Please be aware that all isolators

Please be aware that all isolators located at Zhejiang Hisun´s facilities or to be acquired should have available the possibility of performing a leak test. Response to deficiency 6.a:The finalized leakage testing frequency for isolator gloves of non-sterile product is once per week for routine production schedule, and once before use and after use for infrequent production schedule, based on H3-EV-MF01-050R, Risk Assessment Report of Test Frequency Leak Detection of Glove for Non-sterile Isolator, version 00. The historical testing data and suppliers’ recommendation are included in the assessment report, of which conclusion indicates that the frequency is suitable. The testing frequency has been specified in H3-TM-10209, Leak Detection Operating Procedure for Glove of Isolator, version 05, which procedure is applied for all isolators in Zhejiang Hisun´s API workshops.