Objective
The purpose of this SOP is to ensure compliance of the quality of 1mL Dropper (25 x 75 mm).
Scope
To establish the standard testing procedure of 1mL Dropper (25 x 75 mm) in Pharmaceuticals.
Procedure
Description
1 ml Dropper has a black colored rubber teat and black colored plastic cap with a transparent plastic measuring tube. Each dropper is packed in a polybag.
Inner Diameter
Take 10 no. of a dropper and measure the diameter by vernier caliper. Note down the reading.
Limit: None of the obtained values deviates from specified limits.
Outer Diameter
Take 10 no. of the dropper and measure the diameter by vernier caliper. Note down the reading.
Limit: None of the obtained values deviates from specified limits.
Height
Take 10 no. of Drops and the measurement of height by vernier caliper. Measure the height of the plastic black cap minimum and maximum in mm.
Weight
Take 10 no. of a plastic black cap of a dropper for minimum and maximum weight. Weigh it on balance, the weight value must be within the specification limit.
Polystyrene Dropper
Outer Diameter Top
Take 10 no. of the dropper and measure the outer diameter of the top of the polystyrene dropper by vernier caliper.
Limit: None of the obtained values deviates from specified limits.
Outer Diameter Bottom
Take 10 no. of a dropper and measure the outer diameter of the bottom of the polystyrene dropper by vernier caliper.
Limit: None of the obtained values deviates from specified limits.
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Dropper Hole
Take 10 no. of a dropper and measure the hole diameter of the polystyrene dropper by vernier caliper.
Limit: None of the obtained values deviates from specified limits.
Plastic Tube Height
Take 10 no. of Droppers and the measurement of the height of the plastic tube by vernier caliper. Measure the height of the plastic tube minimum and maximum in mm.
Graduation on Plastic Tube
For 1.0 ml with graduation of tube 0.5 & 1.0 ml (OneSide), 0.2ml, 0.4ml, 0.6ml, 0.8ml & 1.0ml (Other Side)
Black Rubber Teat
Outer Diameter Top
Take 10 no. of a dropper and measure the outer diameter of the top of the black rubber teat by vernier caliper.
Limit: None of the obtained values deviates from specified limits.
Outer Diameter Bottom
Take 10 no. of a dropper and measure the outer diameter of the bottom of the black rubber teat by vernier caliper.
Limit: None of the obtained values deviates from specified limits.
Height
- Take 10 no. of Droppers and measure the height of the black rubber teat by vernier caliper.
- Measure the height of the black rubber teat minimum and maximum in mm.
Weight
Take 10 no. of Plastic black rubber teat of a dropper for minimum and maximum weight. Weigh it on balance, the weight value must be within the specification limit.
Total Height of Dropper after Assembly
Take 10 no. of Droppers and the measurement of height by vernier caliper. Measure the Dropper height minimum and maximum in mm.
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Tags
Test Method
