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Sterilisation validation

G. B. Phillips and W. Miller, Validation of Steam Sterilisation Technical Monograph 1, Parenteral Dmg Association, 1978. [Pg.411]

Validation and Foutine Monitoring of Moist Heat Sterilisation Processes, ISO 11134, International Standards Organization, Geneva, Switzerland. [Pg.412]

Packaging and validated sterilisation procedures to ensure sterility... [Pg.169]

Pharmaceuticals for injection must be presented in a sterile form. Sterility may be achieved by filtration through 0.22 pm filters under aseptic conditions, or by steam, dry heat, radiation or gas sterilisation methods, which may be applied to packaged products. Irrespective of the method, the process must be validated and monitored to assure its effectiveness. As discussed in Chapter 2, this is an example of a process that cannot be assured by verification testing because of its destructive nature. [Pg.230]

The various elements of the ISO standards for a validation programme of a radiation sterilisation process are shown in Fig. 6.11. [Pg.297]

Sterilisation—type of sterilisation. Processes and validation. Control of sterility. Control of residual ethylene oxide, ethylene chlorohydrin, ethylene glycol. [Pg.94]

Sterile products must be manufactured in separate enclosed areas under the supervision of a microbiologist. The sterilisation method has to be scientifically proven, validated and qualified. [Pg.102]

For critical processes such as sterilisation or aseptic manufacture, even for the earliest human studies, the regulatory authorities will expect the process to be qualified, to attain a high degree of assurance that the end-product will be sterile. If drug availability is an issue, the aseptic processing of sterile products may be validated using media fills to simulate the process. [Pg.323]

The method of manufacture must ensure reproducibility between batches and the conditions should be chosen to preclude the possibility of contamination with other plastic materials or their constituents. Containers made should be similar in every respect to the type sample. For the testing on the type sample to remain valid, there must be no change in the composition of the material or in the manufacturing process, particularly with regard to temperature to which the plastic material is exposed during conversion or subsequent procedures such as sterilisation. Scrap materials should not be used. Recycling excess material of a well-defined nature and proportion may be permitted if the appropriate validation is carried out. [Pg.65]

All equipment such as sterilisers, air handling and filtration systems, air vent and gas filters, water treatment, generation, storage and distribution systems should be subject to validation and planned maintenance their return to use should be approved. [Pg.150]

All sterilisation processes should be validated. Particular attention should be given when the adopted sterilisation method is not described in the current edition of the European Pharmacopoeia, or when it is used for a product which is not a simple aqueous or oily solution. Where possible, heat sterilisation is the method of choice. In any case, the sterilisation process must be in accordance with the marketing and manufacturing authorizations. [Pg.151]

Before any sterilisation process is adopted its suitability for the product and its efficacy in achieving the desired sterilising conditions in all parts of each type of load to be processed should be demonstrated by physical measurements and by biological indicators where appropriate. The validity of the process should be verified at scheduled intervals, at least annually, and whenever significant modifications have been made to the equipment Records should be kept of the results. [Pg.151]

Validated loading patterns should be established for all sterilisation processes. [Pg.151]

Each heat sterilisation cycle should be recorded on a time/temperature chart with a suitability large scale or by other appropriate equipment with suitable accuracy and precision. The position of the temperature probes used for controlling and/or recording should have been determined during the validation, and where applicable, also checked against a second independent temperature probe located at the same position. [Pg.151]

After sterilisation, the load should be stored in a controlled manner under ventilated conditions to allow residual gas and reaction products to reduce to the defined level. This process should be validated. [Pg.152]

Pipework systems, valves and vent filters should be properly designed to facilitate cleaning and sterilisation. The use of "dean in place" and "sterilise in place" systems should be encouraged. Valves on fermentation vessels should be completely steam sterilisable. Air vent filters should be hydrophobic and validated for their scheduled life span. [Pg.157]

In this environment bulk product formulated from starting materials of lowest practicable biological load is filtered to reduce or eliminate this load and filled (or dried and filled) into clean or sterile containers. Sterilisation is carried out under closely controlled and validated conditions. Additional precautions against contamination are taken with products that are not sterilised in their final containers. [Pg.296]

It is not sufficient that the finished product passes laboratory tests the whole manufacturing process must be under tight control and the need to qualify equipment and validate sterilising processes (see Glossary) assumes singular importance, not least because of the limitations of official tests for sterility . [Pg.296]

Heat sterilisers should have provision for the entry of leads from the temperature sensing devices placed in product packs or simulated product packs during heat penetration studies (see Validation). [Pg.299]

The microbiological load of products should be as low as practicable prior to sterilisation. It should be monitored and an action level set related to the efficiency of the method of sterilisation to be used, the risk of pyrogens and the validation results. All solutions, in particular large volume infusion fluids, should be passed through a 0.45 micron filter, where possible immediately before filling. [Pg.301]


See other pages where Sterilisation validation is mentioned: [Pg.270]    [Pg.26]    [Pg.230]    [Pg.102]    [Pg.297]    [Pg.34]    [Pg.117]    [Pg.482]    [Pg.482]    [Pg.43]    [Pg.340]    [Pg.345]    [Pg.362]    [Pg.393]    [Pg.98]    [Pg.148]    [Pg.151]    [Pg.152]    [Pg.163]    [Pg.230]    [Pg.233]    [Pg.275]   
See also in sourсe #XX -- [ Pg.230 ]




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