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Cleaning validation Part 2 [ General Cleaning Methods and Concepts]

 General Cleaning Methods and Concepts

Cleaning methods are broadly divided in to three types (1) manual cleaning method (2) Semi-automated  cleaning procedure & (3) fully automated system.

whatever the cleaning method used for cleaning, it is necessary that each cleaning procedure should be fully documented and controlled. The standard operating procedure shall be available for each type of cleaning methods. The documentation should include a clear and unambiguous definition of its intended scope and applicability. This includes definition of a processing equipment and products to which it is applies.

For example a clear distinction must be made between an abbreviated cleaning procedure designed for use between batches of the same product and a rigorous cleaning procedure designed for use between batches of different products. In some cases it is best to dedicate the use of some equipment's to certain products. For example filter bags used in FBD. By dedicating the some equipment's will help to prevent the cross contamination, but the dedicated equipment should be cleaned routinely anyway to  minimized batch to batch contamination and to prevent any problem with microbial contamination. 

Manual Cleaning Procedures

Manual cleaning procedure, by definition are operator dependent. This is not meant to imply that they are not effective. Well written manual cleaning procedure, when preformed by qualified and trained operators, can often be better than automated methods. 
It is not possible to list all possible cleaning sequences which may be used, but the vast majority of cleaning procedure follow the same basic format, in one form or another. Below mention cleaning method are discussed assuming aqueous cleaning system. 

  • Equipment Disassembly (If required):

Most of the equipment's are disassembled to some extent prior to cleaning to ensure that it can be thoroughly cleaned. The disassembly instruction should be clear, complete and written so that the operator does not have to interpret unfamiliar terminology Diagrams and drawing can be extremely beneficial as part of dismantling instruction. 

  •  Primary cleaning/ inspection.

This is a most important step in any cleaning methods and also most operator dependable. The purpose of this step is to eliminate gross accumulation of residual materials. 
Potable water is usually sufficient for this step, which may entail filling the equipment with the water to a predetermined level and circulating it or using a hose to remove the materials. As this step is to depend on physical movement and impingement of the water to be use. The critical part of this step is inspection by the operator and repetition of the primary cleaning step if required. The criteria to e used by the operator in making such a determination should be defined as clearly as possible. 

  • Wash

After removal of most visible materials, the next step is usually to perform actual washing (Cleaning) of the parts or equipment. If the chemical cleaning agents are required in this step is where they will b used. 
In order to minimizing the variability the approved cleaning agents must be defined and the proper concentration  to be used. The detail of cleaning agent and concentration depends on equipment cleaning shall be part of standard procedure.
Since this step relies on dissolution of residual material, the temperature of the water or detergent mixture may be important. So a suitable temperature range should be specified and a means of measuring the temperature must be available to the operator. 

  • Initial Rinse

The wash step usually dissolve most of the residual material, but the washing liquid must still be removed from the equipment. This residual liquid contains water, cleaning agent and residual material from previous usage of the equipment. A single rinse of the equipment sometime provides a sufficient reduction in the level of these items, but a multiple (series of) rinses is generally more effective. Cleaning procedure result in serial reduction in residual contaminant level because of dilution effects. For initial rinse, it may be desirable to use purified water, distilled water, or water of injection(WFI) to ensure that the final rinse is effective to provide the cleanliness required. If the temperature of the rinse water used is important, it should be specified.

  • Final Rinse

The final rinse is used to reduce the quantities of any residuals to their final level without introduction of any more potential contaminants than necessary. The final rinse is generally performed using the highest quality water available. The temperature of water used in this step is not important except to speed the drying process since the main purpose of this step is usually simple to remove already dissolved residuals and to provide a final liquid residue of the highest quality possible.
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