You believe your pharmaceutical facility is taking every precaution to prevent contamination, but then you discover that there are unidentified spots on a batch of tablets or particles floating in a liquid medication. What’s going on? That question may be difficult or even impossible to answer just from looking at your pharmaceutical product. There are many potential sources of contamination, and the contaminant could fall into any of the following three categories:
- Physical contamination—includes fibers or particles, such as dust, that may have contaminated the product during the manufacturing or packaging process.
- Chemical contamination—includes exposure to molecules, vapors, gases, and moisture.
- Biological contamination—includes bacteria, viruses, and fungi, usually introduced by manufacturing personnel.
Some of the most common sources of pharmaceutical contamination are raw materials, equipment, personnel, and the manufacturing facility itself. We’ll take a closer look at each of those categories.
The materials used to manufacture pharmaceutical products can become contaminated due to environmental factors or human error. For example, the materials could be mislabeled or mixed up, leading to the introduction of the wrong ingredient to the manufacturing process. Temperature variations or high humidity at a storage facility could cause the materials to degrade. Water, which is one of the biggest sources of cross-contamination in pharmaceutical manufacturing, could be improperly filtered and the product could be exposed to a pathogen like salmonella or e. Coli.
Equipment can become a vector for contaminants if it is improperly sanitized between uses or if it’s designed in a way that makes it difficult to thoroughly clean or perform routine maintenance. A defective piece of equipment could also be to blame for the contamination. For example, an air filter with pinhole leaks could allow particles to pass through and reach pharmaceutical ingredients.
If manufacturing personnel are improperly trained, disregard facility rules, or make errors due to fatigue or any other reason, they can introduce contaminants to your pharmaceutical products. Personnel can carry microbiological contaminants or act as a vector for other contaminants. As a somewhat broad example, a manufacturing employee could touch an unclean piece of equipment with their bare hands and then touch the packaging material for a pharmaceutical product.
In some cases, the design of a pharmaceutical manufacturing facility may increase the risk of contamination. For instance, if a facility manufactures more than one product and uses some of the same equipment for multiple products, there could be cross-contamination. A facility that is small or poorly organized might also experience mix-ups or cross-contamination between raw materials and finished products.
Failure to properly maintain a facility also increases the chances of contamination. Airborne contaminants could affect a pharmaceutical product if the facility’s air filters or HVAC system aren’t functioning properly. If the facility isn’t temperature-controlled, high heat could lead to contamination (e.g., the heat might cause chemicals from packaging material to leach into a liquid medication). And, of course, if a facility isn’t routinely cleaned and sanitized, the risk of contamination is great.
Identifying Contaminants in Your Products
If you know that your pharmaceutical product has been contaminated but don’t know the source, Avomeen can perform a contamination analysis. We’ll test your product in our GMP-compliant lab and generate a report with all the contaminants we identify. We’ll also work with you to identify the contamination source and come up with a solution so that you can reduce the likelihood of future contamination.