GMP Equipment Use and Cleaning Log Template (Excel)
An equipment log records every use and cleaning of a piece of process equipment, so the state of the equipment is always known. This worksheet adds a hold-time check: it subtracts days since cleaning from the validated clean hold time so you can see what has expired.
| Equipment ID | Product | Batch no. | Operation | Use start | Run time (h) | Cleaning type | Cleaned on | Validated clean hold (days) | Days since clean | Hold days remaining | Operator initials | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
5 | ||||||||||||
4 | ||||||||||||
3 | ||||||||||||
2 | ||||||||||||
7 |
Enter days since clean from the equipment status label. A negative hold remaining means the validated clean hold time has expired and the item must be re-cleaned before use. Logs are GMP records: in the real log do not delete lines, strike through with date and initials.
Automate equipment status from ERP and MES
An optional outline for flagging expired clean hold times from existing equipment and batch data.
Optional. The tool and every export work without this. No spam.
How to use the worksheet
Add one row per use. Enter the equipment ID exactly as on the asset register, the product and batch, the operation, run time, cleaning type and date, the validated clean hold time and the days elapsed. The remaining days column calculates automatically. Export to Excel to print the log, share it with QA, or load it into a CMMS or MES. Keep the template under document control once your site adopts the format.
- One line per use, in time order
- Reference the batch number so the log ties to the batch record
- Record every cleaning, including minor cleans
- Record status changes: clean, in use, dirty, under maintenance
Why GMP expects the log
FDA 21 CFR 211.182 requires a cleaning and use log for major equipment showing the date, time, product and lot of each batch processed. EU GMP Chapter 4 and Annex 15 expect equipment status and cleaning to be traceable. The log lets an investigator reconstruct which product was last made on a vessel, which supports cross-contamination assessment during a deviation or recall.
Reading clean hold time
Clean hold time is the period for which equipment remains in a validated clean state before use, set during cleaning validation. If the hold limit is five days and the equipment was cleaned seven days ago, it is out of validated state and must be re-cleaned or justified by a deviation. The same logic applies to dirty hold time, the interval between end of use and start of cleaning, which you can track in a further column.
Common mistakes and system notes
Typical findings are missing entries between batches, undocumented minor cleans, logs not matching batch records, and use of equipment past its calibration or preventive maintenance due date. In SAP PM, Oracle EAM or Epicor, link the functional location or asset to the equipment ID used here. If a paper log is converted to an electronic one, apply the Part 11 controls for audit trail and signatures.
Frequently Asked Questions
What must an equipment log contain?
At minimum the equipment ID, product, batch number, date and time of use, operation, cleaning date and method, the person who performed and checked the cleaning, and status. Many sites add calibration and maintenance references.
What is clean hold time?
It is the validated maximum time between completion of cleaning and the next use, during which equipment stays clean under defined storage conditions. It is established in cleaning validation by testing residue and bioburden at the end of the hold.
Do I need a log for every piece of equipment?
Major process equipment needs a use and cleaning log. Smaller items may be controlled through a room log or batch record, depending on risk and your quality system. Document the rationale in the SOP.
Can the log be electronic?
Yes, if the system meets 21 CFR Part 11 and EU Annex 11 expectations: unique user identification, secure time-stamped audit trails, controlled access and validated operation. A spreadsheet alone typically does not.
Netray can help pull equipment usage from MES or ERP data and flag expired clean hold times automatically. This worksheet is complete and free on its own.
Related Tools
Cleaning Validation MACO Calculator
Calculate maximum allowable carryover from dose, 10 ppm and ADE criteria, then convert the lowest limit to mg per cm2, per swab and per mL of extract.
Industry TemplatesPharmaceutical Batch Manufacturing Record Template
Generate a GMP batch manufacturing record with material issue, process steps, in-process checks, yield reconciliation and review signatures.
Quality & InspectionGMP Deviation Report Template
Write a structured pharmaceutical deviation report: event, immediate action, classification, impact, root cause, CAPA and QA approval.
Quality & InspectionOOS Investigation Checklist
A step-by-step out of specification checklist covering immediate lab assessment, full-scale investigation, retesting, resampling and batch disposition.
More Maintenance & Reliability tools
See all- MTBF and MTTR Worksheet
- TPM Autonomous Maintenance CIL Standard Template
- TPM Autonomous Maintenance Standard Template
- TPM Pillars and Autonomous Maintenance 7 Steps Reference
- Preventive Maintenance Schedule Template
- Maintenance Work Order Template
- Inherent vs Operational Availability Calculator (MTBF, MTTR)
- Spare Parts Criticality Scoring Worksheet
- Maintenance Backlog Calculator (Weeks of Work and Crew Size)