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Medicinal polyvinyl chloride (PVC) rigid sheet

2020-10-29

Purpose: To establish a standard operating procedure for the inspection of medicinal polyvinyl chloride (PVC) rigid sheets and standardize the inspection process.
2 Scope of application: the inspection operation of the PVC hard sheet purchased by our company.
3 Responsibility: Laboratory technicians and QC directors are responsible for the implementation of this regulation.
4 Content 4.1 Packaging material name: PVC rigid sheet
4.2 Basis: National Drug Packaging Container (Material) Standard of the State Drug Administration (Trial) YBB00182002
4.3 Inspection steps:
4.3.1 Material: visual inspection 4.3.2 Size:
4.3.2.1 The width of is 130±1mm ; there are two kinds of 150±1mm. Use a ruler with a graduation of 1mm to measure at least 3 times, calculate the average value, and use this as the test result.
4.3.2.2 Thickness: Measure with a vernier caliper with an accuracy of 0.02mm, measure at least 3 times, calculate the average value, and use this as the inspection result. The thickness specification size is 0.25~0.35mm, and the allowable tolerance is ±0.02mm.
4.3.3 Appearance quality traits should be colorless, transparent, uniform. Cut out a 1m-long medicinal polyvinyl chloride (PVC) hard piece at a distance of 1m from the outer end, and visually inspect it with natural light at a distance of 60cm.
4.3.3.1 Cracks and scars: not allowed to appear.
4.3.3.2 Bumps and wrinkles: not allowed to appear.
4.3.3.3 Perforation: not allowed to appear.
4.3.3.4 Crystal point: above 1.3mm is not allowed, and no more than 3 per 100cm2 for 1.3mm and below.
4.3.3.5 Black dots, white dots impurities: no more than 20 particles per square meter with a particle size of 0.3-0.8mm, and those with a diameter of 0.8mm are not allowed
4.3.3.6 Precipitation: not allowed to appear
20200923164922 PVC04

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