All cleaning procedures should be validated (shown to be effective) under specific conditions of use. These conditions of use are specified in the SOP.

Employees cannot deviate from the SOP or alter the conditions of use without risking invalidating the cleaning methods. For example, it would seem logical that adding using a stronger sanitizer than the procedure requires would make cleaning faster or better. This is not always the case as you may alter the properties of the solution (e.g. lowering the pH) thus rendering it less effective.

The relevant GMP rules are to only clean under validated conditions and strictly follow procedures. 

The written procedures describe the required conditions under which cleaning is optimal.

These conditions must be followed precisely or you risk unacceptable results. For example, too strong of a solution used in sanitizing could damage the surfaces of counters, tabletops, equipment and accessories. The pH balance has to be accurate or you could end encouraging bacteria growth instead of eliminating it.  Also, the type and quality of the water used can impact results. 

Your SourceOne team understands all of the variables and dials it all in for best results:

Title: Key Components for Optimal Cleaning Conditions

• Strength of the cleaning or sanitizing agent (e.g., 2.0% v/v)
• The type of water or solvent to be used
• The pH of the cleaning agent
• The temperature of the water to be used
• How much to dismantle equipment before cleaning commences
• The contact or residence time for the sanitizing agent on the surface
• What agents to use to clean off the sanitizing agent
• What standard of water to use in the final rinse (GMP, for example, requires purified water for injection as the final rinse)

One essential GMP rule is the keeping of detailed cleaning records. Cleaning records prove that cleaning took place and evidence of the cleaning outcomes.

For example, the surfaces are visually clean or the results of rinse water tests.

The records must also identify who did the cleaning and when and must be signed.

For automatic cleaning procedures such as clean in place (CIP), the cycle conditions are usually automatically monitored and the conditions recorded.

Cycle conditions may include the temperature, flow rate, time, concentration of solvent, and solvent agitation time. Often, CIP systems have alarms when something goes wrong.

The completed and signed records should be attached to the records since they provide the only objective evidence that cleaning has occurred.

• The facility must be regularly cleaned. Particular emphasis is placed on areas or rooms where product is processed.
• Particular emphasis is placed on effectively cleaning all equipment in contact with the product, and it must be cleaned according to validated and detailed procedures.
• All equipment in processing areas not in contact with the product needs regular cleaning to prevent dust and dirt buildup.
• The inside of the factory should be regularly cleaned, but particular attention should be paid to the processing and storage rooms. The floors, surfaces, benches, walls, and ceilings should undergo cleaning at defined intervals.
• Cleaning and sanitation also apply to any equipment in contact with the product during manufacture, such as production and packaging equipment, transfer lines and tanks, and storage containers and drums.