Define the events behind the timestamps before evaluating the interval.
Name the start event
“End of production” can mean different things to different teams. Decide which event starts the dirty hold-time clock and how it is recorded for the equipment concerned.
Name the end event
Specify what counts as the start of cleaning and when a cleaning cycle is complete. Define the conditions under which cleaned equipment is stored and the event that ends the clean hold time.
Test the operating instructions
Walk through a delayed shift, an interrupted cleaning cycle and a change in equipment availability. The procedure should make the status and escalation route understandable in each case. Record any assumption that still needs study evidence.
RECOMMENDED PRACTICE
This article offers editorial working suggestions. It does not replace the original source, site procedures or a documented scientific assessment.
Related regulatory requirements
CV-REQ-000003
Define dirty and clean hold times ↗
CV-REQ-000007
Include microbial and endotoxin risk ↗
CV-REQ-000008
Define cleaning responsibilities ↗
CV-REQ-000009
Prepare a study protocol ↗
CV-REQ-000012
Control time before cleaning ↗
CV-REQ-000013
Document the validation conclusion ↗
CV-REQ-000015
Describe the cleaning study ↗
CV-REQ-000018
Monitor cleaning after validation ↗
CV-REQ-000019
Review the validated state ↗
CV-REQ-000024
Manage the cleaning lifecycle ↗
CV-REQ-000025

