Pharmaceutical Guidelines
Search

SOP for Cleaning of Leaflet Folding Machine (Example Template)

Last reviewed 28 Oct 2026 · 4 min read

Contents
  1. Why this cleaning matters
  2. 1. Objective
  3. 2. Scope
  4. 3. Responsibility
  5. 4. Procedure
  6. 4.1 Health, safety and environment
  7. 4.2 Product-to-product and batch-to-batch cleaning
  8. 5. Records
  9. 6. Training
  10. 7. Distribution
  11. 8. Abbreviations
  12. Frequently asked questions
  13. Is machine cleaning the same as line clearance?
  14. Why check for stray leaflets?
  15. See also
  16. References

In short: This example SOP describes how packing staff clean an off-line leaflet folding machine between products and batches. It covers safety, a part-by-part cleaning checklist, status labels and records. Adapt the machine parts and forms to your own quality system before use.

Why this cleaning matters

Package inserts (leaflets) carry the product-specific information that reaches the patient. A leaflet of the previous product left in the feeder, trays or rollers can be mixed into the next batch, which is a labelling mix-up. Paper dust on rollers can also affect folding. Three GMP expectations apply:

  • 21 CFR 211.67 (US FDA, Equipment cleaning and maintenance) requires written cleaning procedures covering responsibility, schedules, detailed methods, removal or obliteration of previous batch identification, protection of clean equipment before use, and inspection for cleanliness immediately before use. Cleaning and use logs are covered by §§211.67(c) and 211.182.
  • EU GMP Part I, Chapter 5 (Production), paragraph 5.50 expects that, before packaging starts, the work area, packaging lines, printing machines and other equipment are clean and free from products, materials or documents from the earlier operation. Leaflets are such documents.
  • EU GMP Chapter 5, paragraphs 5.13 and 5.21 expect equipment and areas to be clearly labelled with their status, and list the cleaning status labelling of equipment among the measures that prevent cross-contamination.

1. Objective

To describe the procedure for cleaning the off-line leaflet folding machine and effectively removing leaflets, paper dust and other residue of the previous product or batch.

2. Scope

This example SOP applies to cleaning of the off-line leaflet folding machine in the packing area of the manufacturing facility. Replace the placeholders with your own site and equipment details.

3. Responsibility

  • Packing officer / authorised designee: clean the machine as per this procedure and record it.
  • Head of Packing: ensure the procedure is implemented and followed.
  • Quality Assurance: verify line clearance and review the cleaning records.

4. Procedure

4.1 Health, safety and environment

  • Switch off the electrical supply before starting cleaning.

4.2 Product-to-product and batch-to-batch cleaning

  1. Switch off the mains supply of the machine.
  2. Remove the “USE FOR” (in use) label from the machine and affix a “TO BE CLEANED” label as per your site SOP.
  3. Remove all folding plates and deflection plates from the machine and clean them with a clean, dry, lint-free duster.
  4. Using a clean, dry, lint-free duster, clean the following parts in turn (refer to the machine manual or your site’s diagrams):
    • feeder tray
    • leaflet feeder gap-setting roller
    • collection tray
    • all rubber rollers (remove paper dust deposits)
    • all stainless steel rollers
    • wheels
    • platform
    • stacker
    • machine body
    • PLC
    • Pharmacode reader unit and sensor
    • control panel
  5. Check that no leaflet of the previous product remains anywhere in the machine, including the trays, stacker and under the plates.
  6. Remove the “TO BE CLEANED” label and affix a “CLEANED” label showing the equipment code, previous product, SOP number, cleaned by (signature), date, and the date until which the cleaning remains valid (“CLEANED VALID UP TO”).
  7. Record the cleaning in the area and equipment usage and cleaning log.

5. Records

Keep the cleaning log and status labels’ records as part of the packaging documentation. Records must be retained for at least 1 year after the expiry date of the respective product batch (EU GMP Part I, Chapter 4, paragraph 4.11; 21 CFR 211.180(a)), or longer if local law or the marketing authorisation requires.

6. Training

  • Trainer: Head of Packaging or designee.
  • Trainees: Packing and QA staff who clean or check the machine.

7. Distribution

Controlled copies to Head of Quality Assurance and Head of Packaging; original with Quality Assurance.

8. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • PLC: Programmable Logic Controller
  • GMP: Good Manufacturing Practice

Frequently asked questions

Is machine cleaning the same as line clearance?

No. Line clearance checks that the packing line and area are free of previous materials and documents before a new batch starts (EU GMP Chapter 5, paragraph 5.50). Cleaning the machine is one step that supports it. Both are recorded.

Why check for stray leaflets?

Leaflets of different products can look alike. One stray leaflet in a feeder or stacker can end up in the wrong carton, so the check for remaining leaflets is as important as removing dust.

See also

References

  1. US FDA, 21 CFR Part 211, §211.67 Equipment cleaning and maintenance, §211.180(a) General requirements (records) and §211.182 Equipment cleaning and use log, current eCFR text.
  2. European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 4 (Documentation), paragraph 4.11, and Chapter 5 (Production), paragraphs 5.13, 5.21 and 5.50 (in operation since 1 March 2015).

Related articles