Medicine Manufacturing: Steps Involved and Types

Medicine Manufacturing: Steps Involved and Types Introduction: There are various types of medicines ranging from veterinary to medicines for human usage. Over the course of time, conscientious and diligent research has been put into improving the quality and effectiveness of medicines. There are hundreds of thousands of medicines available today meant for different ailments but this galore of medicines can be divided into three basic categories Tablets Syrups Gel Every medicine available comprises of two main constituents: Active ingredient and Additives/Excipients. The main remedy is the active ingredient. Whereas, the additives are added to inculcate rigidity, to increase the quantity so that the raw materials can be easily processed and to dissolve certain active ingredients. All human medicines that are produced on industrial scale must go through extensive testing and if its deemed fit for human usage it is produced commercially. There are various standards that are set to test the quality of medicines such as: European directorate for the quality of medicine (EDQM) and U.S pharmacopeial convention (USP). Tablet Manufacturing: In order to make the process more intuitive a specific product (Aspirin) will be discussed. 1. Raw materials: Phenol Sodium hydroxide Carbon dioxide Acetic anhydride Hydrogen Corn starch Water 2. Weighing: The corn starch, the active ingredient, and the lubricant are weighed separately in sterile canisters to determine if the ingredients meet pre-determined specifications for the batch size and dosage amount. 3. Mixing: The corn starch is dispensed into cold purified water, then heated and stirred until a translucent paste forms. The corn starch, the active ingredient, and part of the lubricant are next poured into one sterile canister, and the canister is wheeled to a mixing machine called a Glen Mixer. Mixing blends the ingredients as well as expels air from the mixture. The mixture is then mechanically separated into units, which are generally from 7/8 to 1 inches (2.22 to 2.54 centimeters) in size. These units are called slugs. 4. Dry Screening: Next, small batches of slugs are forced through a mesh screen by a hand-held stainless steel spatula. Large batches in sizable manufacturing outlets are filtered through a machine called a Fitzpatrick mill. The remaining lubricant is added to the mixture, which is blended gently in a rotary granulator and sifter. The lubricant keeps the mixture from sticking to the tablet machine during the compression process. 5. Compression: The mixture is compressed into tablets by a punch machine. On single-punch machines, the mixture is fed into one tablet mold known as dye cavity by a feed shoe, as follows: The feed shoe passes over the dye cavity and releases the mixture. The feed shoe then retracts and scrapes all excess mixture away from the dye cavity. A punch of the size of the dye cavity descends into the dye, compressing the mixture into a tablet. The punch then retracts, while a punch below the dye cavity rises into the cavity and ejects the tablet. The feed shoe returns to fill the dye cavity again, it pushes the compressed tablet from the dye platform. 6. Coating: Tablets may be coated to reduce swallow difficulties or target specific part of the body where the coating will dissolve and take effect. Coating is done by adding desired coating solution to the drum along with the tablets. Blowers are used to rapidly dry the coated tablets and prevent sticking. 7. Testing: The compressed tablets are subjected to a tablet hardness and friability test, as well as a tablet disintegration test. 8. Packaging: The tablets are transferred to an automated bottling assembly line where they are dispensed into clear or color-coated polyethylene or polypropylene plastic bottles or glass bottles. The bottles are topped with cotton packing, sealed with a sheer aluminum top, and then sealed with a plastic and rubber child-proof lid. A sheer, round plastic band is then affixed to the circular edge of the lid. It serves as an additional seal to discourage and detect product tampering. Syrup Manufacturing: 1. General manufacturing procedure: Syrups should be carefully prepared in clean equipment to prevent contamination. Three methods may be used to prepare syrups. Solution with heat Agitation without heat Percolation Although the hot method is quickest, it is not applicable to syrups of volatile ingredients. When using heat, temperature must be carefully controlled to avoid decomposing and darkening the syrup. Syrups may be prepared from sugars other than sucrose (glucose, fructose), non-sugar polyols (sorbitol, glycerin, propylene glycol), or other non-nutritive artificial sweeteners (aspartame, saccharin) when a reduction in calories properties is desired, as with the diabetic patient. The non-nutritive sweeteners do not impart the characteristic viscosity of syrups and require the addition of viscosity adjusters, such as methylcellulose. The polyols, though less sweet than sucrose, have the advantage of providing favorable viscosity, reducing cap-locking (which occurs when sucrose crystallizes), and in some cases acting as co-solvents and preservatives. 2. Cough syrup manufacturing process: Traditional cough mixtures are formulated around a syrup at 60-75% concentration which is made from sucrose, malt dextrin, glucose, invert syrup etc. The remainder is made up of thickening agents, stabilizers and active ingredients. Manufacturers of cough mixtures generally produce their own syrups as this offers greater control of product quality. The manufacturing process must achieve several functions: Dissolving of the sugars to form a syrup Hydration of powdered ingredients Blending ingredients of widely different viscosity Suspension or dissolving of active ingredients The end product must be smooth, agglomerate-free and homogeneous. High Shear mixer is used for mixing. Gel manufacturing Process: 1. Raw materials: Aluminium Acetate, Povidone Iodine, Propylene glycolCremophor RH 40, Lutrol F 127, Cetylstearyl alcohol, Cremophor A 6, Liquid paraffin, Parabene(s), Alpha-Bisabolol, Triethanolamine, Kollidon 30, Benzoyl peroxide, Betamethasone valerate etc. 2. Heating: The temperature should be high enough to ensure the intimate mixing of liquid phase and to prevent the premature crystallization and congealing of its components. Ointments preparation involves separate oil and water phases containing the required ingredients, heating each phase to between 60-70Â °C. 3. Mixing: Mechanical mixers, such as a steel jacketed kettle with agitator are commonly used to prepare semisolid preparations in pharmaceutical industry. The use of mechanical shear or a combination of fusion processes and mixing can be used to facilitate the dispersion or dissolution of the ingredients in the base to form a single-phase ointment. Time, temperature, and mechanical energy input are the three major variables in the manufacturing of semisolid preparations. 4. Emulsification: After the mixing process, the mixer is send to the emulsifier where the immiscible layers are forced to form an emulsion. 5. Cooling: Cooling rate can influence the final product quality. Different cooling rates after melting, mixing, and emulsification steps should be investigated as a process variable. The most important aspect of manufacture is to ensure all ingredients are fully dissolved and well mixed before packing and that the formulations contain suitable effective preservatives. Mixing is continued with cooling until the cream/gel is formed. 6. Packaging: After cooling, the gel is packed. In suspension, mixing of the bulk must be continued during packing to ensure even dispersion of the active ingredients at all times.

Ensure work safety Essay

Introduction I have read and analyze the current policies and procedures of Coffeeville on work health and safety. I compared them with WHS acts, regulations and codes of practice and developed WHS guidelines for following areas. These guidelines will help employer to control the workplace risks. These guidelines will not only improve safety outcomes but will also support employer in demonstrating that they are meeting obligations under Work Health and Safety laws. WHS criteria WHS Guidelines for respective areas 1. Organizational commitment to locate, adapt, adopt and communicate work health and safety policies in order to be compliant with WHS legislation Store managers and senior leadership have to be committed to ensure WHS management system I functioning properly. They are responsible that all staff members are exercising the WHS procedures. Managers have the responsibility of reviewing the Risk Action Plan on a monthly basis.Leaders of the entire workplace are required to follow the requirements of WHS legislation by communicating to the workforce of its requirements and ongoing changes to adopt and adapt the WHS policies. A proper training of WHS policies and procedure is to be delivered to new employees at time of recruitment. Regular communication and consultation between management and employees is required time to time to maintain health and safety at workplace as per required under WHS legislation. During WHS consultation or meeting all WHS policies and procedures has to be given in writing to workforce. Also suggestions should be asked from employees to make them contribute towards maintaining the workplace safe, risk free and quality decision making. All staff members are told and trained to fill risk and hazard report forms. Teams are to be made to assess risks and hazards at workplace and submit report with suggestions to avoid those risks. All the information such as the hazard inspection reports, minutes of OHS Committee meetings, group meetings, suggestions, circulars or other OHS information should be provided to staff via e-mail, newsletters or handover printout. Accurately explain relevant provisions of WHS Policy, legislation and codes  of practice to staff. Systematically WHS training needs of employees in line with organizational requirements, online employee health and safety program, provide workplace learning opportunities, safety manuals and put clear safety signage. Ensuring the distribution of work health and safety policies and procedures on a range of topics to each division or group, setting up processes to ensure consultation can occur between the national body and state and local groups or divisions. 2. WHS responsibilities for duty holders The Work Health and Safety Policy clearly defines the rights and responsibilities of duty holders. All duty holders have to comply with company policies and procedures. Do not use any faulty equipment, do not misuse any of equipment or never use anything without training if needed, wear proper PPE and report any WHS issues, including hazards, injuries, illnesses and near misses. 3. Human resources and financial commitment for an effective work health and safety management system Human resource department should assigned Health and Safety representative, first aid attendant, fire attendant, health and safety committee to be formed and HR has to make sure of proper training. It is job of HR to provide financial and physical resources to enable the effective implementation of the Workplace Health and Safety. These financial resources must be provided in budget allocation to the Workplace Health and Safety team. 4. How to set up a consultation and participative arrangements according to relevant WHS legislation Part 5 of the WHS Act 2011 (the Act) requires PCBUs to consult with workers about WHS matters that affect their workplace health or safety. As workers now includes all people completing work for the PCBU this includes consultation with employees, contractors, sub-contractors, volunteers, labour-hire workers and any other person completing work for the PCBU. Prior to consulting with workers, PCBUs and workers must initially determine â€Å"work groups†. A â€Å"work group† is a group of workers with similar WHS concerns and work conditions. A work group may cover multiple locations but include similar job activities or a work group may cover a range of job types in a single location. Workers can be represented in the negotiation and determination of a workgroup by their union Once work groups are determined then each work group can determine the best method for WHS consultation. The options for WHS consultation include; i. Health and  Safety Representatives (HSRs) ii. Health and Safety Committees (HSCs) iii. Other agreed arrangements(meetings) 5. How to record and communicate outcomes of consultation over WHS issues and how quickly to provide information about the outcomes of participation and consultation to work teams All consultations over WHS issues and their outcomes are to be recorded using standard templates and document control processes like minute taking if it’s a regular meeting. These documents can be maintained on the Workplace Health and Safety section of company website as examples or case studies. Work teams can be notified with workers newsletter, notice in staff room and staff can also be notified about changes by email to relevant work teams and stakeholders. Policies should to be reviewed regularly in consultation with work teams and relevant stakeholders. All policies should to be authorized by the senior management and their issue date recorded on the relevant document. 6. The process for identifying hazards across the organization including the stages of hazard identification and procedures used to ensure new proposed changes do not create any new hazards To identify hazards the following procedures are recommended: (i) Talk with workers (including contractors) who are or will be performing any tasks to identify all potential hazards and the best ways to eliminate or reduce risk as workers have encountered hazards near misses they as part of their work. We can ask workers to participate in surveys and questionnaire can be given to them to find out more about workplace hazards. (ii) Past incidents/accidents have to be examined to find out what was wrong, why that has happened and whether the incident/accident could occur again. (iii) All faulty appliances are to be reported to relevant sections of company so that they can be fixed or replaced as soon as possible. Proper training should be provided prior of using any machinery or power tools. All faulty machinery is tagged with faulty or do not use signs. (iv) Regular inspections or checks of workplaces are necessary to eradicate hazards and minimize risks. Regular assessment leads to new ideas of making workplace safer for staff. Brainstorming is required before implementing any new policies or any other changes to avoid any new hazards and before implementing on new policies a trial run is necessary. 7. The process of  analyzing risks and ranking them and control procedures to treat risks It is necessary to assess and analyze the risk. Risk assessment determines severity of risk, review of existing risk control measures, action required to avoid or control risks and urgency of action required. Risk assessment involves considering the possible results of someone being exposed to a hazard and the likelihood of this occurring. level of risk = consequence x likelihood Some steps of risk assessment and procedures to treat risks are as followed Identify the hazards i. Walk around your workplace and look at what could reasonably be expected to cause harm. ii. Ask your employees or their representatives what they think. They may have noticed things that are not immediately obvious to you. iii. Check manufacturers’ instructions or data sheets for chemicals and equipment. iv. Remember to think about long-term hazards to health Decide who might be harmed and how i. some workers have particular requirements, eg new and young workers, migrant workers ii. Cleaners, visitors, contractors, maintenance workers etc. who may not be in the workplace all the time, members of the public, if they could be hurt by your activities. Evaluate the risks and decide on precaution i. try a less risky option ii. prevent access to the hazard iii. organize work to reduce exposure to the hazard iv. issue personal protective equipment and provide welfare facilities (e.g. first aid and washing facilities for removal of contamination). Record your findings and implement them i. a proper check was made; ii. you asked who might be affected; iii. you dealt with all the obvious significant hazards, taking into account the number of people who could be involved; iv. the precautions are reasonable, and the remaining risk is low; and v. Involve your staff or  their representatives in the process. A good plan of action often includes a mixture of different things such as: A few cheap or easy improvements that can be done quickly, perhaps as a temporary solution until more reliable controls are in place Long-term solutions to those risks most likely to cause accidents or ill health; long-term solutions to those risks with worse potential consequences; Arrangements for training employees on the main risks that remain and how they are to be controlled; Regular checks to make sure that the control measures stay in place; and Clear responsibilities – who will lead on what action and by when? Review your assessment and update if necessary Few workplaces stay the same. Sooner or later, you will bring in new equipment, substances and procedures that could lead to new hazards. It makes sense therefore, to review what you are doing on an ongoing basis. Look at your risk assessment and think about whether there have been any changes? Are there improvements you still need to make? Have your workers spotted a problem? Have you learnt anything from accidents or near misses? Make sure your risk assessment stays up to date. 8. The procedures for maintaining an effective work health and safety management system These procedures are required so that safe and healthy environment can be provided to workers. It is about setting up a system or standard procedures to be made to follow in different situations regarding WHS. It involves planning and identification of hazards, hazard/risk assessment and control of hazards/risk. The Workplace Health and Safety team has identified the health and safety legal requirements applicable to Coffeeville e.g. legislation, Codes of Practice and Australian Standards, and maintains a library for access by all staff. Objectives and targets are to be set for regarding workplace, health and safety. There must be some guidelines set to implement these procedures. Finance and physical resources to enable the effective implementation of the Workplace Health and Safety Management System. These resources are provided for in the provision of the budget allocation to the Workplace Health and Safety team and the overall budget of the individual work units. The Work Health and Safety Policy clearly defines, documents and  communicates the responsibilities and accountabilities of Senior management executives, Managers and Supervisors, Employees and Contractors and Subcontractors. Coffeeville in consultation with employees identifies training needs in relation to performing work ac tivities competently, including health and safety training. Consultation between management and employees is an essential part of effectively managing health and safety in the workplace. Management must consult with employees so that they contribute to decisions about the implementation of safety practices. A communication network is necessary in order to provide safety and welfare information to staff, contractors and visitors through the following media like WHS website, targeted correspondence and emails to employees and stakeholders, safety manuals, signage and safe work procedures. Coffeeville measures and reports its health and safety performance on a regular basis via WHS inspections, and incident, accident and hazard reports. The Workplace Health and Safety team prepares an annual report for the Coffeeville Executive and Council on the management of health and safety. The report provides the necessary information on the performance of the WHSMS to enable review of the WHSMS on an ongoing basis, ensuring that the systems in place continue to meet the needs of the company. 9. What expert WHS advice to be used It is necessary to employ or engage a suitably qualified person under WHS legislation to advice on issues impacting the health and safety of your employees. Consultant can be hired if there is no suitable person with required skills and knowledge at within organisation or someone from workplace is to be provided with proper training to perform the job. A consultant or qualified can give you advice on: establishing, maintaining or improving safe systems of work identifying, eliminating or controlling workplace hazards actions to eliminate or reduce the risk of a worker being injured Taking samples or measurements of workplace environments (eg air samples, noise readings or ergonomic assessments). Can give advice to review and revival of company’s WHS policy 10. The requirements for strict compliance with WHS legislative framework to meet legal requirements WHS policies and procedures  of company must be designed under the guidelines given in Work Health and Safety Act 2011(WHS Act) and Work Health and Safety Regulations 2011(WHS Regulations). The WHS Act provides a framework to protect the health, safety and welfare of all workers at work and of other people who might be affected by the work. Duty of an organization includes ensuring, so far as is reasonably practicable: provision and maintenance of a work environment without risks to health and safety provision and maintenance of safe plant and structures and safe systems of work safe use, handling and storage of plant, structures and substances provision of adequate facilities for the welfare at work of workers, including volunteers, for example toilets, first aid facilities, and provision of information, training and instruction or supervision that is necessary to protect all persons from risks to their health and safety arising from their work. References: www.vwa.vic.gov.au http://www.safeworkaustralia.gov.au http://simulations.ibsa.org.au/australian_hardware http://simulations.ibsa.org.au/coffeeville

Conflict Between Two Characters Hills Like White Elephants

Cause of Conflict Between Two Characters: Hills Like White Elephants In Hills Like White Elephants, Ernest Hemingway tells a vague yet concentrated story about a crisis in a couple’s relationship that is left open for the reader’s interpretation. The story opens at a Spanish train station, with a brief description of the scenery at the river Ebro and the white hills that lay behind it. An American couple have drinks at the bar while awaiting their train, bickering about seemingly nothing. The two characters never actually say what they are arguing about, forcing the reader to infer what is taking place. It seems as if neither of them are really saying what they want to each other. Jig, the American girl, makes the seemingly innocent statement that the hills â€Å"look like white elephants,† which starts a small argument that turns into an even bigger complication. Hemingway actually uses the white hills as a metaphor for a pregnancy, both figuratively and somewhat evidently. Simply the color (or absence of color perhaps) white is a common symbol for purity as well as innocence, which could very well be connected to the presence of a child. Also note that a pregnant woman’s stomach is often referred to as a hill. Figuratively, the hills could represent an obstacle that must be overcome (the decision of whether or not to abort a child). I also believe that the According to the Oxford English Dictionary, a white elephant is also referred to as â€Å"a possession that is useless orShow MoreRelatedâ€Å"the Lottery† and â€Å"Hills Like White Elephants† Essay881 Words   |  4 Pagesâ€Å"The Lottery† and â€Å"Hills like White Elephants† Regardless of the type of society people live in controversial topics and cowardly individuals can create conflict. 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On this side there was no shade and no trees and the station was between two lines of rails in the sun. [†¦] The American and the girl with him sat at a table in the shade, outside the building. It was very hot and the express from Barcelona would come in forty minutes. It stopped at this junction for two minutes and went to Madrid† (290 paragraph 1). Ernest Hemingway crafts a well written dialogue in thisRead More Symbolism in Hills Like White Elephants, by Ernest Hemingway1687 Words   |  7 Pagesfrequently uses various literary elements in his writing to entice the reader and enhance each piece that he writes. In Hills Like White Elephants, Hemingway uses symbols to teach the reader certain things that one may encounter during daily life. Symbolism may be defined as relating to, using, or proceeding by means of symbols (Princeton). The use of symbols in Hills Like White Elephants is utterly important to the plot line and to the fundamental meaning of the story. 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The portrayal of the male character as well travelled, well-educated, and

Atheism Essay - 1443 Words

Atheism People in our society today who have the atheist point of view on religion, which is the belief that there is no god, are going against the so-called norms of society, and therefor are seen as deviant. Deviance is just an idea. Society determines what is deviant by the ideas they hold of what should be the norm. Atheism is seen as a negative deviance, or below the norm. They have a status that is placed on them in society. It doesn’t necessarily mean that they believe in evil, although that is how it is sometimes viewed from people in society who have a specific religion or faith. Atheism, which is not a new idea, has been evolving in our society, and is the reason for problems leading to debate and court cases, and for†¦show more content†¦But as god beliefs have grown more absurd because of increasing knowledge, some have felt compelled to point out difficulties with these beliefs. And, as religion has grown more tyrannical, atheists have seen the need to organize i n defense of freedom. Atheism has a long and colorful history, but that history has been largely hidden from the publics view due to religious suppression. It is therefore, with great effort, that modern atheists are re-discovering their heritage. Some early Greek philosophers were among the first to write down atheistic ideas. Great thinkers such as Heraclitus, Democritus, Protagorus, and Lucretius expressed views that questioned the existence of gods. Atheism gained a permanent foothold in western culture during the Renaissance and through the Enlightenment. But atheism truly began to thrive around the beginning of the 20th century in what is called the Freethought movement. Current trends indicate that the popularity of atheism should continue to increase into the next century. Sir Thomas Huxley coined the term â€Å"agnostic† in 1869. Popularly the word agnostic is felt to mean that the nature of god cannot be known but that there is a god. Therefore the agnostic is accepted in the community and he is accepted by the church, unlike those labeled or known as â€Å"atheists†. Agnosticism is very closely related to the religious doctrine that the ways of god are incomprehensible, that human reason is deceptive and that man requires aShow MoreRelatedEssay on Atheism1218 Words   |  5 PagesInformative Speech Atheism Specific Purpose: To inform my audience about Atheism, why it important as well as the fundamental elements of being a part of it. I will discuss what Atheism is, how it originated, and the number of people who practice this religion. Central Idea: What is Atheism? Who? When? Where? And Why!? Organizational Pattern: Topical Introduction Forrester Church once said, â€Å"Religion is the human response to being alive and having to die.† In Christianity when oneRead MoreAtheism Vs Agnosticism : Atheism And Agnosticism1004 Words   |  5 PagesAtheism vs Agnosticism? All my life I wondered which of the thousands of religions, if any, is the right one to believe in. I’m sure most religious people have found their selves questioning if the God or higher power they’re devoting their time to is even real. I for one have done that more times than I can count. Today, there’s roughly 4,200 different religions in the world. That’s 4,200 different beliefs in the world, all believing in a different God or a different higher power. How can youRead MoreAtheism Essay1503 Words   |  7 PagesLet’s start off by explaining what atheism is, it’s when you don’t believe in any form of an â€Å"Intelligent Creator† or God, as usually referred to as. 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God can decide to stop all evil in the world if He wanted to but He chooses not to because it is not part of His plan or design for this world. McCloskey’s claim of Atheism being more comfortable than theism is totally false. Humans have the burning desire to believe that life has meaning. McCloskey says that Atheism leads to self-reliance, and self-respect and for this, he can feel a sense of pride. But he ultimately knows that that pride is an illusion and that, if he is right about God’sRead MoreAtheism And The Existence Of Deity1421 Words   |  6 PagesMerriam-Webster Dictionary defines atheism as â€Å"a disbelief in the existence of deity.† This definition of atheism is broad and general. Most people only know that atheism is the lack of belief in a god or gods, but they do not know what atheists do believe in or if atheists have faith in anything. Also, atheism is often seen as the opposite of religion. Religion is the belief in a god or gods, while atheism is the disbelief in the same. Does this view of atheism limit our understanding of what itRead MoreAtheism And The Existence Of God Essay129 4 Words   |  6 Pagesrecurring terms during the discussion on the existence of God. Traditionally the three attitudes one could hold towards the existence of God are theism, atheism and agnosticism. The belief in the existence of God or Gods, in specific of one that intervenes in the matters of the universe is defined as theism (Oxford Dictionaries, English, 2016). Atheism as defined in the Stanford Encyclopaedia of Philosophy (Spring 2013 Edition) refers to the negation of theism or in other words, the denial of the existenceRead MoreThe Problem Of Evil And Atheism1187 Words   |  5 Pagesowe to prove his thesis about the problems of evil and atheism, Rowe asks three fundamental questions. 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Even by just typing into Google, â€Å"What is Atheism?† in a matter of 0.34 seconds, it answers that it is a disbelief or lack of belief in the existence of God orRead MoreAtheism Is Not An Easy Belief3083 Words   |  13 PagesAtheism is just as misunderstood as theism in today’s realm, specifically when one is precarious of the other. Theists have some misunderstandings about atheism, but atheists have their specific misconceptions about theism. These two world understandings are two risky points-of-view regarding thoughts of God. Atheists do not trust that God exists, but theists believe in a God, who made the world and earth. In his artic le, â€Å"On Being an Atheist†, H.J. McCloskey tries to convince his listeners that