The journey from discovery laboratory to pharmacy shelf is long and arduous, particularly for highly potent APIs, which must be handled in compliance with complex regulatory requirements at each stage of the journey.
A typical batch fermentation process starts with sterilization so that all micro-organisms found in the mash and reactor are completely destroyed. The mash is heated in the fermenter or a special cooking vessel by injecting live steam or by means of steam coils set in the vessel. Holding the temperature at 121°C (250°F) for 30 minutes is usually adequate to destroy all living organisms in the mash. However some processes require higher temperatures. As shown in Figure 1, a heating/cooling jacket maintains the temperature of the fermentor.
Biopharmaceutical Chromatography Systems are designed for separating and purifying proteins and bio-engineered products. Flow systems are compact in design to maximize throughput. No dead legs in process pipe can exist since unswept areas are more challenging to completely clean as well as delaying product throughput. The systems must maintain a hygienic design. Wetted surface finish must be < 20 μinch Ra and material traceability is important to maintain system integrity.
A major multinational pharmaceutical company determined that pH maintenance accounts for 46% of all the field work. Customer wanted to increase pH reliability and eliminate rework/scrap due to poor pH measurements. They also wanted to streamline maintenance practices.
Investments are the building blocks of a company's future. Planning and implementing them requires strategy and system and decision-makers who know their goals and carry out the implementation according to plan are more successful than those who rely exclusively on their impulses.Meaningful information forms the basis of a good investment decision and it helps to protect the future prosperity of your company. This white paper will help you answer several question regarding the total cost of ownership (TCO) of production line equipment including “have you clarified the foundations of your investment decisions?” and “how do you determine and calculate the return on investment (ROI) time of an investment?”
Food manufacturers typically install an x-ray inspection system at the end of the production line, although it can be installed at any point during the production process. But, which are the best locations for x-ray inspection? Where are the critical control points to ensure the highest levels of product safety? Should x-ray inspection be at the beginning of the production line, where the raw materials arrive, at some intermediate stage, or at the end of the line before products are shipped out? Or would product safety and quality be better served by installing x-ray systems at more than one critical control point? This white paper addresses these questions to help you understand the most effective locations of critical control points.
In recent years, container closure integrity (CCI) testing has steadily moved up the pharmaceutical manufacturing agenda. Latest research has shown that not only ampoules are prone to CCI defects. Other primary packaging types such as vials, cartridges and syringes equally require thorough testing, especially when filled with lyophilized products. Consequently, the United States Pharmacopeia (USP) has been revising its General Chapter 1207, calling for more quantitative, validated CCI test methods. A significant shift is expected towards non-destructive technologies.