1、目的


                                                                                                                                          


對(duì)無菌醫(yī)療器械產(chǎn)品生產(chǎn)的包裝過程進(jìn)行有效控制，確保經(jīng)環(huán)氧乙烷滅菌產(chǎn)品的包裝有效性。


                                                                                                                                               


2、范圍



 


本程序規(guī)定了無菌醫(yī)療器械產(chǎn)品包裝工藝過程驗(yàn)證的管理職責(zé)、工作程序、內(nèi)容和要求。


                                                                                                                                                                                                                                                                                        


本程序適用于環(huán)氧乙烷滅菌產(chǎn)品包裝的控制，以及包裝驗(yàn)證方案、報(bào)告的編制。


                                                                                                                                                                              


3、職責(zé)


                                                                                                                                          


3.1生產(chǎn)部負(fù)責(zé)成品包裝過程的控制。


                                                                                                                                                            


3.2生產(chǎn)車間負(fù)責(zé)成品的包裝工作。


                                                                                                                                                            


3.3技術(shù)部負(fù)責(zé)成品包裝驗(yàn)證方案的編制。


                                                                                                                                                            


3.4質(zhì)檢部負(fù)責(zé)成品包裝的檢查驗(yàn)證,并形成包裝驗(yàn)證報(bào)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(yīng)清潔完整，具有良好的密封加工性能。


                                                                                                                                                            


4.1.2 標(biāo)簽印刷應(yīng)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(yīng)保證環(huán)氧乙烷能穿透包裝材料。并在滅菌后對(duì)環(huán)氧乙烷滅菌劑能有


效的解析。


                                                                                                                                            


4.2.2 經(jīng)環(huán)氧乙烷滅菌后，其包裝材料及包裝標(biāo)簽與使用的滅菌過程的適應(yīng)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(duì)人體健康產(chǎn)生危害的有毒性物質(zhì)。



 


4.4包裝材料的生物兼容性。                                                                                                                                                         


經(jīng)密封包裝后的產(chǎn)品其表面與包裝材料充分接觸并經(jīng)過環(huán)氧乙烷滅菌后，按照EN30993—X要求確定其細(xì)胞毒性、過敏性、溶血性和皮內(nèi)刺激性。




                                                                                                                              


4.5包裝材料的無菌性保持。                                                                                                                                                         


需經(jīng)環(huán)氧乙烷的產(chǎn)品經(jīng)包裝熱壓封口后應(yīng)保持其封口處的完整性和不透氣性，并應(yīng)確保整個(gè)密封包裝的不透氣性和阻菌性。


                                                                                                                                             


4.6包裝材料貯藏和運(yùn)輸?shù)倪m宜性。                                                                                                                                                      


在指定的運(yùn)輸和貯藏條件下，經(jīng)滅菌后包裝材料的保存期應(yīng)與產(chǎn)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(yīng)在10萬級(jí)潔凈區(qū)內(nèi)制造。


                                                                                                                                                            


4.8包裝封口過程的操作方法按《包裝操作規(guī)程》進(jìn)行。


                                                                                                                                                            


4.9包裝材料的有效性驗(yàn)證按《滅菌包裝》EN868-1：1997進(jìn)行。



 


4.1O在完成了所有的包裝項(xiàng)目驗(yàn)證以后，應(yīng)形成包裝驗(yàn)證報(bào)告，所有的包裝驗(yàn)證記錄報(bào)告由技術(shù)部歸檔保存。     


                                                                                                                                                                                                                                                                                                                   


5、相關(guān)文件


                                                                                                                                          


5.1產(chǎn)品監(jiān)視和測量控制程序YH/QP-20                    


                                                                                                                                  


5.2滅菌包裝 EN868-1


                                                                                                                                                            


5.3醫(yī)療器械生物學(xué)評(píng)估 EN30993-X      


                                                                                                                                                                                                                                                                                            


6、文件記錄     


                                                                                                                                  


6.1包裝驗(yàn)證報(bào)告QP15-01。