The results showed that all performance parameters were in confirmation with the production standard, so a serials of validation protocols were created and test methods were established. All results and validation methods were approved by the national GMP certification center. 因而确认高压灭菌柜的各项性能均达到生产要求,由此建立的一套验证方案及试验方法和结果得到了国家GMP认证中心的认可。