scholarly journals A Proposal for Six Sigma Integration for Large-Scale Production of Penicillin G and Subsequent Conversion to 6-APA

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Anirban Nandi ◽  
Sharadwata Pan ◽  
Ravichandra Potumarthi ◽  
Michael K. Danquah ◽  
Indira P. Sarethy

Six Sigma methodology has been successfully applied to daily operations by several leading global private firms including GE and Motorola, to leverage their net profits. Comparatively, limited studies have been conducted to find out whether this highly successful methodology can be applied to research and development (R&D). In the current study, we have reviewed and proposed a process for a probable integration of Six Sigma methodology to large-scale production of Penicillin G and its subsequent conversion to 6-aminopenicillanic acid (6-APA). It is anticipated that the important aspects of quality control and quality assurance will highly benefit from the integration of Six Sigma methodology in mass production of Penicillin G and/or its conversion to 6-APA.

2011 ◽  
Vol 314-316 ◽  
pp. 2433-2438
Author(s):  
Wei Zhi Wang

By only applying a after the event exam in the quality control of the batch production is not enough to meet the needs of modern large-scale production. To a certain extent, modern quality control is a dynamic process of the steady-state judge and adjustment. A simple and reliable steady-state judge rule and method is the premise to guarantee the normal operation. This paper provides a quantitative method to evaluate production process steady-state by analyzing influence factors based on mathematical statistics. The method is both suitable for simple production process and complex production process with sub-processes.


Author(s):  
Mangal Shailesh Nagarsenker ◽  
Megha Sunil Marwah

The science of liposomes has expanded in ambit from bench to clinic through industrial production in thirty years since the naissance of the concept. This chapter makes an attempt to bring to light the impregnable contributions of great researchers in the field of liposomology that has witnessed clinical success in the recent times. The journey which began in 1965 with the observations of Bangham and further advances made en route (targeting/stealthing of liposomes) along with alternative and potential liposome forming amphiphiles has been highlighted in this chapter. The authors have also summarised the conventional and novel industrially feasible methods used to formulate liposomes in addition to characterisation techniques which have been used to set up quality control standards for large scale production. Besides, the authors have provided with an overview of primary therapeutic and diagnostic applications and a brief insight into the in vivo behaviour of liposomes.


2018 ◽  
Vol 3 (8) ◽  
Author(s):  
Nathalie Jung ◽  
Maike Windbergs

Abstract In the fast-developing fields of pharmaceutical research and industry, the implementation of Raman spectroscopy and related technologies has been very well received due to the combination of chemical selectivity and the option for non-invasive analysis of samples. This chapter explores established and potential applications of Raman spectroscopy, confocal Raman microscopy and related techniques from the early stages of drug development research up to the implementation of these techniques in process analytical technology (PAT) concepts for large-scale production in the pharmaceutical industry. Within this chapter, the implementation of Raman spectroscopy in the process of selection and optimisation of active pharmaceutical ingredients (APIs) and investigation of the interaction with excipients is described. Going beyond the scope of early drug development, the reader is introduced to the use of Raman techniques for the characterization of complex drug delivery systems, highlighting the technical requirements and describing the analysis of qualitative and quantitative composition as well as spatial component distribution within these pharmaceutical systems. Further, the reader is introduced to the application of Raman techniques for performance testing of drug delivery systems addressing drug release kinetics and interactions with biological systems ranging from single cells up to complex tissues. In the last part of this chapter, the advantages and recent developments of integrating Raman technologies into PAT processes for solid drug delivery systems and biologically derived pharmaceutics are discussed, demonstrating the impact of the technique on current quality control standards in industrial production and providing good prospects for future developments in the field of quality control at the terminal part of the supply chain and various other fields like individualized medicine. On the way from the active drug molecule (API) in the research laboratory to the marketed medicine in the pharmacy, therapeutic efficacy of the active molecule and safety of the final medicine for the patient are of utmost importance. For each step, strict regulatory requirements apply which demand for suitable analytical techniques to acquire robust data to understand and control design, manufacturing and industrial large-scale production of medicines. In this context, Raman spectroscopy has come to the fore due to the combination of chemical selectivity and the option for non-invasive analysis of samples. Following the technical advancements in Raman equipment and analysis software, Raman spectroscopy and microscopy proofed to be valuable methods with versatile applications in pharmaceutical research and industry, starting from the analysis of single drug molecules as well as complex multi-component formulations up to automatized quality control during industrial production.


RSC Advances ◽  
2014 ◽  
Vol 4 (108) ◽  
pp. 62965-62970 ◽  
Author(s):  
Jung Sang Cho ◽  
Kyeong Youl Jung ◽  
Mun Young Son ◽  
Yun Chan Kang

Dense spherical Y2O3:Eu3+ phosphor particles with a narrow size distribution were successfully prepared by using a two-step spray drying method. This method is easily scalable and can therefore be applied to the mass production of phosphor particles with high photoluminescence.


Author(s):  
Colin F. Baxter

One of the epic industrial and scientific achievements of the United States during World War II was accomplished at the Wexler Bend Pilot Plant, Kingsport, Tennessee, where fifty hand-picked (their finances were investigated, and all the operators were married with at least one child) Tennessee Eastman employees, working at a phenomenal pace, developed a process for large-scale production of the world’s most powerful explosive, RDX. The success at Wexler Bend opened the door to the next phase: the mass production of RDX.


1983 ◽  
Vol 5 (8) ◽  
pp. 493-496
Author(s):  
Arye Lazar ◽  
Dino Marcus ◽  
Shaul Reuveny ◽  
Haim Grosfeld ◽  
Abraham raub ◽  
...  

Author(s):  
Dong Truong Nguyen ◽  
Chris Clarkson

We investigate stone drill point production, use, maintenance, and discard from a technological perspective at the Late Neolithic workshop of Bai Ben on Cat Ba Island, Northeastern Vietnam. Bai Ben contains over 18,000 retouched chert flakes classified as drill points and dating to c.3000BP. Large scale production of drills most likely took place for reasons of mass production of drilled organic and inorganic objects. Few of such drilled objects are found at the site, perhaps due to poor organic preservation or removal of finished objects for trade and exchange. An analysis of attribute on drills and cores examines the time-ordering of dimensional and morphological changes as reduction continued at the site. The research finds that drills were produced from a diverse range of nodules sizes, blanks, core technologies and raw materials, but similar blanks were selected to produce very similar drill point forms.


Micromachines ◽  
2020 ◽  
Vol 11 (11) ◽  
pp. 1007
Author(s):  
Anna Nastruzzi ◽  
Gabriele Pitingolo ◽  
Giovanni Luca ◽  
Claudio Nastruzzi

Hydrogel microbeads hold great promise for immune-protective cell transplants and in vitro studies. Millifluidic generation of hydrogel microbeads is a highly efficient and reproducible approach enabling a mass production. This paper illustrates the preparation and characterization of highly controlled and reproducible microbeads made by different types of hydrogel using millifluidic approaches. The optimization of the process was made by a design of experiments (DoE) approach. The microbeads’ large-scale production can be potentially used for single cells or clusters encapsulation.


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