7 Reasons for Sterility Assurance in the Pharmaceutical Industry

Sterility is a major concern across several industries. Prime examples of such industries include:

• Healthcare
• Pharmacy
• Food & Beverage
• Cosmetics & Personalized Care
• Biotechnology & Life Sciences
• Agriculture
• Space Exploration

These and many more require sterility assurance of the highest order. However, it is more of a concern in certain industries. To this end, much is tied to the state of sterility assurance in the pharmaceutical industry.

This is why innovation and improvements in sterilization procedures have happened. Products like ethylene oxide sterilizers are a huge testament to this fact. This article discusses why sterility assurance needs to be paid serious attention in the pharmaceutical industry. So, keep reading to stay informed.

How the Pharmaceutical Industry Benefits from Sterility Assurance

A lot can go wrong when sterility is compromised in the pharmaceutical industry. History has repeatedly proven this and the lessons are usually costly. This is to say that sterility assurance is in the best interest of the industry and its consumers. Some of the reasons for this include the following:

1. Safety of Patients

The pharmaceutical industry is responsible for providing the healthcare industry and even the general public with products that help improve people’s health state. So, it is a sharp contrast when the reverse is the case.

Well, this is a huge possibility if/when products are manufactured and/or even packaged under contaminated conditions. This is even more of a concern with sterile products as they can be easily contaminated. Examples of such products include:

• Ophthalmic Solutions – Such as Eye ointments and eye drops
• Injections
• Intravenous Fluids
• Parenteral Nutrition
• Implants – Such as artificial joints, dental implants, and pacemakers
• Catheters – Such as central venous, peripheral intravenous, and urinary catheters
• Bandages & Dressings
• Vaccines
• Blood Products
• Sterile Water
• Irrigation Solutions

Frankly, there are a lot more examples that only prove how much patients are affected by sterility standards in the pharmaceutical industry. This is because the sale and use of contaminated products can result in a wide range of health challenges for patients and the general public.

Some of these issues can even be life-threatening. This is especially true when immunocompromised patients and/or other vulnerable people are involved.

2. Regulatory Compliance

Some standards dictate the operations of pharmaceutical companies. Some of these standards are focused on sterility procedures.

The EMA (European Medicines Agency) and FDA (Food & Drug Administration) are prime examples of health regulatory authorities that have and enforce such non-negotiable standards. For example, the EMA has clear guidelines for when and how a wide range of sterilization methods should be used. By the way, some of the sterilization methods include:

• Gas Sterilization
• Sterile Filtration
• Ionizing Radiation
• Dry Heat Sterilization
• Steam Sterilization

You should also know that most of these companies are bound by standards based on their location. Against this backdrop, the EMA is a European health body; so its standards are mostly binding on companies within its jurisdiction.

The FDA on the other hand acts in the same capacity in the United States. If you would like to find out about its guidelines for pharmaceutical companies in this regard, you can read: https://www.fda.gov/.

Whether it is with the EMA, FDA, or any other pertinent health regulatory body in other locations, there are penalties for violating sterility assurance guidelines. As a result, adhering to these guidelines and generally ensuring that sterility assurance is guaranteed is in the best interest of these companies.

3. Product Integrity

The US pharmaceutical market is intensely competitive. This is also the reality in many other locations, even if the competition is not as intense as it is in the United States. Speaking of how competitive the market scene is in the US, the market was valued at well over 570 billion dollars as of the year 2023.

So, it is only understandable that many players want a large piece of what this market offers. The whole point is that companies in this industry need to play safe. Failure to do this usually means that consumers will look elsewhere, with several alternatives available.

Against this backdrop, product integrity is very important, amongst other things. For example, situations such as product recall on account of contaminated products do so much damage to a pharmaceutical company’s reputation. It can lead to significantly reduced patronage, which in turn affects the amount of generated revenue.

Furthermore, the need for sterility assurance is not just about the safety of pharmaceutical products. It is also about their efficiency. This is because product degradation can happen when harmful microorganisms are not gotten rid of during the manufacturing or even packaging process.

Alterations in the chemical and physical properties are usually the reason for this. As expected, consumers are likely to steer clear of impotent products. Overall, ensuring maximum sterility boosts a pharmaceutical product’s integrity by ensuring the product’s potency and the safety of consumers.

4. Process Control & Validation

Inconsistencies in the production of pharmaceutical products also damage a company’s reputation. This includes inconsistencies in sterility assurance, which is why dependable procedures should be used at all times.

On this note, procedures that solely rely on human resources for sterile assurance are bound to be inconsistent. This is why it makes sense to invest in top-quality sterilization equipment.

Fortunately, some companies have made a name for themselves manufacturing and/or selling such equipment. By the way, the use of the right kind is also important for risk management.

5. International Trade & Compliance

Some pharmaceutical companies have gone beyond local and national involvement. They have also made a name for themselves in the international scene.

However, there is a price to pay for the actualization of this goal, one of which is ensuring optimal sterile assurance. Several international trade standards bother on this. As a result, pharmaceutical companies that fall short are not going to see their goal of going international being realized.

These international standards are also important for the harmonization of sterile assurance standards, which are increasingly being taken seriously by various pertinent health regulatory bodies. The facilitation of smoother trade between countries is one of the reasons for this.

6. Successful Outcome with Personalized Medicine

Medicine has gotten to a point where clinical therapies can be personalized. The possibility of using patient-specific tissues and cells is a major reason for this breakthrough.

Furthermore, personalized medicine has turned out to be a lifesaver for many people. However, its successful outcome is also dependent on the implementation of sterilization procedures.

This is because the quality of sterilization impacts the effectiveness of such procedures and even prevents further complications that may be brought about by contamination. By the way, sterilization plays a major role not only during the actual treatment but also during diagnosis.

7. Employee Safety

Quite a lot has been said about how sterile assurance in the pharmaceutical industry ensures safety. However, it has been about the safety of consumers for the most part.

The safety of employees working in these companies is also tied to sterile assurance. This is because chemical hazards can set in as a result of the failure to ensure sterile assurance. You can read this study for more insight into ensuring employee safety in such settings.

Conclusion

Reliable sterilization procedures are required by companies in various industries. The pharmaceutical industry is one such and a very important one at that. 7 reasons why this is the case have been explained in this article.

However, this calls for investment in the right products and processes. So, players in the industry must be willing to do the needful in light of what is at stake.