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Quality Control Of Packaging Material

This document discusses pharmaceutical packaging materials and quality control testing. It defines primary, secondary, and tertiary packaging. Common packaging materials include glass, plastic, paper, and boards. Quality control tests for glass containers include chemical resistance via powdered glass and water attack tests. Tests are also described for plastic containers, including clarity of extract and non-volatile residue. The document concludes that testing packaging materials is important to ensure the quality, stability, and efficacy of drug products.

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By Mohammad Mudassar. Department Of Quality Assurance, M-pharm First Semester. R. C. Patel Institute of Pharmaceutical Education & Research, Shirpur.
 Definition  Role Of Packaging Material  Types Of Packaging Material  Quality Control Test for Glass Container  Quality Control Test For Plastic Container  Conclusion  Reference 206/10/2016
•Packaging Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Production marketing 306/10/2016
 Role of Packaging:  Protection -against light -against reactive gases -against moisture -against microbes -against physical damage -against adulteration  Presentation  Identification  Information  Convenience 406/10/2016
 Primary packaging Primary Packaging is the material that first envelops 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. 506/10/2016
 Secondary Packaging Secondary Packaging is outside the primary packaging perhaps used to group primary packages together 606/10/2016
 Tertiary Packaging Tertiary Packaging is used for bulk handling , warehouse storage and transport shipping. 706/10/2016
◦ Ampoules ◦ Vials ◦ Containers ◦ Dosing dropper ◦ Syringe ◦ Strip package ◦ Blister packaging 806/10/2016
• Paper and boards • Cartons • Box manufacture 906/10/2016
TYPES OF GLASS: 1) Type I ( Neutral or Borosilicate Glass) 2) Type II ( Treated Soda lime glass) 3) Type III ( Soda lime glass) 4) Type IV ( General purpose soda lime glass) Type I Type II /III 1006/10/2016
QUALITY CONTROL TESTS FOR GLASSES 1) CHEMICAL RESISTANT OF GLASS CONTAINERS A) Powdered Glass Test: It is done to estimate the amount of alkali leached from the powdered glass which usually happens at the elevated temperatures. When the 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: Few containers are rinsed thoroughly with purified water and dried with stream of clean air. Grind the containers in a mortar to a fine powder and pass through sieve no.20 and 50. Step-2: Washing the specimen: 10gm of the above specimen is taken into 250 ml conical flask and wash it with 30 ml acetone. Repeat the washing, decant the acetone and dried after which it is used within 48hr. Procedure: 10gm sample is added with 50ml of high purity water in a 250ml flask. Place it in an autoclave at 121⁰C±2⁰C for 30min.Cool it under running water. Decant the solution into another flask, wash again with 15ml high purity water and again decant. Titrate immediately with 0.02N sulphuric acid using methyl red as an indicator and record the volume. 1106/10/2016
B) Water Attack Test: This is only for treated soda lime glass containers under the controlled humidity conditions which neutralize the surface alkali and glass will become chemically more resistant. Principle involved is whether the alkali leached or not from the surface of the container. Procedure: Rinse thoroughly with high purity water. Fill each container to 90% of its overflow capacity with water and is autoclaved at 121⁰C for 30min then it is cooled and the liquid is decanted which is titrated with 0.02N sulphuric acid using methyl red as an indicator. The volume of sulfuric acid consumed is the measure of the amount of alkaline oxides present in the glass containers. 1206/10/2016
TESTS CONTAINER VOL.OF 0.02N H2SO4 Powdered glass test Type I Type II Type III 1.0 8.5 15.0 Water attack test Type II (100ml or below) Type II (above 100ml) 0.7 0.2 Test Limits 1306/10/2016
2) Hydrolytic Resistance Of Glass Containers: Rinse each container at least 3times with distilled water and fill with the same to their filling volume. Heat to 100⁰C for 10min and allow the steam to issue from the vent cork. Rise the temp from 100⁰C to 121⁰C over 20min. Maintain the temp at 121⁰C to 122⁰C for 60min. Lower the temp from 121⁰C to 100C over 40min venting to prevent vacuum. Remove the container from autoclave, cool and combine the liquids being examined. Measure the volume of test solution into a conical flask and titrate with 0.01M HCl using methyl red as an indicator. Perform blank with water and the difference between the titration represents the volume of HCl consumed by the test solution. Nominal Capacity Of container (ml) Number of containers to be used Volume of test solution to be used for titration (ml) 5 or less at least 10 50.0 6 to 30 at least 5 50.0 More than 30 at least 3 100.0 1406/10/2016
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03 Thermal Shock Test: Place the samples in upright position in a tray. Immerse the tray into a hot water for a given time and transfers to cold water bath, temp of both are closely controlled. Examine cracks or breaks before and after the test. The amount of thermal shock a bottle can withstand depends on its size and design. Small bottles withstand a temp differential of 60 to 80⁰C and large bottle 30 to 40⁰C. A typical test uses 45C temp difference between hot and cold water. 04 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. 1606/10/2016
The most common instrument used is American glass research increment pressure tester .The test bottle is filled with water and placed inside the test chamber. A scaling head is applied and the internal pressure automatically raised by a series of increments each of which is held for a set of time. The bottle can be checked to a preselected pressure level and the test continues until the container finally bursts. 1706/10/2016
Collapsibility test : Applicable to containers which are to be squeezed in order to remove contents. yield 90%of its contents at required rate of flow at ambient temp. Clarity of aqueous extract: Clarity of aqueous extract Select unlabelled portion from a suitable containers Cut these portions into strips Wash it with extraneous matter by shaking with two separate portions of distilled water Transfer to flask – previously washed with chromic acid Rinse with distilled water add 250ml d.w. Cover the flask autoclave at 121Ċ, 30min Colourless , free from turbidity 1806/10/2016 Non-volatile residue Evaporate 100 ml of the extract obtained in the test for Clarity of aqueous extract to dryness and dry to constant weight at 105º. The residue weighs not more than 12.5 mg.
 Leakage test, Collapsibility test Same As Describe in Non- Injectable  Clarity and colour of solution  Acidity or alkalinity  Light absorption  Reducing substances  Transparency 1906/10/2016
Fill a container to its nominal capacity with water and close it, if possible using the usual means of closure; otherwise close using a sheet of pure aluminium. Heat in an autoclave so that a temperature of 121 ± 2º is reached within 20 to 30 minutes and maintain at this temperature for 30 minutes. If heating at 121º leads to deterioration of the container, heat at 100º for 2 hours. Use solution S within 4 hours of preparation 2006/10/2016
 Blank. Prepare a blank by heating water in a borosilicate glass flask closed by a sheet of pure aluminum at the temperature and for the time used for the preparation of solution S.  Clarity and colour of solution S. Solution S is clear and is colorless.  Acidity or alkalinity. To a volume of solution S corresponding to 4 per cent of the nominal capacity of the container add 0.1 ml of phenolphthalein solution. The solution is colorless. Add 0.4 ml of 0.01M sodium hydroxide. The solution is pink. Add 0.8 ml of 0.01M hydrochloric acid and 0.1 ml of methyl red solution. The solution is orange-red or red. 2106/10/2016
 Light absorption. The light absorption in the range 230 nm to 360 nm of solution S using a blank prepared as described under Solution S is not more than 0.20  Reducing substances. To 20.0 ml of solution S add 1 ml of dilute sulphuric acid and 20.0 ml of 0.002M potassium permanganate. Boil for 3 minutes. Cool immediately. Add 1 g of potassium iodide and titrate immediately with 0.01M sodium thiosulphate, using 0.25 ml of starch solution as indicator. Carry out a titration using 20.0 ml of the blank prepared as described under Solution S. The difference between the titration volumes is not more than 1.5 ml.  Transparency Fill the container previously used for the preparation of solution S to its nominal capacity with a 1 in 200 dilution of the standard suspension for a container made from polyethylene or polypropylene. For containers of other materials, use a 1 in 400 dilution. The cloudiness of the suspension is perceptible when viewed through the container and compared with a similar container filled with water 2206/10/2016
 Fill 5 containers with nominal volume of water and heat seal the bottles with aluminium foil.  Weigh accurately each container and allow to stand for 14 days humidity- 60±5% temp. 20Ċ and 25Ċ.  Reweigh the containers.  Loss in wt in each container is NMT 0.2% 2306/10/2016
 The testing of packaging materials is almost requirement for any pharmaceutical industry.  The material of a package affects quality, stability and efficacy of drug product.  The cost of material of a package should be as low as possible without compromising the quality of product.  It should pass the specifications of tests before it reached the local markets and made available to the consumers of product.  The type of test followed should be according to requirements of regulatory agencies. 2406/10/2016
I. Indian Pharmacopoeia, 2007, Government of Indian ministry of health and family welfare, The Indian pharmacopoeia commission, Ghaziabad, volume-I, 6.1, 6.2, 6.3, 361-370 II. Pharmaceutics-1 by R. M. Mehta, Page No.:-74-85 III. The Theory and Practice of Industrial Pharmacy by Leon Lachman, Page No.:-711- 724 IV. http://www.pharmatutor.org/articles/quality-control-testing-packaging-materials (Accessed date 24/09/2016 ) V. https://en.wikipedia.org/wiki/Pharmaceutical_packaging (Accessed date 24/09/2016 ) 2506/10/2016
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