STANDARD OPERATING PROCEDURE Title: Test Method for Rubber Stoppers

1. Purpose
a) It is established to provide a standard procedure for Rubber stopper testing.
2. Scope
a) It is applicable for Rubber stoppers.
3. Responsibilities
a) QC Manager
b) Analyst
4. Procedure
Physical Test:
Description: Grey rubber stoppers.
Surface after Dry Autoclaving: Rubber stoppers are rapped in aluminum foil and autoclave at 180oC for ½ hour. No crack and no sticking are observed.
Chemical Tests:
Aspect of Autoclaved solution: weigh 17 g of Rubber stoppers and transfer it to a titration flask. Add 150ml of CO2 free purified water. Prepare a blank in the same manner, with 150 ml of purified water (CO2 free). Cover the flasks with aluminum foil and autoclave tape.
Autoclave it at 121oC, 15pb for 30minutes. (Solution S)
Note the color of solution after 24 hours standing after autoclaving. Compare the solution with blank; it should be colorless to slightly hazy.
Reducing Substances:
After 24 hours standing, take 50 ml of solution S and titrate it with N/100 iodine solution, using Starch solution as indicator.
Carry put a blank titration.
Limit: Not more 0.5ml of N/100 Iodine solution are required to produce blue color.

pH of solution: pH of Solution S should be in the range of 6.5 – 7.5.

%age Transmission: Take the transmission of solution S at 550nm, use blank preparation as blank.
Limit: transmission must be above 95%