Do you know damaged medicines can make you sick before they make you any better? By damaged medicines, we not only mean the ones that have expired, but also those that go bad due to external environmental reasons, such as high humidity, oxygen and moisture. Mold monitoring and oxygen control in pharmaceutical packaging is very crucial, as it requires protection from a constant threat that's present in the environment.
In this blog, we will look at potential hazards in pharma packaging and their solutions.
Is the Pharmaceutical Industry Performing Poorly when it Comes to Packaging?
The pharmaceutical industry's performance in packaging is a mixed picture — it's strong in some areas but faces challenges in others. A study in the USA looked at 144 product recalls between 2004 and 2011, and about 72% of the recalls were due to microorganisms. These recalls involved non-sterile medicines, over-the-counter drugs, cosmetics, medical devices, and dietary supplements.
The cause of mold in pharma packaging is due to inadequate manufacturing practices and environmental exposure.
Why is Mold a Hidden Hazard in Pharma Packaging?
Starting from the beginning, once the medicines are manufactured, they have to travel a long journey to reach their user. Medicines go through pre-clinical and clinical trials, regulatory approval, storage, and transport before becoming accessible in the market.
The only thing that protects the precious medicines from external factors is their packaging. However, high humidity during these times promotes mold growth, and improper sealing or damaged packaging allows moisture to enter and create a cozy environment for the growth of mold.
The moisture present in the environment can easily come in contact with the medicines and impact their stability. Even the slightest amount of water can induce hydrolysis of drug molecules, leading to the loss of potency of medicines.
In case of tablet or powder form, after coming in contact with water, they can clump together, swell up or change their texture and color. And we all know how wet the atmosphere is, which is a favourable environment for the growth of mold. After any medicine that comes in contact with moisture loses its original form, texture and most importantly, its potency, which is harmful for its consumers, leading to less effective treatment for health-related issues.
Why is Oxygen a Hidden Hazard in Pharma Packaging?
Just like moisture, oxygen in pharmaceutical product packaging is equally responsible for damage, as it triggers chemical and physical changes like oxidation. When oxygen reacts with APIs such as vitamins, biologics, and antibiotics, it leads to degradation.
The therapeutic effects of these medicines are reduced, and in the worst case, they form toxic byproducts. Plus, the presence of oxygen and moisture gives birth to mold that contaminates medicines. Many industries trust oxygen absorbers for pharma to deal with the following issues.
How to Tell If Your Medicine Is Still Safe and Effective?
Is there any way you can tell that your medicine has gone bad? The short answer is yes, you can look out for visible signs of damage due to moisture. Here is an easy guide to tell if your meds have gone bad -
1. Liquid medicines - When the liquid medicine turns bad, it changes its color, the liquid gets thicker, and you can also look out for cloudiness.
2. pills - When pills come in contact with moisture, their color can change, and their structure can appear chipped or cracked; in the worst case, they can crumble.
P.S. Medicines that have gone bad due to moisture develop a foul odor so you can look out for that as well.
The Best Protectors in Pharmaceutical Packaging
To keep medicines fresh, safe and potent, it is very important to use smart packing solutions that will maintain the integrity of drugs from external factors. There are many solutions out there, but the most effective and trusted one is oxygen scavengers, also known as pharma oxygen absorbers.
The(O2 absorber packets/ oxygen packets) are kept inside the medicine packages; their major job is to remove oxygen from the atmosphere inside the package. Oxygen can react with APIs and lead to degradation; the presence of oxygen also supports the growth of microbes, all of which lead to reduced potency, alter therapeutic effects, or form toxic byproducts.
The advanced packaging solutions reduce oxygen levels to below 0.01% in sealed containers, creating an anaerobic environment. By depriving mold of this essential element, oxygen absorbers effectively inhibit its development, preventing spoilage and contamination.
The pharma industry also uses desiccants such as silica gel for moisture protection in pharmaceutical packaging. Silica gel packets keep the atmosphere inside the medicine bottle/box dry by removing moisture and preventing water damage.
Oxygen absorbers in pharmaceutical packaging help prevent the oxidative degradation of drugs, which can lead to reduced potency, color changes, and other undesirable effects. Increase self lfe of the product.
In simple terms, mold needs both moisture and oxygen to grow. That’s why medicine packages often use both silica gel (to control moisture) and oxygen absorber packets (to remove oxygen). This teamwork keeps your medicines fresh, safe, and effective until the day you use them.
