Quality control for rubber closures & secondary material

Quality control for rubber closures & secondary material

1. Quality control tests for rubber closures & secondary packaging materials By: Dr. Kavita Bahmani Assistant Professor Department of Pharmaeutical Sciences, GJUS&T, Hisar , Haryana, India Tuesday, April 21, 2020

2. Sterility Test Fragmentation Test a. For aqueous preparation b. For dry preparation Self-seal Ability pH of aqueous extract Light absorption test Reducing substances Residue on evaporation Tuesday, April 21, 2020 FOR RUBBER CLOSURES

3. Preparation of solution(A) for various tests Wash closures in 0.2% w/v of anionic surface active agents for 5 min, rinse 5 times with distilled water and add 200 ml water & it is suspended to autoclave at 119 123 ºC for 20-30 min covering with aluminum foil. Cool and separate solution from closure Tuesday, April 21, 2020

4. I n this test subject treated closure to sterilization at 64-66 ºc and a pressure of about 0.7 Kilo Pascal for 24 hrs. Tuesday, April 21, 2020 Sterility Test It should not become tacky or soften

5. Place water corresponding to the nominal volume minus 4ml in each of 12 clean vials Close the vials with prepared closures & 16 hr allow it to stand for 16 hr. Using a hypodermic needle with an external diameter of 0.8 mm inject 1 ml of water into vial and remove 1 ml of air Carry out this operation 4 times with new needle each time Pass the liquid in the vials through a filter with a pore size of 0.5µm No. of fragments NMT 10 except in the case of butyl rubber closure where the total no. of fragments NMT 15 Tuesday, April 21, 2020 Fragmentation test (for aqueous preparations)

6. Close 12 clean vials with the prepared closures Using a hypodermic needle with an external diameter of 0.8 mm inject 1 ml of water into vial and remove 1 ml of air Carry out this operation 4 times with new needle Pass the liquid in the vials through a filter with a pore size of 0.5µm No. of fragments NMT 10 except in the case of butyl rubber closure where the total no. of fragments NMT 15 Tuesday, April 21, 2020 Fragmentation test (for dry preparations )

7. Close the vials with prepared closures For each closure, use new hypodermic needle with external dia. of 0.8 mm & pierce the closures 10 times at a different sites Immerse the vials upright in a 0.1% w/v solution of methylene blue & reduce the external pressure by 27KPa for 10 min Restore the atmosphere pressure and leave the vials immersed for 30 min Rinse the outside of the vials None of the vials contains any trace of colored solution Tuesday, April 21, 2020 Self-seal ability

8. Take 20 ml of solution A, add 0.1 ml bromothymol blue Add small amount of 0.01 NaOH , after its addition color changes from blue to yellow The vol. of NaOH required to change the color should not be more than 0.3 ml and if it is done with HCL, the volume of HCL needed should not be more than 0.8 ml Tuesday, April 21, 2020 pH of aqueous extract

9. It must be done within 4 hr of preparing solution A Solution A is filtered through 0.5µ filter and its absorbance is measured at 220-360 nm Similarly, take absorbance of blank without closures and absorbance should not be more than 2.0 Tuesday, April 21, 2020 Light absorption test

10. Tuesday, April 21, 2020 Reducing substances 20 ml of solution A 1 ml 1M H 2 SO 4 20 Ml of 0.002 M KMnO 4 Boil for 3 minutes and then cool Add 1 gm of KI Titrated with 0.01 M sodium thio -sulphate solution using starch as an indicator

11. Take 50 ml of solution A and evaporate to dryness at 105 ºc Then weigh the residue, the amount of residue should not more than 4 mg Tuesday, April 21, 2020 Residue on evaporation

12. No Name of test Description 1 Moisture content All the substances will be measure at temp specified for test 2 Folding endurance Fold the piece back and forth until rupture 3 Density For rigid cellular materials 4 Method for determining air permeability Expressed in pa…s-1. important for using light weighted uncoated paper on machine 5 Paper caliper Single sheet thickness b/w one surface and other 6 Tensile strength Maximum tensile force per unit width that a paper or board withstand before breaking 7 Tear strength Mean force required to continue the tearing of an initial cut in a single sheet of paper 8 Puncture resistance test Energy require to make initial puncture 9 stiffness Degree of resistance offered by board when it is bent 10 Cobb test Test for water absorbency Tuesday, April 21, 2020 For secondary packaging material(Paper & Board)

13. No Name of test Description 11 Rub resistance Test This is resistance of printed test piece to withstand rubbing against another similar test piece 12 Pick Test A specified amount of special oil is added to the printing system & printed on to the test piece. The surface is examined for sign of picks 13 pH, chloride or sulphate Just to check life of the paper/board 14 Roughness & smoothness Important for printing purpose 15 Brightness Measured Reflectance at wavelength of 457 nm 16 Wet burst test It is used to determine wet bursting strength of any paper or board following immersion in water 17 Ash in paper & board Determining of ash content in board & paper 18 Nitrogenous substance estimation It applies to only substances that have strong affinity for acid dyes 19 Ink absorbency Determination of ink absorption by paper & board by K& N ink 20 Wet tensile strength Determination of wet tensile strength on immersion in water Tuesday, April 21, 2020

14. Tuesday, April 21, 2020