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SOP for Cleaning of Strip Pack Machine

Last reviewed 28 Oct 2026 · 5 min read

Contents
  1. 1.0 Objective
  2. 2.0 Scope
  3. 3.0 Responsibility
  4. 4.0 Health, safety and environment
  5. 5.0 Procedure
  6. 5.1 Product-to-product cleaning
  7. 5.2 Batch-to-batch cleaning (same product)
  8. 6.0 Training
  9. 7.0 Distribution
  10. 8.0 Records
  11. Frequently asked questions
  12. Why remove the previous product’s labels and stereos?
  13. Does cleaned equipment need protection until use?
  14. Is a fixed clean-hold time a regulatory requirement?
  15. Related posts
  16. References

In short: This example SOP explains how packaging staff clean a strip pack machine after a product change and after a batch change, so no residue, foil or tablets from the earlier product remain. Adapt the volumes, hold times and labels to your own equipment and quality system.

1.0 Objective

To describe the cleaning of a strip pack machine (example make: Satellite) and the effective removal of residue of the previous product or batch.

2.0 Scope

This example SOP applies to cleaning of the strip pack machine in the packaging area of the manufacturing facility. Insert your site name and equipment code when you adopt it.

3.0 Responsibility

  • Packaging officer or executive: clean the machine as per this procedure and complete the records.
  • Head of Packaging: ensure the procedure is implemented.
  • Quality Assurance: verify cleaning and line clearance as per the site system.

4.0 Health, safety and environment

  • Wear a snood, hand gloves and a nose mask while cleaning.
  • Switch off the electrical supply before starting to clean.
  • Wear heat-resistant gloves when handling heated parts.
  • Refit all guards in their original position after cleaning.

5.0 Procedure

5.1 Product-to-product cleaning

  1. Switch off the mains of the machine.
  2. Remove the “USE FOR” label and affix a “TO BE CLEANED” label.
  3. Destroy rejected tablets or capsules by putting them in water, and record this in the batch packing record.
  4. Cut up and destroy the overprinting and coding stereos of the previous product, as per the site SOP.
  5. Remove the front (FSR) and back (BSR) foil from the foil holding assembly.
  6. Dismantle the change parts. Take the hopper, hopper lid, bowl dish, feeding channel and powder collection tray in polybags to the washing area.
  7. Wash these parts with filtered potable water (example in-house criterion: 25 kg) and approved detergent to remove adhering material, then rinse with filtered purified water (example in-house criterion: 20 kg) to remove detergent.
  8. Give a final rinse with purified water (example in-house criterion: 20 kg). Wipe with a clean lint-free duster and, if needed, dry with filtered compressed air so no trace of the previous product remains.
  9. Clean the sealing roller with a soft brass wire brush.
  10. Remove the other change parts of the previous product, clean them with a lint-free cloth and store them in the racks.
  11. With a clean, dry lint-free duster, clean the machine body, the pneumatic rejection flap system, the cam toe, the inside of the control panel, the tool box and the ink/thinner box.
  12. Clean the NFD system, cutting assembly, rejection assembly, FSR and BSR holders, foil guide roller and foil sensor in the same way.
  13. Remove the “TO BE CLEANED” label and affix a “CLEANED” label showing equipment code, previous product, SOP number, cleaned by, signature, date and “cleaned valid up to”.
  14. Record the cleaning in the area and equipment usage and cleaning log.

Clean-hold time (example in-house criteria): if the cleaned equipment is not used within 48 hours, or dust has settled on the outside, wipe it with a wet lint-free duster followed by a dry one. If it is not used within 72 hours, clean it again before use.

5.2 Batch-to-batch cleaning (same product)

  1. Switch off the machine.
  2. Remove the “USE FOR” label and affix “TO BE CLEANED”.
  3. Remove dust from the body with a dry lint-free duster or vacuum cleaner.
  4. Destroy rejected tablets or capsules in water and record this in the batch packing record.
  5. Cut up and destroy the overprinting and coding stereos of the previous batch.
  6. Remove the FSR and BSR foil. Remove all foil pieces, empty blisters and tablets or capsules from the floor and machine, and empty the collection box.
  7. Clean the sealing roller with a soft brass wire brush.
  8. Clean the bowl, hopper lid, feeding channel and powder collection tray in place with a clean lint-free duster, then the machine body with a clean dry duster.
  9. Clean the cubicle as per the area cleaning SOP.
  10. Replace “TO BE CLEANED” with a “USE FOR” label showing product name, date and signature of the production officer.
  11. Record the cleaning in the area and equipment usage and cleaning log.

Clean-hold time: the 48-hour and 72-hour rules in 5.1 apply here too.

Campaign production (example in-house criterion): when the same product runs as a campaign, completely clean the product-contact parts (hopper, bowl disc, channel or chute, flooding box) on the last working day of the week or after 5 batches, whichever is earlier.

6.0 Training

The Head of Packaging trains packaging and QA staff on this SOP before they carry out the cleaning, and records the training.

7.0 Distribution

Controlled copies go to Quality Assurance and Packaging; the master copy is held by Quality Assurance.

8.0 Records

The cleaning entry in the equipment usage and cleaning log is a GMP record: it should show date, time, product, batch and the signatures of the person who cleaned and the person who checked (21 CFR 211.182). Keep the log and batch packing records at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4 §4.11, or 5 years after QP certification if longer; 21 CFR 211.180(a)), and longer if local law or the marketing authorisation requires.

Frequently asked questions

Why remove the previous product’s labels and stereos?

Written cleaning procedures should cover removal or obliteration of previous batch identification (21 CFR 211.67(b)(4)). Leftover printing material is a common cause of mix-ups.

Does cleaned equipment need protection until use?

Yes. 21 CFR 211.67(b)(5) expects written procedures to protect clean equipment from contamination before use, and EU GMP Chapter 3 §3.36 expects equipment to be stored clean and dry.

Is a fixed clean-hold time a regulatory requirement?

No. The limit is set by each site from a hold-time study and its cleaning validation.

See also cleaning of the blister pack machine, cleaning of the overprinting machine and equipment cleaning in the production department.

References

  • US FDA, 21 CFR 211.67 Equipment cleaning and maintenance (eCFR, current as checked October 2026).
  • US FDA, 21 CFR 211.182 Equipment cleaning and use log; 21 CFR 211.180(a) General requirements for records.
  • European Commission, EudraLex Volume 4, EU GMP Part I Chapter 3 Premises and Equipment, §3.36, and Chapter 4 Documentation §4.11.
  • Equipment manual of the installed strip pack machine.

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