Regulation is at the heart of the pharmaceutical industry — and these guidelines aren’t exclusively associated with research and development. Managing contamination is a huge concern for pharmaceutical manufacturing facilities and these sites are usually developed with an intense onus on safety. Here, Chris Johnson, managing director of ceramic bearings supplier SMB Bearings investigates why this stringent approach doesn’t always translate into plant maintenance.
Medicines
Plant maintenance is no easy feat, particularly in complex facilities like that of pharmaceutical production. Computerised Maintenance Management Systems (CCMS) are now being widely deployed to assist in the maintenance of these plants. These systems can gather, store and analyse condition monitoring data to help engineers intelligently devise a predictive maintenance plan.
Here’s an example of how a CCMS would work. Let’s say a vibration analysis tool is being used to monitor the performance of a bearing on an industrial mixer. Combining powder and granular materials, this machine is integral to the production of pharmaceutical products.
Taking data acquired during vibration analysis, the CCMS can intelligently predict when the bearing might fail by extrapolating the performance over several future batches of production. This intelligence can allow engineers to tackle the problem — in this case, a deteriorating bearing — and replace it before its failure causes unplanned downtime. Sounds simple, right? Unfortunately, there is still room for error.
A common issue in manufacturing facilities is a lack of adequate training for staff. For maintenance engineers, the sheer plethora of equipment on the factory floor would require hours of training for them to completely understand each part, component and instruction for maintaining each intricate detail. For pharmaceutical manufacturing, this complexity is heightened by regulations, as well as the presence of corrosive and chemical ingredients.
Using the bearing example, it would be easy for maintenance engineers to replace the bearing with a like-for-like version, rather than an exact copy. For example, installing a new stainless-steel bearing of the same diameter, even though the original bearing was made of ceramic. Because steel bearings tend to be cheaper, these varieties are more likely to be held in inventory. Therefore, this scenario is entirely conceivable to get operations back up-and-running as quickly as possible.
Bearing material doesn’t always dramatically impact the performance of the bearing. However, in highly corrosive environments, choosing the correct material is incredibly important. While full ceramic bearings offer outstanding levels of corrosion resistance, some steel varieties cannot withstand the aggressive environments that are commonplace in pharmaceutical manufacturing, including those that operate inside an industrial mixer.
Where bearings are concerned, there are other considerations such as hardness and speed requirements. Ceramic materials tend to be up to 30% harder than steel, which improves their durability. However, the material is also much more brittle, meaning ceramic varieties cannot handle the same loads as steel versions. Do CMMSs factor in the properties of different bearing materials when analysing and forecasting equipment health?
Lubrication is another commonly overlooked area. When replacing small parts and components, maintenance engineers must consider whether the part is paired with the correct oil or grease for the application.
Bearings for pharmaceutical environments should be supplied with chemically resistant or food approved lubricants. Unfortunately, buying an off-the-shelf bearing does not guarantee the correct lubricant has been used. In these instances, bearing installation could risk contamination of non-food safe grease — causing much bigger problems than a broken-down mixer.
Computerised software might be beneficial for planning factory maintenance, but engineers cannot rely on digital tools to effectively maintain complicated facilities. Pharmaceutical production certainly falls into the category of complicated manufacturing and while regulation in the industry is incredibly rigorous, we need to ensure component maintenance is too.