Nishka research deploys high end instrumental techniques for Characterization Studies:

Characterization studies are a crucial aspect of pharmaceutical packaging development, particularly for parenteral products such as injectables. The purpose of these studies is to evaluate the composition and properties of pharmaceutical containers, including the glass used and any coatings applied to the container's inner surface.

Nishka Research's expertise lies in the characterization of pharmaceutical containers, including parenteral containers used by innovators worldwide. Our team of experts has extensive experience in evaluating the composition of glass and the properties of coatings applied to the inner/Outer surface of containers. We utilize state-of-the-art techniques and instruments like scanning electron microscope (SEM), Energy Dispersive X-Ray Analysis (EDX), X-ray fluorescence (XRF), inductively coupled plasma spectroscopy (ICP-OES), and atomic absorption spectroscopy (AAS) to perform characterization studies on pharmaceutical parenteral containers. These techniques enable us to determine the elemental composition of the glass and identify the specific type of glass used for the container, as well as to identify the type of coat and its thickness, and to determine its permeability and leaching properties.

In addition to glass composition analysis, our characterization studies evaluate the properties of coatings applied to the inner surface of the container. We use scanning electron microscopy to determine the thickness and permeability of the coating and to assess its leaching properties. This information is essential in evaluating the compatibility of the drug product with the container and determining the appropriate packaging solutions for the specific parenteral product.

By performing comprehensive characterization studies, Nishka Research can provide constructive information to generic product manufacturers regarding the suitability of specific pharmaceutical containers for their products. This information can aid in the development of customized packaging solutions that ensure the safety and efficacy of the drug product.

Characterization studies play a critical part in the development of safe and effective pharmaceutical packaging solutions. At Nishka Research, our commitment to utilizing advanced analytical techniques and providing reliable, accurate, and timely analyses ensures that generic product manufacturers can put forward their products to market with confidence.

What is Siliconization?

Siliconization is a process used in the fabricating of pharmaceutical containers, specifically glass vials and syringes, to prevent drug product interaction with the container surface. The process involves coating the inner surface of the container with a thin layer of silicone oil or silicone resin. This layer of silicone creates a barrier between the drug product and the glass surface, reducing the potential for interactions and minimizing the risk of particle formation and aggregation.

Siliconization is commonly used for parenteral drug products, which are administered via injection or infusion, as the drug must remain stable and pure throughout its shelf life and during administration. Without proper surface treatment, certain drugs may interact with the container surface, leading to contamination, degradation, or losing of efficacy. Siliconization provides a solution to this problem by improving the compatibility between the drug product and the container, ultimately ensuring the quality and safety of the final product.

Chemical composition of pharmaceutical GLASS Container as per regulatory agencies.

Note that the exact composition requirements may vary depending on the specific edition of the USP and any applicable monographs or standards. It's also important to consider that these quantitative composition requirements only provide a general guideline, and other factors including the manufacturing process and quality control measures can also impact the quality and performance of the glass containers.

Contact Us Now:

Discover the power of advanced pharmaceutical container characterization and revolutionize your packaging solutions with Nishka Research. As a global leader in pharmaceutical container and closure analysis and testing, we offer comprehensive services for the characterization of pharmaceutical containers used by innovators.

Our state-of-the-art laboratory, equipped with cutting-edge technologies and staffed by experienced scientists, ensures precise and reliable results. From glass vials and ampoules to plastic bottles and blister packs, we specialize in characterizing a wide range of containers to meet international regulatory standards.

Gain a competitive edge in the market by partnering with us. Let our expert team analyze and evaluate the key parameters of your pharmaceutical containers, including quality, integrity, compatibility, and performance. Our comprehensive characterization reports will provide you with valuable insights to optimize your packaging choices and enhance product safety.

Reach out to Nishka Research, today and take advantage of our global expertise in pharmaceutical container characterization. Together, we can ensure the highest level of quality, compliance, and innovation in your packaging solutions. Contact us now to discuss your specific requirements and start your journey towards superior pharmaceutical packaging.