The Importance of Sterility in Pharmaceutical Businesses and Its Impact on Public Health

In the world of pharmaceuticals, ensuring the safety and efficacy of products is of paramount importance. One crucial factor is to ensure sterility is maintained throughout the manufacturing and packaging procedures to prevent contamination. 

With the U.S. pharmaceutical industry set to reach a staggering $685.45 billion by 2023, there is more pressure than ever for pharmaceutical businesses to prioritize safety and quality. However, with such rapid expansion, it is crucial that pharmaceutical businesses remain focused on maintaining the safety and efficacy of their products.

In this blog, we will explore the importance of sterility in pharmaceutical businesses and its impact on public health.  

The Risks of Contamination in Pharmaceutical Manufacturing

Contamination is a significant risk in pharmaceutical manufacturing and can have severe consequences for public health. Even tiny particles or microorganisms can compromise the safety and effectiveness of a drug.

Contamination can occur at various stages of the manufacturing and packaging process, including during the handling of raw materials, the formulation and mixing of the drug, and the final packaging and labeling. A range of factors, including equipment failure, human error, or inadequate cleaning and sterilization practices can cause it.

The consequences of contamination can be particularly severe in the case of sterile drugs, which are intended to be free of any microorganisms or particles. Contamination of these drugs can lead to serious infections or other adverse reactions, especially in patients with weakened immune systems.

According to a recent report from the Journal of the American Pharmacists Association, there were over 12,000 drug product recalls in the US between 2012 and 2021. The majority of these recalls were due to issues with sterility, which was the main reason for recalls among compounders. For manufacturers, product quality was the most frequent reason for recalls. 

In order to mitigate the risk of contamination, pharmaceutical businesses must prioritize sterility throughout the manufacturing and packaging process. This includes implementing strict cleaning and sterilization protocols, investing in high-quality equipment, and adhering to regulatory standards for sterility. 

The Role of Sterility in Ensuring Drug Safety and Efficacy

Sterility plays a vital role in ensuring drug safety and efficacy. Contamination can compromise the quality of drugs and render them unsafe for use. Maintaining sterility throughout the drug manufacturing process is essential to produce high-quality pharmaceutical products. The process of sterilization involves the elimination of all viable and non-viable microorganisms. 

The pharmaceutical industry has strict guidelines and regulations regarding sterility assurance. Pharmaceutical companies must demonstrate that their manufacturing processes are capable of producing sterile products consistently. Any deviation from these guidelines can result in serious consequences for both the pharmaceutical company and the general public.

In the past few years, there have been various incidents where drug recalls, and shortages of products have occurred due to contamination issues. This has highlighted the importance of ensuring sterility in the drug manufacturing process. Thus, pharmaceutical companies must invest in advanced sterilization technologies and rigorous quality control measures to maintain the sterility of their products.

Pharmaceutical cleanrooms are an essential tool for maintaining sterility in the manufacturing environment. These facilities use specialized equipment and procedures to eliminate both viable and non-viable contamination. A laser particle counter for cleanrooms is used to determine the levels of non-living pollutants, while settling plates with culture media are used to gauge the levels of living pollutants.

Particle counters use laser technology to accurately count the number of particles in the air within a cleanroom. These counters enable cleanroom operators to take proactive measures to maintain a controlled environment by identifying and resolving potential sources of contamination.

Cleanrooms have different ISO specifications depending on the industry they serve. An example would be the ISO 5 classification, which is regarded as a super clean cleanroom classification. According to American Cleanroom Systems, this type of specification is used in industries such as pharmaceutical filling rooms where even the smallest particle can have a significant impact on the end product’s quality. 

To attain this criterion, a cleanroom must possess fewer than 3,520 particles larger than 0.5 microns for each cubic meter and experience 250-300 HEPA-filtered air exchanges within an hour. This classification is similar to the FED standard of class 100 or 100 particles per cubic foot. 

Regulatory Standards for Sterility in Pharmaceutical Businesses

Organizations such as the FDA, WHO, and EMA set regulatory standards for sterility in pharmaceutical businesses. These organizations provide guidelines for manufacturing, testing, and releasing sterile products to ensure their safety and efficacy. The standards cover various aspects, including facility design, equipment, personnel training, and monitoring.

One important aspect of regulatory standards for sterility is the validation of the sterilization process. The validation process ensures that the sterilization method used is effective in eliminating microorganisms and is suitable for the product being manufactured. 

Compliance with regulatory standards for sterility is essential for pharmaceutical businesses to ensure the safety and efficacy of their products. Not adhering to these rules can lead to product recalls and shortages and put the well-being of patients at risk.

In 2022, the FDA issued a warning to Sterling Pharmaceutical Services regarding violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals is a recent example of what happens when companies don’t comply with regulations. Sterility is an essential aspect of pharmaceutical manufacturing, and any violation of regulatory standards for sterility can compromise the safety and efficacy of the products.

The FDA discovered that the company’s practices, facilities, or systems for producing, handling, packaging, or storing did not comply with CGMP. The fact that the company’s products are ophthalmic and directed for use in young children makes the poor manufacturing practices particularly concerning as they could pose a significant risk to the health of the patients.

Therefore, compliance with regulatory standards for sterility is essential in the pharmaceutical industry to ensure the safety and efficacy of the products.

The Public Health Consequences of Poor Sterility Practices in Pharma

In the pharmaceutical sector, inadequate sterilization practices can result in severe public health implications. Contaminated products can cause infections and even death, especially in vulnerable populations such as children, the elderly, and immunocompromised individuals.

The impact of poor sterility practices can be far-reaching, affecting not only individuals but also healthcare systems and economies. The cost of treating infections caused by contaminated drugs can be high, and recalls or legal action can be damaging to a company’s reputation and financial stability.

Pharmaceutical businesses must adhere to strict sterility standards in all aspects of drug manufacturing, from raw materials to final packaging. This requires a commitment to quality assurance and quality control, as well as ongoing training and education for employees.

Ultimately, the public’s trust in the pharmaceutical industry depends on its ability to produce safe and effective drugs. By prioritizing sterility and investing in the necessary resources and expertise, pharmaceutical businesses can not only protect public health but also ensure the long-term success of their operations.

MarketsandMarkets has predicted that the revenue of the global sterility testing market will increase from $1.1 billion in 2023 to $1.9 billion in 2028, with a compound annual growth rate (CAGR) of 10.5% during the same period. This growth is indicative of the increasing importance of sterility practices in the pharmaceutical industry and the need for businesses to prioritize public health by ensuring that their products are free of contaminants.


The importance of sterility in pharmaceutical businesses cannot be overstated. Poor sterility practices can lead to serious public health consequences, such as infections and even death, and can also result in significant financial costs for companies.

It is, therefore, crucial for pharmaceutical businesses to prioritize sterility at every stage of drug manufacturing, from raw materials to final packaging. By doing so, they can ensure that their products are safe and effective, protect public health, and maintain the trust of consumers and healthcare systems alike.

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