1、目的


                                                                                                                                          


對無菌醫療器械產品生產的包裝過程進行有效控制，確保經環氧乙烷滅菌產品的包裝有效性。


                                                                                                                                               


2、范圍



 


本程序規定了無菌醫療器械產品包裝工藝過程驗證的管理職責、工作程序、內容和要求。


                                                                                                                                                                                                                                                                                        


本程序適用于環氧乙烷滅菌產品包裝的控制，以及包裝驗證方案、報告的編制。


                                                                                                                                                                              


3、職責


                                                                                                                                          


3.1生產部負責成品包裝過程的控制。


                                                                                                                                                            


3.2生產車間負責成品的包裝工作。


                                                                                                                                                            


3.3技術部負責成品包裝驗證方案的編制。


                                                                                                                                                            


3.4質檢部負責成品包裝的檢查驗證,并形成包裝驗證報告。


                                                                                                                                                            


4、控制程序


                                                                                                                                          


4.1包裝材料確定的原則


                                                                                                                                                           


4.1.1 包裝材料應清潔完整，具有良好的密封加工性能。


                                                                                                                                                            


4.1.2 標簽印刷應清晰可見無污染及其它制造缺陷。


                                                                                                                                                            


4.2包裝材料與滅菌過程的適合性。


                                                                                                                                                            


4.2.1 在滅菌過程中，應保證環氧乙烷能穿透包裝材料。并在滅菌后對環氧乙烷滅菌劑能有


效的解析。


                                                                                                                                            


4.2.2 經環氧乙烷滅菌后，其包裝材料及包裝標簽與使用的滅菌過程的適應性無不利影響。


         


4.3包裝材料的毒性。                                                                                                                                                               


在使用過程中，包裝材料不得釋放出對人體健康產生危害的有毒性物質。



 


4.4包裝材料的生物兼容性。                                                                                                                                                         


經密封包裝后的產品其表面與包裝材料充分接觸并經過環氧乙烷滅菌后，按照EN30993—X要求確定其細胞毒性、過敏性、溶血性和皮內刺激性。




                                                                                                                              


4.5包裝材料的無菌性保持。                                                                                                                                                         


需經環氧乙烷的產品經包裝熱壓封口后應保持其封口處的完整性和不透氣性，并應確保整個密封包裝的不透氣性和阻菌性。


                                                                                                                                             


4.6包裝材料貯藏和運輸的適宜性。                                                                                                                                                      


在指定的運輸和貯藏條件下，經滅菌后包裝材料的保存期應與產品相一致，確保包裝材料的耐老化性能。


                                                                                                                                             


4.7包裝材料（單包裝袋）應在10萬級潔凈區內制造。


                                                                                                                                                            


4.8包裝封口過程的操作方法按《包裝操作規程》進行。


                                                                                                                                                            


4.9包裝材料的有效性驗證按《滅菌包裝》EN868-1：1997進行。



 


4.1O在完成了所有的包裝項目驗證以后，應形成包裝驗證報告，所有的包裝驗證記錄報告由技術部歸檔保存。     


                                                                                                                                                                                                                                                                                                                   


5、相關文件


                                                                                                                                          


5.1產品監視和測量控制程序YH/QP-20                    


                                                                                                                                  


5.2滅菌包裝 EN868-1


                                                                                                                                                            


5.3醫療器械生物學評估 EN30993-X      


                                                                                                                                                                                                                                                                                            


6、文件記錄     


                                                                                                                                  


6.1包裝驗證報告QP15-01。