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Nipro Innovating Pharmaceutical Packaging with Quality and Precision

Nipro Innovating Pharmaceutical Packaging with Quality and Precision

Ashish Moghe , Managing Director, Nipro PharmaPackaging India

2025-01-09

Q: Tell us about Nipro’s key portfolio in the pharma packaging domain and what are Nipro’s key considerations when designing pharmaceutical packaging solution?

Ashish Moghe: To start with, I would like to highlight that Nipro is a vertically integrated company. This means we produce our own high-quality glass tubing, which offers our customers quality and supply assurances. We convert our glass tubing, in one of our 15 global factories, into high-quality primary pharmaceutical packaging. Our customers can choose from a broad range of ampoules, cartridges for dental and pen applications, pre-fillable syringes, and standard and RTU vials. We offer all necessary components such as plunger stoppers, rods, closures, and backstops. On top of that, we provide a specific portfolio of medical devices for reconstitution and injection, like hypodermic needles or vial-to-syringe adapters. You can source complete packaging solutions from Nipro.

When developing or manufacturing packaging solutions, it all starts with the product and service requirements of our business partners. A cross-functional team of experts from production, technical support, RA & QA, and sales will translate the drug product requirements into suitable glass container solutions and provide the necessary service and support.

Depending on the drug product requirements, different suitable container options will be discussed. Important factors like cosmetic and dimensional quality and related AQLs (Agreed Quality Levels) will be defined. To ensure that containers are produced according to agreed quality, a broad array of 100% in-line inspections and necessary in-process controls will take place. Necessary documentation such as certificates of conformity and certificates of sterility will be provided. Customers can rest assured that Nipro will strive to provide the best products and services to make each project a success.

Q: What materials are commonly used for manufacturing primary glass container for pharmaceutical applications and what quality specifications are essential to consider?

Ashish Moghe: To manufacture primary glass containers for pharmaceutical applications, special glass tubing is required. For liquid drugs, normally Type I, borosilicate glass tubing is used. For any other storage form, soda lime, Type III is an option. Both glass tubing types must comply with regulatory standards, namely the prevailing Pharmacopoeias such as USP, EP, and JP. The glass quality and composition are extremely important to ensure chemical inertness of the glass, high dimensional and cosmetic quality, and the right index of thermal expansion. Choosing the right glass tubing contributes to high-quality primary containers that safeguard your drug product over its shelf-life.

Q: What are the key features of “D2F Pre-fillable Syringes Silicone-oil free” and why such a packaging solution could be interesting for pharmaceutical companies?

Ashish Moghe: Nipro’s ‘D2F Pre-fillable Syringes Silicone-oil free’ are suitable primary packaging solutions for drug products highly sensitive to silicone oil. The absence of silicone oil prevents drug-container interactions related to silicone oil. All aspects that could be influenced negatively by the absence of silicone oil such as break-loose force, gliding force, and container closure integrity have been thoroughly tested and passed all tests.  D2F pre-fillable glass syringes silicone oil free are commercially available and extend the extensive range of Nipro’s pre-fillable glass syringe portfolio.

Q: What packaging solutions does Nipro offer to pharmaceutical companies to support them battling counterfeit medicines?

Ashish Moghe: Nipro’s Ampoules with Anti-Counterfeiting Technology (ACT) help combat counterfeit medicines, a global issue putting patient safety at risk. For the print on these ampoules, Nipro uses special ink that contains light-emitting particles. This ink appears like standard ink to the naked eye but changes color under specific light, therefore works as an additional feature to prove drug container authenticity. This technology is easily applied to existing ampoule types. It presents low regulatory hurdles as the ink is applied to the outside of the ampoule without the risk of coming into contact with the drug product. Nipro’s ampoules with ACT offer an additional feature to prove drug container authenticity and help patients identify falsified medicines.

Q: How is the D2F pre-fillable syringe adapted for nasal spray applications?

Ashish Moghe: Nipro offers the Exadose™ Nasal Sprays in a D2F pre-fillable glass syringe format. The pre-fillable glass syringes with a proprietary designed nasal spray tip offer easy, controlled and comfortable intranasal administration. The device features a unique two-step plunger design that ensures precise delivery of half a dose into each nasal cavity. Additionally, the device offers a very uniform spraying performance, as distributed particle sizes are within narrow limits.  The Exadose nasal spray is part of Nipro’s RTU packaging solution and will be delivered in standard D2F nest&tub configurations. It is an ideal choice for nasal medicines that require a fast time-to-market.

Q: Sustainability has become a key mantra for every business as of today. How is Nipro addressing the sustainability factor in terms manufacturing and packaging design?

Ashish Moghe: Nipro is addressing sustainability in manufacturing and pharmaceutical packaging by developing eco-friendlier processes and packaging solutions that reduce environmental impact while maintaining product quality and safety. One important process is the use of recyclable materials, such as cullet recycling, where broken or waste glass is reprocessed into new packaging, reducing raw material usage and energy consumption. Another step is the increasing use of green energy in the manufacturing process. Nipro has invested in large photovoltaic installations in their plants in Germany and India substantially reducing the CO2 footprint of both plants. An additional step is the installation of a state-of-the-art WFI installation in our German plant. The installation operates with cold instead of hot water reducing the use of energy and making the production a bit greener. By incorporating sustainable practices throughout many production processes and the supply chain, Nipro helps pharmaceutical companies meet environmental goals while ensuring the safety and efficacy of their products.

Q: Kindly mention any expansion plans or upcoming launches we can expect from Nipro Group in this year?

Ashish Moghe: At CPHI India, we're excited to share an exclusive update with you! In 2025, we’ll be offering a broader range of customizable products tailored to meet the specific needs of our pharmaceutical clients. We’re also introducing cartridges to the Indian market, designed to support the insulin & dental industry. Aligned with the "Make in India" initiative, we have future plans for expansion of tubing plant by setting up a green field tubing plant in Pune.

Articles about interviews | January - 09 - 2025

 

 

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