摘要
目的调试T800/H2/C3型层流式隧道机械设备,确认其机械性能。方法在层流式隧道空载、不加热、只开风机条件下检测各工段的风速、压差、沉降菌、悬浮粒子及选用抗生素玻璃瓶的初始微生物、清洁度、灭菌效果等。结果风速、压差均合格。沉降菌检测培养为0;粒径≥0.5μm的悬浮粒子小于或等于100个/Cf,无粒径≥5μm的悬浮粒子,空气洁净度达100级;进隧道口的抗生素玻璃瓶初始微生物、清洁度及其灭菌效果等检查均符合《T800/H2/C3型层流式隧道验证方案》规定。结论该隧道设备在空载、不加热、开风机条件下静态验证符合《T800/H2/C3型层流式隧道验证方案》,可进行动态满载加热试生产运行验证。
Objective To adjust the mechanical instrument of Model T800/H2/C3 laminar flow tunnel so as to determine its tunetion. Methods The air flow speed, pressure gradient, fallout bacteria and suspended granules were all examined at each working stage while the laminar flow tunnel was off-loaded, non- heated or only the fan was turned on. The initial microorganisms, cleanness degree and sterilization effects were tested by antibiotic glass bottle. Results The air flow speed and pressure gradient were up to standard. No fallout bacteria were found in culture. Less than 100/Cf of suspended granules with diameter≥ 0. 5 μm were found. No suspended granules with diameter ≥ 0. 5 μm were found, The air cleanness degree reached 100. Initial microorganisms, cleanness degree and sterilization effects by antibiotic glass bottle at the entrance of the tunnel met the demands of the Test and Verification Scheme of Model T800/H2/C3 Laminar Flow Tunnel. Conclusion The tunnel is up to the standard of Test and Verification Scheme of Model T800/H2/C3 Laminar Flow Tunnel under static test while it is off-loaded, non- heated or when only the fan is turned on. It can be tested under dynamic condition while thlly loaded and heated for production.
出处
《中国药业》
CAS
2006年第21期44-45,共2页
China Pharmaceuticals
关键词
层流式隧道
空载不加热
风机空气洁净度
玻璃瓶清洁虚
静态验证
laminar flow tunnel
off- loaded and rton- heated
air cleanness degree of fan
cleanness of glass bottle
static test