Dec Group Offers Customized DPI Manufacturing Solutions

Technological developments in the pharmaceutical industry have advanced rapidly over the last decades. One field of particular interest has been aseptic and sterile primary packaging. Primary packaging of pharmaceutical products often involves filling containers (including vials, syringes and bottles) with powders and/ or liquid solutions. Manufacturing staff, equipment and premises are all subject to stringent quality controls – and for good reason: patient safety. In order to ensure the safety and quality of pharmaceutical products, every manufacturer in the pharmaceutical industry is compelled to adhere to the Good Manufacturing Practice (GMP) guidelines. Recently, a complete draft revisionI of Annex 1 (Manufacture of Sterile Medicinal Products) of the GMP has been released. This document intends to provide information on the latest status, trends and technologies in parenteral filling equipment.

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In the medical and healthcare industry, there is an increasing demand for prefilled syringes as a drug delivery format. It offers various advantages such as ease of drug handling, high dosing accuracy and maintaining drug stability. This form of drug delivery system minimizes potential contamination from bacteria which further ensures patient safety. Dual chamber syringes combine the storage of a powdered and a diluent into one primary packaging. By simply exerting pressure on the plunger, the liquid of the lower chamber is forced into the chamber that houses the drug substance, allowing the content of both chambers to be mixed and easily administered. This simplifies the administration process and ensures a longer shelf life of the drug substance, which provides great advantages compared with conventional vial drug delivery systems. DecFill® can help overcome the challenges to optimize your production efficiency. DecFill® aseptic filling lines are designed to meet a wide range of applications from laboratory needs to commercial production. The DecFill® range features semi-automated to fully automated filling lines which can both be optimized for different speeds, capacities, and container types.

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As pharmaceutical suppliers around the globe are preparing to meet the deadline for serialization compliance, the question naturally arises what the next step should be. The answer? Aggregation: linking individual products to their secondary and even tertiary packaging. This whitepaper will take you through the ‘what, why, where, who, when & how’ of the concept and execution of aggregation.

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