Case Study High Voltage Leak Detection for Low

Case Study : High Voltage Leak Detection for Low Conductive Product Pharmapack Limited Nikka Densok Limited

Contents ① Test Product Information (Low Conductivity) ② Inspection Principle ③ Introduction of Production Line – Enema Formulation （Weighing ~ Dispensing ~ Filling ~ Packaging) ④ Scope of Pinhole Inspector (Specifications, Transfer System, Inspection Screen Indication） ⑤ Report of Experiment to Select Pinhole Inspector (Good Product Signal, Bad Product Signal, False Rejection of Good Product) ⑥ Report of Result in Production

Test Product Information • Mainly Glycerin Enema • Product is Low Conductive between 2. 0 – 3. 5μS/cm. Product No. 7 IA 7 IB 7 IC 7 ID 7 HM Conductivity [μ S/cm] 2. 79 3. 34 3. 88 3. 45 2. 23

Introduction of Production Line – Enema Formulation （Weighing ~ Dispensing ~ Filling ~ Packaging)

Inspection　Principle

Examination to Select Pinhole Inspector • Step 1 　　Examination of Electrode and Transfer System • Step 2 　　Analysis of Good /Bad Signal Values • Step 3 　　Definition of Upper Reference for Detection

Step 1 　　Examination of Electrode Configuration ①Definition of Inspection Area : where Sealing Mold and Main Mold contact each other. ②Examination of Electrode Configuration - should be able to inspect the defined inspection area. Inspection Area

Transfer and Inspection System

Analysis of Good/Bad Product Signal Values

If Upper Limit is set higher, chance of failure to discharge bad products to good product line will be higher. Upper Limit If Upper Limit is set lower, chance of false rejection to reject good product will be higher.

Pinhole Inspector Model HDY-02+DL

General Specifications • Application • Product Size • Maximum Capacity : BFS Bottles : 30 ml – 150 ml : 85 pcs/m.

Transfer and Inspection System

Production Bach Display

An Example of Inspection Result

Pinhole Test Result of Glycerin Product Lot No. Reject Rate(%) Pinhole Rate (%) Ａ Ｂ Ｃ 0. 12 0. 14 0. 18 0. 000 0. 016 Ｄ Ｅ 0. 23 0. 17 0. 008 Ｆ 0. 12 0. 008