Line clearance 2026

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  1. Click ‘Get Form’ to open the Line Clearance Form in the editor.
  2. Begin by entering the Product Name, Batch #, Package SKU #, and Package Line in the designated fields.
  3. If this batch follows a sequence run of the same product, check the corresponding box. Ensure that Batch #s are changed throughout the line.
  4. For Line Clearance Start Up, check the box when all products from the previous run have been removed from the line, including weigh-offs and damaged containers.
  5. Confirm that effluent restricted items are properly hooked up with line flushes/rinses to appropriate washout totes/tanks.
  6. Ensure all packaging components and labeling not on the current BOM have been removed from both staging area and line floor.
  7. Verify that all filler lines and hoses have been thoroughly flushed for product changeover.
  8. Check that flush from transfer lines is neutral and water is colorless and foam-free before proceeding.
  9. For Line Prep Start Up, obtain Shop Order/Packaging BOM and verify batch approval by QA/QC.
  10. Inspect all staged components for damage and ensure scales are set up correctly for specified fill weight.

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There are three types of line clearance: equipment line clearance, product line clearance, and area line clearance.
1. Quality Assurance. Line clearance is a vigilant gatekeeper, preventing remnants of the previous production run from lingering on the production line. This meticulous removal of residues and contaminants safeguards the integrity of the subsequent batch, reducing the risk of cross-contamination.
The 3 Cs of line clearance, which are cleanliness, compliance, and confirmation, play a crucial role in maintaining pharmaceutical industry standards and preventing cross-contamination or mix-ups.
The term line clearance is understood to mean the checking that the equipment and workplace have been cleared of all products, documents and materials from previous packaging orders not required for the current order and that the equipment is clean and ready for operation.
Clearance: The process of completely isolating a given section of line or equipment from all other lines or equipment through tagged, and if possible locked, switching devices that provides a visual open. The use of proper grounding methods and work procedures is required when working on de-energized equipment.