Container and closure .pptx

Hammad md Athar
MET iop , M pharm

1. M. Pharm Sem- I I Presentations QUALITY CONTROL TEST FOR PACKAGING MATERIALS , FLEXIBLE PACKAGING & EVULATION OF PHARMACUTICAL PACAKGING MATERIALS SUBMITTED TO SAVITRIB AI PHULE, PUNE UNIVERSITY , PUNE FOR PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF MASTER OF PHARMACY IN THE SUBJECT P harmaceutical M anufacturing Technology IN THE FACULTY OF SCIENCE AND TECHNOLOGY Bhujbal Knowledge City, MET’s Institute of Pharmacy, Adgaon, Nashik, 422003. Maharashtra, India Academic Year-2021-2022 Presented By- Hammad Md Athar Guided By-Mrs. Dr S.P Ahirrao mam 1

2. Quality control tests for: 1.Containers Glass container Plastic container Metal container Rubber 2.Closures Rubber closure Plastic closure Metal closure 3.Secondary Packaging Materials Paper Carton/carboards 2

3. QC Test For Glass Containers 3 1.Chemical Resistance Test: USP and IP provide two tests to determine chemical resistance of glass containers. 1)Powdered glass test 2)Water attack test 2.Hydrolytic Resistance Test 3.Arsenic Test Thermal Shock Test Internal Bursting Pressure Test

4. 1)Powdered glass test When the glass is powdered the leaching of alkali can be enhanced in the powdered is critical. The principle involved in the powdered glass test in estimate the amount of alkali leached form the glass powder. The amount of acid that is necessary to neutralize the released alkali. It is for type TYPE I,TYPE III and TYPE IV glasses,while water attack test is for TYPE II glass only. Prepare glass sample,wash it,10 gm sample +50 ml purified water.Autoclave it at 121°C Cool it and decant in another flask and 15 ml water and decant it again Titrate decant solution with 0.02 N sulphuric acid using methyl red ass indicator, volume of titrant used is recorded.

5. 2)Water attack test Rinse container thoroughly with water,fill it by 90% with water Autoclave it at 121°C for 30 min then cool it and decant. Water attack test is for TYPE II glass only. The principle involved in the water attack test is to determine whether the alkali leached form the surface of a container is within the specified limits or not. Decanted liquid is titrated with 0.02 N sulphuric acid using methyl red as indicator and volume of titrant used is recorded. 5

6. Tests Containers Limits ml of 0.02 N H2SO4 1. Powdered Glass Test Type I Type III Type NP 1.0 8.5 15.0 2. Water Attack Test type II (100ml of less) type II (over 100ml) 0.7 0.2 Table shows limit of alkalinity for glass containers: 2.Hydrolytic Resistance Test:(Test 1) Rinse container with CO2 free water for 3 times,fill it to particular vol. and autoclave at 100°C for 10 hrs,allow to rise temp to 121°C for 60 min then low down temo to 100 °C Titrate with 0.01 N HCL using methyl red as indicator Perform blank and measure amount of HCL consumed 6

7. 3.Arsenic test For containers intended for aq. Parenterals Inner and outer surface of container is washed properly with water Autoclave at 100°C for 10 min Increase temp. from 100-121°C(20 min) Maintained at 121°C for(60 min) Containers are cooled & liquids are combined and measured 10ml is taken & to it add 10ml HNO3,dried at 130°C 10ml molybdate is added & refluxed Measure absorbance at 840nm & perform blank test (abs of test solution< abs of std arsenic solution 10ppm) 7

8. 4.Thermal shock test Sample container is placed in upright position in tray & tray immersed in hot water for given time Then container is transferred in cold water bath,cracks are examined before and after test(45 ° C temp. diff) Small bottles-60-80 ° C Pin bottles-30-40 ° C 5.Internal bursting pressure test The most common instrument is the American Glass Research increment pressure tester. Bottle is filled with water ,placed inside chamber Internal press. automatically raised by series of increment at set time Bottle checked at selected press. level until container finally bursts 8

9. QC Test For Plastic Container Leakage test:10 containers filled with water & fitted closure,kept inverted for 24 hrs,passes test if no signs of leakage Transperancy test:5 containers filled to their nominal capacity(as per IP 1996),cloudiness of suspension compared against container filled with water Water vapour permeability test:Fill five containers with nominal volume of water and heat seal the bottles with an aluminum foil-poly ethylene laminate or other suitable seal. Weigh accurately each container and allow to stand (without any overwrap) for 14 days at a relative humidity of 60+5% and a temperature between 20 -25 °C.Reweigh the containers. The loss in weight in each container is not more than 0.2%. 9

10. Collapsibility test:This test applicable to containers. Which are to be squeezed in order toe remove the contents. A container by collapsing inwards during use yields at least 90% of its nominal contents at the required rate of flow at ambient temperature. Clarity test:Select unlabelled, portions from suitable containers, taken at random sufficient to yield a total area of sample required taking into account the surface area of both sides. Cut these portions into strips none of which has a total area of more than 20 cm2. Wash the strips free from extraneous matter by shaking them with at least two separate portions of distilled water for about 30 seconds in each case, then draining off the water thoroughly. 10

11. QC Test For Metal Container Take 50 empty tubes filled with ointment base ,sealed and kept overnight A metal bacteriological filter assembly is set with filter & heated to the m.p of ointment base Base from all tubes squeezed at certain rate & passed through filter under vacuum.Wash with CHCL3 and observe particles 11

12. QC Test For Closures To measure the force required to make hypodermic needle penetrate through closure P e n e t r a t i o n test Vol. of NaOH-NMT 0.3ml Vol. of HCL – NMT 0.8ml (titration using bromothymol blue indicator) Methylene blue used to check sealability of container Applicable to multidose containers Alkalinity or acidity Self sealability test 12

13. Applicable to closures intended to be pierced by hypodermic needle F r a g m e n t a t i o n test 50 ml sol. Is evaporated at 105°C Residue obtained NMT 4mg Residue on e v a p o r a t i on Measure light abs. at 220-360nm Absorbance NMT 2 Light absorption 13

14. QC Test For Secondary Packaging Materials Cartons: 1.compression: used to asses the strength of erected package thereby estimating degree of protection that it will provide to the content 2.Carton opening force: carton should spring open to its original shape without need for extra force 14

15. Papers and cardboards Moisture content Folding endurance Air permeability Tensile strength Tear strength Stiffness Bursting strength 15

16. FLEXIBLE PACKAGING 1.- POLYETHYLENE (PE) • It is the oldest thermoplastic film It can be: Transparent, Metallized, • Thickness range between 25µ to 100µ • Excellent heat sealability • It is only suitable for flexo printing • PE is a film with very low barrier properties • It is only suitable to protect against moisture • This material is mainly used as an inner layer for laminates • It is also used as single layer to pack products requiring low protection like: Frozen vegetables, Frozen Fish, Napkins, …

17. 2.- CAST POLYPROPYLENE (CPP) • It is very similar to PE but with better machinability properties • Thickness range between 20µ to 40µ • It is transparent, but with a more crystalic view compared to PE • It has very low protection barrier values • Better printability properties than PE, but still must be printed in flexo • Used as simple layer for applications such as toast bread or cupcakes • Not used as laminating layer

18. 3.- BI-ORIENTED POLYPROPYLENE (BOPP) • It is the most used thermoplastic film • Thickness range between 15µ to 40µ (most between 20µ-30µ) • It can be : transparent, white, opaque, metallized, lacquered, pearly, … • It has very lower heat sealing properties than PE or CPP • Better barrier properties than PE or CPP • Excellent printability in flexo • Used as simple- or laminated layer • Used in Snacks, pasta, dish was powders, biscuits, frozen food, … 4.- (BI) ORIENTED POLYESTER (BOPET - PET) • Thickness: 12µ (recently found in 8/9µ) • It has no heat sealing capability • Very high barrier properties • Excellent printability properties • Used as part of a lamination • Used in Cheese, meat, detergents, coffee, soups, … 5.- ORIENTED POLYAMIDE (OPA) Most usual thickness: 15µ • It has no sealing properties (needs a sealing layer) • It has high protection barrier values • Medium printability properties • Used in laminations in combination (at least) with a sealing layer • Applications: Chesse & meat (thermoforming), spaghetti, …, • Pharma applications: Mainly in cold forming, …

19. 6. PAPER It is not (obviously) a plastic film • It has no sealing properties (needs a sealing layer) • It has no protection barrier values • Printable in flexo • Used in laminations in combination (at least) with a sealing layer • Applications: Sachets (Pharma & Food), bread, Tee, Coffee, … 7.- ALUMINIUM It is not (obviously) a plastic film • It has no sealing properties (needs a sealing layer) • It has excellent barrier properties • Its printability is relatively poor • Used in laminations in combination (at least) with a sealing layer • Usually it is combined in a sendwich between a sealing- & printing layer • Applications: Sachets (Pharma & Food), Tee, Coffee, …

20. Stability aspect of packaging

21. EVULATION OF PHARMACUTICAL PACAKGING MATERIALS Evaluation of closures .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.  

22. Evaluation of Plastic 1.Leakage Test Fill 10 containers with water, fit with intended closures and keep them inverted at room temperature for 24hr.The test is said to be passed if there is no signs of leakage from any container. 2. Collapsibility Test This test is applicable to the containers which are to be squeezed for removing the contents. A container by collapsing inward during use, yield at least 90% of its normal contents at the required rate of flow at ambient temperature. 3.Water Vapour Permeability Test Fill 5 containers with normal volume of water and heat seal the bottles with an aluminium foil. Weigh accurately each container and allowed to stand for 14days at a relative humidity of 60±5% and a temperature between 20 and 25⁰C.Reweigh the containers. The loss in weight in each container is NMT 0.2% .

23. References: 23 Lachman., & Liebarman’s. (2013). Industrial pharmacy ( IV ed.). CBS Publisher and Distributors.1004-1007 Evans, E. R., & Halls, I. H. (2005). Pharmaceutical packaging technology. (D. A. Dean, Ed.). Taylor & Francis.182,183,335-337 QUALITY CONTROL TESTING OF PACKAGING MATERIALS | PharmaTutor Indian Pharmacoepia Goverment Of India Ministry Of Health And Family Welfare(2018). (8 𝑡ℎ Ed., Vol. I). The Indian Pharmacoepia Commission.1025,1057-1060