INNOVATE @KAPOOR GLASS
Glass Ampoules and Tubular Vials produced by Kapoor Glass are safe and reliable products to package Injectable/Parental Drugs for Human as well as Veterinary usage. Each component of this Primary Packaging material such as the quality of Neutral Borosilicate Glass Tubing, Equipment used for the production, Lead-free ceramic colours used for the application of breaking systems as well as printing of text and identification/code rings is carefully selected for this application always ensuring the highest safety for both the Patient and the Medical Practitioner.
However, for special drugs and formulations, there exists special needs and requirements in terms of pH-sensitive formulations, high/aggressive pH solutions or products that might be subjected to exaggerated conditions such as higher temperature or extended shelf life, which may cause accelerated decay of the glass, giving rise to shiny ‘glass like’ extractables.
Special precautions and some innovative techniques are adopted during the manufacturing process of Optima+ USP Type 1 Glass Ampoules and USP Type 1 Tubular Vial to further improve the neutrality of the inner glass surface for added stability of sensitive drugs.
The ultimate standard for dimensional accuracy of key parameters of ampoules is achieved using a high-performance vision system with internally developed software utilizing learning control algorithms. Ampoules produced using this system exhibit up to 50% improvement in key tolerances stipulated under ISO 9187:1- 2018.
Glass Ampoules are produced on High-Speed rotary Ampoule forming machines. The process of Ampoule forming relies on the adjustment of multiple burners which utilize Air, Oxygen Gas a fuel such as Propane or Liquified Petroleum Gas. However, based on our experience of over 60 years in the conversion process, we realized that even minor changes such as inlet pressure fluctuations, the temperature of the inlet fuels and even variations in the density of air due to ambient temperature changes can affect the formation of Ampoules in terms of dimensions.
To overcome these issues, our engineers developed a superior Process Control Solution, Dimension+. The objective of the system was to offer Glass Ampoules to customers across the World who face challenges in their new High-Speed Washing/Filling/Sealing machines where higher speeds result in higher wastages and rejections leading to significantly higher costs.
The underlying principle of this system was that supplying Ampoules with a significant reduction in dimensional variation should not result in significantly higher wastages during the production process.
Under this process, each ampoule is measured with the help of an advanced high-resolution camera system equipped with speciality lens and lighting system. The data is analysed, and the machine burners used for heating the glass are continuously optimized to ensure high repeatability of the dimensions of the Ampoules being produced. The high process capability of this system ensures a 50% reduction in Stem Diameter as well as a 30% reduction in Constriction and Bulb Diameter when compared to ISO 9187: 2010. Pharmaceutical companies do not need to invest in additional change parts to use Dimension+ Glass Ampoules.
Ampoules produced under the control of our Dimension+ System have proven themselves across the world on multiple lines and demonstrated a significant reduction in wastages due to washing, filling & sealing quality defects and reduction in operator intervention.
INNOVA SURFACE +
This technique allows ampoules to operate at higher speeds in pharmaceutical lines with reduced instances of vials causing blockages due to higher surface friction. High-speed movement of vials also results in impact and additional friction also causes irreversible surface defects such as scratches that can lead to stoppages due to breakages.
LyoSAFE vials are designed to operate with the least number of breakages inside pharmaceutical freeze dryers. This is done by online control of base geometry and distribution of glass. Online and Offline measurements are carried out additionally to ensure the lowest wastages and process downtime during the lyophilization or freeze-drying process.
Vials lines equipped with this special technology can save significantly on unscheduled equipment shutdowns and costs associated with wastages of not only the expensive formulation but also costly closure systems.