Simultaneously Installation, Validation and Maintenance of Water System used in Health Industry |
Author(s): |
Aviral Sharma , ZIFAM PYREX MYANMAR CO. LTD; Kavita Singh, ZIFAM PYREX MYANMAR CO. LTD |
Keywords: |
Water System Validation, Validation, Purified Water System Validation, Validation, Pharmaceutical |
Abstract |
Water is part of each pharmaceutical product [1]. It is used in the pharmaceutical industry in various ways, for example, for example, as a raw material, inactive pharmaceuticals, pharmaceutical agents, pharmaceutical intermediates, pharmaceutical analysis, cleaning solvents, etc. In the formulation of a medicine, it is necessary to use water of high purity in each phase of the formulation of each medicine. Water because it is impossible to obtain pharmaceutical water from an external pharmaceutical supplier. Water is used in the preparation of all pharmaceutical forms, but parenteral drugs are very dangerous. Today, each pharmaceutical production unit has a purified water system, while the parenteral drug manufacturing unit needs water for injection systems [4] (WFI system). Most drug regulatory authorities cite guidelines for various types of water, such as purified water, sterile water for injections, bacteriostatic water for injections, etc., which can be used in several ways. Any means of pharmaceutical production. The quality of pharmaceutical water depends to a large extent on the quality of the water system [9-10]. However, before the water produced in a unit can be used, the water supply system [2] must be validated and the reliability of water treatment, storage and distribution confirmed. The continuous monitoring of the water system is a clear regulatory requirement and an important financial burden for the personnel and resources of the company. Proper planning of the water supply system with personal skills in all physical, chemical, technical and microbiological areas related to water is essential. The correct pharmaceutical water system must respect and respect the requirements of the Pharmacopoeia. Have the correct scanning system in the right places and at the correct frequency. |
Other Details |
Paper ID: IJSRDV7I50219 Published in: Volume : 7, Issue : 5 Publication Date: 01/08/2019 Page(s): 227-232 |
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