layers of different materials chosen for specific requirements. It consists of facing and backing. Facing is in contact with product and backing provides questioning effect. 10

11. Unit dose packaging 11

12. Types of unit dose packaging 12

13. Packaging materials: Glass. Plastics. Metals. Paper and paper board. 13

14. MATERIALS USED FOR MAKING OF CONTAINERS : GLASS- e.g.bottles,vials,ampules,syringes,i.v containers, aerosol containers. PLASTIC- e.g.bottlespouches,tapes,tubes,aerosolcontainers,laminates. 14

15. RUBBER - e.g. closures, caps,vialswrapers,plungers. Metals - e.g . collapsabletubes,foils,needles,aerosol containers 15

16. Paper or cardboard : e.g . secondary packaging labels,inserts,displayunits,pouches,laminates,cartons,carrogated boxes,foils,paper drums 16

17. Composition of glass: Glass is composed principally of sand, soda ash, lime stone and cullet. Sand is almost pure sillica,soda ash is sodium carbonate, lime stone is calcium carbonate. Cullet is broken glass that is mixed with the batch and acts as fusion agent for the entire mixture. GLASS CONTAINERS: 17

18. TYPES OF GLASS Type I—Highly resistant borosilicate glass. Type II—Treated soda lime glass. Type III—soda lime glass. NP—soda glass (non parenteral usage). 18

19. Glass used in Laboratory vails Colored Glass 19

20. E VALUATI ON OF PACKAGING MATERIALS TESTS FOR GLASS CONTAINERS: 1) Powdered glass test 2) Water attack test Preparation of specimen for powdered glass test: Rinse 6 or more containers and dry them Crushed in to fragments Divide 100gms of coarsely crushed glass in to three equal parts 20

21. place 1 portion in a mortar Crush further by striking 3 or 4 blows with hammer Nest the sieves (# 20,40 at least) Empty the mortar in to sieve 20 Shake the sieves and remove the glass particles from # 20 and 40 Crush them again and sieve them Transfer the retained portion on # 50 21

22. Spread the specimen on a glazed paper and remove iron particles with the help of magnet Wash with 6 portions of 30ml acetone Dry the contents for 20mins at 140 o c Transfer to weighing bottle and cool in a desiccator . Final specimen should be used in powdered glass test 22

23. POWDERED GL ASS TEST: ( according to USP volume 27) Transfer 10gms of prepared specimen in a 250ml conical flask digested previously with high purity water in a bath at 90 o c Add to conical flask containing 50ml high purity water Cap all the flasks and auto clave Adjust temperature to 150 o c Cold the temperature to 121 o c for 30mins Cool the flasks under running wate r 23

24. Wash the residue powdered glass(4 times with 15ml purity water) Add the decanted washings to main portion. add five drops of methyl red solution. Titrate immediately with 0.02N sulphuric acid. Record the volume of 0.02N sulphuric acid. Volume does not exceed i.e. indicated in the USP as per the type of glass concerned 24

25. 2). WATER ATTACK TEST :(USP) rinse 3 or more containers with high purity water fill each container to 90%of its over flow capacity cap all the flasks and autoclave for 60mints empty the contents and cool the contents in 250ml conical flasks to a volume of 100ml.add 5 drops of methyl red solution titrate with 0.02N sulphuric acid while warm record the volume of 0.02Nsulphuric acid consumed volume should not exceed as indicated in USP as for type of glass 25

26. PLASTIC CONTAINERS: Plastics are synthetic polymers of high molecular weight. Plastics as packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality and the freedom to design. Plastic containers are extremely resistant to breakage and offer safety consumers. Two types of plastic are available in market. 26

27. Thermoplastic type : - On heating, they are soften to viscous fluid which hardens again on cooling. e.g. polyethylene ,PVC ,Polystyrene, polypropylene, Polyamide, Polycarbonate. Thermosetting type :- When heated , they may become flexible but they do not become liquid. Phenol formaldehyde ,urea formaldehyde, melamine formaldehyde TYPES OF PLASTICS: 27

28. DRUG-PLASTIC CONSIDERATIONS A packaging system must protect the drug without altering the composition of the product until the last dose is removed. Drug-plastic considerations have been divided into five categories: Permeation Leaching Sorption Chemical reaction Alteration 28

29. TESTS FOR PLASTIC CONTAINERS 1.Leakage test for plastic containers (non injectables and injectables 1996 IP): fill 10 plastic containers with water and fit the closure keep them inverted at room temperature for 24 hrs no sign of leakage should be there from any containe r 29

30. 2.WATER PERMEABILITY TEST FOR PLASTIC CONTAINERS(INJECTABLE PREPARATIONS IP 1996): fill 5 containers with nominal volume of water and sealed weigh each container allow to stand for 14 days at relative humidity of 60% at 20-250C reweigh the container loss of weight in each container should not be more than 0.2% 30

31. COLLAPSIBLE TUBES Metals: The collapsible metal tube is an attractive container that permits controlled amounts to be dispensed easily, with good reclosure,and adequate protection of the product. It is light in weight and unbreakable and lends itself to high speed automatic filling operations. Any ductile metal that can be worked cold is suitable for collapsible tubes, but the most commonly used are tin, aluminium and lead. Tin is most expensive and lead is cheapest. 31

32. RUBBER: Rubber is used mainly for the construction of closure meant for vials, transfusion fluid bottles, dropping bottles and as washers in many other types of product. BUTYL RUBBER: Advantages: Permeability to water vapor . Water absorption is very low. They are relatively cheaper compared to other synthetic rubbers. Disadvantages: Slow decomposition takes place above 130 C. Oil and solvent resistance is not very good. 32

33. NITRILE RUBBER: Advantages : Oil resistant due to polar nitrile group. Heat resistant. Disadvantages: Absorption of bactericide and leaching of extractives are considerable. CHLOROPRENE RUBBERS : Advantages: Oil resistant. heat stability is good. 33

34. SILICON RUBBERS : Advantages: Heat resistance. Extremely low absorption and permeability of water. Excellent aging characteristic. Disadvantages: They are very expensive. 34

35. TESTS FOR RUBBER/RUBBER CLOSURES 1.FRAGMENTATION TEST(IP 1996): place a volume of water corresponding to nominal volume-4ml in each of 12 clean vials close vial with closure and secure caps for 16hrs pierce the closure with number 21 hypodermic needle(bevel angle of 10 to 140c)and inject 1ml water and remove 1ml air repeat the above operation 4 times for each closure count the number of fragments visible to naked eye Total number of fragments should not be more than 10 35

36. 2.SELF SEALABILITY TEST FOR RUBBER CLOSURES APPLICABLE TO MULTI DOSE CONTAINERS ONLY(IP 1996): fill 10 vials with water to nominal volume and close the vials with closures pierce the cap and closures 10 times at different places with no 21 syringe needle immerse the vials in 0.1 %W/v solution of methylene blue under reduced pressure restore the nominal pressure and keep the container for 30 min and wash the vials none of the vial should contain traces of colored solution 36

37. TAMPER RESISTANT PACKAGING: The requirement for tamper resistant packaging is now one of the major considerations in the development of packaging for pharmaceutical products. Tamper resistant package is one having an indicator to entry in which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. 37

38. FDA approves the following configurations as tamper resistant packaging: Film wrappers Blister package Strip package Bubble pack Shrink seals and bands FOil , paper, plastic pouches Bottle seals Tape seals Breakable caps Aerosol containers 38

39. FDA REGULATIONS When the FDA evaluates a drug, the agency must be firmly convinced that the package for a specific drug will preserve the drug’s efficacy as well as its purity, identity, strength and quality for its entire shelf life . The FDA does not approve containers as such, but only the materials used in the container . A list of substances considered ``Generally Recognised As Safe’’ (GRAS) has been published by the FDA. 39

40. FDA Regulations for Tablets and Capsules Description: Overall general description of container closure system, plus: For Each Packaging Component: Name, product code, manufacturer. Materials of construction. Description of any addition treatments. Suitability: Protection : Light exposure . Moisture permeation. Seal integrity or leak tests for unit-dose packaging.    Safety : (for each material of construction, as appropriate) Chemical composition of all plastics, elastomers, adhesives, etc. For tablets, capsules, and powders, appropriate reference to the indirect food additive regulation may be submitted. For rayon and cotton fillers, data from USP monographs. For non-USP materials, data acceptance criteria should be provided. For desiccants and other absorbent materials: the size and shape should differ from that of the dosage form. 40

41. FDA Regulations for ointments and aerosols Description : Same as for tablets and capsules. Suitability : Protection : Light exposure Reactive gases(e.g., oxygen) Solvent loss Moisture permeation Microbial contamination Seal integrity or leak testing of tubes and unit dose containers . Safety: (for each material of composition, as appropriate) Chemical composition of all plastics, elastomers, adhesives, etc. For topical drug products (plastic coatings for metal tubes), and plastic drug delivery system components: USP Containers testing. For topical delivery systems: appropriate reference to indirect food additive regulations . 41

42. CONCLUSION :  Packaging is one of the most important part of pharmaceutical industries . Quality maintenance is major role played by packaging material. Along with that it gives pharmaceutical elegance and convenience to user to product. Many a times the packaging is may become a ideal unique identification for some of brand in market. Quality control of such important part is also a vary valuable work . 42

43. References: Leon Lachman , Herbert A. Liberman , The Theory & Practice Of Industrial Pharmacy. Pg. 711-732 Dean DA, Evans ER, Hall H. Pharmaceutical packaging technology Pg:210-65. Remington. The Science and Practice of Pharmacy, Vol-1;Pg:1047-10 . Howard C. Ansell Loyd V. Allen, Pharmaceutical dosage forms, Pg. 67-91. N.k. Jain Pharmaceutical product development pg no 341-378 Cooper and Gunn’s –dispensing for pharmaceutical students pg no13-22 Michael E. Aulton the design and manufacturing of medicines no 626-639 Copper and Gunn's tutorial pharmacy Materials of plant pharmaceutical plant construction .Pg no R.M.MEHTA Packaging materials Pharmaceutics-I Pg no Indian Pharmacopiea,2007,Vol-1;Pg:599-25  Encyclopedia of Packaging Technology", http://www.pharmaceutical-technology.com. 43

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