As anyone in the pharma industry can attest, since about 2000, the number of FDA inspections has increased. The agency has more inspectors on the street and is issuing more warning letters. Between 2007 and 2013 alone, the number of FDA warning letters skyrocketed 78%, with biotech and pharma companies receiving a large portion of them.
This tight regulatory environment has put significant additional pressure on pharma companies to examine all aspects of their business. This includes R&D and packaging, all the way down to getting the products into the hands of end users.
Of course, that’s a good thing. The FDA’s primary concern is ensuring companies follow Current Good Manufacturing Practices (CGMPs) to ensure that their products are safe, pure, and effective.
There are many potential sources of contamination. A major one is cross-contamination, which is frequently caused by dust. Just imagine how easy it would be, in an environment without proper dust containment, for employees to unintentionally carry a drug from Suite A to Suite B on their clothing.
Here, we look at how cross-contamination prevents pharmaceutical manufacturers from achieving safe, pure, and effective products.
Cross-contamination and safety
Cross-contamination poses a threat to the safety of both the people who will eventually take the drug and the employees who make it. Over the past 5 to 7 years, we’ve seen a rise in the toxicity levels of pharmaceutical ingredients. This is driven in part by growing demand for new advancements in medicine to combat diseases like Alzheimer’s disease and new forms of cancer.
The side effects of these highly toxic ingredients can be serious, there is the potential for drug interaction, and they may cause severe adverse effects in certain populations. That’s why no one should even be exposed to them if not under a doctor’s care.
Cross-contamination and purity
The relationship between these two factors is clear: contaminated is the opposite of pure. And an impure drug will likely also be unsafe and/or ineffective.
Cross-contamination and effectiveness
Finally, beyond having an unintended effect, a cross-contaminated drug may not have its desired effect.
This means the people taking the medication won’t receive the treatment that they need. If you’re lucky, ineffective medications are merely harmless to the people who take them. But, even so, they can result in a recall.
Earlier this year, a couple sued a company over ineffective fertility medication. And this study found that ineffective antimalarial, AIDS, and other drugs are at the root of a public health crisis in undeveloped countries.
How to prevent dust cross-contamination
According to cGMPs, if a company discovers that a drug is contaminated, they must not distribute the product. They must also correct the problem that resulted in the contamination. If the contamination isn’t discovered until after the drug has been distributed, the company should issue a recall, which can have disastrous consequences, both financially and in terms of PR.
Gerard Geiger, Nilfisk’s Business Development Manager for the Pharmaceutical industry, suggests a two-pronged approach to prevent dust cross-contamination.
- First, identify the source of the contamination. The best way to prevent cross-contamination is to capture the dust as quickly as possible.
- Second, implement process controls. These may include equipment modifications, engineered control systems, or even building controls into the facility design.
One example of a process control appropriate for a highly toxic environment is a bag-in/bag-out dust containment system with multistage filtration. For example, a system with a cyclonic filter that feeds into a HEPA filter. This type of system can safely collect toxic material into a disposable bag that an operator can easily discard without being exposed.
Another option is to encompass equipment in a dust shroud or some other external covering to keep the dust contained. Yet another is to control the airflow into and out of rooms via positive or negative pressure.
If you’re concerned about cross-contamination, contact us. We can help you select the best solution for your application.