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Pharmaceutical Excipient Good Manufacturing Practices
Published in Graham P. Bunn, Good Manufacturing Practices for Pharmaceuticals, 2019
Where potable water is supplied from a municipality, the FDA has allowed reliance on data provided by municipal water authorities to demonstrate the water is potable. However, recent experience with FDA visits indicate it is appropriate, from time to time, to recheck the water quality at the point of use in the plant since this is often a long distance from the municipal testing point. Where purified water is used, the process must be validated to demonstrate continuing conformance to the specification for the purified water as well as for adequate control of microbes.
A comprehensive validation framework addressing utility parameter validation for application in small and medium enterprises (SMEs):A case study in pharmaceutical industry
Published in Cogent Engineering, 2023
Vothia Surian Subramaniam, Joshua Prakash, Shahrul Kamaruddin, Sze Wei Khoo
Performance qualification of the water system covered checking of total organic carbon (TOC), conductivity and microbial level in the water produced by the reverse osmosis water system as well as weekly sanitization of the system which were performed to eliminate any existence of bacteria on the internal surface of piping system. Sanitization was carried out by circulating hot water at 85°C through the piping system for two hours after closing all the user points. Also, during this process, each user point was flushed with the circulating hot water for five minutes to ensure the inner surface of the water outlets was cleaned properly. Once the sanitization process was over, the reverse osmosis system started to supply water to purified water tank again. The hot water supply from the purified water tank was drained out slowly and loop temperature was let to reach approximately 25°C before purified water samples were collected at various selected water user points in the factory. These samples were then sent to microbiology lab for microbial count testing. Similarly, chemical lab tested total organic carbon and conductivity level of the collected water samples. These tests were performed daily for four weeks to confirm the chemical and microbial characteristics of produced water met the acceptance criteria.
Flow behaviors of a viscoelastic polymer solution at 3D micro pore-throat structure
Published in Journal of Dispersion Science and Technology, 2019
Zijia Li, Long He, Hao Li, Xiaoxi Yu, Mingwei Zhao, Yining Wu, Xuepeng Wu
The hydrolyzed polyacrylamide (HPAM) polymer (relative molecular mass ≈ 1.0 × 107, Sinopharm Chemical Reagent Co., Ltd, China) is used for viscoelastic fluid preparations. HPAM has been widely used for enhanced oil recovery process and studied for its rheological viscoelasticity.[5] The solution was prepared by adding the HPAM polymer powder into water and stirring the mixture for four hours under room temperature 25 °C. The polymer concentration was fixed at 0.6%wt, which is close to application concentration on site. Measured by the rheometer, the stable shear viscosity of HPAM solution is 1153 mPa·s at 25 °C, and the relaxation time is 12.6 ms−1. To highlight the distinct hydrodynamic properties of polymer solutions, ultra-purified water was prepared for control group experiments, with viscosity of 1.0 mPa·s at 25 °C. The purified water was collected from a reverse osmosis unit (ULUPURE, UPT-II-5T) with an electrical resistance of 18.25 MΩ. The volumetric injection rate was controlled by a precision syringe pump from Harvard Apparatus. By comparing the flow patterns and velocity profiles between purified water and polymer solutions, we were able to observe the flow instabilities originated from the elasticity of the polymer and the influence of the restraint of geometric conditions.
Photodegradation of the pure and formulated scoparone in liquid solutions: kinetics and mechanism
Published in Environmental Technology, 2022
Jinxiang Luo, Huijun Xie, Wei Ding, Yongqiang Zhang
All chemicals used in the experiments were analytic grade or higher and were used as received without further purification. SPR was obtained from Yuanye Biotechnology Co., Ltd (Shanghai, China) (≥98% purity) (This product is 98% SPR TC), and its stock solution (1000 mg/L) was prepared in brown volumetric flask by HPLC grade methanol and stored in the dark at 4°C. HPLC grade methanol was supplied by Sinopharm chemical reagent Co., Ltd (Shanghai, China). Reverse osmosis-purified water (RO), Ultra-pure water (UP), Natural sea water, and River water were obtained and treated before experiments describing as our previous report [29]. 5% SPR EC was prepared by 5% scoparone+50% N-methylpyrrolidone + 10% tween-85 + 35% turpentine according to our reported work [18].