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The newest laboratory freeze dryer by ilshinbiobase

Many people search for a freeze dryer and are surprised, even overwhelmed, with the number of choices available. The biggest question seems to arise when trying to determine the best laboratory freeze dryer: since “everything” begins at the lab. One of the most important factors in determining the right lyophilizer for your needs is the temperature its collector coil can reach. Lab freeze dryers cool anywhere from -50° C (-58° F) to -105° C (-157° F). Collector temperatures are important in the lab because many samples contain solvents such as acetonitrile and DMSO or acids such as TFA. These solvents require a colder collector temperature to give a temperature differential and prevent melt

Giving medicine the protection it deserves - Valor® Glass

As well as our article on Rubber Stoppers having a big influence on the performance during freeze drying, selecting the right Glass Vial can also improve the efficiency of your freeze-drying cycle and the lyophilization cake. What can be advisable is to check with a supplier of packaging that this is indeed an item that should be suitable for a freeze-dry application. If an injectable it needs to be Type I glass for example also very important is the method of manufacture, the future availability, etc since all have an influence on whether it will be suitable. Freeze Dryer – Best Practice for vials When freeze drying, ideally you want as flat and as thin a base to the vial as possible, to en

A giant from Korea – IlshinBioBase

Improvements in the process of Freeze drying and of the equipment to carry it out have been a continuous challenge since this technology’s very beginnings. The design of units for efficient cycle under aseptic conditions has led to the development of specific equipment solutions for use in laboratory as well as in industrial applications. With more than 30 years of experience in this field, Ilshin has specialized in the design and production of GMP equipment for the industrial sector. That is why the design of equipment is focused on strict compliance with current legislation and the trends established by the most demanding customers. The company was established in Korea in 1988 and has now

Why Emerging Markets? Why Emerging Freeze dryer Manufacturers?

Few years ago, multinational pharma companies seeking growth and respite from market uncertainty in Europe and the United States found a haven in emerging markets. However, a more somber outlook soon replaced early euphoria. Some emerging markets either suffered downturns or showed weaker growth forecasts as commodity prices fell; some healthcare systems struggled to scale up adequately their provision of care; and local companies became increasingly effective competitors in the pharma market. Furthermore, multinationals themselves often found it difficult to scale up in emerging markets, with particular challenges in talent recruitment, compliance, and organizational setup. To capture oppor

Shelves

The manufacturing of freeze dryer shelves is a key process: as well known shelves are generally considered the most important PCP (product c

The Coming of Age of Lyophilization

Many biotechnologically manufactured substances are not sufficiently stable in aqueous solutions. Because of this, liquid formulations are quite difficult or in some cases, merely impossible to preserve for longer periods. One solution, however, is freeze-drying, by which water is extracted from the substance in solution under vacuum and low temperatures. Still, before being administered to the patient, the drugs must be reconstituted. The freeze-drying offers drug manufacturers a range of options for packaging, such as sterile WFI syringes and dual chamber systems. With the growth of the biologics market, four of the world’s top-five selling drugs are delivered by injection. Because these d

Application of QbD principles in the development of lyophilized products in aseptic environment

This article aims to explain, in a very clear way, how the development of a process should be carried out for a vial lyophilized product in aseptic environment and how to define the workable space of design in which are achieved the critical attributes of product quality. Reliability through QbD At the end of 2007, the Q8 guide of the ICH (International Conference of Harmonization) already introduced us very clearly to where to focus our effort in the future of drug manufacturing processes. Specifically, it defined the following concepts that will be key for the correct understanding of the present article: Quality Target Product Profile Quality critical attributes Risk analysis (Q9). To lin

Lyophilization 4.0

The term ‘Industry 4.0’ was first coined by the German federal government in a national strategy to promote the computerization of manufactu

The 6 most challenging samples in lyophilization cycle development

In our previous article about QbD, it was mentioned that lyophilization has been considered an art, and cycles developed by trial and error. Here the aim is to give some artistic guideline about the most challenging samples you will encounter in lyophilization cycle development. #1: DMSO (Dimethyl Sulfoxide). DMSO has become popular in the laboratory because of its ability to dissolve both polar and non-polar compounds. It’s miscible in a wide range of organic solvents as well as water. When performing lyophilization in samples containing DMSO there are a few things that need to be taken into consideration: DMSO quickly affects acrylic components which are used in most lyophilizers’ lids an

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