Northeast Laser & Electropolish is now pleased to announce that the company has validated its laser welding, electropolishing and passivating lines.
Kurt England, a principal in the organization, explained the value of validation.
“We have seen a significant increase in requirements that a line or process be validated, especially when dealing with medical component manufacturers. This is quickly becoming a prerequisite for winning business. We have already validated several of our dedicated lines and have now expanded that to cover complete departments. Our goal is to have all areas validated by mid 2012.”
For those unfamiliar with process validation, a Validation Plan (VP) consists of an Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). A protocol for each qualification stage, approved and signed by the management team, is needed before the validation process can begin.
“In short, the organization is verifying that the equipment used has been installed properly and that the process is stable and repeatable within the limits of its normal operating conditions. This is something that the medical manufacturing community takes very seriously,” added Mr. England.
Northeast Laser & Electropolish provides laser marking, laser engraving, laser welding, laser cutting , electropolishing and passivating services to a wide range of companies throughout the United States and abroad.