Cloud computing systems have two ends - a front end consisting of user computers and clients that access applications, and a back end of servers, data storage, and computer programs. The front and back ends are connected through a central server, with the back end accessed publicly through the internet and monitoring traffic and requests from clients on the front end to ensure everything runs smoothly.
Tot el dia cuinant? Ja no sap que fer per dinar? Venen convidat? És l´aniversari dels nens? Doncs aqui hi tens unes quantes receptes pq no perdis el temps!
This document discusses integrity testing of sterilized filters as mentioned in EU Annex 1 Paragraph 113. It presents the risks of not performing pre-use integrity testing, such as filter failure and need for reprocessing. Alternative process designs are proposed to allow pre-use testing while maintaining sterility of the filtrate side, such as using diversion valves or redundant filtration systems. The document suggests rewording the language in Paragraph 113 from "should" to "may" to allow end-users more flexibility based on risk assessments showing pre-use testing may not significantly increase safety.
This document provides a position paper on pre-use/post-sterilization integrity testing of sterilizing grade filters. It analyzes the implications and risks of requiring such testing, and assesses common assumptions versus available data. The paper finds that requiring pre-use, post-sterilization integrity testing would increase complexity and risks contamination of the downstream sterile side without clear benefits to drug safety. Most filter damage is detected by standard post-use testing, and there is no evidence that pre-use failures can be missed. The paper recommends not requiring such testing but leaving the decision to filter users based on risk assessments.
Cloud computing systems have two ends - a front end consisting of user computers and clients that access applications, and a back end of servers, data storage, and computer programs. The front and back ends are connected through a central server, with the back end accessed publicly through the internet and monitoring traffic and requests from clients on the front end to ensure everything runs smoothly.
Tot el dia cuinant? Ja no sap que fer per dinar? Venen convidat? És l´aniversari dels nens? Doncs aqui hi tens unes quantes receptes pq no perdis el temps!
This document discusses integrity testing of sterilized filters as mentioned in EU Annex 1 Paragraph 113. It presents the risks of not performing pre-use integrity testing, such as filter failure and need for reprocessing. Alternative process designs are proposed to allow pre-use testing while maintaining sterility of the filtrate side, such as using diversion valves or redundant filtration systems. The document suggests rewording the language in Paragraph 113 from "should" to "may" to allow end-users more flexibility based on risk assessments showing pre-use testing may not significantly increase safety.
This document provides a position paper on pre-use/post-sterilization integrity testing of sterilizing grade filters. It analyzes the implications and risks of requiring such testing, and assesses common assumptions versus available data. The paper finds that requiring pre-use, post-sterilization integrity testing would increase complexity and risks contamination of the downstream sterile side without clear benefits to drug safety. Most filter damage is detected by standard post-use testing, and there is no evidence that pre-use failures can be missed. The paper recommends not requiring such testing but leaving the decision to filter users based on risk assessments.