Line Clearance in Manufacturing

Line clearance is a standardized procedure in manufacturing for ensuring equipment and work areas are free of products, documents, and materials from a previous process. Line clearance procedures help operators prepare for the next scheduled process and avoid mislabeling or cross-contamination of finished products. Line clearance is most commonly used in regulated industries, such as pharmaceuticals, medical device, and food and beverage manufacturing.

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A typical line clearance procedure can be broken down into 3 parts:

1. Clearing - The physical removal of any materials from the previous process that are not necessary for the next process, such as unused parts, labels, or packaging.

2. Cleaning - The disinfection and drying of all surfaces and equipment. The depth of cleaning depends on whether the line clearance is taking place between batches of the same product or a product changeover.

3. Checking - A supervisor/quality manager is notified to inspect the line thoroughly before the next scheduled process can begin. This step can also include recalibrating scales and checking the temperature and humidity of the work area. The date and time of line clearance completion is documented.

The line clearance procedure often involves a checklist specific to an organization’s process that is signed by the operator and supervisor/quality manager.

Line clearance is not only important for maintaining safety, quality, and efficiency, but it is a requirement of Good Manufacturing Practices within the pharmaceutical industry.

The FDA Code of Federal Regulations Title 21 states:

“Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:

1. Assignment of responsibility for cleaning and maintaining equipment;
2. Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;
3. A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;
4. Removal or obliteration of previous batch identification;
5. Protection of clean equipment from contamination prior to use;
6. Inspection of equipment for cleanliness immediately before use.
7. Records shall be kept of maintenance, cleaning, sanitizing, and inspection”

Manufacturers that fail to perform and document line clearance procedures can be subject to regulatory action.

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Using a paper checklist to perform and document line clearance can be time-consuming and prone to human error. According to a CXV Global survey of 30 pharmaceutical professionals, 100% of respondents experienced a line clearance error in the last 12 months and 96% said that their current line clearance process is in excess of 60 minutes.

Tulip apps can guide end users through workflows to ensure that necessary steps and checks are completed, tracking progress and recording line clearance completion in real-time. The app can be integrated with an ERP system and configured to fit the steps of your line clearance process without writing a single line of code.

Interfaces can be deployed directly into a process on mobile tablets, PCs, and Edge Devices. If using both hands is required, operators can use Tulip apps on hands-free wearables. Wearable headsets can be controlled with voice dictation, and provide real-time data and work instructions at a glance.