Silicone Quantitation from Siliconized Rubber Stoppers by Using FTIR

User Benefits

- The present work provides an easy extraction method for fast and accurate quantitation of silicone. - The methodology can be adapted for extractable and leachable study of materials like pre-filled syringes, medical tubings and various drug delivery systems.

Introduction

Silicones are extensively employed in various industries due to their unique properties. In the pharmaceutical industry, they find numerous applications such as active ingredients, antifoaming agents, and excipients. They are also utilized in siliconization, pharmaceutical manufacturing operations, and packaging materials. Siliconization plays a vital role in the production of pre-fillable syringes, cartridges and rubber stoppers. Its purpose is to lubricate between the components which facilitates smooth gliding. It also enables a secure connection between the components like glass bottle and rubber stopper. By carefully optimizing the siliconization process parameters, it is possible to achieve a uniform coating while minimizing the presence of free silicone. To obtain quantitative information on the siliconization layers, it is essential to extract the silicone from siliconized components using organic solvents and then perform FTIR spectroscopy. This technique can provide crucial insights into the amount of silicone used on to the rubber stoppers. The present work demonstrates the application of FTIR for quantification of silicone in rubber stoppers.

April 15, 2025 GMT