A buffer is an aqueous solution that consists of a mixture of a weak acid and its salt (acid buffer) or a weak base with its salt (basic buffer). Its pH changes very little when a small amount of strong acid or base is added to it and is thus used to prevent a solution's pH change. Buffer solutions are used for a wide range of chemical ...
The systems most commonly used for biopharmaceutical processing include single-phase liquid blending as well as liquid-liquid, gas-liquid, and solid-liquid …
Definition. Mixing is defined as an unit operation in which two or more components are treated in such a way that each particle / molecule of the components lies as nearly as possible in contact with a …
The purpose of this study is three-fold: (1) to understand the impact of bottom-mounted disposable mixer design on drug product quality and process performance, (2) to identify …
Various processes that have been successfully developed for wastewater treatment (treatment of industrial wastes/effluents) have been surveyed with special reference to biological treatment including design of bioreactors. Limitations of each process, design and performance characteristics of different kinds of bioreactors …
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1. Introduction. Powder handling and processing of fine powders is a major problem in many industries due to powder cohesion, and is a topic of great importance in the pharmaceutical industry, where more than 80% of all pharmaceutical products are in solid form [1].. In the pharmaceutical industry, product homogeneity is an extremely important …
Abstract. Micromixing is a crucial process within microfluidic systems such as micro total analysis systems (μTAS). A state-of-art review on microstructured mixing devices and their mixing phenomena is given. The review first presents an overview of the characteristics of fluidic behavior at the microscale and their implications in ...
nonsterile surfaces, introduction of particulate matter or biological fluids, and mix-ups with other conventionally manufactured products or CSPs. 2. The preparation is performed in accordance with evidence-based information for physical and chemical compatibility of the drugs (e.g., FDA-approved labeling, stability studies). 3.
The vortexer has been used to suspend cell or tissue samples for use in tissue analysis and cell culture. When investigating proteins and enzymes, a vortex mixer is essential for the homogeneous mixing of samples with reagents and buffer. It is also utilized in heating and mixing samples in pharmaceutical areas.
Mixing, stirring, and shaking laboratory equipment can be quite specialized so it is important to obtain the correct item for the task. Due to the complexity in mixing, there are numerous different types of laboratory …
Titration is a common technique used in analytical chemistry to determine the concentration of an unknown solution by gradually adding a solution with a known concentration. The reactant of known concentration is added bit by bit until neutralisation is achieved. Neutralisation is usually indicated by a change in the colour of the solution ...
With a wide range of offerings—including analog or digital; open air, incubated, CO 2 resistant, or refrigerated; and benchtop, floor, and stackable models—Thermo Scientific orbital shakers, rockers, and rotators are designed to deliver outstanding performance, accuracy, and reproducible results for your application needs.
Filling is one of the key unit operations during the fill-finish process of biological drug products. The formulated and sterile filtered drug substance is aseptically filled into primary packaging containers, e.g. glass or polymer vials, syringes, or cartridges, at a defined fill weight corresponding to a defined fill volume enabling the delivery of the …
The development of the Pulmozyme formulation and manufacturing process has been previously reported (1). Plastic ampuls are manufactured using blow–fill–seal (BFS) technology (2). BFS has gained wide acceptance for pharmaceutical solutions (e.g., eye, nose, and ear drops, contact-lens solutions, inhalations, oral, or topical solutions) and ...
This chapter describes a typical biologicsBiologics drugDrug/device combination products product manufacturing process and typical work to support that …
The 304 stainless steel coupons were partially submerged in a beaker with 3M sodium chloride solution or a saturated sodium chloride solution for 30 minutes while mixing on a stir plate. The soiled coupons were then air dried at ambient temperature overnight (> 16 hours) prior to washing with 80°C deionized water by agitated immersion …
scale. The mixing at scales above the Kolmogorov's scale is ensured by the breakage and random mixing of the eddies. In addition, ero-sion occurs for eddies between Taylor and …
These solutions consist of a weak acid and a salt of a weak acid. An example of an acidic buffer solution is a mixture of sodium acetate and acetic acid (pH = 4.75). Alkaline Buffers. These buffer solutions are used to maintain basic conditions. A basic buffer has a basic pH and is prepared by mixing a weak base and its salt with strong acid.
Pages: 56–58,63 Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system. …
Pharmaceutical Technology, Pharmaceutical Technology-07-02-2019, Volume 43, Issue 7. Sterile filtration is often required for biologics but presents degradation and compatibility challenges. Selection of a sterilization strategy for a drug product that requires aseptic manufacturing is generally determined by the stability of the drug …
In today's pharmaceutical development, excipients are an integral part of pharmaceutical products, used in multiple ways, and have well defined functional roles. For proteins and vaccines, these roles …
4', class ii, type a2, purair bio biological safety cabinet, sterile, air science W 56.3" × D 34.9" × H 64.2", ISO Class 5, Biosafety Level 1, 2 or 3 Containment, Base Stand Included Product No: 6930 6930
Bioprocessing is the creation of useful products through the use of a living thing—usually cells or cell components, viruses, or an entire organism. End products can be anything from biofuels produced from algae, or antibiotics created from mold, such as penicillin. Beer produced from yeast is another example of bioprocessing.
Mixing is extremely important, and sometimes it takes a little bit of time for a homogeneous solution to be formed. From the diluted solution (first tube from the left), transfer 1 mL and mix with 1 mL of water and so on. The dilution in the first tube will be 1/2, in the second tube 1/4, and so forth.
This chapter describes a typical biologics drug product manufacturing process and typical work to support that process. Unit operations addressed include dilution strategies and mixing, sterile filtration, filling, capping, and inspection, with a separate discussion on hold time monitoring. As each unit operation is discussed, manufacturing ...
Definition. Mixing is defined as an unit operation in which two or more components are treated in such a way that each particle / molecule of the components lies as nearly as possible in contact with a particle / molecule of the other components. If this is achieved it produces a theoretical 'ideal' situation, called a perfect mix.
Figure 4.5. 2: Preparation of 250 mL of a Solution of (NH 4) 2 Cr 2 O 7 in Water. The solute occupies space in the solution, so less than 250 mL of water are needed to make 250 mL of solution. 45 milliliters of water remain in the graduated cylinder even after addition to the mark of the volumetric flask. Example 4.5. 2.
However, an alginate solution formed from high molecular weight polymer becomes greatly viscous, which is often undesirable in processing . For example, proteins or cells mixed with an alginate solution of high viscosity risk damage from the high shear forces generated during mixing and injection into the body . Manipulation of the molecular ...
The low water solubility of pharmacoactive molecules limits their pharmacological potential, but the solubility parameter cannot compromise, and so different approaches are employed to enhance their bioavailability. Pharmaceutically active molecules with low solubility convey a higher risk of failure for drug innovation and …