Foamtec UltraSORB Wipers: Enhancing GMP Cleaning in Silicone Dispersion Processes for Implantable Medical Devices

The Role of Silicone Dispersions in Medical Device Manufacturing

Solvent-based silicone dispersions to coat or mold components (silicone dip casting) are widely used to produce implantable medical devices. These dispersions typically involve dissolving high-purity silicone elastomers in solvents such as xylene, toluene, or heptane, forming a uniform liquid that can be molded via dip casting. The solvent ensures even distribution and adhesion while evaporating, leaving behind a precisely controlled silicone coating.

The Cleaning Challenges in Silicone Dispersion Processing

During the preparation and application of silicone dispersions, GMP facilities must ensure that:

1. Mixing and Coating Equipment – Tools such as mixers, spray nozzles, and dipping tanks accumulate silicone residue, leading to contamination and process inefficiencies.
2. Containers and Transfer Vessels – Buckets and transfer lines require thorough wipe-downs to remove excess dispersion and prevent buildup.
3. Work Surfaces & Glove Changes – Operators routinely wipe benchtops, tooling, and gloves to prevent unwanted transfer of uncured silicone.

Conventional cleanroom wipes, such as polyester wipers or non-absorbent polypropylene wipes, are inefficient because they spread silicone rather than absorb it, leading to higher solvent consumption, increased wiping time, and operator fatigue.

How Foamtec’s UltraSORB Wipers Improve Cleaning Efficiency

 

Foamtec’s UltraSORB sponge wipers offer a highly absorbent, fiber-free solution designed to reduce solvent usage, labor time, and overall cleaning effort in silicone dispersion applications.

1. Maximum Absorption & Solvent Efficiency

1. • UltraSORB’s open-cell polyurethane foam construction efficiently absorbs much of the dispersion without the need for solvent minimizing cleaning time and flammable solvent consumption

1. • Traditional wipers require excess solvent to dissolve silicone, whereas UltraSORB traps and removes the dispersion with less solvent application.

2. Reduction in Solvent Consumption

2. • A facility using polyester wipes may require up to 250 ml of xylene per session per workstation, leading to excessive solvent exposure.

2. • UltraSORB wipers cut solvent use by 30-50%, as operators achieve superior silicone removal with fewer wipes and less liquid.

3. Faster, More Effective Wiping Process

3. • Instead of multiple passes with standard wipers, UltraSORB requires fewer wipes per task, reducing operator labor time by up to 40%.

3. • For example, if a process typically takes 15 minutes with polyester wipes, UltraSORB can achieve the same result in 8-10 minutes with fewer wipes.

4. Lower Waste Generation & Cost Savings

4. • Conventional wipers may require multiple wipes per cleaning cycle due to low absorption and silicone spreading. UltraSORB’s high-capacity absorption reduces the number of wipes used per shift.

4. • A GMP facility may use 100+ polyester wipes daily per production line, whereas UltraSORB can cut this to 50-60 wipes, reducing cleanroom waste disposal costs.

5. Superior Surface Cleanliness & Operator Ergonomics

5. • UltraSORB wipers prevent silicone buildup on tooling, transfer containers, and work surfaces, ensuring cleaner operations and fewer rework cycles.

5. • Operators handle fewer wipes, reducing hand fatigue and exposure to solvent vapors compared to standard cleanroom wipers.

Conclusion

For GMP facilities utilizing silicone dispersions in implantable medical device manufacturing, Foamtec’s UltraSORB sponge wipers provide a critical advantage by reducing solvent consumption, labor time, and waste while ensuring superior contamination control. By transitioning from traditional polyester wipers to UltraSORB, medical device manufacturers can enhance process efficiency, improve operator safety, and achieve significant cost savings in their cleaning protocols.