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Humidity is a natural phenomenon, but for many industrial human activities, it can be a serious impediment to both progress, safety, and quality. This is especially true in the pharmaceutical industry. Humidity can have serious effects on life-saving medication in storage or in transit, and maintaining the efficacy and potency of medication is paramount. Humidity can cause revenue losses, and more importantly can result in ineffective medications taken by, or administered to patients.
It is safe to say that climate control in the pharmaceutical industry is pivotal. Humidity control not only lowers costs, but it increases revenue without needing to sacrifice quality in an industry where quality has the potential to be the difference between life and death. The WHO (World Health Organization) has implemented strict regulations to guard public safety. Their recommendations deem that levels of relative humidity must be right around 50%. Anything that exceeds or falls short of that mark can result in the detriment to a product’s efficacy, as well as its shelf life, visual appearance, and yield.
Humidity can directly impact medicine quality by causing melting, dilution, deformation, deliquescent, hydrolysis, agglomeration, and weathering. It can also have indirect effects on the medicines as it promotes mildew and mold growth, discoloration, oxidation, volatilization, sublimation, oil flooding or separation, burning, taste change, embitterment, dissolution, and attracts insects and pests.
To prevent these issues, storage spaces and warehouses for pharmaceuticals should always take the appropriate measures to regulate humidity and temperature according to the specific requirements of the drugs they stock to maintain maximum quality.
Some products cannot be manufactured in less-than-ideal conditions when it relates to humidity. For example, enzyme-based diagnostics are particularly susceptible to changes in humidity and higher than 10% changes in levels of relative humidity. Seasonally speaking, summer conditions are not ideal for drug manufacturing due to high levels of airborne moisture.
Humidity in a production lab can typically be remedied by refrigeration-based air systems, operated by either direct expansion systems or chilled water. However, there is an inherent risk of having the dew point approaching 0 degrees, causing cooling coils to freeze. Sometimes such conditions become necessary to achieve the required level of humidity needed for effective humidity control in a production area.
One of the biggest effects on relative humidity levels and their potential drop to under 45% is static build-up. Static is a lot more prominent in areas where humidity is too low. Static charge accumulation can affect the behavior of any solvents used in the production of medications by drying them out.
When drugs dry out, they can either stick together, crumble, or dry to a point that pressing and packaging them becomes a serious issue. This is not only wasteful, but can prevent the production facility from meeting production requirements in terms of volume, quality, and timeliness.
When humidity is too high, the moisture in the air is absorbed by the products. Not only can this lead to a degradation of the drug’s potency, but it may also lead to increased levels of toxicity. Additionally, high humidity (especially reaching 60 percent or more) promotes an environment where bacteria, viruses, mold, mites, and fungi thrive. In this respect, high humidity is even more destructive than when it is too low.
On the production end, extra moisture can cause drugs to crumble or to stick to one another. This may not only impede proper packaging, but it can clog up the production apparatuses, halting the machinery’s functionality until the issue is cleaned or repaired. This will cause production delays by bringing operations to a halt until the situation is remedied.
In addition to the aforementioned concerns, there is no shortage of issues that can be caused by uncontrolled humidity. Humidity forces production equipment to work harder, which leads to higher energy consumption and higher production costs. Even the equipment used for testing medications can degrade when the humidity is out of control.
The pharmaceuticals themselves could react negatively to the humid air, generating a chemical reaction that could leak potentially hazardous fumes into the air and endanger equipment operators. Since many harmful fumes are odorless and otherwise undetectable by human senses, they may not realize that they are being affected until it is too late.
Humidity can also cause a buildup of ice and condensation. This can happen to the materials that the production equipment is made out of, as various materials react differently to humidity. This could cause the machine malfunction, or cause moisture to settle into the product. In storage, it can also warp the packaging, making it more difficult to sell once it goes on the market.
The WHO has very specific guidelines for the production and storage of medications in terms of the climate that they are produced and stored in. It is important for production facilities and storage warehouses to abide by the specific guidelines, as the long-term effects of drugs with hindered potency or heightened toxicity can be disastrous. Vaccines may have shorter life efficacy spans, and the effectiveness of life-saving medications may be limited. This could result in a tragic amount of preventable deaths or further illness. For these, and many other reasons, investing in the assurance of optimal climate and humidity control is paramount for companies operating in the pharmaceutical industry.
Fixed Install Dehumidifier