Why batch to batch cleaning require before periodic cleaning? Can we skip batch to batch cleaning?
Batch to batch cleaning is required to ensure that any built up residues of previous batches are not transferred to the next batches of the same product. Also it ensures that equipment is adequately cleaned to manufacture further batches.
But sir in periodic cleaning also have flushing and outer surface cleaning so that.
Yes, that is also true. However, the periodic claeaning is conducted after manufacturing of a few batches. Therefore, batch to batch cleaning is also equally important. However, Cleaning validation is not required. The Acceptance criteria would be just visually clean through visual observation of equipment after claeaning). This is achieved through “Stick with a mirror” and a “torch” a s a source light to carefully observe critical parts of the equipmrent or which those parts which can not be easily seen by our naked eyes.
Different cleaning situation may arise during the manufacturing of drug products, such as;
a. Batch to batch changeover cleaning.
b. Product to product changeover cleaning
In case of non-dedicated drug product manufacturing facility, different cleaning procedures may exist
depending on the manufacturing step and nature of the next manufacturing step to be followed in the same equipment. This results in two different levels of cleaning as explained below.
Level 1 Cleaning
This is used between manufacturing of different batches of the same product.
Example – In a manufacturing Campaign for product A,
there are 3 Batches to be manufactured as shown below.
Batch 1 Batch 2 Batch 3
For a given equipment &/or equipment train, if batch 1 in the campaign is to be followed by Batch 2 in the campaign, then a level 1 cleaning is required.
Level 2 Cleaning
This is used between manufacturing of different Batches of different Product and / or at the end of manufacturing campaign even if same product is planned for the next campaign.
The above two degrees or levels of cleaning differs from each other in terms of the degree of risk associated with it, acceptance limit, degree of cleaning & method of
verifying the cleaning process, Table 1.
Table 1: Comparison between levels of cleaning
Level 1 Level 2
Risk Lowest Highest
Limit Highest Lowest
Cleaning Less Extensive More Extensive
Cleaning Visual Inspection Analytical Testing to detect residues