Equipment cleaning methods

Password Master List made globally available in Validation Report. [FDA 483, 2002] The validation of the computer system used to control the XXXX process is incomplete. Your proposed corrective actions for deficiencies 2,3, and 4 regarding validation appear satisfactory except that the validations will not be completed until the end of March, 2001 and imply that you will continue to use the unvalidated computer systems and equipment cleaning methods until them. [FDA Wanting Letter, 2000]... 

Present Process And Equipment , Equipment Cleaning Method.—... 

Present Process And Equipment — Equipment Cleaning Method -... 

Cleaning procedures should be detailed and provide specific understandable instructions. The procedure should identify equipment, cleaning methods, solvents and detergents approved for use, inspection and release mechanisms, and documentation. For some of the more complex systems, such as clean-in-place systems, it is usually necessary both to provide a level of detail that includes drawings and to provide provision to label valves. The time that may elapse from completion of a manufacturing operation to initiation of equipment cleaning should also be stated where excessive delay may affect the adequacy of the established cleaning procedure. For example, residual product may dry and become more difficult to clean. 

Equipment cleaning methods should be validated, where appropriate. In general, cleaning validation efforts should be directed to situations or process steps where contamination or incidental carryover of degradants pose the greatest risk to API quality and safety, in early synthesis steps, it may be unnecessary to validate deaning methods where residues are removed by subsequent purification steps. 

Gleaning. Fouling films are removed from the membrane surface by chemical and mechanical methods. Chemicals and procedures vary with the process, membrane type, system configuration, and materials of constmction. The equipment manufacturer recommends cleaning methods for specific apphcations. A system is considered clean when it has returned to >75% of its original water flux. 

Both parties need to identify responsibilities for choosing the right equipment for the process, preparing equipment for the process, and decontaminating equipment. Consider whether chemical and process hazards have been addressed in the selection, preparation, and decontamination of equipment. Examine the need to contractually address containment and disposal of residual process fluids and decontamination materials. If food products or pharmaceuticals are involved, cleaning methods may also be an issue to address in the contract. 

Contamination of peroxides has been a major source of accidents by runaway decompositions, particularly during handling and use. Therefore all equipment that is in contact with peroxides must be thoroughly cleaned. When a diluent is used, it should be properly selected and its purity must be strictly controlled. The use of dedicated loading/unloading equipment and avoidance of the use of shared or manifold equipment are methods to reduce the possibility of cross-contamination. 

Equipment List of equipment used, validation of the equipment, validated methods for cleaning, and procedures for contamination control... 

Equipment — On introduction of each new piece of equipment or process, the cleaning method should be validated, using one or an appropriate combination of the following methods ... 

From the point in the process where full GMP compliance begins, the excipient should be produced in qualified equipment using a validated manufacturing process and testing should be done using validated methods. Where production equipment is not dedicated, validated cleaning methods are also needed. Full GMP compliance is required no later than the final excipient purification step or the manufacturing step where the excipient molecule has been synthesized, whichever occurs later in the process. 

Usually the most difficult aspect of cleaning validation is in determining how to evaluate the efficacy of the cleaning method. Equipment should be sufficiently clean so that the incidental carryover in the first batch after cleaning presents an acceptable risk to excipient quality and performance. Once this determination has been made, it is possible to calculate the maximum amount of residue carried over into the excipient batch. Then a calculation can be made as to how much residue can be left on the equipment surface, assuming the residue is uniform throughout the equipment. 

Waste associated with equipment cleaning represents the largest source of waste in a paint facility. Methods that reduce the need or frequency of tank cleaning or allow for reuse of the cleaning solutions are the most effective. Source reduction methods include ... 

Determine Procedure The basic reactions are the same as in drinking water and waste water treatment. Therefore, knowledge about necessary equipment (Chapter B 2), ozone mass transfer (Chapter B 3) and reaction kinetics (Chapter B 4) including influencing parameters are very helpful for the development of new cleaning methods or recipes. 

D Equipment Installation and qualification of equipment and cleaning methods... 

Typically, the first full-scale events are demonstrations. Some scale-up studies may be performed at full scale just before the formal demonstrations are initiated, however. This would be true in those cases in which the results of the development-ranging studies do not provide sufficient confidence or assurance. In addition to providing assurance that the process can be duplicated at full scale, demonstrations provide a platform for operator training, SOP development, laboratory method fine-tuning, equipment cleaning, and most important, site experience with the demonstrated process. It should be noted that most companies are constrained by a budget for product development, which means that they cannot afford doing a battery of demonstrations. 

Verifying that manufacturing equipment and product formulation are finalized (e.g., as specified in a development transfer report)—This is necessary since cleaning methods are product- and formulation-specific and will change if the formulation or equipment is changed. 

Various processes that result in a reduction of the mineral matter and sulfur content can be employed to clean coal. The ash content of raw coal is often used to select the best cleaning method, and the ash content of the cleaned coal is used to measure the effectiveness of the cleaning process. In the commercial pulverization of coals, the amount and nature of ash is considered carefully before selecting pulverizing equipment or setting up the process. 

Any contaminated equipment should be cleaned using wet cleaning methods, such as a wet cloth prior to removal from the weigh hood. 

Researches are carried out by equipment manufacturers, for example, remote plasma cleaning method was presented by Applied Materials Inc. at the 1997 Semicon West [43]. This method improved the usual decomposition ratio of NF3 ca 50% to more than 99%. Plasma is normally generated in a chamber, however,... 

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