We’ve all taken medicines at some point in our lives. And, considering how important meds are, you can imagine that you don’t want to take something that’s subpar or of low quality.
Today, pharmaceutical companies and drug manufacturers do a great deal of work and spend a lot of money to ensure that their products are of the highest standards for quality. But, as you can imagine, things don’t always go their way. Over the years, there have been different types of contamination befalling pharmaceuticals, all affecting the quality of care that people can access.
In this article, we’ll look at some of the most notable pharmaceutical contamination types, as well as how to prevent physical contamination if you’re going into drug making.
What Is Pharmaceutical Contamination?
The pharmaceutical industry is one that relies heavily on care and a requirement to follow some really strict laws. If you think about it, this is quite understandable – the products being made here will end up being ingested by people, and the last thing anyone wants is to end up taking defective products.
To that end, pharma companies and drug manufacturers spend a lot of resources looking to combat pharmaceutical contamination. In a nutshell, this phenomenon refers to the presence of foreign substances or impurities in drugs and other pharmaceutical products. As you would imagine, the consequence of contamination is that the medicines become incredibly unhealthy, and their safety gets compromised.
According to reports, contamination costs pharmaceutical companies hundreds of millions of dollars – and, this was back in 2018. With the global pandemic and other diseases expanding the need for pharmaceuticals, you can only imagine how much more this issue has continued to cost companies. Just as well, this number gives you a picture of just how important it is for companies to ask, “How can you prevent pharmaceutical contamination?”
Besides the compromise of drug safety, pharmaceutical contamination also has some serious effects for the people who work with the drugs and the environment in general. This is why pharma companies need to follow some really strict rules that govern their processes and operations.
Types and Causes of Contamination
As you would imagine, there’s not a single definition of pharmaceutical contamination. Sure, it refers to the phenomenon where drugs and other pharmaceutical products come in contact with impurities. But, considering that there are different types of impurities and different ways through which they can actually get in contact with these products, it is important to understand the types of contamination that can arise here.
Fro, capsules to traditional pills and synthetic variations, here are a few types of contaminants that you need to be wary of:
Chemical Contamination
To put it simply, these are contaminants of a chemical nature. This form of contamination is seen by many as the most dangerous of the bunch, mostly because it essentially involves chemicals that we might not necessarily see.
However, chemical contamination itself can be broken down into two major aspects:
Raw Materials
Every drug is made of different components or raw materials. And, many of these raw materials tend to contain impurities. From sourcing to their very nature and much more, drug manufacturers need to account for these impurities as part of their processes and ensure that they have channels to get rid of them.
Purification can help, but it is also important to ensure that ingredients and raw materials are sourced properly.
Cross-Contamination
When drugs are being manufactured, the process itself involves several steps. And, there is always the potential for cross-contamination as part of any of these steps.
Whether it is improper cleaning of manufacturing equipment or the wrong methods of separating raw materials, different chemicals can be introduced to these drugs, essentially reducing their potency and even making them dangerous for consumption.
Microbiological Contamination
The next form of contamination is microbiological. Although it might not necessarily be among the most popular forms, it remains a dangerous form of contamination nonetheless.
So, what are the types of contaminants that fall into this category?
Airborne Organisms
The air we breathe in itself is impure. And, there are so many types of contaminants that could easily travel through it and into pharmaceutical products. We’re talking contaminants like fungi, bacteria, and more. And because it’s impossible to see these organisms, they are especially dangerous.
Many of these contaminants easily find their way into the production areas, and once they do, they can have different effects on the quality of the medicines.
Poor Hygiene
These same contaminants can also be passed by people. When the professionals working at the drug manufacturing and treatment facilities don’t exhibit proper hygiene, contamination is a given.
As far as microbial contamination in pharmaceutical industry plants is concerned, this is easily one of the major sources. And, it is also one of the easiest to address.
Contaminated Water
The next major source of microbial contamination in pharmaceutical industry locations is bad water. At the end of the day, every drug available today is made with a percentage of water intake. If this water contains harmful microorganisms and isn’t properly treated, then contamination is assured.
Physical Contamination
The final type of contamination is the physical kind. Here, we’re talking about materials that physically get into the pharmaceutical products, directly affecting their potency.
Particle Contamination:
Basically, this form of contamination describes the presence of harmful particles in medicine and other pharmaceutical products. These particles can come from anywhere – packaging materials, tools used to make the drugs and much more.
Foreign Matter Entrance:
In some cases, you can also see the introduction of foreign matter in pharmaceutical products. For these types of contamination, you have materials like plastic, metal, glass, and other particles that could easily enter into the product and affect it.
The Notable Effects Of Pharmaceutical Contamination
So, we understand the question, “What are the types of contaminants in the pharmaceutical industry?” Now, let’s look at what these contaminants can cause and why you need to really be concerned about them if you’re making a pharmaceutical product:
Risks To Everyone’s Health
Of course, the overarching theme when it comes to contaminants is the fact that they can be dangerous to the health of anyone who takes them. Here’s a simple breakdown:
- Chemical impurities or contaminants in drugs can cause some adverse reactions such as toxicity.
- Microbial reactions can also cause effects as many of these microbes react with the human body
- As for physical contaminants, they generally cause discomfort – especially for people who already don’t feel comfortable with medicine.
All of these effects can vary in their degree of severity. And, these degrees will vary based on the nature of the contaminant in question. But, what no one can dispute is the fact that they are very challenging for sure.
A Drop In Efficiency
In many cases, you’ll find that the efficiency of a drug is only enhanced when it is pure and without any impurities. So, if these impurities abound, you’re sure to notice a drop in the efficiency of the product.
On the side of the customers, this just means that whatever health and wellness goals they have will not be achieved. But, for the product manufacturers, it can be a reputational disaster.
Worse Infections
Imagine taking a drug hoping it’ll solve a disease, only to end up with yet another. This is what microbial contaminants can cause. These contaminants themselves can easily cause significant illnesses in patients who consume them, thus compounding the issues that the patients would now have to deal with.
The Presence Of Allergies
Just about everyone has allergies already. But, many of these contaminants that can enter into drugs can cause even worse allergies.
These reactions can range from mild skin infections to respiratory challenges that threaten the lives of the patients. And, as you can imagine, all of these would only compound patients’ woes.
Lengthy Health Consequences
This depends on the nature of the contaminant itself, but there is a possibility of developing some serious long-term health consequences due to contamination.
Things tend to get worse when the person takes the contaminated drugs time and again. They could exacerbate a pre-existing problem, or even develop new ones.
Your Reputation Takes A Hit
Of course, there is the fact that any publicity that comes from these contaminants will hurt your company and your brand deeply.
They say that no publicity is bad publicity, but this is one form of publicity you don’t want to have. As a pharma company, you could lose a lot of credibility when your product has contaminants. And, while you can take steps to remediate this issue, the stigma of this contamination will continue to follow your brand.
Problems With The Law
For drug manufacturers, the effects of contaminants go beyond just the fact that you end up suffering a major reputational hit. There are also the lawsuits you could face, as well as regulatory scrutiny. When you eventually have to settle in court, you’d probably end up paying a hefty fine if you’re lucky.
Beyond that, many drug manufacturers have had to recall their products when they noticed that they had contaminants. These recalls themselves lead to more money being spent for logistics, as well as remediating the issues that have been caused by the contamination.
How To Mitigate & Prevent Pharmaceutical Contamination
So, we can clearly see the different types of contaminants and how badly they can affect both consumers and producers of pharmaceutical products. The next question now is –how can you prevent physical contamination and ensure that your products are safe overall?
Here are a few strategies that can help ensure that your pharmaceutical products are in the clear:
Embrace Good Manufacturing Practices
They’re called GMPs for short, but Good Manufacturing Practices will go a long way in ensuring that your products are in the clear.
These practices clearly state the principles and operations you need to ensure to see to it that your pharmaceutical products are consistent and controlled to meet all quality standards. They cover everything, from equipment maintenance to activities around facilities and even personal hygiene.
Never Make Drugs Without Testing
Look through any drug that is made today, and you’ll see that one of the most important parts of its manufacturing process has been quality control and testing.
As a drug manufacturer, it is impossible to overstate the importance of this. At every stage of the manufacturing process, you know what you’re hoping to achieve. So, ensure that you have strong quality control steps in place to check your achieved output against the required one. If you need to make any tweaks, then make them,
Be Deliberate About Your Raw Materials
When asking, “How can you prevent physical contamination?,” this is one of the most important things you want to keep in mind. Before you even begin with the production process, you want to make sure that you have sourced your raw materials properly.
Two things need to be in top shape here:
- The source of the raw material
- The partners you engage to get the raw materials
Ensure that both are good, and you shouldn’t have any problems whatsoever.
Maintain Your Equipment
At the end of the day, you can’t produce your drugs on your own. You need tools to help you out, and those tools will need to be properly maintained.
From cleaning to physical maintenance, ensure that this equipment is in top shape before you start with product development. At every point, check them and make sure that they are ready to handle capsule or pill manufacturing.
Control Your Surroundings
As we’ve stated already, there are several types of contaminants that can come from the immediate environment when you’re making pills.
It doesn’t matter if you’re making CBD gummies or drugs that can treat malaria. At the end of the day, you want to make sure that the environment in which these products are being made is optimized. Ensure that factors like temperature and humidity are controlled, and make sure that there are no sources that could release physical contaminants too.
Train Your Workers
For large-scale drug makers, it is important to ensure that everyone involved in the manufacturing process is properly trained. Ensure that they can handle the equipment well, and see to it that they follow hygiene protocols when working.
At the end of the day, it probably won’t be possible to police every part of the drug manufacturing process. But, by ensuring that the people working in your plant are reliable, you can go a long way in ensuring safety.
Watch Your Storage Regimen
After drugs are made, they need to be stored – especially if they won’t be shipped out to retailers or users immediately. To that end, make sure that your storage and packaging procedures are tight and foolproof.
After ensuring proper protocols during drug manufacturing, the last thing you want is for the packaging to be done wrongly.
Follow The Laws
One of the best parts of being a drug manufacturer is that there are already laws that help you to define success and protocols to be followed. Determine these laws, and find out what they require. Then, follow them.
At the end of the day, you would be required to show that your products follow these guidelines when presenting them to the market. So, you might as well ensure compliance now.
Conclusion
Being a drug manufacturer means having to worry about a lot of things. And, contaminants are definitely among those. With the guidelines we provide at Sainty Tec, you can rest assured that your products will be top-notch.
Frequently Asked Questions
Why is it that contaminants affect the safety of pharmaceutical products?
To understand this, consider the fact that pharmaceutical products go through rigorous processes to be formulated. There’s a balance to be strict when it comes to ingredients, and the presence of any impurity will easily throw that balance out of whack.
I think I’m dealing with a contamination problem. What do I do?
The moment you think your drug is being contaminated, immediately shut down the production process and try to remediate the issue. This way, you can make changes where necessary and ensure that no further fallout comes from this issue.
How do I test for and identify pharmaceutical contaminants?
Generally, you have different methods available to you. From quality control tests to environmental monitoring and raw material validation, you have different steps to go through to ensure that your drug is completely free of contaminants.
We would recommend that you engage these methods extensively going forward.