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                      血液制品潔凈廠房設計要點DEIIANG

                      發布時間:2021-07-18 00:35 人氣: 來源:http://www.gao88.cn

                      一、血制品的生產制造工業廠房理應為單獨房屋建筑,不可與其他藥物同用,并應用專用型的生產制造設備和機器設備。

                      二、原料血漿、血制品檢驗實驗室理應合乎國務院辦公廳《病原生物實驗室生物安全管理條例》、國家行業標準《實驗室生物安全通用要求》的相關要求。

                      三、原料血漿檢驗實驗室理應歸口管理,應用專用型檢測機器設備,并理應有原點消滅或消毒殺菌的機器設備。若有空調機組,理應歸口管理。

                      四、原料血漿破袋機、合拼、分離出來、獲取、散裝前的巴氏消滅等工藝流程最少在D級清潔區域內開展。

                      五、血漿融漿區域、成分分離出來區域及其病毒滅活后生產制造區域理應彼此之間分離,生產線設備理應專用型,各區域理應有單獨的空氣過濾系統軟件。        http://www.gao88.cn                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             

                      六、血制品生產制造中,理應采取一定的有效措施防止病毒除去和/或消滅前、后產品的交叉式環境污染,病毒感染除去和/或消滅后的產品理應應用防護的專用型生產制造地區與機器設備,并應用單獨的空氣過濾系統軟件。

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