Pharmaceutical & medical G
ENSURING STERILITY AND PRECISION IN PHARMA
lobally, the pharmaceutical manufacturing industry is governed by stringent regula- tions 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 Medi- cines and Healthcare products Regulatory Agency (MHRA), which ensures the consistent production of high-quality pharmaceutical products. From mixers that blend sensitive compounds, to pack- aging machines that must work flawlessly to prevent contamination, every piece of machinery in a pharmaceu- tical 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-temper- ature sterilisation and even ethylene oxide (EtO) gas treatments are standard in pharmaceutical production. These processes eliminate bacteria and other contami- nants without damaging sensitive components. Ethylene oxide is particularly useful for steri- lising delicate parts that cannot endure high heat, ensuring that sterility is maintained without compro- mising 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 uncom- promising cleanliness standards?
THE CRITICAL ROLE OF SPECIALTY BEARINGS
This is where 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 are not up to the task. In pharmaceutical settings the risk of contamination is too high to rely on substandard components. Bearing failures not only halt produc- tion, they can introduce contaminants that ruin entire batches of pharmaceuticals. This results in significant financial losses, and also safety risks. Fortunately, specialty bearings — particularly
76
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 over six years. This trend continued into 2023, as with microbial and chemical contamination dominating recalls. In such a high-stakes environment, where 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.
those made from corro- sion-resistant materials like stainless steel or ceramics — are designed to withstand the aggressive cleaning and sterilisation processes required in pharmaceutical manufac- turing. These bearings not only prevent corrosion, but also maintain their perfor- mance over time which reduces risks of downtime and contamination.
DURABILITY AND PRECISION IN EXTREME CONDITIONS
The types of bearings used in pharma manufac- turing 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 expo- sure 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 like 316 stainless steel, acetal resin, and ceramic, offer the durability and precision needed to keep pharma- ceutical equipment running efficiently and safely.
For example, corrosion resistant 316 stainless steel ball bearings are ideal for use in equipment that under- goes 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 appli- cations that demand high precision and resistance to extreme temperatures or aggressive chemicals. Lighter and harder than steel bearings, they offer durability and performance critical in pharmaceutical manufacturing. By reducing friction and providing unmatched corrosion resistance, these specialty bear- ings help manufacturers minimise downtime, prevent contamination, and ensure reliable production lines. Given the surge in drug recalls due to 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.
SMB Bearings
www.smbbearings.com January 2025 Instrumentation Monthly
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96
