SOP for Cleaning of De-blistering Machine (Example)

In short: A de-blistering machine removes tablets or capsules from blister packs (for example for rework or sample recovery), so it handles loose product and foil pieces. This example SOP describes how to clean it between products and between batches of the same product so no residue or mix-up carries over. Adapt volumes, hold times and labels to your own site.

About this example SOP

This is an illustrative template, not a regulatory requirement. Values in square brackets, hold times and the campaign limit are example in-house criterion values; set them from your own cleaning validation and risk assessment. Principles behind it: EU GMP Part I, Chapter 5 (Production), sections 5.18 to 5.21 on preventing cross-contamination, and 21 CFR 211.67 (equipment cleaning and maintenance). See also SOP for cleaning of de-foiling machine, SOP for cleaning of blister pack machine, Principles of cleaning validation and SOP for equipment cleaning in the production department.

1.0 Objective

To describe the procedure for cleaning the de-blistering machine and effectively removing residue of the previous product or batch.

2.0 Scope

This example SOP applies to cleaning of the de-blistering machine at the packaging area of the manufacturing facility. Insert the make and model of your machine.

3.0 Responsibility

• The officer or executive who operates the machine is responsible for removing residue of the previous product or batch as described here.
• The Head of Packaging is responsible for implementing the procedure.
• QA reviews cleaning records and verifies line clearance.

4.0 Procedure

4.1 Health, safety and environment

1. Switch off the electricity supply before starting to clean the machine.
2. Wear a snood, hand gloves and a nose mask during cleaning.
3. After cleaning, fit all guards back in their original position.

4.2 Product-to-product cleaning

1. Switch off the mains of the de-blistering machine.
2. Remove the “USE FOR” status label and attach a “TO BE CLEANED” label as per the labelling SOP.
3. Wipe the machine body with a clean, damp, lint-free duster.
4. Remove all foil pieces, empty blisters and tablets or capsules stuck to the blister guide, tablet collection bin, de-blistered blister collection bin, rubber roller, de-foiler roller and other parts. Destroy rejected tablets or capsules by placing them in water, and record the quantity in the BPR.
5. Detach the removable parts (rubber roller, stainless steel rotary shaft, collection box, stainless steel guard, acrylic guard) and rinse them with [X] kg of potable water.
6. Clean these parts with the approved detergent solution.
7. Rinse them with [X] kg of filtered potable water to remove traces of detergent.
8. Finally rinse with [X] kg of purified water and wipe with a clean lint-free duster. Make sure the parts are dry and show no trace of the previous product.
9. Wipe the machine body with a clean damp lint-free duster, then with a dry one.
10. Clean the cubicle as per the room cleaning SOP.
11. Remove the “TO BE CLEANED” label and attach a “CLEANED” label filled in with equipment code, previous product, SOP number, cleaned by (signature), date and the “cleaned valid up to” date.
12. Record the cleaning in the area and equipment usage and cleaning log.

Hold times (example in-house criterion):

• If the cleaned machine is not used within 48 hours, or if dust or powder has settled on outer surfaces, wipe it with a damp lint-free duster followed by a dry one.
• If the cleaned machine is not used within 72 hours, clean it again before use.

4.3 Batch-to-batch cleaning (same product)

1. Switch off the mains of the machine.
2. Remove the “USE FOR” label and attach a “TO BE CLEANED” label.
3. Wipe the machine body with a clean, dry, lint-free duster.
4. Remove all foil pieces, empty strips and tablets or capsules stuck to the rubber roller, stainless steel roller, collection box and other parts. Destroy rejected tablets or capsules by placing them in water, and record in the BPR.
5. Clean the acrylic guard, stainless steel guard, collection box and machine body with a dry, clean, lint-free duster.
6. Clean the cubicle as per the room cleaning SOP.
7. Replace the “TO BE CLEANED” label with a filled-in “CLEANED” label (as in 4.2, step 11).
8. Record the cleaning in the area and equipment usage and cleaning log.

Hold times: the same 48-hour and 72-hour rules as in section 4.2 apply (example in-house criterion).

Campaign use (example in-house criterion): if the machine runs on a campaign basis, remove and fully clean the product-contact parts (hopper, bowl disc, channel or chute, flooding box where fitted) on the last working day of the week or after 5 batches, whichever is earlier.

5.0 Records

Cleaning labels, the usage and cleaning log, and the BPR entries are batch-related GMP records. Keep them at least 1 year after the expiry date of the respective product batch (EU GMP Part I, Chapter 4, section 4.11; 21 CFR 211.180(a)), longer if local law or the marketing authorisation requires.

6.0 Training and distribution

• Trainer: Head, Packaging Department. Trainees: packaging and QA staff.
• Controlled copy 1: Head of QA. Controlled copy 2: Head of Packaging. Master copy: Head of QA.

7.0 Annexures

None.

Frequently asked questions

Why clean a de-blistering machine at all?

It handles loose dosage units and foil fragments of one product, so residue can reach the next product. EU GMP Chapter 5 and 21 CFR 211.67 expect equipment to be cleaned so that carry-over does not affect quality.

Is dry cleaning enough between batches of the same product?

It can be, if your cleaning validation or risk assessment supports it. The dry batch-to-batch method here is an example in-house criterion.

Why destroy recovered tablets in water?

Rejected units must not re-enter the stream or be mistaken for good product. Your site’s reject-handling SOP defines the approved method and quantity reconciliation.

References

1. European Commission. EudraLex Volume 4, EU GMP Part I, Chapter 5: Production (cross-contamination, sections 5.18 to 5.21).
2. European Commission. EudraLex Volume 4, EU GMP Part I, Chapter 4: Documentation, section 4.11.
3. US FDA. 21 CFR 211.67, Equipment cleaning and maintenance.
4. US FDA. 21 CFR 211.180(a), General requirements (record retention).

Revision history