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Reconstitution Time for Lyophilized products: overcome the challenges!

A number of drugs are unstable in an aqueous environment, even when exposed for a short duration, thus requiring packaging, storage, and shipping in a powder or lyophilized state to keep the product stable during its shelf life. Used for parenteral administration, these drugs are commonly known as powder for injection (PI), powder for reconstitution, dry powder injection, or powder for constitution. Typically, PI drugs are supplied in glass vials with rubber plugs and are mixed or reconstituted with a diluent (usually 5% dextrose solution, normal saline, bacteriostatic water, or sterile water for injection) before administration. An incompletely dissolved product can be hazardous to the pati

Isolators available on the Market

Isolators are routinely found within the pharmaceutical industry and are widely used in Europe (and increasingly in the US) for aseptic compounding applications. But what are the best isolators on the market? To answer this question we definitively need to get deeper in the manufacture world and their alliances. In fact, complex filling lines require competent management of the interaction between filling machine, isolator system and subsequent machines, e.g. freeze-dryers or overseal capping machines. Challenges include the safe functioning of the interfaces, the simplicity of the overall controls system and easy of operation of the individual components. In order to give some guidance: Bar

Side Maintenance Door or Back Maintenance Door in a Lyophilizer

With integrated Automatic Loading System and/or due to room restrictions, the position of the lyophilizer maintenance door is a delicate matter. In another article we will detail the different LUS (loading/unloading system) in the market; for now, we should take into consideration that they will be front-sided LUS or front-back-sided: in other words they will “stress” one or two chamber wings. From a general point of view a one sided-LUS is able to release the mechanical pressure on the chamber since it keeps 3 free sides for setting up condenser and maintenance door. Is in fact essential to leave one side of the chamber empty or else the hinges will be under higher load and the accuracy of

Overcome the distance

Several questions showed up after our previous post, here there is a more precise information about the different strategies and manufacturing approach from different freeze dryer suppliers. There are two clear trends in the market when considering the manufacturing alternatives for freeze dryers: Single production site, with integrated design, manufacturing, testing and FAT. Multiple production sites, with independent design, manufacturing, testing and FAT. The decision of some freeze dryer manufacturers to select one of these models had different chapters over the last years. The increasing demand from pharmaceutical companies in Asia to install high quality and technological advanced free

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