Did you know that Oxygen (O2) monitoring in LN2 areas is an OSHA and JHACO (Joint Commission) requirement? What are the dangers of LN2? Many facilities will have a room with LN2 – which can be lethal. Nitrogen gas is lighter than air, so you should know before you enter a room that O2 levels…
Vaccines are critical tools in maintaining the health of our communities. The logistics of delivering vaccines and verifying that they consistently maintain their recommended temperature has always been a difficult task. At times, vaccines were found being stored outside of the manufacturer’s recommended range. Prolonged temperature excursions can result in the vaccines becoming ineffective. In…
Background A medical device manufacturing facility in Carlsbad, CA has two ISO Class 8 cleanrooms, an ultra low temperature freezer with epoxies, and a home style fridge. One cleanroom is temperature only, and the other is temperature, humidity and differential pressure. For Quality Control, the cleanrooms and the areas outside of them are required to…
Following the installation of your CM system is when the fun really begins! Throughout the project definition and pre-implementation planning stages, system requirements were defined based upon user needs. Now that the system has been installed, end users will need to begin the full process of transitioning from the legacy system to the new system…
After assembling a Project Team, and compiling the Equipment List and Annotated Floor Plans, the next key step in implementing a Continuous Monitoring (CM) system is to evaluate candidate vendors and select the one that will best meet your needs. Not all vendors are alike, and each has their own unique set of strengths and…
We have been closely watching progress on the new Food Safety Modernization Act (FSMA) and sharing information throughout the past months to help keep our clients aware of changes that may affect their facilities and/or procedures. Now, we would like to turn our attention to a part of the FSMA, Section 111, Sanitary Transport of…
Written by Paula Underwood The Challenge The Fort Meade, Maryland Forensic Toxicology Drug Testing Laboratory needs to measure incoming water pressure for their Reverse Osmosis (RO) Water Purifier. Currently, when the water pressure drops, they have no way of knowing. This affects the Analytical Machines that use the RO machine, as it stops making water…
The Children’s Hospital of Aurora Colorado is one of the top-ranked pediatric hospitals in the United States. They were founded in 1908 in Denver, Colorado and have been helping heal sick children for over one hundred years. Over one thousand pediatric specialists and more than 3,000 full-time employees work there to help their young patients.…
Each department will have its own set of quality standards and operating requirements, and it’s important to secure the Department Director’s commitment to assign department-level system owners to oversee both the initial implementation and the on-going support of the system. The primary goal of the system owners is to ensure the system is initially set…
There is no such thing as “One Size Fits All” when it comes to implementing a Continuous Monitoring (CM) system. Each department within an organization will have its own unique set of needs and requirements. Having each department follow exactly the same set of specifications and/or standard operating procedures will likely not be an optimal…