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Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard


MODULE 5: MICROBIOLOGY TECHNICAL REQUIREMENTS
Section: 1.7.3.7

Question:  What does "autoclave maintenance... shall include a pressure check" mean?  Does that specifically mean that the pressure relief valve shall be checked and documented?  If would be extremely helpful if these sections could be written more specifically.

TNI Response:  Since PV=nRT, checking the temperature and assuring no leaks (so that V is constant) is sufficient to meet the requirements of the standard. Another suggestion: A note could be made in a logbook indicating that seals were checked and no cracks were found.  The 2016 standard added in the PV= nRT language and called it sufficient.