DEHT
mean Dirty equipment holding time study
-Dirty
equipment hold time mean the time between after manufacturing of the product
and the cleaning of that equipment.
-Purpose of the study of dirty equipment holding time
study is to establish holding time of
dirty equipments by studying Microbial load and effectively removal of residue
from equipment for specified period till next batch or next product is taken.
-If Uncleaned equipment hold for longer period of time there may
be chance of the microbial growth to define the time period how long equipment can
be kept and use.
-Dirty equipment is harder to clean if hold for the long
period of time, There may be chance of left
over of the residue into the equipment.Hence to define the time period how long
equipment shall be kept uncleaned.
-Different Guideline suggest to perform dirty equipment holding
time study; although any guideline did not describe a process for dirty
equipment hold time study.
-After
performing the dirty equipment holding time study it need to be document
Holding time study protocol should
have following details:
1.
Purpose of the study
2.
Scope
3.
Responsibility
4.
Details of equipment
5.
Sampling plan
6.
Sampling and analysis procedure
7.
Acceptance criteria
8.
Report preparation and evaluation of
results
9.
Conclusion
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