简介:AbstractAlbumin solutions derived from human plasma have demonstrated clinical benefits as intravenous fluid therapy in clinical settings such as liver disease, sepsis, intensive care, and surgery. For all plasma-derived medicinal products, there is a potential risk from pathogens, including relevant blood-borne viruses, emerging viruses, and prion proteins. To minimize the risk of transmissible infections, the production of human albumin solutions includes rigorous donor selection and plasma testing, and effective pathogen removal and inactivation methods such as fractionation and pasteurization. Compliance with international pharmacopeial standards for purity and prekallikrein activator and aluminum content is crucial, as is post-marketing pharmacovigilance for the continuous monitoring of adverse events. This review focuses on the effectiveness of manufacturing methods in the production of plasma-derived albumin, to ensure the safety of hyperoncotic solutions for volume expansion. We evaluated evidence identified through online database (PubMed) searches and from unpublished sources, on the manufacturing and pathogen safety of plasma-derived albumin solutions. The results confirmed the already established and evolving pathogen reduction capacity of the reviewed manufacturing methods. Up-to-date post-marketing pharmacovigilance data and log10 reduction factors for known and emerging pathogens during albumin production are included. Towards the goal of ever-increasing clinical safety, potential areas of improvement, such as compliance rates for the completion of donor health questionnaires, are also discussed. Taken together, the current manufacturing and pathogen reduction steps result in albumin products of greater purity than previous-generation products, with a high margin of pathogen safety against known and emerging pathogens, such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
简介:摘要:TRD工法属于引进技术,也叫渠式切割水泥土连续墙技术,尽管该技术在内地应用多年,但仍然有很多细节值得研究,有很多方面需要重视。按照现有的规范规程,尤其是在《渠式切割水泥土连续墙技术规程》中强调,TRD工法在实施前,应进行试验分析,检验TRD工法的现场适用性。但《渠式切割水泥土连续墙技术规程》没有给出具体是试验设计。 另外,在实际操作中,因为没有统一的指导说明,TRD试验段的实施往往被承包方忽视,没有列入投标建造成本,但后期补充索赔,往往各方又存在争议和扯皮。因此,本文的重要意义在于提醒参建方,TRD工法的现场试验需要重点设计并且应列入成本。本文就技术角度,对TRD工法的试验设计与分析做出阐述,也希望本文的试验设计能成为TRD投标造价的指导性参考。
简介:主题摘要:BT模式下招标筹建砼工厂,集中供应原材料,在日常监督管理下生产砼,统一进行结算,取得了良好的经济及社会效果。