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SOP for Cleaning a Strip De-Foiling Machine

Last reviewed 19 Oct 2026 · 7 min read

Contents
  1. Objective
  2. Scope
  3. Responsibilities
  4. Regulatory context
  5. Safety and preparation
  6. Product-to-product cleaning
  7. Batch-to-batch cleaning
  8. Campaign cleaning and cleaning-status labels
  9. Example clean-hold times
  10. Inspection, release, and records
  11. Training and distribution
  12. Related procedures
  13. Frequently asked questions
  14. Are 48-hour, 72-hour, or seven-day clean-hold times GMP limits?
  15. Is a dry or damp cloth sufficient to clean every product residue?
  16. When should a campaign clean be performed?
  17. References

In short: This illustrative SOP template describes cleaning a strip de-foiling machine during product and batch changeovers. It separates the dry- and wet-wipe approaches from site-approved cleaning requirements. The example clean-hold times conflict and its water-destruction instruction for rejected tablets is not a universal method; set both through your own justified, approved procedure before use.

Objective

Describe how to remove foil, empty strips, and product remnants from a strip de-foiling machine and control the equipment’s cleaning status between uses.

Scope

This template is for a strip de-foiling machine in a pharmaceutical packaging area. Complete the site, room, equipment ID, and applicable cleaning-procedure references in the controlled copy. Confirm which surfaces contact product or packaging and which cleaning method applies to each.

Responsibilities

Example in-house criterion (not a pharmacopoeial requirement): A trained Packaging Officer or Executive performs the cleaning and records it. The Head of Packaging ensures that the procedure, equipment status controls, and training are implemented. The relevant quality unit verifies line clearance or release as required by the site’s approved procedure.

Regulatory context

For U.S. drug CGMP, 21 CFR 211.67(a)–(b) calls for cleaning, maintenance, and appropriate sanitising of equipment at suitable intervals and written procedures for cleaning and maintenance. The regulation describes procedure elements such as responsibilities, schedules, methods and materials, equipment assembly, preventing contamination before use, and inspection before use. Section 211.100(a)–(b) requires approved written production and process-control procedures and documentation of performance and deviations.

For EU GMP, EudraLex Volume 4 Annex 15 (2015), §10.1 states that cleaning validation should confirm the effectiveness of cleaning procedures for product-contact equipment. Section 10.8 says the effects of the time before cleaning and the time between cleaning and use should be considered when defining dirty and clean hold times. These sources do not prescribe this example’s specific 48-hour, 72-hour, seven-day, or five-batch intervals.

Safety and preparation

Example in-house criterion (not a pharmacopoeial requirement): Wear the protective clothing and equipment specified by the site risk assessment and the approved handling procedure. This example names a snood, gloves, and a nose mask; confirm that these items are suitable for the materials and task.

Before cleaning:

  1. Confirm the machine ID, previous product and batch, cleaning status, and whether the approved changeover instruction requires a product-to-product or batch-to-batch clean.
  2. Stop the machine and isolate its electrical supply using the approved equipment-specific safety procedure. Prevent restart and wait for movement to stop before accessing internal parts.
  3. Remove the “Use For” status label and apply the controlled “To Be Cleaned” label with the required equipment and product details.
  4. Follow the machine manufacturer’s safe-access instructions when removing foil, empty strip, or tablets/capsules from the strip guide plate, slitter blade assembly, guards, and other parts. Do not put hands into an unsafe or unisolated mechanism.

Product-to-product cleaning

This example proposes this method for a product change:

  1. Switch off and isolate the machine using the approved safety procedure.
  2. Remove the previous “Use For” label and apply the “To Be Cleaned” label.
  3. Wipe the machine body with a clean lint-free duster dampened only with a site-approved cleaning material, if that method is approved for the equipment surface.
  4. Remove foil pieces, empty strips, and tablets or capsules from the strip guide plate, slitter blade assembly, stainless-steel guard, inside surfaces, and other identified locations.
  5. Clean the cubicle under its current approved cleaning procedure. Inspect the machine and area before applying the clean status label.

This example names a wet lint-free duster but does not identify any cleaning agent or define the method for product-contact surfaces. Do not assume that a damp cloth alone is an effective cleaning method for residues from every product.

This example directs operators to put rejected tablets or capsules into water for destruction and to record the activity in the batch production record (BPR). Do not treat water immersion as a universal destruction method; use only the approved rejected-product handling and waste procedure.

Batch-to-batch cleaning

This example proposes a dry-cleaning approach between batches of the same product:

  1. Switch off and isolate the machine under the approved safety procedure.
  2. Remove the current “Use For” label and apply the “To Be Cleaned” label.
  3. Use a clean, dry, lint-free duster to remove foil pieces, empty strips, and tablets or capsules from the machine body, stainless-steel guard, slitter blade assembly, slitter guide plate, and other specified parts.
  4. Clean the cubicle under its approved procedure. Inspect the cleaned equipment, then change its status using the controlled label process.

Example in-house criterion (not a pharmacopoeial requirement): Dry wiping is suitable only when the site’s approved changeover procedure identifies it as adequate for the residue and risk. If visible residue remains, the equipment is damaged, or the changeover instructions require further cleaning, keep the machine out of use and follow the relevant cleaning procedure.

Campaign cleaning and cleaning-status labels

Example in-house criterion (not a pharmacopoeial requirement): This example says that, during campaign use, contact parts including the hopper, bowl disc, channel or chute, and flooding box are cleaned at the last working day of the week or after five batches, whichever occurs first. Confirm that these parts belong to this de-foiling machine before applying the instruction.

After cleaning, remove the “To Be Cleaned” label and apply the controlled “Cleaned” label. This example lists equipment code, previous product, SOP number, cleaner’s identity/signature and date, and a “cleaned valid up to” date. Use the fields and release decision approved by the site’s quality system.

Example clean-hold times

Example in-house criterion (not a pharmacopoeial requirement): This example gives different instructions after cleaning:

Cleaning contextExample instruction
Product-to-productIf the machine is not used within 48 hours after cleaning, or dust/powder settles on the outside, wipe with a wet lint-free duster followed by a clean, dry lint-free duster; if not used after cleaning within seven days, re-clean before use.
Batch-to-batchIf the machine is not used within 48 hours after cleaning, or dust/powder settles on the outside, wipe with a wet lint-free duster followed by a clean, dry lint-free duster; if not used after cleaning within 72 hours, re-clean before use.

These intervals conflict and are not a universal regulatory rule. Set the clean-hold time through your own justified, approved procedure, including the effect of intervening external wiping and whether the required re-clean applies to the full machine or only specified surfaces, before use.

Inspection, release, and records

Inspect the machine before use and confirm the equipment status label is valid, visible residue is absent, and guards are in their approved operating position. Keep the equipment out of use if cleaning is incomplete, a part is damaged, or the status cannot be confirmed.

Example in-house criterion (not a pharmacopoeial requirement): Record the equipment ID, previous and next product/batch as applicable, cleaning type, date and time, parts and surfaces cleaned, materials used, observations, cleaner and verifier, status-label details, and any deviation or rejected-product action in the equipment and batch records required by the site.

Retain batch-specific GMP records at least one year after expiry of the respective product batch. Under EU GMP Part I Chapter 4 §4.11, batch documentation is retained for one year after expiry or at least five years after Qualified Person certification, whichever is longer. 21 CFR 211.180(a), current eCFR edition (2026), requires at least one year after expiry for production, control, or distribution records specifically associated with a drug-product batch. Apply any longer period required by applicable law or the marketing authorisation.

Training and distribution

Example in-house criterion (not a pharmacopoeial requirement): Train Packaging and QA personnel on the cleaning and verification steps assigned to them before they perform those steps. Distribute the controlled procedure through the site’s document-control process.

This example lists the Head of Packaging as trainer, Packaging and QA staff as trainees, controlled copies for QA and Packaging, and the original held by QA. Confirm the current role names and distribution list before issuing a controlled copy.

Frequently asked questions

Are 48-hour, 72-hour, or seven-day clean-hold times GMP limits?

No universal interval is set by the cited regulations. They are conflicting example values and require a justified, approved rule for the equipment and cleaning state.

Is a dry or damp cloth sufficient to clean every product residue?

Do not assume so. Use the approved cleaning method for the residue and surface, and maintain the required validation or other evidence of effectiveness for product-contact equipment.

When should a campaign clean be performed?

This example proposes after five batches or at the end of the working week, whichever comes first. Confirm the equipment parts and approve the interval for the site’s process; do not treat that example as a universal GMP frequency.

References

  1. United States Electronic Code of Federal Regulations. 21 CFR §211.67(a)–(c), equipment cleaning and maintenance, and §211.100(a)–(b), written procedures and deviations (current eCFR edition, 2026; accessed 19 October 2026). §211.67; §211.100.
  2. European Commission. EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Annex 15: Qualification and Validation (2015; applicable from 1 October 2015), §§10.1 and 10.8. Official Annex 15 PDF.
  3. European Commission. EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Part I, Chapter 4: Documentation (January 2011), §4.11. Official Chapter 4 PDF.
  4. United States Electronic Code of Federal Regulations. 21 CFR §211.180(a), general record-retention requirements (current eCFR edition, 2026; accessed 19 October 2026). Official eCFR.

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