Volume I of I TYPE III DRUG MASTER FILE INDUCTION SEALING WADS [EXCEL PACK LTD, NEW DELHI, INDIA] 1 TYPE III DMF FOR INDUCTION SEALING WADS EXCEL PACK LIMITED ; NEW DELHI; INDIA FEBRUARY – 2007 (Version 1.0) INDICTION SEALING WADS EXCEL PACK LIMITED 1004-05-06, DEVIKA TOWER 6, NEHRU PLACE NEW DELHI – 110019 INDIA TEL: 0091 (11) 41655308 / 310 FAX: 0091 (11) 41656337 E-MAIL:
[email protected] 2 TYPE III DMF FOR INDUCTION SEALING WADS EXCEL PACK LIMITED ; NEW DELHI; INDIA FEBRUARY – 2007 (Version 1.0) INDICTION SEALING WADS INDUCTION SEALING WADS TYPE III DMF COMPREHENSIVE TABLE OF CONTENTS SECTION CONTENTS PAGE NO. NUMBER INTRODUCTION 4 1. PRODUCT DESCRIPTION 4 2. PROCESS DESCRIPTION 8 3. STATEMENT OF CONFIDENTIALITY 9 A ADMINISTRATIVE INFORMATION 10 PERSONS AUTHORIZED TO INCORPORATE THE 13 B D.M.F. BY REFERENCE C DESCRIPTIVE INFORMATION 14 a COMPONENT DESCRIPTION 14 b MATERIALS OF CONSTRUCTION 15 c ALTERNATE, INTERCHANGEABLE MATERIALS OF 18 CONSTRUCTION D MANUFACTURING PROCESS DESCRIPTION 20 E SPECIFICATIONS 34 1.0 SPECIFICATIONS FOR MATERIAL OF CONSTRUCTION 34 2.0 IN PROCESS TESTS 39 3.0 SPECIFICATIONS FOR FINISHED PRODUCTS 50 F TEST METHODS 54 1 DETERMINATION OF GRAMMMAGE PER SQUARE 54 METER 2 MOISTURE CONTENT 55 3 BOND STRENGTH 56 4 SEAL STRENGTH 60 5 WINDING CHECK 61 6 MELTING POINT 62 7 VISCOSITY 63 8 CONGEALING POINT 64 G QUALITY SYSTEM 67 3 TYPE III DMF FOR INDUCTION SEALING WADS EXCEL PACK LIMITED ; NEW DELHI; INDIA FEBRUARY – 2007 (Version 1.0) INDICTION SEALING WADS INTRODUCTION 1. PRODUCT DESCRIPTION: The company is engaged in the manufacture of induction heat seals for sealing of all kinds of plastic and glass bottles.