Allergen Changeover and Line Clearance Procedure

Purpose. Describes the steps for clearing and cleaning a production line between products with different allergen profiles and verifying the line before the next product starts.

1.When this procedure applies

This procedure applies whenever the next scheduled product has a different allergen profile from the product just completed, whenever a product is followed by an allergen free product, and at the end of a production week before the deep clean. The line leader must check the production schedule and the product specifications to decide whether a changeover is required.

2.Line clearance

All product, rework, packaging and labels from the completed product must be removed from the line, the surrounding area and the packaging bays. Rework must be labelled with product name, allergen status and date and returned to the rework store. The line leader must complete the line clearance section of the changeover record before cleaning starts.

3.Cleaning

The line will be dry cleaned to remove visible residue, then wet cleaned and sanitised following the cleaning instruction for that line, paying attention to the hard to reach areas listed on the line diagram. Clean in place systems will run the validated allergen cycle. Colour coded cleaning equipment for allergen cleaning must be used and returned to its station.

• Dry clean and remove visible residue
• Wet clean with the specified detergent and contact time
• Sanitise and allow to dry
• Clean in place on the validated allergen cycle
• Return colour coded equipment

4.Verification

The line leader must inspect the line for visible cleanliness and the quality assurance officer must take allergen swabs from the locations on the line diagram. The next product will not start until the visual inspection has passed and the swab result has been recorded as a pass. A failed swab requires the affected area to be recleaned and reswabbed.

5.Line set up

The line leader will set up the line for the next product, confirm the correct packaging and labels against the approved artwork, complete the label check and record the start of the batch in the batch record.

6.Records

The changeover record, the swab results and the label check form part of the batch record for the next product and must be filed with it. Any failure during changeover must be recorded in the non-conformance register.