CEHT and DEHT

we have to perform the CEHT and DEHT
should this study be performed for the individual equipment i.e for RMG , FBD?
Can we use the IPC for that purpose , on the basis of that result we can apply it on all the equipments.

Hi Mr. Aman,

I don’t know about IPC…is it In-process control ?

However the CEHT / DEHT can be planned based on the few assessment.

  1. Product specific assessment.
  2. Equipment size / shape evaluation [Geometry…]

& finally a worst case apporach can be selected for the same…others can be extrapolate.

Happy Reading !!

how we can select the worst case in CLEANED EQUIPMENT HOLD TIME STUDY
LETS SUPPOSE we have FBD , RMG , COMPRESSION MACHINE , BLENDER. out of that which is the equipment we have to taken for the CEHT study.

Iam not an expert on this subject. I have gained some knowledge over last few years looking at the cleaning processes and talking to my fellow collegues who are experts.

Clean Hold Time:

The time elapsed from the end of the cleaning process until the beginning of the use of the cleaned equipment for manufacture of the next product

Essentially, the best reason to conduct such a study is that nothing stays clean forever, no matter how well protected it is in storage. Re-contamination of the equipment may be an event-related phenomenon. Heating, Ventilation, and Air Conditioning (HVAC), personnel, storage areas, etc., may all have an impact upon the clean status of equipment. In dealing with possible ways the equipment could be re-contaminated, one should consider both endogenous sources (such as the growth of microorganisms already within the equipment) and exogenous sources (such as the entry of external contaminants into the equipment).

Although regulatory agencies expect manufacturers to document and address hold times, they do not describe a process for establishing hold times. The concern with clean-hold times is that clean equipment will not stay clean indefinitely despite using appropriate storage conditions. Holding soiled equipment makes it more difficult to remove pharmaceutical soil and allows biological contamination to proliferate.

Normally such hold time studies for the three validation trials should be held and it should range from 2 h–217 h or 9 days which covers the worst case depending up on Size and geometry and cleaning conditions and complexities( As describe by Mr.Ashish). What we need to expect is that the results should be below the acceptable residue limit (ARL) for an extended period of time after cleaning and it should not be and a cause for concern during storage of properly cleaned, dried, and covered equipment.

Three Important Issues for the CEHT Include:

  1. The characteristics of the cleaned equipment

  2. The nature of possible re-contaminants

  3. The storage conditions of the equipment

NOTE: These three factors are interrelated in terms of effects on re-contamination of cleaned equipment.

I posted this hold time protocol in Validation Templates section.
I will try to post Worst case protocol with basis and explanation at an appropriate time.