SOP for Cleaning a Blister-Pack Machine

In short: This illustrative SOP outlines how a packaging team can clean and release a blister-pack machine after production. Use the site’s validated cleaning instructions and equipment manual for the machine-specific parts, cleaning agents, quantities, hold times and safety steps.

Example in-house criterion (not a pharmacopoeial requirement): The sequence and responsibilities below are a template for adaptation under the site’s approved cleaning matrix, validated procedure and safety system.

Objective

Describe a controlled process for removing product, packaging and cleaning residues from a blister-pack machine before it is released for its next use.

Scope

This example covers routine cleaning between batches of the same product and product-changeover cleaning. The approved site cleaning matrix should define which cleaning level applies to each changeover and whether additional validation or verification is required.

This example refers to a Rotovac 210S and lists a hopper, hopper lid, bowl dish, feeding channel, product collection tray, sieve plate, chute, feeder rollers, powder tray, guide brush and track, pressure and scraper plates, foil assemblies, punching tool, lifter, swiveller and online de-foiling assembly.

Responsibility

Packaging operator: Carry out the approved cleaning steps and record the work.
Packaging supervisor or designee: Check that the selected cleaning procedure matches the planned changeover and that the machine is ready for the next step.
Quality unit: Review or release the equipment when required by the site’s approved quality system.

Procedure

Select the cleaning instruction. Identify the product and batch just processed, the next product where known, the machine ID and the cleaning category required by the approved cleaning matrix. Follow the validated procedure for that machine, product and changeover. EU GMP Annex 15 (2015), §§10.1 and 10.5, ties cleaning validation to the actual product-contact equipment and variables that affect cleaning performance.
Prepare the machine safely. Stop the line, remove product and packaging material, and isolate electrical and other hazardous energy according to the current equipment manual and site safety procedure before opening guards or dismantling parts. This example names a snood, gloves and nose mask as protective equipment (example in-house criterion).
Identify and remove leftover materials. Collect tablets or capsules, foil, empty blisters, rejected packs and coding materials. Segregate them and dispose of them through the approved product-waste and packaging-waste procedures. This example destroys rejected tablets or capsules by putting them in water (example in-house criterion).
Dismantle only approved parts. Remove product-contact parts that the validated cleaning instruction says to remove. Use the approved manual to identify which parts can be dismantled, how they are removed, and how they are protected during transfer to the wash area. Do not force parts or use an unapproved tool.
Clean using the validated method. Apply the specified cleaning agent, water quality, quantity, temperature, contact time, mechanical action, rinse sequence and drying method for this equipment and changeover. Follow the validated method for detergent removal and product-residue removal; do not substitute water quantities or cleaning agents based on this generic example. FDA’s CGMP equipment Q&A (2015), Q6, explains that cleaning instructions and validation should fit their intended use and the equipment and residues involved.
Inspect and perform required checks. Inspect accessible surfaces for visible product and packaging residue. Perform any swab, rinse, residue or other checks required by the approved cleaning procedure. Visual inspection is an important cleaning-validation criterion but generally cannot be the only criterion; repeated cleaning and retesting until results pass is not an acceptable validation approach (EU GMP Annex 15 (2015), §10.2).
Dry, reassemble and protect the machine. Dry parts using the method in the approved instruction, reassemble them according to the manual, and protect cleaned product-contact surfaces from contamination. Confirm that guards and safety devices are restored before the machine is returned to service.
Label and document the status. Complete the approved equipment status label and cleaning log with the machine ID, previous product and batch, cleaning category, procedure reference, cleaning date and time, operator, reviewer where required, and any checks or deviations. Apply the site’s validated clean-hold time to the equipment status; EU GMP Annex 15 (2015), §10.8, says the time between cleaning and use should be considered when setting clean-hold times.
Release for use. A designated person confirms completion of the required cleaning steps and records before changing the status to clean or ready for use. If an acceptance check fails or a deviation occurs, keep the equipment identified as not released and follow the approved investigation and disposition process.

Example in-house details

This example gives 29 kg of filtered potable water for the first wash, 20 kg of filtered potable water for a detergent rinse and 20 kg of purified water for a final rinse (example in-house criterion; use the quantities in your validated method).

This example wipes the machine if it remains unused for 48 hours and cleans it again if it remains unused for 72 hours (example in-house criterion).

For campaign use, this example cleans selected contact parts at the end of the working week or after five batches, whichever comes first (example in-house criterion).

This example directs operators to use a soft brass brush on the PSR, wash the vacuum cleaner with purified water and use compressed air to dry parts when needed.

This example refers to cubicle-cleaning SOP CQA-131.

Training

Train packaging staff on the current approved procedure, equipment-specific disassembly, cleaning agents, safety controls and required documentation before they perform the task.

Distribution

Maintain controlled copies for packaging and quality functions according to the site document-control procedure.

Annexure

Attach the site-approved cleaning checklist, equipment-part diagram and changeover matrix when the site adopts this template.

Related reading: equipment-cleaning SOP for production, cleaning-validation SOP and cleaning the de-foiling machine.

Revision history

This example includes no revision entries. Record approved revisions in the site’s controlled document history.

References

European Commission. EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Annex 15: Qualification and Validation (2015; in operation since 1 October 2015), §§10.1–10.15. Official Annex 15 PDF; official EudraLex Annex 15 index.
U.S. Food and Drug Administration. Questions and Answers on Current Good Manufacturing Practice Requirements: Equipment (2015), Questions 6–8 and 10–12; references 21 CFR 211.67. Official FDA guidance page.
European Commission. EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Part I, Chapter 4: Documentation (2011), §4.11. Official Chapter 4 PDF.
U.S. Food and Drug Administration. 21 CFR Part 211, §211.180(a), batch-specific record-retention requirement. FDA Basic CGMP Requirements.