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…

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.

Statistical Techniques

Statistical Techniques

There is a requirement in both the 21 CFR 820 and ISO 9001 to utilize statistical techniques.  According to the FDA, “Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.  Sampling plans, when used, shall be…

Lyophilization Logger Bottles Web

How Can I Validate My Lyophilization Process?

The lyophilization process is essentially freeze-drying, where the environment is at a very cold temperature and the product is within a “vacuum”. During the process, there is a concern with making sure that the shelf is heating up the product to proper temperatures. Typically, this is a stainless steel shelf of a certain size that can be heated from underneath. This heat is applied to the product while under a vacuum and when…

Handling-Storage-Distribution blog

Handling, Storage, Distribution

Once product has been manufactured and packaged, there are requirements for how you handle, store and distribute the finished product.  21 CFR 820 breaks down the requirements for each of these processes.  A manufacturing company should establish procedures that will deter mix-ups, damage, deterioration or contamination from happening during handling and storage of product.  These…