China's national drug watchdog on Tuesday cited substandard disinfection as a major factor leading to the lethality of a suspect antibiotic injection, which has allegedly killed six people.
The "Xinfu" drug manufactured in June and July by Anhui Huayuan Worldbest Biology Pharmacy Co. wasn't sterilized properly, with both the sterilization temperature and time below the state-required safety level, said China's State Food and Drug Administration (SFDA).
"As required, the drug should go through a 30-minute disinfection process at 105 degrees Celsius. But the company lowered the temperature to 100 to 104 degrees Celsius and shortened the time to only one to four minutes," said Wang Zhexiong, an official with the safety supervision department of the SFDA.
Disinfection cabinets were also overloaded with the injection, and thus could not effectively wipe out bacteria,Wang said.
The administration promised to punish the company for its production faults and held related producers and managers accountable, but gave no details.
The administration has sent out an investigation team to inspect the pharmaceutical company in East China's Anhui Province.Test on the injection sample conducted by the team has detected excessive bacteria.
Wang said further analysis is needed to find out what kinds of bacteria the sample contains.
Since the first report of the problematic injection on July 27,the drug is blamed for killing six and causing illness to at least 80 people in 10 provinces including Zhejiang, Heilongjiang, Hunan and Shandong.
(Xinhua News Agency August 15, 2006)
