SOP for Cleaning Instruments and Equipment

In short: This example SOP provides a framework for cleaning laboratory instruments and equipment. Use the approved instructions for each device, protect samples and electrical components, inspect the equipment before use, and keep the required records.

Objective

To describe an example process for cleaning and checking instruments and equipment used in a pharmaceutical quality control laboratory.

Scope

Use this framework only for equipment covered by an approved site procedure. Cleaning agents, rinse water, disassembly, frequency and acceptance criteria depend on the equipment, its intended use, manufacturer instructions and the site’s quality system.

For equipment used in manufacturing, processing, packing or holding drug products in the United States, 21 CFR 211.67 (eCFR current to 23 October 2026) requires written cleaning and maintenance procedures. It also specifies procedure elements such as responsibilities, schedules, methods, protection of clean equipment and inspection before use. Apply the rules that govern the site and equipment in question.

Responsibilities

Example in-house criterion: Assign trained personnel to perform the cleaning, a second person or responsible reviewer to check it when the site’s procedure requires, and a Quality representative to resolve deviations or unclear equipment status. Record the actual responsibilities in the approved procedure.

Procedure

1. Prepare the equipment

Confirm the instrument or equipment identity and check its operating status. Finish or safely pause any analysis in progress, protect samples and records, and follow the manufacturer’s instructions and the site’s safety procedure before cleaning.

Example in-house criterion: Isolate electrical or other energy sources when the equipment procedure requires it. Do not apply liquid to electrical or electronic parts, and use the specified protective equipment.

2. Clean according to equipment-specific instructions

Follow the current approved instructions for the equipment. Use only the specified cleaning agent, tools, rinse water and method. Disassemble and reassemble parts only when the procedure and manufacturer instructions permit it. Protect cleaned equipment from contamination before use.

For equipment within the scope of 21 CFR 211.67, the written procedure also addresses removal or obliteration of previous batch identification and inspection for cleanliness immediately before use. Do not use one generic cleaning method for devices with different materials, designs or intended uses.

3. Water baths

For a dissolution tester water bath or disintegration tester water bath, follow the equipment-specific procedure for draining, cleaning, rinsing and refilling. Use the cleaning agent and water quality stated in that procedure or the manufacturer’s instructions. Check the bath and surrounding surfaces for residue, leaks or signs of damage before returning the equipment to service.

4. Inspect and record the status

Inspect the equipment after cleaning and before use, as required by the applicable procedure. Confirm that removable parts are reassembled correctly and that the instrument is suitable for its intended use. If the equipment is damaged, visibly unclean or of uncertain status, keep it out of use and notify the responsible person.

Example in-house criterion: Identify the equipment as clean or awaiting review in a controlled log or status system. Record the cleaning date, the person performing the work, any required check, and any exception or follow-up action.

5. Maintain the equipment log and retain records

For equipment covered by 21 CFR 211.67, cleaning, maintenance, sanitising and inspection records are maintained under §§ 211.180 and 211.182. Where 21 CFR 211.182 applies, the equipment log records major cleaning, maintenance and use with the date, time, product and lot number; the section also describes dating and signing or initialling entries and a limited exception for certain dedicated equipment.

Retain cleaning, inspection and use records at least 1 year after the expiry date of the respective product batch, and longer if local law or the marketing authorisation requires. For batch-associated records required by U.S. 21 CFR Part 211, § 211.180(a) sets a minimum of 1 year after batch expiry.

Related procedures

See also maintenance of laboratory instruments, equipment calibration and qualification, and cleaning laboratory glassware.

Abbreviations

• CFR: Code of Federal Regulations
• QC: Quality Control
• SOP: Standard Operating Procedure

References

• U.S. Food and Drug Administration. Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR 211.67, eCFR current as of 23 October 2026. Official eCFR text.
• U.S. Food and Drug Administration. Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR 211.182, eCFR current as of 23 October 2026. Official eCFR text.
• U.S. Food and Drug Administration. Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR 211.180(a), eCFR current as of 23 October 2026. Official eCFR text.