Essay on Water Purification in Pharmaceutical Manufacturing

Essay on Water Purification in Pharmaceutical Manufacturing

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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 25c 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.

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