Templates and records · ISO 22716 · Clause 5.5

ISO 22716 equipment cleaning and sanitisation record

A contaminated cream usually starts in a poorly cleaned tank. The record shows that each piece of equipment is cleaned and sanitised by the intended method before each use and between batches.

In one sentence

The equipment cleaning and sanitisation record shows which equipment was cleaned, when, with which agent and method, by whom and with what check, and whether its status is clean or pending, because ISO 22716 recommends that all equipment be subject to a cleaning programme and, where needed, sanitisation with specified, effective agents (5.5), and that equipment be checked as clean before manufacture (7.2.2).

Content reviewed on 17 October 2026

Where the standard requires it: ISO 22716 · Clause 5.5 Chapters are those of ISO 22716:2007, the only edition published, confirmed by ISO in 2022. It is a guidelines standard: it recommends; the obligation comes from Article 8 of Regulation (EC) 1223/2009.
Type of information: Mandatory record ISO 22716 recommendation (5.5 and 7.2.2), enforceable through Article 8 of Regulation 1223/2009
Who fills it in: Production operator Verified by the shift leader or quality, depending on the product's risk
When: After each use and between batches And at the intervals set for continuous production or successive batches of the same product
How long it is kept: Defined by the company ISO 22716 asks for the archiving period to be set according to applicable legislation (17.5.2). As a reference, the product information file is kept for ten years after the last batch was placed on the market (Article 11(1) of Regulation 1223/2009).

What the standard requires

What ISO 22716 demands and what it leaves to your judgement

The standard asks for a cleaning programme and, where appropriate, a sanitisation programme for all equipment, using specified, effective agents. If equipment is dedicated to continuous production or to successive batches of the same product, it must be cleaned at appropriate intervals.

Before each manufacturing or packaging operation you must make sure the equipment is clean and, if necessary, sanitised, and that the area has been cleared of materials from the previous operation (7.2.2 and 7.3.2). Defective equipment is identified and taken out of use (5.6.3).

The company decides the method and frequency according to the risk of each product; what is required is that they are defined, applied and can be demonstrated.

Read it in context: Facilities, equipment, and raw materials, in the ISO 22716 Academy

Structure

Fields the template should include

Equipment and identification
Last product and batch made
Type: cleaning, sanitisation or both
Procedure and agents used, with concentration
Date, time and person carrying it out
Check: visual, rinse, microbiological swab
Equipment status: clean, pending, out of use
Validity of the clean, if the equipment stands idle
Verification and signature

Example

Example: cleaning an emulsion vessel

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Equipment	Vessel R-02, 500 l · Elmwood Laboratories (fictitious company)
Previous product	Moisturising cream CH-30 · batch 26-0418
Procedure	CP-05 version 3: hot water, 2% alkaline detergent, rinse and sanitisation with 70% alcohol
Carried out	18 April 2026, 16:40 · manufacturing operator
Check	Visual conforming · microbiological swab on the bottom valve, result at 72 h
Status	"Clean" label valid for 72 hours
Verification	Shift leader, 18 April, 17:10
Swab result	Fewer than 10 cfu · conforming · 21 April

At the audit

Mistakes auditors commonly flag

Cleaning records without the previous product, so the risk of carry-over cannot be assessed.
An agent or concentration different from the one in the procedure.
Equipment idle for weeks with a "clean" label and no validity date.
Hoses and transfer fittings with no recorded cleaning.
Nobody has ever checked that the cleaning method is effective.

In Kimobox

How this record is kept in Kimobox

1Equipment cleaning and maintenance are scheduled as periodic records, with reminders.
2Each clean is recorded with its equipment, date and who carried it out, and can be consulted from the manufacturing order.
3Cleaning procedures are managed as controlled documents, in their current version.
4A nonconforming result is opened as a nonconformity linked to the equipment and the batch.

Frequently asked questions

What people ask us before getting started

What is the difference between cleaning and sanitisation?

Cleaning removes dirt and product residues; sanitisation reduces microbial contamination to an acceptable level. ISO 22716 asks for cleaning always and sanitisation where necessary according to the product's risk.

Does cleaning have to be validated?

The standard requires the agents to be effective, without demanding formal validation as in pharmaceuticals. Checking effectiveness with swabs or rinses, at least when the method is introduced and periodically thereafter, is the usual way of demonstrating it.

How often is equipment cleaned in continuous production?

At appropriate intervals set by the company, depending on the product, its microbiological sensitivity and the time in use. The standard asks for those intervals to be defined.

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Sources

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

ISO 22716:2007 — Cosmetics. Good Manufacturing Practices (GMP). Guidelines on Good Manufacturing Practices ISO · 2007 ed., confirmed in 2022
Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products EUR-Lex · 30 November 2009, consolidated text