Valtronic USA Adds a Bioburden ISO Class 8 Cleanroom
SOLON, Ohio, Oct. 28, 2013 /PRNewswire/ -- Valtronic USA has recently qualified a new ISO Class 8 cleanroom. Our 288 square ft. bioburden ISO 8 cleanroom is a modern facility with temperature, humidity, & contamination controls. It provides us with the ability to package electronic and mechanical assemblies in a pouch ready for EtO (Ethylene Oxide) sterilization. It completes the production chain for our customers' products, and allows Valtronic to provide a complete contract manufacturing solution for active implants.
"The project began as a request from a new customer and we anticipate a very positive response from other implant manufacturers regarding this capability. Our new facility has provided us with the space to add this capability with room to expand it when needed," said Jim Ohneck, Global Vice President of Sales and Marketing. "We started preparing for expansion like this when we moved to our current facility last year and the right customer helped us complete it even earlier than expected. Providing this capability saves customers production time and the vertical integration also offers cost efficiencies."
Working with an independent lab for testing, the cleanroom has proven to meet ISO 8 standards of less than 3,520,000 particles greater than or equal to 0.5 micrometer per cubic meter of air according to ISO 14644-1. The qualification was led by two Engineers and our Quality Manager. Our technicians were trained on cleanliness controls in the ISO 8 cleanroom to ensure best-in-class production for today's demanding medical device market.
Valtronic is a niche "mechatronics" manufacturing solutions company. We produce integrated electronic and mechanical products. Our customers are leading global suppliers of medical implants and devices, diagnostic imaging equipment and sensitive aerospace and industrial assemblies. For over 30 years we have helped hundreds of companies develop and produce Class II & III medical devices and advanced miniaturized electronic assemblies.
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