Medical Devices

Contamination Control Challenges in the Medical Device Industry

Medical device facilities face unique challenges in contamination control that requires “State-of-the-Art” decontamination Technology. The fact is that Medical Device facilities vary and have different types of environments and concerns specific to their product. One manufacturer may produce a number of medical devices, and have a rapidly growing list of products specific to of the needs of the medical industry. Another manufacturer needs to maintain operations for creating both sterile medical devices and ingestible medications. The merging of these two development processes creates additional potential for problems.

Cross-contamination:

Cleanroom facilities in the medical device industry face an increased risk of contamination from one part of the operation to another. Compounds used to make one component, or a combination product, can have adverse effect on the creation of a different component.

Resistance:

Medical device R&D can also be threatened by microbes with an ability to resist the activity of biocides. Responses to biocides depend on a number of factors, including the species of organism. Decontamination with chemical disinfectants is extremely important to overcome resistance. Moreover, sporicidal agents may be required, as not all typical cleanroom disinfectants are effective against fungal spores.

Cosmetics:

Another challenge that has been experienced by some medical device manufacturers is Cosmetics. That is, the product is fine, functional and safe. However, due to non-viable and harmless particulate matter the product is just not pristine to the eye and necessitates its being reworked, or worst yet, rejected! Customized Performance's team of decontamination specialists can work with you to improve product yield.

Protect Your Investment

You've invested considerable amounts of money in the cleanroom(s) and the equipment. Your decontamination investment is equally important. Without proper cleaning and operating procedures, tiny particles could ruin the results of years of dedicated research. The fact is, contaminants can be devastating.

Your company's goal and mission is to create products that potentially affect the quality of life for millions of people. Safety is one of your highest concerns — as it is ours. We share your concern for the safety of your customers, your employees and the well-being of your business. That's why we deliver decontamination, cleanroom and controlled environment cleaning that meets the most exacting standards.

Our highly educated, reliable business development managers are your resource for information about the best products and cleaning methods for your specialized environment. They will examine your procedures and help you develop SOPs. At Customized we also know many clients have invested in demanding SOP's and schedules to ensure their producing pristine product. At Customized we are ready to carry out the tasks in full compliance with your requirements.

We Understand Your Needs for Maintaining Your Specialized Environment

We're the micro-cleaning and decontamination experts with a full appreciation of the specific challenges you must overcome to maintain proper conditions in your controlled environment or cleanroom. We never lose sight of our mission to provide you with service that meets or exceeds your expectations.

Make Customized Performance a central part of your proactive program for cleanroom excellence.