Friday, December 27, 2019
The Love Song Of Alfred Prufrock Analysis - 1803 Words
To many, the allure of poetry lies in the chance to draw our own understandings and conclusions. In this paper, I will be discussing T.S Eliot s The love Song of Alfred Prufrockâ⬠in comparison to Allen Ginsberg s A Supermarket in California. The first poem, The Love song of Alfred Prufrock by T.S Elliot, talks about a man who is quite doubtful and insecure about himself who kept questioning whether or not breaking out of his comfort zone was worth it. The second poem, A Super market in California by Allen Ginsberg follows a trip to a supermarket in California that the author takes while addressing his friend with questions. This paper will include an extensive analysis of my own interpretation of these two poems as well as theâ⬠¦show more contentâ⬠¦We will also see questioning come up many times throughout the poem. By questioning himself so much, the reader may infer that he is very indecisive and doubtful. Thirdly, another line that the author will repeat throughout t his poem is In the room, women come and go/Talking of Michelangelo.â⬠This can perhaps tell the reader that the author is living in a society in which the talk of popular artists is something common. The reader can also see the very awkward and apprehensive persona that the author has throughout this poem. During the social gatherings, the author isn t happy to be dealing in a situation that requires being amiable or pleasant. ââ¬Å"There will be time, there will be time/ To prepare a face to meet the faces that you meetâ⬠It is clear to see that the author isn t necessarily happy or excited to be present, but is dreading the social interaction that requires pretending to be gracious. The author is fed up with all these social gatherings that are only about exchanging fake smiles and greetings. He is afraid that if he says what he actually wants to say or acts how he actually wants to acts then he will be judged or laughed at. This feeling that the author has of being unable to be his true self is again recognized by the time that has passed. ââ¬Å"I have seen the moment of myShow MoreRelatedAnalysis Of The Love Song Of J. Alfred Prufrock1386 Words à |à 6 Pagesââ¬Å"The Love Song of T.S Eliotâ⬠In ââ¬Å"The Love Song of J. Alfred Prufrockâ⬠the reader can clearly understand that T.S Eliot is straightforward as one can get within a poem. In the beginning of the poem, one can infer that Prufrock is being used as a facade to convey Eliotââ¬â¢s inner self who is an introvert that doesnââ¬â¢t quite fit in with the modern day society. ââ¬Å"Prufrockâ⬠sees his personal life as a burden that he cannot mend while he tries to conform into the middle class society that everyone views asRead MoreAnalysis Of Love Song By Alfred Prufrock747 Words à |à 3 Pagesenviable? T.S. Eliot a poet from the early 1900ââ¬â¢s suggests answers to these through his poem Love song. The text is told through an elderly man named Alfred Prufrock, he is questioning his own life about what he has done and fail to do with the time he has been alive. Feeling sorry for himself Prufrock suggest answers and reasonings to what it really means to be alive but falls short on happiness every t ime. Prufrock is lacking happiness for three reasons, second guessing himself to the point where he alwaysRead MoreCritical Analysis : The Love Song Of J. Alfred Prufrock895 Words à |à 4 PagesEssay Two- Critical Analysis Writing a critical analysis is diving into the text. Readers must break down all parts of the text and pin pointing the author s purpose for the writing. A very challenging poem to analysis is T.S. Eliotââ¬â¢s ââ¬Å"The Love Song of J. Alfred Prufrockâ⬠. It has been declared that ââ¬Å"The Love Song of J. Alfred Prufrockâ⬠started that Anglo-American modernist movement with poetry. The poem was the first poem with American poetry to flow free verse. At the time, it was deemedRead MoreLiterary Analysis Of The Love Song Of J. Alfred Prufrock Essay1336 Words à |à 6 PagesA Literary Analysis of T.S. Eliotââ¬â¢s ââ¬Å"The Love Song of J. Alfred Prufrockâ⬠T.S. Eliot was one among few poets and authors that dominated the years between the First and Second World Wars. Eliot showed his use of modernism techniques through ââ¬Å"The Love Song of J. Alfred Prufrockâ⬠, creating a powerful reputation around the world, particularly as a member of The Lost Generation in the 1920s. Eliot moved to and settled in London where he worked with famous poets including Ezra Pound, and published hisRead MoreAnalysis of The Love Song of J. Alfred Prufrock Essay602 Words à |à 3 PagesAnalysis of The Love Song of J. Alfred Prufrock J. Alfred Prufrock constantly lived in fear, in fear of life and death. T. S. Eliot divided his classic poem into three equally important sections. Each division provided the reader with insight into the mental structure of J. Alfred Prufrock. In actuality, Prufrock maintained a good heart and a worthy instinct, but he never seemed to truly exist. A false shadow hung over his existence. Prufrock never allowed himself to actually live. He hadRead More Love Song of J. Alfred Prufrock Essay: An Analysis846 Words à |à 4 PagesAn Analysis of The Love Song of J. Alfred Prufrock The general fragmentation of The Love Song of J. Alfred Prufrock is obvious. The poem seems a perfect example of what Terry Eagleton calls the modern transition from metaphor to metonymy: unable any longer to totalize his experience in some heroic figure, the bourgeois is forced to let it trickle away into objects related to him by sheer contiguity. Everything in Prufrock trickles away into parts related to one another only by contiguityRead MoreLiterary Analysis Of The Love Song Of J. Alfred Prufrock1497 Words à |à 6 PagesLiterary Analysis of The Love Song of J. Alfred Prufrock The human psyche has perpetually been characterized by a nagging sense of doubt. When one makes the decision to follow through (or, rather, not follow through) with an action, it is unlikely that he does so without questioning whether he made the right choice; this is recurring theme in literature, evident in works such as Crime and Punishment and A Separate Peace. T.S. Eliotââ¬â¢s The Love Song of J. Alfred Prufrock explores the universal natureRead MoreAnalysis Of The Poem The Love Song Of J. Alfred Prufrock1529 Words à |à 7 PagesAnalysis of the setting of the poems ââ¬Å"The Love song of J. Alfred Prufrockâ⬠and ââ¬Å"Something Whispered in the Shakuhachiâ⬠ââ¬Å"The Love song of J. Alfred Prufrockâ⬠and ââ¬Å"Something Whispered in the Shakuhachiâ⬠are poems written by T.S. Eliot and Garrett Hongo correspondently. Both poems put a great emphasis on the depiction of the narratorââ¬â¢s emotion. The poems are focused on feelings and emotions of their narrators. At the same time, it should noted that a lot of attractive in both poems is given to the settingRead MoreThe Love Song Of J Alfred Prufrock Analysis934 Words à |à 4 Pagesyou do something that you love than you will have a deeper desire to continue or to succeed in it. In The Love Song of J. Alfred Prufrock a man doesnt know why his life is so horrible. He wanders the streets of his past looking for why hes life is so dull. The man doesnt know what is wrong with his life, he doesnt understand why life is so hard. T. S. Eliot in The Love Song of J. Alfred Prufrock teaches us about how hard life can be on a single and routine man. Prufrock, the main character, demonstratesRead MoreAnalysis Of The Love Song Of J Alfred Prufrock1007 Words à |à 5 Pagesinterrelation between time and decay conveys the transformative impact of industrialisation upon modern society. Modernity altered the human psyche into a detached, fragmentation of its previous form prior to the Modernist world. The Love Song of J. Alfred Prufrock and Preludes provide a poetic representation of how the corrosion of traditionalism preceded a sense of abandonment and isolation which infects individuals within the urban setting. Despite conveying early 20th century receptions of industrialisation
Wednesday, December 18, 2019
Financial Crisis Of 2008 The Sec - 1156 Words
Since the financial crisis of 2008 the SECââ¬â¢s mission has been to protect investors and win back the trust of the public in capital markets. In efforts to combat fraud and preventing another financial crisis, the SEC has grown their staff and is working on revamping their technological capabilities. For the last 3 years we have seen aggressive enforcement, strategic reforms and new regulations with in the division. FISCAL YEAR 2012 In the 2012 fiscal year the SEC heavily emphasized regulations under the Dobbs Frank act and the Securities Exchange Act of 1934. In this fiscal year under the Dobbs Frank act the SEC issued its first Whistleblower Program award. The Whistleblower Program allows the division to award individuals with high-quality information, which leads to an enforcement action. The success of this program has helped the SEC catch predators early on. It saves the division time and resources by uncovering and tipping off the crime to them. The program also helps identify fraud much earlier on. This can help elevate some of the damage to investors and even mitigate the number of possible victims. Also under the Dobbs Frank act the SEC barred 36 individuals from working in the securities industry. Another area where the SEC turned its attention to was The Securities Exchange Act of 1934. In September of 2012 the SEC made its first financial penalty against an exchange. The New York Stock Exchange was in violation of the NMS (National Market System)Show MoreRelatedFinancial Crisis Of 2008 Struck The World1398 Words à |à 6 PagesWhen the financial crisis of 2008 struck the world, there were multiple business scams and schemes that became exposed, creating a colossal uproar and unrest around the world. When the stock market collapsed, people all across America took a hit, with 2.4 trillion dollars of the Americans peopleââ¬â¢s savings vanishing in just a few weeks. This financial crisis also brought to light an unprecedented amount of fraud, over exposing people who were cutting corners. One of the most famous scams that surfacedRead MoreWhich Factor Was Most Responsible For The Financial Crisis895 Words à |à 4 PagesWhich factor was most responsible for the financial c risis The financial crisis from2007 to 2008 is considered the worst financial crisis since the Great Depression of the 1920s and destroyed the U.S. economy severely. It led the housing prices fell 31.8%, the unemployment rate rose a peak of 10% in the United States. Especially the subprime market, began defaulting on their mortgage. Housing industry had collapsed. This crisis was not an accident, it caused by varies of factors. The unregulatedRead MoreToo Big to Fail: The 2008 World Financial Crisis and Its Aftermath1779 Words à |à 7 Pagesï » ¿ Too big to fail: The 2008 world financial crisis and its aftermath The 2008 world financial crisis begin the banking and housing sector, but spread like a contagion through the entire economy. Many date the beginnings of the problems far back before 2008, back to the historically low interest rates put into place by the Federal Reserve in the wake of the last financial crisis. Interest rates plummeted after the dot.com boom and bust, followed by the attacks on the World Trade Center. ThisRead MoreThe Big Short1293 Words à |à 6 Pagesswaps on subprime mortgage bonds, CDOââ¬â¢s, and the eventual collapse of the subprime market. Following the subprime mortgage crisis, the Department of the Treasury released a new regulatory plan, The Department of the Treasury Blueprint for a Modernized Financial Regulatory Structure, which is referred to as ââ¬Å"the Paulson Plan.â⬠The Paulson Plan was completed in March 2008 and consisted of a series of short-term and intermediate-term recommendations that were meant to immediately improve and reformRead MoreThe Great Recession and The Dodd-Frank Act1177 Words à |à 5 Pagesa response to the Great Recession in order to prevent potential financial debacle in the future. This regulation has a significant impact on American financial services industry by placing major changes on the financial regulation and agencies since the Great Depression. This paper examines the history and impact of Dodd-Frank Act on American financial services industry. The worldââ¬â¢s financial system was almost brought down in 2008 by the collapse of Lehman Brothers that was a major internationalRead MoreThe Sarbanes Oxley Act ( Sox ) Essay1233 Words à |à 5 Pagesto Pompper (2014), ââ¬Å"incidents of high-profile deception over the pastâ⬠four decades ââ¬Å"have threatened the reputation of the â⬠¦ accounting functionâ⬠(p. 131). For instance, an investigation was conducted into the financial audit and reporting process after the savings and loan banking crisis in the 1980s (Pompper, 2014). In addition, the criminal convictions of executives and bankruptcies of Fortune 500 companies such as Enron and WorldCom in the turn of the century motivated Congress to pass the Sarbanes-OxleyRead MoreTopic 6 ââ¬â Bailouts And Buyouts. I Would Like To Start With749 Words à |à 3 Pagesbeginning of the book Bailout nation, Barry Ritholtz discusses key factors that led to the 2008 Housing Market Bubble Burst and reforms about what s hould be done. The first point is to (1) repeal the Commodity Futures Modernization Act (CFMA) of 2000. Credit default swaps and collateralized debt obligations were exempted from regular oversight. He mentions that all derivatives should be regulated as any financial securities out there in the market. (2) The Nationally Recognized Statistical Rating OrganizationsRead MoreThe Subprime Mortgage Crisis Of 2008 Impacted The Us1581 Words à |à 7 PagesMortgage Crisis of 2008 impacted the US According to data from the United States Census Bureau: 501 thousand new single-family houses were sold in 2015 compare to 1,051 thousand in 2006. Real estate always impacted the economy by creating jobs and housing opportunities for families. But around 2006 because of a shortage of homebuyer, the nation saw an increase in the number of mortgage credits and subprime loans granted which lead to the 2008 subprime mortgage crisis, a nation wide banking crisis, puttingRead MoreThe Madoff Scandal1070 Words à |à 5 PagesThe Madoff scandal 16 December 2008 The repercussions from the collapse of Bernard L. Madoff Investment Securities LLC, whose founder and owner was arrested last Thursday after admitting that his $17 billion investment advisory business was a giant Ponzi scheme, continue to widen. According to a criminal complaint filed by the FBI and a civil action brought by the Securities and Exchange Commission (SEC), the elderly Madoff estimated that the losses from his fraud exceeded $50 billion. TheRead MoreIfrs Adoption Challenges : Ifrs755 Words à |à 4 Pagesadoption would sacrifice the ââ¬Å"gold standardâ⬠of U.S. GAAP, and a lack of enforcement. The SEC drafted its new strategic plan for the next 4 years in February 2014. In doing so, it appeared to be backing away from its earlier plan to support IFRS (Chasan, 2014). This becomes evident by contrasting the SECââ¬â¢s 2010-2015 plan with its new plan. The 2010-2015 plan reads: The agency will promote high-quality financial reporting worldwide through, among other things, support for a single set of high-quality
Tuesday, December 10, 2019
Clinical Observation free essay sample
University of Phoenix Clinical Research Paper May 12, 2008. Clinical Research Paper As I mentioned before I was a musician for a long time. One of the things that always caught my attention is the sudden change people experienced when we performed at social events such as weddings or private parties. People change when listening to music; it affects the way they act. While they are eating we started to play romantic music or something smooth. They usually wear formal cloth. And then we started to play a different kind of music, something like polkas, or a fast beat rate music people begin to experience a mood change. After the ceremony is over then the open dance is open to the public. That is when people get excited and jump, scream, laugh. Drinking also made its part. At the end of ceremony they all had have some drinks. Drunk people often ask us to play a special song and they often over-reach when we did not play they request. We will write a custom essay sample on Clinical Observation or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page I have a bad experience one time, it was a school teacher who hire o band to play at his party. He looked very intellectual; he was wearing a tie and a coat, wearing glasses for better vision. And the way he talked showed his good education level. The band played for five hours, at the last hour he started to act weird. He wanted to sing, and started to act aggressive at his family. He was asking us to play only corridos (short music stories) and the kind of music he wanted. He did not look as a teacher anymore. Music and beer made their part in his body. Music change his mood and alcohol his acts. I always observe these kinds of people and ask my self how they will act after two of three hour more. This is call naturalistic observation according to the reading from chapter 1. Almost everyone observes and describes others in an attempt to understand them (Carpenter, S. Huffman, K. 2008) I always do that everywhere. All sounds and music can put out an influence on our body temperature and make our body adapt to changes in heat and cold. Music can flood us with warmth. Loud music with a strong beat can rise our body heat a few degrees, while soft music with a weak beat an lower it. Music does this by influencing blood circulation, pulse rate, breathing, and sweating and regulates stress. (Campbell) The level of stress hormones in the blood declines significantly in those listening to relaxing. I and my wife experience this kind of therapy. While she was pregnant we were taught relaxation techniques by listening to music. Sometimes this music can overcome the need for medication. People with hard stress related jobs often times go to music for relaxation. I even play my Clarinet when feeling stressful, it is really works. I had also experienced the contrary. I have played at funerals. When we play we made all those people cry more that if there is not music. It is par of their tradition to have music in their funerals. People experienced many changes when listening to music. I even learned that I learn more when studying while listening to music according to the first week of skills for professional development class. References Carpenter, S. Huffman, K. (2008). Visualizing Psychology. P. 18 Ch: 1. Retrieved on May 12, 2008 from University of Phoenix Ebook Collection. Hoboken NJ.
Tuesday, December 3, 2019
Pharmaceutical Engineering
Introduction Recently, the pharmaceutical industry has grappled with an increased cost in production partly because of uncertainty with regards to the necessities for regulatory compliance. Of particular interest is the validation of particularly the automation systems as well as the accreditation of Practices for Heating, Ventilation and Air Conditioning (HVAC).Advertising We will write a custom essay sample on Pharmaceutical Engineering specifically for you for only $16.05 $11/page Learn More Initially, the existence of many yet acceptable interpretations of these regulatory requirements led to confusion between manufacturers leading to inconsistencies in processing practices. With the inception of these practices, a part from increased costs in production, there has been a decrease in the rate at which new products come to market. (World Health Organization, 1997) In the year 1994, a body representing the pharmaceutical engineers in conjunction with b oth the International Society for Pharmaceutical Engineers (ISPE) and the Food and Drug Administration (FDA) agreed on a common course that led to the creation of Baseline Pharmaceutical Engineering Guides. These guides are aimed at aiding pharmaceutical manufacturers ââ¬Å"in the design, construction and commissioning of facilities that comply with the requirements of FDAâ⬠(ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, 1999). As such, pharmaceutical industries are required to meet the current good manufacturing practices (cGMPs) which ought to coincide with the entire governing laws and policies. The joint interpretation of these regulations is important for the purpose of consistency, flexibility and enhancement of innovative approach in the design, construction and validation. The scope of this guideline is limited to the development of new products as well as the existing ones which tend to have limited baseline description. However, th ese guidelines are not intended to substitute the existing laws and regulations which apply to the same. To supplement this document, there is need to incorporate the existing laws and regulations to the same for the purpose of completeness. Basically, this guide owes its guidance from the following sensitive parameters: the critical processing step, product exposure, level of protection, critical parameters, critical instruments and systems, Good Engineering Practice (GEP) and enhanced documentation.Advertising Looking for essay on health medicine? Let's see if we can help you! Get your first paper with 15% OFF Learn More With regards to critical processing step, this is significant in defining consistent regulatory requirements and as such, it specifies the extent of product exposure and the level of protection. However, due to environmental regulations upon a specific methodology employed, standard operating procedures (SOPs) are used hence; this enhances flexibili ty in manufacturing designs thereby reducing the processing costs within the regulatory requirements. With regards to critical parameters, this has an effect on the quality of a product. This ought to be identified, regularly checked and controlled to maintain the product quality. In order to identify these parameters, manufacturers should have knowledge about the processing steps and as such document the rational for afterward examination. Critical parameters define critical instruments and systems and just like the parameters, they require in-depth documentation. As regards GEPââ¬â¢s, the guide requires that all processing elements in a facility to ââ¬Å"routinely undergo some form of commissioningâ⬠(Milton, 2002). Basically all the engineering aspects of a processing system needs to be inspected regularly, tested and above all recorded down for documentation. GEP requires that prior to setting of the plant, all the stakeholders be involved in ââ¬Å"the planning, design , construction and commissioning phases to ensure systems are documented onceâ⬠(Latham, 1995). Enhanced documentation is a plus to the Good Engineering Practices. The essence of doing an exhaustive documentation stems from the fact that most systems and commissioning documents do not undergo regular update long after inception. Regulations entail change control with respect to certain document. Moreover, validation for the regular inspection of the critical systems to enhance consistency in quality has to be supported by documentation (Wichmann, 1997). Guide with respect to design of sterile manufacturing facilities Traditionally, the design and construction of a Bulk pharmaceutical chemical (BPC) plant is just like a chemical manufacturing plant and as such, they have ceased from being pharmaceutical dosage-form industries.Advertising We will write a custom essay sample on Pharmaceutical Engineering specifically for you for only $16.05 $11/page Lea rn More While chemical manufacturers give tolerances for traces of contaminants in the final product, ââ¬Å"pharmaceutical facility and processing design requires provision for minimizing cross contamination and trace contaminationâ⬠(International Conference on Harmonisation (ICH), 2009). In the ISPE guide concerning the recent facility design of BPC, the principles are based on the dosage-form pharmaceutical industries. Consequently, the guideline has become a vital tool in helping a project team meet the minimum restrictions for a facility design in line with cGMPs requirements. Just like in BPC, ISPE gives guidelines with respect to sterile chemicals manufacture in ââ¬ËSterile Manufacturing Guideââ¬â¢. This document was obtained courtesy of great minds in the pharmaceutical fraternity composed of a task force of 50 personalities. The essence of this guide which dwells on engineering issues is meant at providing cost efficient facilities. It generally focuses on the aseptic processes that ultimately lead to terminal sterility of the final product. The primary features of this guide are: Product requirement, ââ¬Å"GMP critical parametersâ⬠and ââ¬Å"Critical Devicesâ⬠, Terminal sterilization, Aseptic processing area, Protection of the product, Flow of people and material, integrated facility design, Barrier-isolator technology, Consistent HVAC principles, In operation condition for HVAC, Good Engineering Practice, Direct impact systems, Enhanced documentation and Indirect impact systems (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 2007). The product requirement decides the vital aseptic needs of a given facility and as such, the ââ¬Ëcritical parametersââ¬â¢ can be established. The aseptic processing area is a region where formulation of the product takes place after which is packaged and sealed. This is a critical area where control of persons and materials ought to be perfect to bar cross contamination. An efficient way of a voiding this is by barrier-isolator technology which ought to be incorporated in the design initially during installation. HVAC principles give the baselines for aseptic manufacturing processes. Engineers and designers should take heed of this stage of operation where ââ¬Å"regulators are particularly interested with the in the environment during in-operation conditionâ⬠(Orange Guide, 2007). This is so because it is believed that this is the time when the product may be exposed. Designers should be in a position to identify the potential sources of microbial/ particulate contamination and the ways of ensuring quality air free of contamination.Advertising Looking for essay on health medicine? Let's see if we can help you! Get your first paper with 15% OFF Learn More Baseline standards also come in handy in the selection of materials as well as finishes since this impact directly on the quality of the final product. It would be insignificant for one to spend much in instrumentation and control yet the no GMP is achieved. As regards Good Engineering Practice, this needs to be applied to the entire facility to ensure compliance of the product with respect to quality needs. This guide brings forth the term ââ¬Ëdirect Impact Systemââ¬â¢ which basically means the facilities which have a direct impact on the product. Moreover, it highlights the term ââ¬ËIndirect Impact Systemââ¬â¢ which generally means the opposite of the former term. These systems ought to be ââ¬Å"supported by enhanced documentationâ⬠(International Cleanroom Standards, 2007). Qualification for compressed air The facilities designed to support pharmaceutical operations ought to comply with the GEP and cGMP. These systems just like as it has been stated initially, t hey may have either direct or indirect impact on the quality of the product. The former system ought to be comprehensively documented and inspected with respect to critical GMPs limits. The stakeholders should agree on the degree of qualifications prior to the installation process. The impact assessment process is represented in the flowchart below: With regards to direct system, the fundamental parameters that ought to be analyzed are: purified water, water for injection, clean steam and HVAC and compressed special gas. The indirect systems that need to be checked are raw water treatment, cooling system, effluent treatment, heating system and boiler house. Commissioning overview normally takes ââ¬Å"equipments from installation to operation as well as incorporating a systematic method for testing and documentationâ⬠(European Commission, 2005). Both commissioning and validation procedures come up with equipment lists, component lists, utility verification forms, systematic drawings and operating procedures. However, while validation focuses on user responsibility, commissioning focuses on supplier responsibility. Moreover, while validation is approved by the quality assurance team, commissioning is approved by engineering project team. Since compressed air system is a direct system, qualification work is needed. User Requirement Specification (URS) requires that quality of air be generated from the system at generation and point of use is determined. Furthermore, it calls for safety measure and prevention of contamination. Qualification for Nitrogen gas Air monitoring methods are used to regulate the emission of dangerous gases in the environment by keeping them within the set emission limits. The gases with limited emission limit include Carbon monoxide, compounds of Nitrogen Oxides, Ozone, Sulphur Dioxide and Hazardous air pollutants. The roles of industries are to mitigate these toxic emissions within safe limits. This is achievable through ââ¬Å" Air Pollution Control Devices that include: Mechanical collectors (Hepa filters), Hazardous solvents (thermal oxidation, gas absorption scrubbers and adsorption) and selective catalytic reduction techniquesâ⬠(Daly, 1985). Qualification for Steam systems Steam is widely used in processing of pharmaceutical products important for treatment. Steam exhaust from boilers also referred to as utility steam come in contact with products directly acting as potential source of ââ¬Ëdirect impact systemââ¬â¢. This may be in form of condensate which settles on the products depositing contaminants (rust and additives) on the product. The quality of steam is determined by the Good Manufacturing Practices (GMPs) which determines the final quality of the product. Steam comes in handy when carrying sterilization processes that include: Manufacture of Injectable or Parenteral solutions, which are always sterile. Biopharmaceutical manufacturing and manufacture of sterile solution e.g. ophtha lmic products (Dââ¬â¢Elia 1994). Clean steam may cause contamination through humidification among other forms of contamination. Clean steam system design enhances formation of quality products. This is achieved by: ââ¬Å"avoidance of corrosion, prevention of entry of contaminants into the system and, preventing microbial growth in the systemâ⬠(Reeuwijk, 1998). For the purpose of validation process of steam utility, a sequential process ensures generation clean steam: ââ¬Å"Develop a User Requirement Specification (URS), develop a Functional Specification (FS), Undergo Design Qualification (DQ), Installer Qualification (IQ), Operational Qualification (OQ) and finally Performance Qualification (PfQ)â⬠(Commission Directive 2003 EC, 2003). Conclusion In a conclusion, for any pharmaceutical manufacturing industry, the need for ISPE Guide in the initial installation of facilities is vital to minimize cost due to redesigning of the entire system. The validation and commiss ioning of the processes should be done for once and for all by involving all the stakeholders to limit redesigning costs. Essentially, by implementing ISPE guidelines one will have basically met all the requirements for accreditation procedures set for pharmaceutical industry. This is so because it coincides with the requirements for FDA and WHO (Heinemann, 2003) Bibliography Commission Directive 2003 EC, 2003. Laying dawn the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. London: Department of Health. Dââ¬â¢Elia, L., 1994. ââ¬Å"Bioprocess Engineering-Systems, Equipments Facilitiesâ⬠.Utility for Biotechnology Production Plants. New York City: John Wiley and Sons, Inc. Daly B., 1985. Woods practical guide to fan engineering. Colchester, Woods of Colchester Ltd. Third impression. Cambridge: Cambridge University Press. European Commission, 2005. The rules governing medicinal products in the European Community, Volume IV. Good manufacturing practice for medicinal products. European Commission. Brussels: ViVio. Retrieved fromhttps://www.cen.eu/Pages/default.aspx Heinemann, D., 2003. Good Laboratory and Clinical Practices, Techniques for the Quality Assurance Newnnes, Oxford. International Cleanroom Standards, 2007. International Organization for Standardization. Brussels: ViVio. Available at: https://www.iso.org/developing-standards.html International Conference on Harmonisation (ICH), 2009. Quality Risk Management ââ¬â 09. London: Department of Health. Web. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 2007. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients ââ¬â 07 , London: Department of Health. Retrieved from: ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, 1999. Sterile Manufacturing Facilities, First Edition. London: Department of Health. Latham, T., 1995. ââ¬Å"Clean Steam Systemsâ⬠. Pharmaceutical Engineering.15 (2), p. 3. Milton, A., 2002. GLP Quality Audit Manual. Interpharm Press, third edition, ISBN 1-57491-106-6 (2002). Orange Guide, 2007.ââ¬ËRules and Guidance for Pharmaceutical Manufacturers and Distributors,â⬠commonly known as the,ââ¬â¢ MHRA, February 2007, New York University Press. Reeuwijk, P., 1998. FAO Soils Bulletin 74, Guidelines for quality management in soil and plant laboratories, New York University Press. Wichmann, B., 1997. Software in scientific computing, National Physical Laboratory. Measurement Good Practice Guide No. 5. Cambridge: Cambridge University Press. World Health Organization, 1997. Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials, Volume 1. Geneva: ILO Publications. This essay on Pharmaceutical Engineering was written and submitted by user Natasha M. to help you with your own studies. You are free to use it for research and reference purposes in order to write your own paper; however, you must cite it accordingly. You can donate your paper here.
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