El Anexo I recoge el uso de los Indicadores Biológicos cómo método de control en las validaciones y revalidaciones de los sistemas de esterilización, y los sugiere para monitorizar los ciclos.

Además indica que se ha de hacer una verificación de población e identidad en cada nuevo lote.

 

Sterilization

 8.34 The selection, design and location of the equipment and cycle/programme used for sterilization should be based on scientific principles and data which demonstrate repeatability and reliability of the sterilization process. Critical parameters should be defined, controlled, monitored and recorded.
8.35 All sterilization processes should be validated. Validation studies should take into account the product composition, storage conditions and maximum time between the start of the preparation of a product or material to be sterilized and its sterilization. Before any sterilization process is adopted, its suitability for the product and equipment, and its efficacy in consistently achieving the desired sterilizing conditions in all parts of each type of load to be processed should be validated notably by physical measurements and where appropriate by biological indicators (BI). For effective sterilization, the whole of the product, and surfaces of equipment and components should be subject to the required treatment and the process should be designed to ensure that this is achieved.

..,.

8.37 Validated loading patterns should be established for all sterilization processes and should be subject to periodic revalidation. Maximum and minimum loads should also be considered as part of the overall load validation strategy.

8.41 Suitable BIs placed at appropriate locations may be considered as an additional method to support the validation of the sterilization process. BIs should be stored and used according to the manufacturer’s instructions. Where BIs are used to support validation and/or to monitor a sterilization process (e.g. for ethylene oxide), positive controls should be tested for each sterilization cycle. If BIs are used, strict precautions should be taken to avoid transferring microbial contamination to the manufacturing or other testing processes. BI results in isolation do not give assurance of sterilization and should not be used to override other critical parameters and process design elements.

8.42 The reliability of BIs is important. Suppliers should be qualified and transportation and storage conditions should be controlled in order that BI quality is not compromised. Prior to use of a new batch/lot of BIs, the population and identity of the indicator organism of the batch/lot should be verified. For other critical parameters, e.g. D-value, Z- value, the batch certificate provided by the qualified supplier can normally be used.

 

En Tiselab disponemos de una amplia gama de Indicadores Biológicos para los diferentes métodos de esterilización, así como para los diferentes tipos de cargas. Con nuestra larga experiencia comercializando Indicadores Biológicos, os podemos ayudar en la elección del Indicador Biológico más adecuado según la aplicación, y en la optimización de número de lotes para disminuir los controles en la recepción y la gestión de los mismos.

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