Benefits and limitations of external calibration required to validate the physical parameters of an autoclave: A brief discussion from an oncology centre in eastern India

Debabrata Basu; Prokash Mondal; S K Rafikul; Sanjib Ghorai

doi:10.4103/jacm.jacm_5_22

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Benefits and limitations of external calibration required to validate the physical parameters of an autoclave: A brief discussion from an oncology centre in eastern India

Debabrata Basu, Prokash Mondal, S K Rafikul, Sanjib Ghorai

Keywords : Autoclave external validation, process drawbacks, third-party calibration cost, quality assurance, thermocouples

Citation Information : Basu D, Mondal P, Rafikul SK, Ghorai S. Benefits and limitations of external calibration required to validate the physical parameters of an autoclave: A brief discussion from an oncology centre in eastern India. 2022; 24 (1):32-34.

DOI: 10.4103/jacm.jacm_5_22

License: CC BY-NC 4.0

Published Online: 11-07-2022

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Abstract

Validation is a documented procedure for obtaining, recording and interpreting the data required to establish that a process will consistently comply with manufacture's predefined specification. In healthcare facility sterilizer validation is often required because continuous operations and their relevant age, the machine may give false results that compromise the sterility assurances. Because early prediction of steriliser malfunctioning is impossible, and malfunction gets detected only when it runs. The main objective of this article is to discuss about the requirement of only autoclave physical parameters calibration is how much effective without using of chemical or biological indicators and what is the drawbacks of this system. The requirement of any steriliser monitoring is to prove that the process is effective and can deliver a product that is reproducible and meets the required quality requirements. A successful load monitor always meets all the acceptance criteria of an entire load, and gives a well validated sterility assurance.

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