Spray drying is one of the most remarkable technologies currently to be applied to pharmaceuticals. It is a continuous process that converts, in a single step, a liquid feed into a powder and is an ideal …
The pharmaceutical industry is one of the most regulated and demanding industries, with strict guidelines and quality standards that must be met at all times. Industrial pumps play a vital role in the pharmaceutical industry, facilitating the movement of liquids and gases during the production process. As the industry evolves, there is a …
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One major advantage of continuous pharmaceutical manufacturing over traditional batch manufacturing is the possibility of enhanced in-process control, reducing out-of-specification and waste material by appropriate discharge strategies. The decision on material discharge can be based on the measurement of active pharmaceutical …
Abstract. The importance of size reduction in relation to pharmaceutical active agents and excipients is well known. A variety of types of equipment are used for …
In January 2011, the U.S. Food and Drug Administration published new process validation guidance for pharmaceutical processes. The new guidance debunks the long-held industry notion that three consecutive validation batches or runs are all that are required to demonstrate that a process is operating in a validated state. Instead, the new guidance …
Pharmaceutical Granulation Processes, Mechanism, and the Use of Binders 263. complicated by additional constraints of minimal drug quantity availability and aggres-sive timelines. It is important ...
Process mapping is a process that basically outlines the different steps it takes to reach a predetermined goal, which can be anything from more product efficiency to customer satisfaction. Process mapping is usually done by outside pharmaceutical consultants who specialize in mock FDA training and process mapping, along with many …
Enzymes are biological catalysts (also known as biocatalysts) that speed up biochemical reactions in living organisms. They can also be extracted from cells and then used to catalyse a wide range of commercially important processes. For example, they have important roles in the production of sweetening agents and the modification of …
43 based on process data, and thus the properties/attributes in question are not directly measured but 44 . are inferred from process data). 45 . Scope 46 This document addresses preliminary considerations (general principles) for process models, reflecting 47 . the use of performance-based approaches in pharmaceutical manufacturing processes.
Pharmaceutical process vessels are containers or tanks equipped with the accessories and controls required to complete parts of the process in the pharma assembly line. They are used when the production process includes a liquid component, with manufacture and storage being their primary functions. With the high sanitary and …
Summary. Milling is a powerful unit operation to aid in the control of particle size for a variety of processing, bioavailability, reactivity, and safety-related …
Pharmaceutical processes use a wide variety of dryers. This article gives a brief review of some of the practical challenges in process design and operation to ensure final product quality, meeting specification reliably, in a highly regulated environment. Both primary and secondary processing are considered, including tablet coating.
Various terms such as crushing, disintegration, dispersion, grinding, and pulverization have been used synonymously with milling.1,2 Briefly, the process is related to the …
Abstract. Crystallization is a major technological process for particle formation in pharmaceutical industry and, in addition, plays an important role in defining the stability and drug release properties of the final dosage forms. Industrial and regulatory aspects of crystallization are briefly reviewed with reference to solid-state properties ...
SCALING The challenge of scaling a granulation process from laboratory to commercial production has been completed successfully innumerable times, yet it remains a daunting challenge in that no single, broadly …
In the pharmaceutical industry, the most common way to achieve these properties is by mixing the drug substance with a variety of excipients and granulating …
Gap analysis is a process that compares two sets of data to identify the differences between them. In a business context, gap analysis involves examining the current state of a process, procedure, or capability and comparing it to the desired future state. The purpose of gap analysis is to assess where you are versus where you want to …
Many on-line tools are routinely applied to monitor, measure or control processes. Commonly used PAT tools that are well-integrated and routinely used in manufacturing include thermocouples and pressure sensors. ... Preparing Calibration Sets for Use in Pharmaceutical Analysis by NIR Spectroscopy, J. Pharm. Sci. 97(3) 1236 …
In nanopharmaceuticals, this is useful to apply to the equipment used for milling processes that break down coarse particles into finer ones. Bead mills, which use grinding media to disperse particles in …
"The manufacture and use of a drug product, including its components, necessarily entail some degree of risk."—International Conference for Harmonization (ICH) Q9. This paper examines the role of risk management in pharmaceutical product development in the context of patient safety and drug efficacy. Its objective is to …
Biopharmaceuticals are large molecule drugs that are hundreds of times the size of conventional pharmaceuticals or small molecule drugs. There are two types of biopharmaceuticals: biologics and biosimilars. Biologics are large protein-derived molecules grown in cells and purified into active agents. Similar to generic conventional drugs ...
Process piping systems are vital to the success of any pharmaceutical or biotech development and manufacturing facilities. In fact, piping design is an integral part of pharmaceutical facility design. Since piping systems are frequently in contact with product materials, the design needs to be efficient and meet the stringent rules and standards set …
Indeed, granulation is used to improve the formulation properties such as flowability, compressibility, and so on for pharmaceutical manufacturing. Different types …
Commonly used mills in pharmaceutical Grinding Processes are ball mill, hammer mill, fluid energy mill, and disintegrator. Ball mill is primarily used.
Completion of the particle formation process in the spray dryer creates a dispersed particulate aerosol, from which the solid material needs to be separated from the process gas stream. One of two different methods is typically used for product capture in a pharmaceutical spray drying process; cyclone separation or baghouse filtration.
Drug Discovery. The synthesis of new molecules plays a key role in the drug discovery process. A drug candidate results from a lengthy and intense research activity where many molecules are synthesized and extensively tested. This generates informative structure-activity relationships for the conversion of this knowledge in the optimization and ...
Ultratargeted marketing materials generated in-house. Generative AI is transforming nearly all aspects of the pharmaceutical industry, revamping the way companies operate and potentially unlocking billions of dollars in value. The McKinsey Global Institute () has estimated that the technology could generate $60 billion to …
This process takes an average of 10–15 years. After accounting for the costs of failed trials, the median capitalized research and development investment to bring a new drug to market has been estimated at $985.3 million (95% CI, $683.6–$1228.9 million), and the mean investment was estimated at $1335.9 million (95% CI, $1042.5–$1637.5 ...
Abstract. This paper examines fine grinding techniques in current use in the pharmaceutical industry. Experimental results are given for fine grinding of vitamin C, chosen as a model substance representative of pharmaceutical products, using eight …