§ 211.182 Equipment cleaning and use log.
A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 211.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.
[73 FR 51933, Sept. 8, 2008]
How BatchGlow handles this
Each cleaning is recorded against the equipment with its cleaning template, who cleaned it and when, and a signature; the equipment's cleaning status and clean-hold expiry are set from it.
What it asks for, in plain words
- 21 CFR 211.182
- Cleaning, maintenance (except routine maintenance) and use of major equipment are recorded, in chronological order, in individual equipment logs that show the date, time, product and lot number of each batch processed; equipment dedicated to one product whose lots are made in numerical sequence needs no individual log, and then these records are part of the batch record. The persons who perform and double-check the cleaning and maintenance (with automated equipment, the person verifying it) date and sign or initial the log.
These summaries are BatchGlow's reading of the text on this page, checked against it on 5 Oct 2026. The text governs.