Premia™ Precision is the new quality standard for elastomer components by Aptar Pharma. The new standard caters to sensitive and valuable injectable therapies.
The new solution enables pharmaceutical manufacturers to meet their quality and regulatory objectives. It also helps manufacturers meet the rising requirements of consistency and control. The range of injectable therapies has increased with more complex biological and GLP-1 drugs. This makes the demands higher on primary packaging components.
The demands go beyond the regulatory expectations to be more focused on the quality, consistency, and production control of components. Premia™ Precision combines multiple quality criteria into one. The criteria include impact-related quality criteria and manufacturing controls driven by risks. It is also concerned about the management of visible and subvisible particles. Additionally, process monitoring through data generation of production takes place. Also, 100% automated vision inspection of each component occurs. Through all these, a defined quality standard is established.
Aptar Pharma Strengthens Injectable Quality Standards
Premia™ Precision was developed by Aptar Pharma to mitigate quality risks during manufacturing. The technology helps provide consistent parts for injectables.
Beatrice Leprince, President, Aptar Pharma Injectables, said, “As injectable therapies become more complex and valuable, pharmaceutical manufacturers need component quality standards that reflect increasingly demanding expectations for consistency and performance. Premia™ Precision demonstrates our commitment to advancing quality for sensitive injectable applications by combining our elastomer expertise, industrial capabilities and a rigorous approach to defect prevention and control.”
Nicolas Voisin, Senior Global Quality Director, Injectables, Aptar Pharma, added, “Premia™ Precision brings together impact-based quality limits, robust operational controls and 100% vision inspection in one standard. Together, these measures support a consistent approach to component quality throughout production and final verification.”
Products provided by Aptar Pharma include elastomeric components, innovative coatings, and solutions that are immediately available. In addition, the company has products that provide aseptic transfer solution for use in vials. Pre-filled syringes and auto-injector are also provided as applications by Aptar Pharma.
Over 60 years of expertise in precision manufacturing are offered by the company. The injectables portfolio of the company helps in solving the problems faced in injectables systems. Pharmaceutical manufacturers are provided with collaboration by Aptar Pharma for meeting complex development requirements. Besides, the customer-focused strategy helps to facilitate decision-making process and build confidence among customers.
The new product offered by the company is Premia™ Precision. Therefore, support to challenging injectable applications is improved by Aptar Pharma. Premia™ Precision from Aptar Pharma will be formally introduced during CPHI Milan from October 6-8. It will also be introduced at the PDA Universe conference. PDA Universe Conference is being held in Palm Springs, California, from October 6-7. Visitors will have the opportunity to meet with Aptar Pharma’s experts for injectables.
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News Source: Businesswire.com
