QUALITY CONTROL OF PACKAGING MATERIAL

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QC Test for Containers QC Test for Closures QC Test for Secondary Packaging Materials

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QUALITY CONTROL OF PACKAGING MATERIAL:

QUALITY CONTROL OF PACKAGING MATERIAL PREPARED BY: MOHAMMAD KHALID Assistant Professor Krishna Pharmacy College, Bijnor (UP) 28 March 2020 Krishna Pharmacy College, Bijnor 1

Contents::

Definition Role Of Packaging Material QC Test for Containers QC Test for Closures QC Test for Secondary Packaging Materials Conclusion Reference Contents: 28 March 2020 Krishna Pharmacy College, Bijnor 2

INTRODUCTION:

INTRODUCTION Packaging : Packaging is the science, art and technology of enclosing or protecting products for distribution, storage , sale, and use Quality control of a packaging component starts at design stage. All the aspects of a pack development may give rise to quality problems. It must be identified & minimized by performing quality control tests . 28 March 2020 Krishna Pharmacy College, Bijnor 3

INTRODUCTION Continue….....:

QC - backbone of pharmaceutical industry. Defects in packaging – harmful for dosage form Quality control of a packaging component starts at the design stage. All aspects of a pack development that may give rise to quality problems must be identified and minimized by good design . INTRODUCTION Continue…..... 28 March 2020 Krishna Pharmacy College, Bijnor 4

INTRODUCTION Continue….....:

The packaging materials are classified into three classes, Primary:- ampoules, vials, plastic bottles, polymer-coated foils. Secondary:- cartons, labels, leaflets Tertiary:- O uter cartons , shipper INTRODUCTION Continue…..... 28 March 2020 Krishna Pharmacy College, Bijnor 5

QUALITY CONTROL TEST FOR CONTAINERS:

Different types of container materials. 1. Glass Container 2 . Plastic Container 3 . Metal Container 4 . Rubber QUALITY CONTROL TEST FOR CONTAINERS 28 March 2020 Krishna Pharmacy College, Bijnor 6

Quality Control Test for Glass Containers:

1 . Chemical Resistance Test a ) Powdered Glass Test b ) Water Attack Test 2 . Hydrolytic Resistance Test 3 . Arsenic Test 4 . Thermal Shock Test 5 . Internal Bursting Pressure Test Quality Control Test for Glass Containers 28 March 2020 Krishna Pharmacy College, Bijnor 7

1. Chemical Resistant Test:

a ) Powdered Glass Test : It is done to estimate the amount of alkali from powdered glass with happen at elevated temperature. When glass is powdered, leaching of alkali is enhanced, which can be titrated with 0.02N sulphuric acid using methyl red as an indicator. Step 1: • Preparation of glass specimen Step 2: • Washing the specimen 1. Chemical Resistant Test 28 March 2020 Krishna Pharmacy College, Bijnor 8

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10g of specimen/sample + 50ml of highly purified water, Autoclave it at 121̊ C. Cool it and deacant solution in another flask again add 15ml water and decant solution Titrate the decant solution with 0.02N sulphuric acid using indicator and record the volume Limits: . Test Container Vol. of 0.02N H2SO4(ml) Powdered Type I 1.0 Glass Test Type III 8.5 Type N.P 15 Test Container Vol. of 0.02N H2SO4(ml) Powdered Type I 1.0 Glass Test Type III 8.5 Type N.P 15 28 March 2020 Krishna Pharmacy College, Bijnor 9

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b) Water Attack Test: This test is for Type II glass. The principle involve in this is whether the alkali leaches from surface of container. Rinse thoroughly container with high purity water. Fill it by 90% of it’s capacity with water. Autoclave it at 121̊C for 30 minutes. Then it is cooled and liquid is decanted Decanted liquid is titrated with 0.02N Sulphuric acid using methylred as an indicator The volume of sulphuric acid consumed is recorded and compare with limits 28 March 2020 Krishna Pharmacy College, Bijnor 10

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Test Container Vol. of 0.02N H2SO4(ml) Water Attack Type II 1.0 Test Size(ml)-100 0.7 Less than 100 0.2 2. Leakage Test: Drug filled container is placed in contained filled with colored solution ( methyleneblue ) and autoclave at 121̊C for 10 min. under pressure . Later on the container are observed whether colored get entered in container or not. 28 March 2020 Krishna Pharmacy College, Bijnor 11

3. Hydrolytic Resistant Test : :

3. Hydrolytic Resistant Test : Rinse the container with CO2 free water for 3 times. fill till a particular vol. autoclave it At 100̊C for 10 min. allow to rise temp. to 121̊C for 60 min. Low down temp to 100̊C. Cool it Specific amount of liquid solution is titrated with 0.01N HCL using methyl red as an indicator. Perform the blank with water and difference between the titration represents vol. of HCL consumed by test liquid 28 March 2020 Krishna Pharmacy College, Bijnor 12

Limits::

Capacity of container (corresponding to 90% average flow volume)(ml) Volume of 0.01 M HCL Type I or type II glass (ml) Volume of 0.01 M HCL Type III glass (ml) Not more than 1 2.0 20.0 More than 1 but NMT 4 1.8 17.6 More than 2 but NMT 5 1.3 13.2 More than 5 but NMT 10 1.0 10.2 More than 10 but NMT20 0.80 8.1 More than 20 but NMT 50 0.60 6.1 More than 50 but NMT 100 0.50 4.8 More than 100 but NMT 200 0.40 3.8 More than 200 but NMT 500 0.30 2.9 Limits: 28 March 2020 Krishna Pharmacy College, Bijnor 13

4. Arsenic Test ::

4. Arsenic Test : Wash inner and outer surface of container with D.W. for 5 min. Test solution is same as that of hydrolytic resistant test (50ml) Pipette out 10 ml and add 10ml of nitric acid on the water bath maintaining the temperature Dry residue in oven at 130̊C for 30 min. & cool it & add hydrogen molybdate & refux for 25 min. Cool the solution and determine absorbance at 840nm. Perform blank. 28 March 2020 Krishna Pharmacy College, Bijnor 14

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Limits : The absorbance of test solution should not exceed the absorbance of arsenic standard solution of 10ppm. 5. Internal Bursting Pressure Test: Instrument used American glass research increment pressure tester . The test bottle is filled with water and placed inside test chamber The internal pressure auto- matically raised by series of incre-ment at set time Bottle are checked at preselected pressure level until container finally burst. 28 March 2020 Krishna Pharmacy College, Bijnor 15

6. Thermal Shock Test::

6. Thermal Shock Test: Place sample container in upright position in tray & immersed tray in hot water for a given time Transfer the container in cold water bath temp. should be controlled. Examine cracks before & after test.(45̊C temp. difference should be there.) The amount of thermal shock a bottle can withstand is based on construction . STEP-1 STEP-2 STEP-3 Small bottles- 60 - 80̊C Pint bottles- 30-40 ̊C 28 March 2020 Krishna Pharmacy College, Bijnor 16

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Quality Control Test for Metal Container:

28 March 2020 Krishna Pharmacy College, Bijnor 18 Quality Control Test for Metal Container Take 50 empty tubes filled with ointment base, sealed & kept over night. A metal bacteriological filter assembly fitted with filter paper & heated to melting range of ointment base Base from all tubes squeezed at certain rate & passed through filter under vaccum . further wash with CHCL3 and observed for particles. STEP-1 STEP-2 STEP-3

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28 March 2020 Krishna Pharmacy College, Bijnor 19 Observations: Particles 1mm and above 50 Particles 0.5mm to 1mm 10 Particles 0.2mm to 0.5mm 2 Particles less than 0.2mm Nill Total score 62 Limits : Lot of tube passes test if total score is less than 100. Lot of tubes fails if total score is above 150 If it is between 100 – 150 test is repeated again with 50 more tubes

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28 March 2020 Krishna Pharmacy College, Bijnor 20 QUALITY CONTROL FOR METALLIC TINS: Protocols of test: Dimensions: Limit: Specimen metallic tins with tolerance 170mm  10mm. Diameter : Inner diameter: - Limit: It should not be less than 98mm. Outer diameter: – Limit: NMT 105mm

Quality Control Test for collapsible tubes:

28 March 2020 Krishna Pharmacy College, Bijnor 21 Quality Control Test for collapsible tubes

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28 March 2020 Krishna Pharmacy College, Bijnor 22 Quality Control Test for Strip and Blister packing 3/4th of water is poured in desiccator. Strip and Blister were placed inside desiccators and vaccum is applied Later on strips, blisters were taken out. water present over the outer surface were wiped out. The content of strips and blisters were removed and presence of moisture was checked If there is no leakage, content will not be wetted. It indicate perfect sealing.

QUALITY CONTROL TEST FOR CLOSURES:

Sterility Test Fragmentation Test Self- Sealability pH of aqueous extract Light Absorption Test Reducing Substance Residue on Evaporation Penetrability 28 March 2020 Krishna Pharmacy College, Bijnor 23 QUALITY CONTROL TEST FOR CLOSURES

 Preparation of sample solution:

28 March 2020 Krishna Pharmacy College, Bijnor 24  Preparation of sample solution

1. Sterility Test::

28 March 2020 Krishna Pharmacy College, Bijnor 25 1. Sterility Test:

2. Fragmentation Test::

Take 12 clean vials and place closures containing 4ml of water Allow to stand for 16 hrs . Use hypodermic needle to inject 1ml of water into the vial & remove 1ml of air . Carry this operation for 4 times with new needle each time . Pass the water present in vial through a filter with pore size of 0.5µm No. of fragments of closure retain should be as per the limits Limit : No . of fragments – NMT 10(in case of butyl rubber) No . of fragments –NMT 15 28 March 2020 Krishna Pharmacy College, Bijnor 26 2. Fragmentation Test:

3. Self-Sealability::

Fill 10 vials with nominal volume of water and place closures Pierce cap for 10 times at different sites with hypodermic needle Immerse vials in 0.1%w/v solution of methylene blue under pressure Keep the container immersed for 30 minutes Wash the vials & none of vials should contain traces of color solution 28 March 2020 Krishna Pharmacy College, Bijnor 27 3 . Self- Sealability :

4. pH of Aqueous Extract::

28 March 2020 Krishna Pharmacy College, Bijnor 28 4. pH of Aqueous Extract: Take 20ml of sample solution and add 0.1ml of bromothymol blue Add 0.01M of NaOH till color change from Blue to Yellow. Volume required is measured LIMITS:Vol . of NaOH – NMT 0.3 ml If HCL is used –NMT 0.8 ML 5. Light Absorption Test: It must be done within 4 hr of preparing sample solution. It is filtered and its absorbance is measured at 220nm to 360nm. Blank is done without closure and absorbance must be NMT-2.0

6. Reducing Substance:

28 March 2020 Krishna Pharmacy College, Bijnor 29 6. Reducing Substance 20ml of sample solution + 1M sulphuric acid 20ml of sample solution + 0.002M Potassiumpermagnet Boil for 3 min. and cool it Add 1 Kg of Potassiumiodide Treat the solution with Na thiosulphate using starch solution as indicator. Blank Titration is done and difference of sample and blank should be NMT-0.7ml

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28 March 2020 Krishna Pharmacy College, Bijnor 30 7. Residue on Evaporation: The 50ml of sample solution is evaporated at 105̊C. Residue obtained should be NMT 4mg. 8. Penetrability: This is to measure the force required to make a hypodermic needle penetrate easily through closure. It is measured by using piercing machine. The piercing force must not exceed a stated value, the hypodermic needle can get damage as a result of undesirable hardness of closure.

Testing of Paper & Board:

Testing of Paper & Board The test pieces for paper & board are conditioned for the tests to be carried out in standard conditions. Those conditions are Temperature - 23  C  1  C Relative humidity – 50%  2% 28 March 2020 Krishna Pharmacy College, Bijnor 31

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Name of the Test Description Moisture content All the substances will be measured at temperature specified for test Folding Endurance Fold the test piece back & forth until rupture occurs Density of paper & board For rigid cellular materials Method for determining air permeability Expressed in  m pa­­­­­­ -1 s -1 . It is important for using lightweight uncoated paper on machine having vacuum pick up system Grammage or substance (g/m 2 ) The weight of material per unit area of sample Paper Caliper Single sheet thickness between one surface and other Tensile strength The maximum tensile force per unit width that a paper or board will withstand before breaking Tear strength The mean force required to continue the tearing of an initial cut in a single sheet of paper Burst strength The maximum uniformly distributed pressure, applied at right angles to surface that a test piece of paper & board will stand under conditions of test. Hydraulic pressure is applied to diaphragm, bulging it until test piece bursts. Puncture resistance Energy required to make initial puncture Stiffness of thick paper & boards Degree of resistance offered by paper/board when it is bent Creasibility of boards Method to determine creasing quality of board within the range of 300-1000  m Cobb test(g/m 2 ) Test for water absorbency 28 March 2020 Krishna Pharmacy College, Bijnor 32

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Rub resistance This is resistance of printed test piece to withstand rubbing against another similar test piece Pick test/IGT test A specified amount of a special oil is added to the printing system & printed on to the test piece. The surface is then examined for signs of pick. pH, chloride or sulphate The acidity or alkality (pH) can help the life of the paper board Roughness/smoothness This is very important for ‘printablity’ of the paper. Brightness This is the reflectance factor measured at the effective wavelength of 457 nm Opacity This is ratio expressed as percentage of luminous reflectance factor of a single sheet of paper with a black backing to intrinsic luminous reflectance factor. Dennison wax test This is a older test and was replaced by the IGT test Wet burst strength It is used to determine wet bursting strength of any paper or board following immersion in water Wet tensile strength It is to determine wet tensile strength on immersion in water Ash in paper & board This is a method of determining the ash content in paper & board Detection & estimation of nitrogenous agents in paper It applies only to substances that have a strong affinity for acid dyes Ink absorbency The determination of ink absorbency of paper & board by K & N ink. 28 March 2020 Krishna Pharmacy College, Bijnor 33

QC TEST FOR SECONDARY PACKAGING MATERIALS:

The test pieces of paper and board are taken for test to be carried out in standard condition a ) Temperature: 23̊C ± 1̊C b ) Relative Humidity: 50% ± 2% 1. Moisture Content 2 . Folding Endurance 3 . Air Permeability 4 . Tensile Strength 5 . Stiffness 6 . Burst Resistance 28 March 2020 Krishna Pharmacy College, Bijnor 34 QC TEST FOR SECONDARY PACKAGING MATERIALS

TEST FOR CARTONS:

TEST FOR CARTONS Compression: This method is used to assess the strength of erected package Carton opening force: The method is used to hold the flat carton as delivered, by its creases between thumb & first finger press. Coefficient of friction: Both static & kinetic coefficients of friction are determined by sliding the specimen over itself under specific test conditions. Crease stiffness: This involves testing a carton board piece & folding it through 90  . It will then try to recover its former position when bending force is removed. Joint shear strength: This is a method of testing the glued lap seam on the side of a carton for strength of the adhesive using a tensile testing machine. 28 March 2020 Krishna Pharmacy College, Bijnor 35

CONCLUSION:

Package for a specific drug will preserve the drugs efficacy as well as its purity, identity, strength and quality for its entire shelf life . It is mandatory for the manufacturers to prove the safety of packaging of material by performing the quality control tests as per the specification . 28 March 2020 Krishna Pharmacy College, Bijnor 36 CONCLUSION

REFRENCES:

Pharmaceuticals Packaging Technology , Taylor and Francis by Dean D.A, Evans E.R fifth edition page no. 188-189 . Quality Control of Packaging Materials in the pharmaceutical Industry-Kenneth, Harburn . Pharmaceutical Packaging Technology by D.A. Dean, L.R. Evans, I.H. Hall . The Theory and Practice of Industrial Pharmacy by Leon Lachman A. Liberman , Joseph L.Kanig III rd edition Indian Pharamacopoeia 1996 volume II page A- 127, 131,132 British pharmacopoeia volume IV, page A- 355 European pharmacopoeia volume I, page- 301 United states pharmacopoeia 2004, page-2288 www.googleimagesearch.com “Packaging”; Cooper and Gunn’s Tutorial Pharmacy, sixth edition, CBS publicashers page no. 139-140 28 March 2020 Krishna Pharmacy College, Bijnor 37 REFRENCES

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