DataTrace in Autoclaves

DataTrace in Autoclaves

Getting accurate product temperature throughout an autoclave validation can be a difficult task but is imperative to calculating lethality within an autoclave cycle. Whether it is for an initial equipment and process validation or for yearly equipment qualifications, maximizing efficiency while maintaining that strict temperature accuracy (0.1° C) is critical to a successful project. Mesa’s…

Food Safety

The Basics of Retort

Retort is basically heating and sometimes agitating food and its container to remove potentially harmful organisms. One such organism is Clostridium botulinum. Clostridium botulinum is a rod-shaped, anaerobic, spore-forming, motile bacterium with the ability to produce the neurotoxin botulinum. The botulinum toxin can cause a severe flaccid paralytic disease in humans and animals and is…

14+ Years of Expertise

Compliance and Validation Services Expert Spotlight

Mesa Labs’ Compliance and Validation Services expert Zach Sparks has more than 14 years’ experience in: IQ/OQ/PQ qualifications and temperature mapping of incubators, freezers, refrigerators, autoclaves, depyrogenation ovens, and lyophilizers. Cleanroom qualifications, including viable and non-viable particulate monitoring for routine monitoring and ability to determine the placement of the non-viable particulate measuring equipment to meet…

New Food Safety Regulations

FSMA: The Preventative Controls Rule

September 19, 2016 marked the day when larger businesses must comply with new standards set forth by the FDA’s Food Safety Modernization Act (FSMA). The first year of compliance will affect the larger businesses, generally those with 500 or more employees. Under FSMA, the FDA now can suspend facility registrations and has the authority to…

Reduce Potential Risks

Risk Controls

Based on the results of your Risk Evaluation, you will need to identify Risk Controls. Risk Controls are measures that you take with your medical device to reduce the identified potential risk(s) and/or their impact. ISO 14971 requires the manufacturer to “identify risk control measure(s) that are appropriate for reducing the risk(s) to an acceptable…

CVS site

Mesa Labs Compliance and Validation Services

Mesa Labs announces Compliance and Validation Services by launching a redesigned website to better highlight the areas where Mesa services can offer the most benefit. Having been a manufacturer of monitoring and validation equipment for decades, Mesa is uniquely suited to offer calibration and validation services as well as being ideally positioned to help its customers maintain compliance.