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Manufacturing Process Book By Raghuvanshi Pdf 108

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Manufacturing Process Book By Raghuvanshi Pdf 108

Prior to the 20th century, drugs were generally produced by small scale manufacturers with little regulatory control over manufacturing or claims of safety and efficacy. To the extent that such laws did exist, enforcement was lax. In the United States, increased regulation of vaccines and other biological drugs was spurred by tetanus outbreaks and deaths caused by the distribution of contaminated smallpox vaccine and diphtheria antitoxin.[26] The Biologics Control Act of 1902 required that federal government grant premarket approval for every biological drug and for the process and facility producing such drugs. This was followed in 1906 by the Pure Food and Drugs Act, which forbade the interstate distribution of adulterated or misbranded foods and drugs. A drug was considered misbranded if it contained alcohol, morphine, opium, cocaine, or any of several other potentially dangerous or addictive drugs, and if its label failed to indicate the quantity or proportion of such drugs. The government's attempts to use the law to prosecute manufacturers for making unsupported claims of efficacy were undercut by a Supreme Court ruling restricting the federal government's enforcement powers to cases of incorrect specification of the drug's ingredients.[27]

All commercially available products comprised of fragrance ingredients on the market can be traced back to the innovation of fragrance companies as their manufactured products (both of natural and synthetic origin) are sold on to companies further down the supply chain for formulation, packaging and distribution. International fragrance companies are mainly responsible for the discovery, creation, process development and manufacturing of synthetic fragrance ingredients with all of these representing active areas of current research activity within the field today (Figure 2).

Later, in 2003 Anastas went on to publish the 12 principles of green engineering [42], the relevance of continuous manufacturing to these is displayed in Table 3. Together these clearly demonstrate the compatibility of the flow approach with a green chemical manufacturing future. It is also not difficult to see how continuous manufacturing has implications for important green chemistry metrics such as atom economy, reaction mass efficiency, effective mass yield, carbon efficiency and environmental (E) factor (sometimes referred to as the Sheldon E Factor) [43]. These parameters are an integral part of contemporary process evaluation frameworks such as the SELECT (safety, economics, legal, environmental, control, throughput) criteria and there is an increasing demand to keep these numbers as close to optimal as possible.

Whilst the observation of improved processing control under flow conditions compared to batch is not necessarily always the case, there are many instances in which other advantages can be gained by adopting a flow approach. Many of these improvements are inherently linked to the physical engineering of the flow system which are designed to yield improved mixing, better heat transfer and a more structured and consistent processing environment (equating to constant dosing and mixing rates, defined and reproducible reaction timing and exacting control over all processing parameters). Flow chemistry therefore offers a powerful tool for chemists both from a research perspective and later in terms of manufacturing capacity. This has already been widely demonstrated by the pharmaceutical and agrochemical industries where the uptake of flow chemistry has been significant and widely impactful [30]. In the coming years we will undoubtedly see increasing adoption across the entire field of organic synthesis representing a wider spectrum of related industry sectors. 153554b96e

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