Water Purification in Pharmaceutical Manufacturing Introduction In this assignment an overview of water purification in pharmaceutical manufacturing will be briefly explored. The system(S)/equipment used in that process will be identified and installation qualification and operational qualification of this equipment will be discussed. As water purification is one of the crucial process in pharmaceutical manufacturing understanding of what this process entail is IQ and OP. As water is used widely in pharmaceutical production either in manufacturing or cleaning and technology is always progressing to obtain the most purified form of it. Purified water is an ingredient in the manufacturing of the medication (tablets, powder etc.) however it cannot be used for injection or parenteral products. “The United States pharmacopoeia (USP), and the European pharmacopoeia (Ph Eur.) set the high purity water standards for the pharmaceutical industry. Both the USP and Ph Eur. work closely with the Food and Drug Administration (FDA), the European Agency for the evaluation of medicinal products (EMEA), the pharmaceutical industry, and the health professions, to establish authoritative pharmaceutical standards. These standards are enforceable by the FDA and the governments of other countries, and are recognised worldwide as the hallmark of quality. The FDA enforces current good manufacturing practice (cGMP), as well as the current USP ” In the pharmacopoeia there is strict specification set out for purified water (EP&USP). Purification of water could be done by distillation or reverse osmosis. USP standards Organic < 0.5ppm TOC, Conductivity, 1.3 microS/cm at 25c in-line m... ... middle of paper ... ... to chemical attacks the result of carbon filter failure in pre-treatment”. (Adapted from APU lectures innopharmalabs) Conclusion Pharmaceutical companies operate to specification that exceeds the requirements of USP and EP. References [1] apps.who.int › prequal › trainingresources › pq_pres › presentations [2] Benjamin L. Austen (B.Sc. (Eng.) Dip. Eng. MIEI) Pharmaceutical water systems a thermal-fluid analysis of pipe dead-legs http://doras.dcu.ie/17237/1/bengamin_l_austin_20120701111118.pdf [3]http://msdssearch.dow.com/PublishedLiteratureDOWCOM/dh_003b/0901b8038003b454.pdf?filepath=liquidseps/pdfs/noreg/609-02003.pdf&fromPage=GetDoc [4] Johnson WM. Validation of water systems for sterile and nonsterile products. In: Berry IR. Nash RA. (Eds). Pharmaceutical Process Validation. 2nd ed. Revised and Expanded, New York: Marcel Dekker Inc, 1993; pp 299-317.
Stephenson, R., & Blackburn, J. J. (1998). The Industrial Wastewater Systems Handbook. New York: Lewis Publishers.
The key stakeholders are Peter Vyas, the manager of filtration unit and Cynthia Jackson who is the vice president of water management division. Vyas was convinced that the survival of the unit depended upon innovative growth and thus he appointed a technology evaluation team with the responsibility of using technology to solve the problem of obtaining clean water in remote regions, by developing a small-scale oxidation system that enabled waste-water disinfection in small batches. His utmost concern is the technological aspect of developing the product. On the other hand, Cynthia’s perspective was shaped by the marketing angle of the product. She recommended the development of future proposals using a rigorous three phase process which links the markets analysis and technological development to busines...
Water is the most abundant and vital substance on our planet. Every living thing needs water in order to survive It is a necessity, especially when dealing with society. Every household needs water, whether for laundry, cooking, plants, personal hygiene, or even drinking, whatever the reason, it is vital that the water we use remains in good quality and is not contaminated.
Little do people know, unfetted, or unfiltered water is as much good as it is bad for you. Not purifying your water can cause many different health problems. However, it can also be very benificial. Non-distilled water is great for cooking. Purified water pulls out the minerals in foods and lowers their nutrient value. That does not mean it is safe to go into your body though.
These rules and regulations, whether from the FDA or the EPA, are in place to protect the public from consuming unsafe water. Some of these directives may also make bottled
Tap water goes through a certain safety procedure to make sure the water is safe to drink.
The company scrutinized in the above process that the cause for the purification of water process was delay to the following methods.
Ultra Filtration processes are limited by the high cost incurred due to membrane fouling and replacement. Additional pretreatment of feed water is required to prevent excessive damage to the membrane units. The water treatment plant is not yet affected by this problem but, pretreatment might be necessary in the near future considering the ultrafiltration membrane durability.
Pharmaceutical waste seems to be one of the dominant elements that are prevalent in our waters, and other aspects of the environment. These aforementioned elements are largely becoming a concern in today’s society because its effects have proven to be harmful towards our environment, and all of its existing forms of life. Through various ways, whether controllable or uncontrollable, pharmaceutical waste slowly and increasingly multiplies its presence within the environment. Additionally, it eventually trickles down into our waterways and causes a large array of damages. Some of the most common ways that this waste gets into the water includes: disposal through the drainage systems, farming fertilization methods and the maintenance of treatment plants. These methods are self-explanatory through their brief discussions, but it helps decipher whether the disposal of these dangerous wastes are intentional or not.
Curtis, Rick. "OA Guide to Water Purification." OA Guide to Water Purification. Princeton Unversity, Mar. 1999. Web. 09 Jan. 2014.
The notion that the water that is in the clear plastic bottle just purchased is pure; purer than the water flowing from the tap is the fundamental reason of choice, one over the other. Millions upon millions of people every day make that choice with a confidence anchored in the trust that the company name on the plastic bottle guarantees it. The choice and use of this source of water purity is at the heart of a growing controversy. More importantly this choice has become both a personal and environmental health problem that has grown far beyond what anyone had predicted earlier when it seemed absurd to pay for a bottle of water when you could have a drink right out of the tap for free. Adding further to the growth of water in a plastic bottle across the world, we have expanded our love affair with the prestige of a name brand water bottle associated more with its’ status rather than its’ purity and thirst quenching capacity.
The water purification system has a very big impact in our lives and we appreciate people helping us to keep our water safe and reliable to create a more healthy body and sometimes a meal.
Over one billion people do not have access to clean water and less than 10% of the world’s population receive a treated water supply. I find this intriguing; as well as being essential to preserving life, water contributes to our lifestyle in so many ways, from the generation of steam for industrial use and electricity generation to the foods we eat. Today chemical engineers face the challenge of ensuring water is purified as well as finding solutions to the wasting of this precious resource. I am particularly interested in the process of water purification from subsurface aquifers and surface sources, such as lakes and rivers, to produce portable drinking water. The reason that this sector has sparked a significant interest is because I come from Somalia, a country where clean water is so difficult to obtain.
Irrigation with inadequately treated wastewater poses serious public health risks, as wastewater is a major source of excreted pathogens - bacteria, viruses, protozoa, ...
Aoki, T., Munemori, M.. Continuous Flow of Free Chlorine in Water. Journal of Analytical Chemistry. 1983, 55, 209-212