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Validation

Laser processes are a widely used technology for the assembly of medical devices and marking of both medical devices and pharmaceutical products. This is primarily due to the unique ability of a laser to apply finely controlled and repeatable energy on target. These laser features must be validated to FDA expectations using a methodology that is statistically significant and tests the critical functions of the lasing process. The test protocols must have the capability of being easily reutilized for a validated process if a change to the process or equipment occurs.This reusability saves time, money and demonstrates testing consistency by applying a common protocol. It is critical to statistically determine if there was a significant change impacting the validated parameters.

 

The performance of all laser systems will deteriorate in time. This is due to wear both mechanical and photonic in nature. Lens coatings deteriorate, lasing pumps become unstable and fibers develop distortions. This photonic related wear is not readily apparent as the rate toward complete failure is slow. This leads to an increasingly unstable process with no obvious root cause. The astute characterizing of a laser process will forecast these failure modes. It is very easy to go down a validation path that is cumbersome to sustain and yields little value in controlling the process and more importantly, can appear suspect to the FDA.

 

Laser Guardian has extensive experience in the FDA compliant validation of lasers for manufacturing of medical devices. We know the right statistical and test tools to apply resulting in a robust validation process that is FDA sustainable. Laser Guardian will work closely with your Engineering and Quality staff to ensure they understand the validation techniques employed. We can also apply this same methodology so that your new laser can be acceptance tested prior to vendor shipment and meets your performance requirements.  

Gain the peace of mind to know that your operation is compliant with state and federal regulations and your new laser operates to your requirements. We are insured with an E & O liability policy specifically for laser consultation. Contact us by email or phone for further information or to set up an on-site appointment.

 

 

 

 

The Laser Guardian team is knowledgeable in developing IQ, OQ and PQ protocols & reports based on Six Sigma methodologies. We know laser processes.

 

Ensure your processes are well tested and Ppks are high to reduce the potential of recalls and FDA audits.