Criteria for Choosing the Right Inspection System for Pharmaceutical Packagings

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DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Types of Inspection Systems for the Pharmaceutical Industry

“Zero defects one hundred per cent of the time will cost you an infinite amount of money,” noted Lynn Torbeck, a consultant who specializes in cGMP statistics and their applications in the pharmaceutical industry.

Although no single inspection system is capable of achieving zero defects all the time, some will get closer to that ideal than others. Furthermore, the commercial viability of various inspection systems differs dramatically, and these production and business considerations must also play a role in determining the ideal quality assurance programme for any given situation.

It is important that every tablet manufacturer, packager and brand owner considers the benefits and limitations of each inspection practice, and selects the ideal programme given their situation and objectives, and implements the programme to its fullest capability. Nothing less will serve to protect consumers and limit liability exposure.

No In-Line Inspection

Few tablet manufacturers and packers rely solely on sampling to assure final product quality – such a programme puts the company at risk. Not only are they assuming the greatest risk that a critical defect such as a foreign tablet or foreign matter makes its way into packaged product, but also they are fully exposed to a liability lawsuit and/or regulatory ramifications – if (even by chance) such an incident occurs.

Although, this approach is cost effective in the short run, with no capital costs associated with automated processes or labour costs associated with 100 per cent inspection, the long term costs can be significant. They are exposed to the most severe regulatory actions and the largest legal settlements – should a problem arise.

Manual Inspection of for Pharmaceutical Packagings

Currently, the most common type of inspection in use on tablet manufacturing and packaging lines is manual inspection. The primary advantages of manual inspection are low capital costs and a strong basis for claiming diligence – if the company is confronted with a liability situation.

The disadvantages of manual inspection include high labour costs, and most importantly, the fact that people are notoriously poor at inspection, especially over a time as diligence decays.

Also, yield can suffer dramatically because manual inspectors often feel that their job is to pull product off the line and they won’t succeed until their buckets are full. Lastly, adding people to the process can actually increase the incidence of foreign matter and the risk of contamination – through both unintentional mistakes and malicious acts. A variety of mechanical systems, like inline conveyors and rotary tables are available to assist manual inspection. Although, these are designed to facilitate the inspection process, the benefits and drawbacks of manual inspection remain unchanged regardless of the technology that assists the operation.

Mechanical Sorting

Mechanically sorting tablets on manufacturing and packaging lines can be very effective in removing broken tablets as well as dust and coating flakes. But they cannot detect and remove foreign tablets that are of the same size and shape as good products. They also cannot detect and remove foreign tablets based on colour differences, and even their ability to remove a product of a different size is limited to the minimum axis.

A common type of mechanical sorting system in use in the pharmaceutical industry today is the diverging roller sorter. In addition to its limitation in removing foreigners described above, its other disadvantage is its mechanical complexity.

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