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Chaitanya QA

Quality assurance

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Chaitanya QA

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  1. CHHATRAPATI SHIVAJI COLLEGE OF PHARMACY, DEORI Subject:- Quality Assurance Topic :- Packaging Material, Quality Control Test For Container Presented by :- Chaitanya M. Rakhade Class:- 3rd Year, 6thsem Guided by:- Badwaik Sir

  2. INTRODUCTION:- • Along with safety and efficacy, quality is one of the most important criteria to assess the fitness of a medicinal product for use by the patient. • PACKAGING MATERAIL:- • Any material that is used for packaging of products for their distribution and sale is said to be packaging material. • TYPES OF PACKAGING:- • Primary Packaging – • Those packages, which are in direct contact with the pharmaceutical formulation. • The aim of primary packaging is to protect the formulation from environment, chemical, mechanical & other hazards. • The smallest unit of distribution or use. • Examples- bottles, blister packs, strip packs, vials, ampoules, tin.

  3. Secondary Packaging:- • Those packages, which are used to cover primary packs. • Their aim is to provide additional protection during warehousing and to provide information about drug product. • Protect the flexible containers. • Examples- cartons, boxes, leaflets. • Tertiary Packaging:- • Those packages, which are used to cover secondary packs and prevent damage to the products . • It is used to bulk handling and shipping. • Examples- container, barrel, edge protector, pallets.

  4. COMPONENTS OF PACKAGING :- • Container • Closure • Carton/ Outer • Box • CONTAINER:- • The containers remain in direct contact with drug or in which the product or medicine is placed and enclosed. • Examples- Glass, Plastic, metal, etc. • Glass Container- • Glass has been widely used as a drug packaging material. • Glass are economical, strong, impermeable, chemically inert, reaction free, etc. • It mainly used in liquid dosage form.

  5. TYPE OF GLASS:- • Type 1- Highly resistant borosilicate glass • Type 2- Treated soda-lime glass • Type 3- Soda-lime glass • Type 4- General purpose soda lime glass • FOR QUALITY CONTROL TEST GLASS:- • 1. Powdered glass test- • To estimate the amount of alkali leached from the powdered glass, which happens at elevated temperatures. • Sample containers are rinsed with purified water and dried • The containers are grinded in a mortar to a fine powder and passed through sieve no. 20 and 50 • 10gm of the sample is washed with acetone and dried

  6. 50ml of purified water is added to the dried sample and autoclaved at 121°C for 30 min and cooled and filtrate • The filtrate liquid is titrated with 0.02 N H,SO, using methyl red as indicator. • 2. Water attack test:- • This test is for type II glass. The principle involved in this is whether the alkali leaches from surface of container. • The container is rinsed thoroughly with high purity water. It is then filled with water upto 90% of its capacity • It is then autoclaved at 121°C for 30 min. Then it is cooled and liquid is decanted • Decanted liquid is titrated with 0.02N H2SO4 using methyl red as an indicator • The volume of H2SO4 consumed is recorded and compared with limits

  7. 3. Hydrolytic Resistance:- Fill bottles to 90 % of their calculated overflow volume with distilled water and cover with aluminium foil Place the container in autoclave at 121 C for 60 min Then remove the container from autoclave and cool them Combine the liquids from container to in conical flask and add 0.15 ml methyl red indicator and then titrate with 0.01 M HCl

  8. Result:- sample preparation compare with standard preparation. 4.Crushed Glass Test:- Take containers and crushed in mortorand pestle Powdered glass is passed through sieve No 20 and 50 and washed with acetone and dried Take 10 g of powder and place in a conical flask and add 50 ml of purified water, cap the flask Place the container in autoclave 121°C for 30 min remove and cool the flask Separate the solution into another flask add 5 drops of methyl red indicator and titrated with 0.02N H₂SO4 Glass pass the test- If the colourof test solution not change from pink to yellow. Some Other Test Are- Arsenic Test. Whole Container Test.

  9. Plastic Containers:- • Plastic container are light weight, non-breakable nature, low toxicity and low reactivity. • They are made from various kinds of polymers • Test for parenteral and non parenteral preparations- • 1. Leakage Test:- • Fill 10 containers with water • Fitted with intended closure • keep them inverted at room temp. for 24 hrs. • Test is passed → if no signs of leakage • 2. Collapsibility Test:-(Applied to contain to be squeezed) • A container by collapsing inward • yield at least 90% of its normal content at the required rate of flow at ambient temp.

  10. 3. Clarity of Aqueous Extract:- Select random container, unlabeled, unmarked & non-laminated portions is selected These portions are cut into strips, none of which has a total surface area of 20 cm² Strips are washed free from extraneous matter by shaking them with at least two separate portions of distilled water for about 30 sec Sample is taken into flask, 250 ml of distilled water is added to the flask, covered and autoclaved at 121°C for 30 min The extract is cooled and examined It should be colourlessand free from turbidity. Some Other Test Are- Transparency Test Water Vapor Permeability Test

  11. Metal Container:- • The metals commonly used for construction of containers • Various metals e.g.- tin-plated steel, mild steel, stainless steel, aluminium and lead. • Quality Control Test- • Select 50 tubes (clean each tube) • fill the tube with a suitable molten ointment base, class the each tube and allowed to stand overnight at a temp. 15 to 20 C • Take a metal bacteriological filter with fitter paper of Suitable porosity, and related above melting range of ointment base • Base from all tubes squeezed at certain rate and passed through filter under vaccume • Wash the walls of filter with three successive quantities of 30 ml chloroform, allow the filter paper to dry • Examine the filter paper under oblique lighting with magnifying glass with graticule of 1mm square.

  12. Limit- If total score is <100 = Complies with test (Pass) If total score is >150 = Fail the test If total score is 100-150 = Repeat the test. • REFERANCE :- • The Book Of Quality Assurance(edition 2019-20) By Prof.(dr.) R. Sundhararajan, dr. Minal T. Harde, Published By Takur Publication. • Pharmaceutical Quality Assurance (2nd Edition Nov 2021) By DR. Randir Singh Dahiya, DR.Suresh K. Beniwal, Ms. Renu Saharan, Published By NiraliPrakashan.

  13. Thank You !!

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