First, the necessity of steam quality testing:
1. Pharmaceutical GMP Guide-Water System "proposes that the indicators that need to be tested for purified water, water for injection, and sterilized steam include: microbial limit, conductivity, TOC, bacterial endotoxin, non-condensable gas content, dryness, and superheat value;
2. Sampling frequency:
2. Sampling method:
1. Strictly refer to EN285 standard, use special tube pitot tube sampling;
2. Pure steam quality standards:
3. Sampling conditions:
The steam generator runs normally above 30M;
Sampling devices such as sampling bottles must be sterilized by dry heat at 180 ° C for 2H, or dry heat sterilized at 250 ° C for 1H, and Erlenmeyer flasks must be sterilized at 121 ° C for 30M.
Microorganisms, endotoxins, and physical and chemical items are sampled separately, and the same sampling device must not be used.
Need to prepare circulating water storage device and 220V power supply.
Fourth, test equipment:
1. Approved by British DEKONSOLUTIONS (SVMS) for high-rate steam samplers in China
2. Use 316L shaped pipe, stainless steel braided hose connection, and circulating water power device.
Five, test qualifications:
1. UK DEKONSOLUTIONS (SVMS) authorized sales and service qualification certificate;
2. British DEKONSOLUTIONS (SVMS) product training certificate;
1. Provide data report of sampling time, sampling location, sampling volume, etc .;
2. Provide product qualification certificate, SOP file, operator qualification document.