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Microbiological Considerations
Published in Anne F. Booth, Sterilization Validation & Routine Operation Handbook, 2017
An understanding of the viable microorganisms on a finished device is necessary and required to support the validation process. Bioburden data are important because the extent of the treatment of a sterilization process is a function of the bioburden on the product, the resistance of the bioburden, and the sterility assurance level required. The assessment of the bioburden needs to include the number of microorganisms with their identities. The identification need not be exhaustive, but confirmation of Gram stain characteristics and genus provide useful information and can be used to monitor changes over time and as a comparison to organisms recovered during environmental monitoring. Bioburden ranges typically found on device types are illustrated in Table 11.
Risk Assessment and Mitigation in Aseptic Processing
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
The success criterion for the attribute of sterility is given as either a Probability of a Non-sterile Unit (PNSU) or a Sterility Assurance Level (SAL). (The current preference is for the use of PNSU, rather that SAL, because PNSU is a far easier concept for the novice to interpret.) The minimum expectation for PNSU, which is a probabilistic term properly reserved for physical sterilization methods such as moist heat, is that there must be no greater than one non-sterile unit in one million units. In probabilistic terms, this is 1 × 10−6 for all sterilization processes, including those used to prepare packaging materials such as containers and closures for aseptic assembly.
Japanese Approach to Validation
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Satoshi Sugimoto, Mitsuo Mori, Kiyoshi Mochizuki, Keisuke Nishikawa, Takuji Ikeda, Yusuke Matsuda, Hiroaki Nakamura, Yasuhito Ikematsu
In principle, moist-heat sterilization should be performed at 121.1°C for 15 minutes or, if not feasible, at F0 value for no less than 8 minutes. If sterilization of pharmaceutical products at F0 8 minutes is not feasible, alternative sterilization conditions should be established by identifying process parameters to ensure a SAL of <10−6 by scientific validity. The commercial supply of large volume parenteral solutions requires that the manufacturer assesses the bioburden of raw materials of pharmaceutical products and manufacturing environments and establish moist-heat sterilization conditions for the sterilization of the solutions. The basic concept for the manufacture of large volume parenteral solutions is to secure a manufacturing environment that is free from spore-forming bacteria that have higher heat resistance than the indicator microorganism employed for establishing sterilization conditions and to ensure the sterility of pharmaceutical products by the routine monitoring and control of bioburden. The targeted value of bioburden for pharmaceutical products before sterilization should be <1 CFU/product. If bioburden testing reveals the presence of microorganisms exceeding the target value, the presence or absence of heat-resistant (spore-forming) microorganisms should be determined and, if present, the Sterilization Resistance Test should be performed with samples of detected microorganisms to verify that the sterility assurance level (SAL) is <10−6. Critical parameters of moist-heat sterilization include temperature profile (usually indicated by F0 value), temperature, steam pressure, exposure time, and loading pattern.
Low-cost biofuel-powered autoclaving machine for use in rural health care centres
Published in Journal of Medical Engineering & Technology, 2020
Yusuf Kola Ahmed, Morufu Olusola Ibitoye, Abdul Rasak Zubair, Janet Mosunmola Oladejo, Suleiman Abimbola Yahaya, Saheed Olayinka Abdulsalam, Ridwan Oladipupo Ajibola
Sterilisation decontaminates a surface by killing the microorganisms present on it in order to prevent potential infection due to such surface or substance [19,20]. Sterility assurance level (SAL) is the probability of one microorganism surviving on an object [15]. According to the US CDC, SAL of 10−6 is recommended for critical medical devices such as invasive medical instruments [21]. For steam autoclave, US CDC also recommends 30 min minimum exposure time for linen-wrapped critical instruments at 121 °C and 203 kPa pressure in order to achieve SAL of 10−6 [22]. Due to the differences in microbial thermal resistance properties (D, Z) and initial quantity of microbe on a sample Po called bio-burden, different heating time and temperature are required to meet SAL of 10−6 as shown in Equations (1, 2) [15].
Toward Efficient Low-Temperature Ozone Gas Sterilization of Medical Devices
Published in Ozone: Science & Engineering, 2020
Sandy A. Thill, Marc Spaltenstein
Medical device regulations are extremely demanding, and new sterilization technologies must prove their reliability and effectiveness against the most resistant microorganism. In the case of ozone sterilization, spores of Geobacillus stearothermophilus have been recognized to be the most resistant (de Souza Botelho-almeida et al. 2018; Dufresne, Hewitt, and Robitaille 2004; Dufresne, Leblond, and Chaunet 2008; Mahfoudh et al. 2010; Ohkawa et al. 2004; Sakurai et al. 2003). The selection of the biological indicators and the tests of this study were performed following the standards of the International Organization for Standardization (ISO) on the guidance for the selection, use and interpretation of results of biological indicators for the sterilization of health-care products (ISO 11138–7:2019). As absolute sterility does not exist, a retreated surgical instrument is defined as ‘sterile’ when a sterility assurance level (SAL) of 10−6 is reached (CEN 2001). In other terms, in 1 million sterilized devices less than one should present a living germ. However, it is not possible to directly prove such low probabilities; therefore, extrapolations of survivor curves can be performed when the characteristics of a sterilization process fulfill certain criteria.