1、目的


                                                                                                                                          


对无菌医疗器械产品生产的包装过程进行有效控制，确保经环氧乙烷灭菌产品的包装有效性。


                                                                                                                                               


2、范围



 


本程序规定了无菌医疗器械产品包装工艺过程验证的管理职责、工作程序、内容和要求。


                                                                                                                                                                                                                                                                                        


本程序适用于环氧乙烷灭菌产品包装的控制，以及包装验证方案、报告的编制。


                                                                                                                                                                              


3、职责


                                                                                                                                          


3.1生产部负责成品包装过程的控制。


                                                                                                                                                            


3.2生产车间负责成品的包装工作。


                                                                                                                                                            


3.3技术部负责成品包装验证方案的编制。


                                                                                                                                                            


3.4质检部负责成品包装的检查验证,并形成包装验证报告。


                                                                                                                                                            


4、控制程序


                                                                                                                                          


4.1包装材料确定的原则


                                                                                                                                                           


4.1.1 包装材料应清洁完整，具有良好的密封加工性能。


                                                                                                                                                            


4.1.2 标签印刷应清晰可见无污染及其它制造缺陷。


                                                                                                                                                            


4.2包装材料与灭菌过程的适合性。


                                                                                                                                                            


4.2.1 在灭菌过程中，应保证环氧乙烷能穿透包装材料。并在灭菌后对环氧乙烷灭菌剂能有


效的解析。


                                                                                                                                            


4.2.2 经环氧乙烷灭菌后，其包装材料及包装标签与使用的灭菌过程的适应性无不利影响。


         


4.3包装材料的毒性。                                                                                                                                                               


在使用过程中，包装材料不得释放出对人体健康产生危害的有毒性物质。



 


4.4包装材料的生物兼容性。                                                                                                                                                         


经密封包装后的产品其表面与包装材料充分接触并经过环氧乙烷灭菌后，按照EN30993—X要求确定其细胞毒性、过敏性、溶血性和皮内刺激性。




                                                                                                                              


4.5包装材料的无菌性保持。                                                                                                                                                         


需经环氧乙烷的产品经包装热压封口后应保持其封口处的完整性和不透气性，并应确保整个密封包装的不透气性和阻菌性。


                                                                                                                                             


4.6包装材料贮藏和运输的适宜性。                                                                                                                                                      


在指定的运输和贮藏条件下，经灭菌后包装材料的保存期应与产品相一致，确保包装材料的耐老化性能。


                                                                                                                                             


4.7包装材料（单包装袋）应在10万级洁净区内制造。


                                                                                                                                                            


4.8包装封口过程的操作方法按《包装操作规程》进行。


                                                                                                                                                            


4.9包装材料的有效性验证按《灭菌包装》EN868-1：1997进行。



 


4.1O在完成了所有的包装项目验证以后，应形成包装验证报告，所有的包装验证记录报告由技术部归档保存。     


                                                                                                                                                                                                                                                                                                                   


5、相关文件


                                                                                                                                          


5.1产品监视和测量控制程序YH/QP-20                    


                                                                                                                                  


5.2灭菌包装 EN868-1


                                                                                                                                                            


5.3医疗器械生物学评估 EN30993-X      


                                                                                                                                                                                                                                                                                            


6、文件记录     


                                                                                                                                  


6.1包装验证报告QP15-01。