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Pharmaceutical Manufacturing and Packing Sourcer

Got it Covered


A major medical device manufacturer recently revealed significant airborne reduction counts.Their facility, based in the US, achieved this result by evaluating their contamination control methods at floor level.The facility had been using several hundred cases of peel-off mats every year, but found that, by switching to polymeric floor coverings, they witnessed a reduction in costs and an improvement in contamination control performance. As well as a reduction in foot- and wheel-borne contamination, they measured a 75 per cent reduction in the level of airborne contaminants – a considerable figure by any standard.

Controlling microbial contamination is essential to medical device performance and reliability, and as a result the manufacturer must always be on the lookout for opportunities to maximise the sterility of the environment in which they work.As the complexity of device design increases, so does the process of assuring that microbial contamination is controlled during manufacturing. Manufacturing process control is also essential to achieve the appropriate surface quality and optimal functionality, as well as maintaining sterility at all stages. Cleanroom design and equipment for the reduction of particles is an essential element in the process. Small, light particles of less than 5μm in diameter, which are normally invisible to the naked eye, are commonly referred to as airborne molecular contaminants (AMCs) or ultra-fine particles (UFPs).They can become suspended for several hours in the environment surrounding the manufacturing equipment, where they spread quickly throughout the area they are in, polluting the atmosphere, and risk products and processes.

Contaminants are generated by the people undertaking the device Got it Covered Reducing contamination in cleanroom environments is a constant challenge, and technologies that assist the manufacturer in this respect are a welcome innovation. One particularly attractive option is the use of polymeric flooring coverings, which offer up to a 75 per cent reduction in airborne contaminants manufacturing, the process itself, the facilities on-site and the equipment involved, and must be continually controlled and removed from the air.To achieve a truly efficient and effective level of contamination control, an integrated contamination control process must be put in place. A major element of this is an effective flooring system. Eighty per cent of microbial contamination is believed to enter the cleanroom at or near floor level. If contamination is not captured and eliminated at this key point, it can enter and rise to a critical airborne height through the vortices of air created by personnel and wheeled traffic.



Example Case Study

A major medical device manufacturer operating in the field of hybrid manufacturing evaluated the polymeric floor coverings, and performed a study in order to compare them with the peel off mats that were previously being used at their facility.Various consumables were commonly used in the facility’s gowning room, including bouffants, face masks, garments, ESD shoes, and gloves. Blue peel-off mats were used to capture dirt from operatives’ casual shoes, typically worn to and from the manufacturing plant, as they entered. The company that owned the building where tests were conducted spent $24,000 (£15,000) on peel-off mats per year, and also disposed of approximately one imperial ton (2,028lbs/920kg) of used plastic peel-off mat sheets per year.



Opportunity for Improvement

A polymeric floor covering can provide a much more viable alternative to peel-off mats.A key feature of polymeric floor covering is its ability to embed particulate within its cellular structure, rather than to bind it with surface adhesive, as is done with the peel-off mat.The flooring should be cleaned with a damp mop and detergent and then dried with a squeegee.

The lifetime of a typical polymeric flooring material is between three and four years. During that period, a manufacturer could easily find themselves spending in the region of $72,000 (£45,000) on peel-off mats. Further benefits of polymeric material include the following factors:
  • Fewer particles in the gowning room
  • Improved yields
  • Reduced product rejects
  • Reduced expense (in that no peel-off mats will need to be purchased, stored and peeled)
  • A greener solution (as plastic peel-off mat sheets will not need to be disposed of)
  • Reduced cleaning costs due to no adhesive carry over into the critical production areas
  • Fewer particles being redistributed back into the atmosphere during the rip up process of peel-off mats


Method of Product Evaluation

In the above example, a project plan was developed and presented to the management of the hybrid manufacturing company. Financial feasibility was analysed for several sizes of polymeric flooring.The required spend was calculated to be the equivalent of 20 months-worth of blue peel-off mats which would cover a much smaller surface area and provides a lower level of performance. A financial benefit was then forecasted based on the lifespan of polymeric floor coverings.

The management of the hybrid manufacturing company in question went on to approve the project plan. In order to measure performance, airborne particle counters were added to the gowning room, and particle data measurements were collected over a 12-week period, with blue peel-off mats in use. Polymeric flooring material was then installed and particle data measurements were taken over a further 12 weeks.The results from one week’s worth of tests are shown in Figure 4 and 5.



Conclusion

The test results show that the gowning area was much cleaner with the new technology installed – a 75 per cent airborne particle reduction was achieved by using polymeric floor coverings instead of peel-off mats. The airborne particle attraction is achieved through a combination of factors, including a supple and smooth surface. Shortrange lectromagnetic forces (Van der Waals) enable the polymeric flooring to attract, collect and retain particles until cleaning takes place.

Cost savings were evident; due to the long life of the polymeric floor coverings, $80,000 will have been saved on the purchase of blue peel-off mats over the same timeframe. A significant cost saving will also be achieved through reduced contaminated batches and improved product yields.

Time Saving
Custodians generally report a time saving of two hours per day due to not having to peel and dispose of peel-off mats. It was also reported that the product was easier to use in that no overt action was needed.

A Greener Solution
Pressure to reduce energy usage and carbon footprints, together with the elimination of waste, are now targets for many organisations. Regulators around the world have become less tolerant of practices that have been found to do harm to the environment. It is now a given that regulators are headed toward more stringent rules about materials used in the facility and how they are handled.Therefore some managers believe that commencing the adjustment process for potential changes now may be more economically efficient and less disruptive to their work and bottom line than racing to meet regulatory deadlines in the future.

Due to the medical device facility ceasing to use peel-off mats, there is significantly less plastic going to waste – more than five tonnes of plastic over the next five years will not be going into landfill as a result. Furthermore, at the end of their working life, polymeric flooring and mats are 85 per cent recyclable and do not contribute to landfill waste.The facility in the case study will itself not only be looking to expand the use of polymeric flooring to other areas within their own building, but also to other manufacturing plants globally, in order to save further costs and also to reduce their carbon footprint. Given the level of particle reduction and cost savings that this technology can bring, it is recommended that any facility operating in the life sciences field evaluates use of polymeric floor coverings.


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Eva Paraskevaides is Marketing Manager for Dycem Limited. Eva has over eight years of experience at the company and a wealth of contamination control knowledge. Her previous roles have included PR and communications for the construction industry. Eva has a degree in Business Studies from the University of the West of England and is CIM certified. Email: eva.paraskevaides@dycem.com
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