OVERVIEW ON QUALITY CONTROL TEST OF PRIMARY AND SECONDARY PACKAGING MATERIAL


Mr.Aniket Mahesh Ramdasi, Dr.Swati S.Rawat, Dr. Sunil S. Jaybhaye, Mr. Yogiraj P. Muley, Ms. Komal D. Kangne
Pharmaceutical Science, Institute of Pharmacy, Badnapur, Dist. Jalna, Maharashtra
Abstract
The quality is normally understood as an index or measurement. It is the degree of excellence, a degree of conformation to standard. It is also the distinctive inherent features, property and virtue. Quality Control or Quality evaluation is the operational techniques to fulfill the requirement of quality. Testing is considered to be as a tool for the quality evaluation through the measurement of different qualitative parameters with respect to physical, Chemical, mechanical and optical properties of packaging materials. Pharmaceutical package is an integral part of Pharmaceutical product. An ideal package protects the product from harmful effects of environmental gases, moisture, microbes etc. Primary package is in direct control with the product and secondary package is the package which surrounds the primary package. Containers are tested by many methods of which commonly used test for glass are Crushed glass test, Whole-Container test, Chemical resistance of test, Water Attack Test etc. Similarly test. Closure materials are tested by Transparency test Penetrability Fragmentation test Self seal ability test, Extractive test etc. The requirement of packaging material testing is set according to specification of regulatory agencies like WHO GMP, USFDA and ICH guidelines. [01,03,09]
Keywords: Blister package, Closures, Primary package, Glass, ,Secondary package
Journal Name :
EPRA International Journal of Research & Development (IJRD)

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Published on : 2024-11-24

Vol : 9
Issue : 11
Month : November
Year : 2024
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