Sterilization of Components

The sterilization of components and equipment will be validated for each load configuration using the cGMP autoclave. Cycle Development Testing and Performance Qualification Testing will qualify each sterilization process. A separate Performance Qualification and Cycle Development Testing Report will be written for each load configuration. The process will be considered validated when the acceptance criteria is met for three (3) successful consecutive runs. 

Perform one or more cycle development test runs used in the load configuration to determine appropriate cycle type, temperature and dwell period, hard-to-heat items or areas, load item preparation, and minimum and maximum load configurations. 

Identify and document the quantity, placement, and physical description of each component to be included in the load configuration. Determine the load configuration from Cycle Development Test studies. 

Perform load and chamber temperature mapping and verify that the temperature distribution in the chamber is uniform for the load configuration, and that all measured points within the load configuration receive thermal treatment sufficient for sterilization. Perform three (3) runs on the maximum load and a minimum of three (3) runs on the minimum load. 

Record the range of all process or equipment parameters (set points, flow rates, timing sequences, concentrations, etc.) verified during cycle Development and Performance Qualifications testing. 

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Bioburden testing is performed on components prior to steam sterilization as verification that the sterilization parameters are sufficient for sterilization of components. The method for determining the bioburden level of components is included in the manufacturing site standard test method. For product component bioburden summary, refer to (provide reference attachment number). 

Performance Qualification (PQ) verifies the performance of critical utility systems or processes. Critical utility systems such as WFI and Pure Steam are challenged throughout proposed operating ranges for extended periods of time, while an extensive program of quality monitoring is performed. Critical processes such as sterilization of components are challenged three (3) consecutive times under worst-case conditions. 

Validation of support processes. Define test functions and acceptance criteria for critical validation support processes such as washing of components, sterilization of components, depyrogenation, etc. 

Washing of components Sterilization of components Depyrogenation of components... 

The interval between the washing and drying and the sterilization of components, bulk-product containers, and equipment, as well as between sterilization and use, should be as short as possible and subject to a time-limit appropriate to the validated storage conditions. 

Design drawings, methods of manufacture envisaged, in particular as regards sterilization, and diagrams of components, sub-assemblies, circuits, etc. 

Seeds of Lespedeza sericea were surface sterilized by soaking in Captan (1 g/1) 1 h, 35% Clorox for 20 min, and washing with IN HCI and water. For quantitation of components in Lespedeza roots, seeds were sown on moistened filter paper in plastic Petri dishes. 

In general, aqueous ophthalmic solutions are manufactured by methods that call for the dissolution of the active ingredient and all or a portion of the excipients into all or a portion of the water and the sterilization of this solution by heat or by sterilizing filtration through sterile depth or membrane filter media into a sterile receptacle. If incomplete at this point, this sterile solution is then mixed with the additional required sterile components, such as previously sterilized solutions of viscosity-imparting agents, preservatives, and so on, and the batch is brought to final volume with additional sterile water. 

T. Chaly, J.R. Dahl, R. Matacchieri, D. Bandyopadhyay, A. Belakhlef, V. Dhawan, S. Takikawa, W. Robeson, D. Margouleff, D. Eidelberg, Synthesis of 6-[ F]fluoro-dopamine with a synthetic unit made up of primarily sterile disposable components and operated by master slave manipulator, Appl. Radiat. Isot. 44 (1993) 869-873. 

Three-dimensional processing of materials by electron beam to produce uniform isotropic irradiation of components, which are to be sterilized or bulk/surface modified. ... 

SUBJECT Determination of Components Bioburden before Sterilization... 

Section Val. 1900 includes four aseptic processes associated with monitoring and qualification programs covering determination of components bioburden before sterilization sterility test failure investigation, bacterial endotoxin determination in WFI, in-process finished product, and monitoring the bioburden, spore bioburden, and endotoxin present on stoppers and unprocessed vials. 

Sterilization can be accomplished by several means, including heat, chemicals, radiation (ultraviolet (UV) or y-ray), and microfiltration. Heat is widely used for the sterilization of media and fermentation equipment, while microfiltration, using polymeric microporous membranes, can be performed to sterilize the air and media that might contain heat-sensitive components. Among the various heating methods, moist heat (i.e., steam) is highly effective and very economical for performing the sterilization of fermentation set-ups. 

Addition to an aseptic processing line of new equipment made of different materials (e.g., stainless steel versus glass, changes between plastics) that will come in contact with sterilized bulk solution or sterile drug components, or deletion of equipment from an aseptic processing line. 

The standardized milk is forewarmed by heating to 71° to 88°C for 10 to 30 min or to 149°C for 1 to 2 sec (Edmondson 1970). These heat treatments are essential to stabilize the milk protein and mineral components against heat-induced precipitation during subsequent sterilization of the concentrate (Morr 1975 Fox 1981 Hall and Hedrick 1966 Edmondson 1970 Darling 1980). 

There have been several studies on the sterilization of food and its components by means of ionizing radiation. These have established the innocuity of foodstuffs irradiated at doses below 10 kGy, and doses at this level were recommended by FAO/IAEA/WHO as being safe.224... 

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