First, the necessity of steam quality testing:
1. The steam quality test originally originated from the test project required by the British National Health Service. Now it is more and more required to perform tests in the pharmaceutical industry and the medical and health industry. The HTM10 (later HTM2010) (Replaced by HTM2031) The range of deviation of steam quality has been widely accepted, and international and European standards (ISO11134, EN285) also originate from this.
2. After the superheated steam is generated, the steam will only be used as a hot gas without much sterilization effect, but the excessively high temperature will cause damage to the parts and packaging; the excessively humid steam will cause "wet packs" and water As an insulator, it prevents heat transfer to the surface of the part, causing some places to heat slowly, which affects the sterilization effect; the gas separated by the steam when it is heated or condensed turns the water vapor into a mixture of water vapor and other gases, which is an unwanted Pollution, while the gas is distributed on the porous load surface, preventing heat conduction and steam from contacting the load surface, affecting the sterilization effect.
3. "Guidelines for Pharmaceutical GMP-Water System" proposes that the indicators for water injection and sterilization steam to be tested include: microbial limit, conductivity, TOC, bacterial endotoxin, non-condensable gas content, dryness, and superheat value;
1. Refer to EN285, comply with HTM2010 and HTM2031
2. Pure steam quality standards:
1. The steam generator runs normally above 30M;
2. Try to avoid the use of steam from other terminals when testing the same steam generator;
3. Prepare 220V power supply and water storage device.
Fourth, test equipment:
1. Original British DekonSolutions (DEKONSOLUTIONS (SVMS)) steam quality test OPTION B or OPTION D (including condensate sampling), with original quality certificate and certificate of origin
2. Use 316L shaped pipe, stainless steel braided hose connection, and circulating water power device.
Five, test qualifications:
1. The company has the sales and service qualification certificate authorized by British DEKONSOLUTIONS (SVMS);
2, personnel UK DEKONSOLUTIONS (SVMS) product training certificate;
1. The British DEKONSOLUTIONS (SVMS) design test report in compliance with EN285 standard;
2. Contains SOP test files and qualification documents of testers.