In August 2010, the U.S. Food and Drug Administration warned drug manufacturer Hyaluron to clean up its act after finding contaminants in several products. December of the same year saw a recall of the famous antacid Rolaids due to contamination. In fact, the pharmaceutical industry news portal In Pharma found that the manufacturer of Rolaids, Johnson and Johnson had 15 recalls in 2010 alone. Many other companies were the subject of FDA recalls or warnings due to contamination. However, the problem was not detectable to the human eye. The drugs looked the same as they always have. The contamination problem was actually in the particles that made up the drugs.
Particle Contamination
Outside of the pharmaceutical industry, particle contamination doesn’t seem like a major problem. This is especially true in comparison with the meat packing industry that is fraught with visible contamination issues. However, particles in drug formulas can cause chemical reactions to occur or not occur, changing the makeup of the drug. The precise chemical formula used to manufacture the drug was tested and approved because it was safe for human use. The addition of other chemical particles—even an abundance of one of the drug’s ingredients—can change the formula, causing many effects on the human body.
For these reasons, a large part of pharmaceutical manufacturing is particle management. The system uses filtration, particle counts and more to ensure that the drug manufacturer matches the tested and approved formula. This isn’t always possible.
Sources
Particle contamination in drug manufacturing comes from two types of sources, the intrinsic sources and the extrinsic source. An abundance of particles from one or more of the ingredients in the drug formula is an example of an intrinsic source. It means a contaminant from the chemicals normally used to create the drug. Intrinsic sources for contamination come from ineffective filtration.
Extrinsic sources are introduced from outside the drug formula. They come from the air inside the plant, cleaning solutions, metal particles from the machine’s operations, dust, mold and more. This type of contamination comes from ineffective filtration as well. They are also introduced by leaks in the sterile environment in which the drug is produced—broken seals, open seams, breaks, etc. Both types of contamination can lead to a complete plant shutdown once detected through the inspection portion of the manufacturing process or by an FDA inspection.
Prevention
Preventive maintenance is one way that drug companies can infiltrate the particle contaminants before they make it to the batch of product. Concentration on inspecting the machinery for leaks is important, as is ensuring that all systems are properly calibrated. Vigilant testing schedules will also catch the problematic batch before it is distributed. Pharmaceutical Formulation Quality, a pharmaceutical industry trade publication, suggests making as much of the process automated as possible to eliminate human error and also points in the production process where environmental contaminants can be introduced.
The FDA does periodic inspections on all drug manufacturing plants to ensure that the particles within the drugs are supposed to be there and in appropriate amounts. As small as the particles may be, they can lead to large financial problems like recalls, production shutdown and product liability lawsuits.
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