Medical Plant Has Facilities Challenges

October 30, 2006
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GRAND RAPIDS — For Brent Wybenga, facilities manager at Rose Technologies, taking care of the workspace is more than just keeping it neat and tidy.

As a medical device manufacturer, Rose Technologies has strict standards of upkeep that revolve around the production environments and the products being manufactured, as well as customer requirements, governing agency regulations and specific equipment requirements.

“It is unique in that it requires a higher level of cleanliness, and tighter environmental controls within the production environments,” Wybenga said. “The most challenging area is controlling the environmental conditions within the production environments and how it affects the specific manufacturing process.”

Wybenga said variables such as temperature, humidity, positive air pressure and particle counts are important and vary with each product material and manufacturing process.

“We monitor the necessary parameters with data logging sensors and make any necessary changes,” he said. “Air quality testing and certification of the production areas is also an important part of the process.”

The testing is done based on the level of room classification, but usually occurs every six to 12 months.

“Room classifications can be from a class 1, 10, 100, 1,000, 10,000 and 100,000, or a specific ISO class,” Wybenga said. “The level of classification can be based on a number of parameters, but generally is based on the number of high-efficiency particulate air filters, particle counts, number of air changers per hour and positive air pressure measurements.”

The company has system controls that it follows, including good manufacturing processes, standard operation procedures and a quality checklist.

System audits are performed periodically by customers and outside consultants to ensure compliance, Wybenga said.

Wybenga said the 28,000-square-foot facility, which could be best compared to aerospace or electronic component manufacturing facilities, needs to meet federal requirements.

“Cleanliness is important, too, in order to meet FDA and customer requirements, and most importantly to ensure that the end user, the patient in the ER room or surgical suites, can be assured the products are clean and sterile.”    

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