Quality is a crucial aspect of any medical device company. Total Quality Management (TQM) programs have become the standard approach to ensuring quality in medical device manufacturing. Using cleanroom wipers plays a critical role in the success of TQM programs. Cleanroom wipers are essential for maintaining a clean and sterile environment in medical device manufacturing. Choosing the correct type of wiper can significantly impact the quality of the final product.
Medical device manufacturing is a highly regulated industry where the smallest particle can be considered a foreign material affecting product quality. It is well understood that foreign materials can be introduced into the manufacturing process in many ways. Still, it needs to be better understood that the use of improper wipers is one of the primary sources. Many facilities use “lint-free” wipers constructed of knitted polyester or non-woven Polycellulose or polypropylene fabrics. However, evaluations carried out using the PolyCHECK particle identification system have shown that these wipers are one of the primary sources of particle contamination above 20 microns in size. Even when airborne particle counts are in control, spikes in rejects and rework rates are common when these wipers are used on the device or to clean tools and work surfaces that come in direct contact with the device.
The PolyCHECK particle identification system allowed a device manufacturer to identify the underlying cause of persistent FM rejects. Once foam wipers were implemented reject and rework rates were reduced by more than 75% and inspection times were reduced by 17%
The use of outdated wipers can have a significant impact on the TQM program of medical device companies. Quality control personnel must be aware of the potential sources of foreign materials in their manufacturing processes and take appropriate steps to mitigate them. Upgrading to cleanroom foam or microfiber wipers designed to resist particle shedding due to the abrasion encountered in normal wiping can help reduce particle contamination and improve the quality of the final product. Cleanroom foam and microfiber wipers have a higher capacity to trap and retain particles and are less likely to release them back into the environment. These advanced wipers can lead to fewer product rejects, lower rework rates, and improved customer satisfaction.
The video highlights the volume of particles that shed form traditional cleanroom “lint free” polyester wipes.
It is essential for medical device manufacturers to regularly assess their wiper selection to ensure that they are using the most suitable wipers for their manufacturing processes. Upgrading to cleanroom foam or microfiber wipers may require an initial investment. Still, it is a cost-effective solution in the long run as it helps to reduce the cost of quality control and improve the overall efficiency of the manufacturing process.
In conclusion, using cleanroom wipers plays a critical role in the success of TQM programs in medical device manufacturing. Quality control personnel should be aware of the potential sources of foreign materials in their manufacturing processes and take appropriate steps to mitigate them. Upgrading to cleanroom foam or microfiber wipers can significantly reduce particle contamination and improve the quality of the final product, leading to fewer product rejects, lower rework rates, and improved customer satisfaction. Medical device companies that prioritize the selection of the right wiper can achieve high-quality products and an efficient manufacturing process.
PolyCHECK® Expedites Particle Contamination Troubleshooting & Cleaning Validation [Video]
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