A Complete Packaging Line

A packaging line is just like a chain and a very busy place, with many machines doing many different things. The design and layout of equipment has major impact on the efficiency of the packaging line. Well designed equipment will lend itself to efficient production of a consistent standard, whereas older equipment can often be inflexible and may have elements of poor design such as areas where packaging components or product may be trapped. These traps" can result in products being incorrectly packed, e.g. A carton containing the wrong leaflet or product from a different batch.

This represents a significant risk to the patient and is one of the major reasons for product recall in the industry. The greater the number of stages there are in a packaging line, the lower its efficiency will be. With modern order patterns of short runs it may for example be better to have two slow speed fillers feeding a single cartonner rather than a single high-speed filler.

Appropriate validation of the packaging lines will challenge the robustness of the packaging operation establishing the conditions under which efficiency maximized.

Design considerations for a line layout should include the ability to manage quick change-over, perform line clearance between batches of product and clean the line in an easy and controlled manner. The majority of problems on packaging lines are related in some way to poor line clearance; it is therefore important to design these problems out. A typical packing line will consist of several feeders for packaging components and product. Devices will normally be located in critical positions on the line to detect presence or otherwise of the materials.

For example, a device installed on the carton feeder will ensure that a carton is supplied for each product or tray of product and a barcode reader will verify that it is the correct one. A checkweigher will make certain that underfilled or overfilled bottles are identified and ensures via the reject device that they are excluded from the batch. The layout of the equipment should guarantee that easy access is provided for operators and the engineers to access this equipment when adjustments and or maintenance are required.

Any validation exercise must start with a detailed Validation Master Plan (VMP). A VMP will normally include the company validation policy, explaining how the company will manage the validation exercise and details of the organizational structure relevant to the validation activities. The VMP should also include a summary of the facilities, systems, equipment and processes which are to be validated and indicate the format which is to be used for documentation. All critical equipment and systems must be identified and listed in the VMP, including a list of critical devices and/or details of the operating system and the software used.

A high level plan of activities should be developed and broken down into stages within a schedule. Any validation activity is only as good as the change control process used; the VMP should include details of how any changes will be managed. Finally, a list of references to any other relevant documentation should be included.