SOP for Cleaning of Lifter and Swiveller (Example Template)

In short: This example SOP describes how packing staff clean a lifter and swiveller on a packing line between products and batches, so that no residue of the previous product remains. It covers safety, labels, hold times and records. Adapt the equipment names, times and forms to your own quality system before use.

Why this cleaning matters

Packing-line machines handle containers that carry the product name and batch identity. Residue, dust or loose material from the previous product can mix with the next batch. Two 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. Records are kept under §§211.67(c), 211.180 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.

1. Objective

To describe the procedure for cleaning the lifter and swiveller and effectively removing residue of the previous product or batch.

2. Scope

This example SOP applies to cleaning of the lifter and swiveller in the packing area of the manufacturing facility. Replace the placeholders with your own site and equipment details.

3. Responsibility

• Packing officer / executive: clean the lifter and swiveller 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

• Wear snood, hand gloves and nose mask during cleaning.
• Switch off the electrical supply before starting cleaning.
• After cleaning, refit all guards in their original position.

4.2 Product-to-product cleaning

1. Switch off the mains of the lifter and swiveller.
2. Remove the “USE FOR” (in use) label from the machine and affix a “TO BE CLEANED” label.
3. Wipe the machine body with a damp lint-free duster.
4. Press the operating button and bring the lifting arm to the downward position, as described in the machine manual.
5. Clean the IPC holder with a damp lint-free duster, then with a clean dry lint-free duster.
6. Clean the body of the lifter and swiveller in the same way (damp, then dry lint-free duster).
7. Clean the conveyor belt, including the area inside the belt, in the same way.
8. Clean the base of the machine and the floor area around it.
9. 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.
10. Record the cleaning in the area and equipment usage and cleaning log.

4.3 Batch-to-batch cleaning (same product)

1. Switch off the mains and change the labels as in 4.2 (steps 1 and 2).
2. Bring the lifting arm to the downward position as in 4.2 (step 4).
3. Clean the IPC holder with a damp lint-free duster, then a clean dry one.
4. Complete the label and the cleaning log as in 4.2 (steps 9 and 10).

4.4 Campaign production (example in-house criterion)

If the machine runs on a campaign basis, remove and clean the contact parts (hopper, bowl disc, channel or chute, flooding box) completely on the last working day of the week or after 5 batches, whichever is earlier.

4.3 Hold time after cleaning (example in-house criteria)

• If the cleaned machine stays unused for 48 hours, or if dust or powder is visible on its outer surfaces, wipe it with a damp lint-free duster followed by a clean dry lint-free duster.
• If the machine stays unused for more than 72 hours after cleaning, clean it again before use.

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.
• Trainees: Packing department staff who clean 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
• 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.

Do we need to validate this cleaning?

Packing machines are normally non-product-contact, so visual checks and a defined routine are usually used. Whether further verification is needed depends on your own risk assessment. See Principles of Cleaning Validation.

See also

• SOP for Cleaning of Strip Pack Machine
• SOP for Cleaning of De-blistering Machine
• SOP for Equipment Cleaning in Production Department

References

1. US FDA, 21 CFR Part 211, §211.67 Equipment cleaning and maintenance, and §211.180(a) General requirements (records), current eCFR text.
2. European Commission, EudraLex Volume 4, EU GMP Part I, Chapter 4 (Documentation), paragraph 4.11, and Chapter 5 (Production), paragraph 5.50.