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WJPR Citation
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| All | Since 2020 | |
| Citation | 8502 | 4519 |
| h-index | 30 | 23 |
| i10-index | 227 | 96 |
HOLISTIC VALIDATION OF INTEGRATED PHARMACEUTICAL WATER SYSTEMS: FROM PRETREATMENT TO PURE STEAM AND PURIFIED WATER
Tania de. La. Cruz, Alberto Leyva*, Sonny Robles, Anabel Duarte, José C. Pradere
Abstract Pharmaceutical water systems are fundamental to product quality and patient safety, requiring rigorous validation across pretreatment, purified water, and pure steam subsystems. This study presents a holistic validation approach encompassing activated carbon filtration (ACF), reverse osmosis (RO), purified water (PW), pure steam, and condensate recovery, with extended determinations across multiple production cycles. Pretreatment with ACF and RO consistently removed chlorine ( Keywords: Pharmaceutical water systems, Pure steam validation, Purified water quality, Condensate recovery, Good Manufacturing Practices. [Full Text Article] [Download Certificate] |
