Systems should be analyzed not only for their basic ability to contain the powders of interest, but also for how efficiently they integrate into the production process. For instance, will the system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?
Water is one of the most widely used raw materials in the pharmaceutical plant. Several grades of water are used throughout the plant. One grade, Water for Injection (WFI), is water purified by reverse osmosis or distillation as specified by the United States Pharmacopeia (USP). Specific tests for Conductivity apply to WFI Water produced on site for manufacturing purposes.
Biopharmaceutical Chromatography Systems are designed for separating and purifying proteins and bio-engineered products. The systems must maintain a hygienic design. Wetted surface finish must be < 20 μinch Ra and material traceability is important to maintain system integrity. pH measurement plays an important role in the purification process, providing feedback control of buffer and effluent feed through the column. The system’s wetted components must withstand Cleaned in Place (CIP) and Steamed in Place (SIP) cycles, which can stress a sensor with high heat and caustic. The pH sensor must be able to make accurate and stable pH measurements after the cleaning cycles.
In fermentation and cell culture, one of the most critical process challenges is to maintain the optimal pH level. Fermentation process utilizes a living organism such as a yeast, bacteria, or fungus strain to produce an active ingredient. Fermentation process is normally shorter in duration (2-7 days). Cell culture is a process in which a mammalian cell is grown to produce the active ingredient. The cell culture process is typically longer (2-8 weeks).
Conductivity measurement plays an important role in the purification process. Conductivity is one of the determinants of when to start and when to end the collection process. Tighter conductivity controls will increase purity yields. In addition, it may improve secondary collection processing.
For many decades the only practical metric of airborne microbial contamination has been the colony forming unit (cfu). Adapting growth-based approaches for monitoring modern aseptic manufacturing processes has sometimes proven difficult. Although microbiologists have bemoaned the limitations of measuring only cfu, no alternative metric or technique has yet been adopted. In this article we will review one such alternative microbiological method, commonly called laser induced fluorescence (LIF).
After multiple successful facility projects across the world, Extract Technology were approached by a major Pharmaceutical Company and given the challenge to update the older generation of containment equipment from 1990’s technology to the advanced technology available today.