According to the Sedgwick 2023 State of the Nation Recall Index, 2022 saw a surge in drug recalls … with sterility failures topping the list for the first time in more than 6 years.1
This trend continued into 2023 with microbial and chemical contamination dominating recalls. In such a high-stakes environment, in which even minor defects can lead to significant health risks, every component of the production line plays a crucial role in maintaining high standards.
Here, Chris Johnson, Managing Director at specialty bearing manufacturer, SMB Bearings, explains why bearings are essential to ensuring sterile and precise operations.
Globally, the pharmaceutical manufacturing industry is governed by stringent regulations that demand precision, sterility and reliability throughout every stage of production.
In the UK, for example, manufacturers are required to comply with good manufacturing practice (GMP) standards, regulated by the UK Government’s Medicines and Healthcare products Regulatory Agency (MHRA), which ensures the consistent production of high-quality pharmaceutical products.2
From mixers that blend sensitive compounds to packaging machines that must work flawlessly to prevent contamination, every piece of machinery in a pharmaceutical plant needs to function with near-perfect efficiency.
At the same time, these machines are exposed to some of the harshest conditions. Strict cleaning protocols involving corrosive chemicals, high-temperature sterilisation and even ethylene oxide (EtO) gas treatments are standard in pharmaceutical production.3
These processes eliminate bacteria and other contaminants without damaging sensitive components.
Ethylene oxide is particularly useful when it comes to sterilising delicate parts that cannot endure high heat, ensuring that sterility is maintained without compromising material integrity.
However, any component that cannot withstand these aggressive cleaning methods becomes a liability — both in terms of performance and safety. For manufacturers, this presents a challenge: how can they ensure that their equipment operates at peak efficiency while meeting the industry’s uncompromising cleanliness standards?
The critical role of specialty bearings
This is when specialty bearings come into play. Bearings are essential in any machinery but they take on an even more critical role in pharmaceutical manufacturing. Used in mixers, conveyors, centrifuges and packaging machines, bearings ensure that all moving parts operate with the precision needed to maintain sterile environments.
Standard bearings — made from materials that cannot resist corrosion or endure the wear and tear of frequent cleaning — simply aren’t up to the task. In pharmaceutical settings, the risk of contamination is too high to rely on substandard components.
Bearing failures not only halt production, but they can also introduce contaminants that ruin entire batches of pharmaceuticals.
This results in significant financial losses and also safety risks.
Fortunately, specialty bearings — particularly those made from corrosion-resistant materials such as stainless steel or ceramics — are designed to withstand the aggressive cleaning and sterilisation processes required in pharmaceutical manufacturing.
These bearings not only prevent corrosion but also maintain their performance with time, which reduces the risk of downtime and contamination.
Durability and precision in extreme conditions
The types of bearings used in pharma manufacturing must be robust enough to operate in extreme conditions without losing precision. For example, packaging machines must work flawlessly to ensure that no contaminants enter the final product.
Bearings in these machines have to withstand these repeated cycles of high-pressure cleaning and exposure to harsh chemicals, all while maintaining smooth and precise movements to avoid damaging delicate packaging materials.
Similarly, mixers and centrifuges in pharmaceutical plants rely on bearings to keep their movements consistent — even after several hours of operation. Here, precision is just as important as durability; slight inconsistencies in rotation or speed can lead to product variations that could compromise the safety or effectiveness of drugs.
Ensuring reliability in pharma manufacturing
Corrosion-resistant bearings, made from materials such as 316 stainless steel, acetal resin and ceramic, offer the durability and precision needed to keep pharmaceutical equipment running efficiently and safely.
For example, corrosion resistant 316 stainless steel ball bearings are ideal for use in equipment that undergoes regular cleaning with corrosive chemicals. These bearings are not only resistant to rust but are also highly durable, ensuring that they continue to perform optimally even after repeated cleaning cycles.
Ceramic bearings are particularly suited for applications that demand high precision and resistance to extreme temperatures or aggressive chemicals.
Lighter and harder than steel bearings, they offer the durability and performance that’s critical in pharmaceutical manufacturing. By reducing friction and providing unmatched corrosion resistance, these specialty bearings help manufacturers to minimise downtime, prevent contamination and ensure reliable production lines.
Given the surge in drug recalls derived from sterility failures and contamination, as highlighted in the Sedgwick 2023 State of the Nation Recall Index, investing in corrosion-resistant and high-precision bearings is crucial for pharmaceutical manufacturers.
These components play a pivotal role in maintaining stringent production standards, helping to prevent contamination risks and ensuring compliance with regulations, thereby safeguarding patient health in an increasingly high-stakes environment.
References
- https://marketing.sedgwick.com/acton/media/4952/us-sotn-2023-index-report-download-pr.
- www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice.
- www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices.