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Occupational Health and Safety
Published in Terry Jacobs, Andrew A. Signore, Good Design Practices for GMP Pharmaceutical Facilities, 2016
Hazardous materials are defined by their flammability, toxicity, and reactivity characteristics. The handling, use, and storage of hazardous materials in a pharmaceutical manufacturing facility present the potential risk of exposure to personnel, the facility, and the environment. To manage these potential risks, it is critical that facility designers have a thorough understanding of the types of hazardous materials that are planned to be used in the facility, as well as the manner in which they will be handled, used, and stored. Minimum requirements addressing the use and storage of hazardous materials are specified by country-specific regulations and codes. Relevant codes in the United States includeOSHA regulations contained in 29 CFR 1910, Subpart HNFPABuilding Officials and Code Administrators International (BOCA)
VOCs In Wastewater
Published in Ralph L. Stephenson, James B. Blackburn, The Industrial Wastewater Systems Handbook, 2018
Ralph L. Stephenson, James B. Blackburn
The pharmaceutical manufacturing industry includes facilities which manufacture, extract, process, purify, and package chemical materials to be used as human and animal medications. This industry includes facilities in the following SIC codes: 2833 Medicinal Chemicals and Botanical Products;2834 Pharmaceutical Preparations; and2836 Biological Products Except Diagnostic Substances.
Pharmaceuticals
Published in James G. Speight, Handbook of Petrochemical Processes, 2019
The pharmaceutical industry includes the manufacture, extraction, processing, purification, and packaging of chemical materials to be used as medications for humans or animals (Gad, 2008). Pharmaceutical manufacturing is divided into two major stages: the production of the active ingredient or medicine (primary processing or manufacture) and secondary processing, the conversion of the active medicines into products suitable for administration.
Optimization of Pharmaceutical Processes
Published in Journal of Quality Technology, 2023
The third section (Chapters 9–12) focuses on continuous manufacturing to help the pharmaceutical industry implement innovative technologies to improve product quality and modernize pharmaceutical manufacturing to tackle the underlying causes of drug shortages or recalls. In Chapter 9, Patrascu and Barton introduce and demonstrate a new dynamic modeling paradigm, non-smooth modeling, for the simulation and optimization of continuous manufacturing processes in the pharmaceutical industry. In Chapter 10, Laky et al. present mathematical models relevant to an API's synthesis, crystallization, filtration, and drying steps. Each step encourages QbD to use an integrated simulation framework for process analysis and optimization. In Chapter 11, Nikolakopoulou et al. describe a plant-wide model developed for a compact modular, reconfigurable system for continuous-flow pharmaceutical manufacturing, discuss the supervisory control design methodology, and present the dynamic optimization formulation to determine optimal dynamical operations. They demonstrate a computational case study for a compact modular plant for the continuous upstream manufacturing of atropine. In Chapter 12, Boojari et al. develop an end-to-end biopharmaceutical production process from API lovastatin through a systematic approach to the synthesis and design process.
Benchmarking green chemistry adoption by the Indian pharmaceutical supply chain
Published in Green Chemistry Letters and Reviews, 2018
Vesela R. Veleva, Berkeley W. Cue, Svetlana Todorova, Harshrajsinh Thakor, Nitesh H. Mehta, Krishna B. Padia
At the same time, both India and China’s pharmaceutical industry has come under scrutiny for the pollution resulting from drug manufacturing. In particular, the emergence of antibiotic resistant bacteria, or “superbugs,” has been attributed in part to insufficient attention to management of pharmaceutical manufacturing waste (6). As early as 2007, Larsson et al. (7) highlighted this problem in a study of pharmaceutical manufacturing effluents in Hyderabad, India, and called for the incorporation of environmental considerations in ICH good manufacturing practice (GMP) guidelines. Recently, Indian authorities closed four polluting companies in the Hyderabad area (8) and China has taken regulatory action on almost 40% of the factories in 30 industrial provinces, raising concern about the security of the pharmaceutical supply chain (9). Researchers, NGOs, and policy makers have called for action by the global pharmaceutical industry to address the environmental performance of its entire API supply chain. This is a critical issue for companies as failure to comply with existing standards could disrupt the manufacturing and sales of pharmaceuticals to U.S. and EU-based companies and healthcare systems.
A meticulous overview on drying-based (spray-, freeze-, and spray-freeze) particle engineering approaches for pharmaceutical technologies
Published in Drying Technology, 2021
Sagar Pardeshi, Mahesh More, Pritam Patil, Chandrakantsing Pardeshi, Prashant Deshmukh, Arun Mujumdar, Jitendra Naik
The pharmaceutical manufacturing process relied on particle technology which is the forefront of product development. The micromeritics and physicochemical properties can be modified using particle technology.[7] On the front of solubility and permeability characteristics of drug components, poorly soluble drugs are processed to improve the solubility characteristics. Many advanced processes like nanocrystalization, solid dispersion, hot-melt extrusion, co-solvency, complexation, and so forth are used to improve the solubility characteristics while drying will be either an intermediate or final step of processing. The drying process includes spray drying, freeze drying, spray freeze drying, tray drying, vacuum drying, and so forth.[3,8] During the manufacturing of solid dosage forms and a few of the parenteral products from the pharmaceutical manufacturing process use drying steps. In the food and biotech industries, drying is an important step during the manufacturing of the finished products. The dried powder in pharmaceutical manufacturing compressed into a tablet, processed to converted into pellets, filled into the capsule, or use directly for inhalation. The inhaled aerosolized dry powder directly gives a therapeutic effect to the lungs or is transported to the brain via the olfactory lobe without the interference of the blood–brain barrier.[9] The lyophilized powdered dosage forms are used as a powdered injection while certain antibiotics are delivered as a reconstituted solution. The solid powders are also fitted into the transdermal carriers for therapeutic effect beneath the skin. In conventional approaches, micronization and drying are simultaneously used to make the micronized powder for final processing.[10,11]