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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. Pharmaceutical manufacturing is divided into two major stages: (i) the production of the active ingredient or drug (primary processing, or manufacture) and (ii) secondary processing, the conversion of the active medicines into products suitable for administration. However, before a medication can be manufactured at any scale, much work goes into the actual formulation of the medicine. Formulation development scientists must evaluate a compound for uniformity, stability, and many other factors. After the evaluation phase, a solution must be developed to deliver the medication in its required form such as solid, semisolid, immediate or controlled release, tablet, and capsule.
RFID Tags
Published in Lu Yan, Yan Zhang, Laurence T. Yang, Huansheng Ning, The Internet of Things, 2008
Peter J. Hawrylak, M.H. Mickle, J.T. Cain
One area of major advantage for RFID is the ability to write information to RFID tags providing a key benefit in the fight against counterfeit drugs. There are numerous cases of patients unknowingly receiving and/or using counterfeit drugs, leading to potentially fatal results. The Federal Drug Association (FDA) is the regulatory body in the United States responsible for regulating the pharmaceutical industry. They have recently imposed a requirement for an e-Pedigree for all prescription medications, which is a record of every point of handling in the supply chain for that particular medication and used at the receiving end to verify the authenticity of the medication by verifying the chain of custody. The FDA mandate does not specify that RFID must be used, but only requires an electronic record of this information. RFID tags are one possible solution to the e-Pedigree mandate as they can be written to and updated during transit through the supply chain. Each RFID tag can contain the information about who transported the medication and when they took possession of the medication. This information, along with the unique identification assigned to each RFID tag, can be used to verify that the medication is not a counterfeit. In this application, RFID will help safeguard the public.
Future of Parenteral Manufacturing
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
James Agalloco, James Akers, Russell Madsen
The pharmaceutical industry is highly regulated, primarily by agencies such as FDA (United States), EMA (Europe), and MHLW (Japan).* These agencies seek to ensure the safety and efficacy of pharmaceuticals by means of registration requirements and inspections designed to ensure that the manufactured products comply with the standards contained in their approved applications and that appropriate manufacturing controls required by the various Current Good Manufacturing Practice (CGMP) regulations are in place. The industry must also concern itself with pharmacopeial standards contained in the USP, JP, and Ph. Eur.† Also, compliance with other regulations such as environmental and employee safety and health remains.
When risks need attention: adoption of green supply chain initiatives in the pharmaceutical industry
Published in International Journal of Production Research, 2019
Anil Kumar, Edmundas Kazimieras Zavadskas, Sachin Kumar Mangla, Varun Agrawal, Kartik Sharma, Divyanshu Gupta
The pharmaceutical industry is growing rapidly in terms of enhancing research and design in the industry; however, proper execution of supply chain activities in this sector generates huge pharmaceutical waste, which is harmful to the environment and has a direct impact on human health (Xie and Breen 2012; Faisal 2016). In the last few decades, the consciousness of people about the environment has increased and regulatory bodies have also started to focus on world environmental issues such as scarcity of resources, global warming and carbon emissions (Xie and Breen 2012; Tseng and Chiu 2013). To help industries to minimise their ecological impact, managers and practitioners suggest employing green principles to its supply chain network (Xie and Breen 2012). The pharmaceutical value chain accounts for sophisticated products and involves higher investment for research and development (Tseng and Chiu 2013). The increased global and domestic pressures on environmental sustainability, economic and safety considerations (Jha 2007) steer the pharmaceutical industry to manage green supply chain (GSC) initiatives in its business. GSC initiatives help to improve the pharmaceutical industry ecological and economic gains by recycling unused/unwanted medicines and disposing of products in an eco-friendly manner. From a holistic view, GSC initiatives in the pharmaceutical industry can be defined as the inclusion of green practices at each stage of the supply chain i.e. green sourcing, eco-friendly designing, green manufacturing, green distribution, reverse logistics, etc. (Narayana et al. 2014; Kumar et al. 2015; Mangla, Madaan, and Chan 2013; Dubey, Gunasekaran, and Papadopoulos 2017).
Survey of particle production rates from process activities in pharmaceutical and biological cleanrooms
Published in Science and Technology for the Built Environment, 2019
Oluwaseyi T. Ogunsola, Junke Wang, Li Song
The pharmaceutical processes include dispensing, packaging, granulation, compression, and milling/blending. For some processes, they also include some detailed categories or sub-processes. For example, dispensing processes include two types: open powder and liquid powder. Due to the measurements and data analysis obtained for each process, which are expressed in the same styles, this paper only selects one of the pharmaceutical processes to show the details. Herein, the open powder dispensing process is selected.