Both FDA’s 21 CFR 820 and ISO 9001 have requirements for document control. The goal with this section of the standards is to demonstrate that your quality system is compliant, that you design and manufacture products to meet design controls, and that your company is addressing risk management concerns. The FDA typically takes the approach…Details
Another item that is required by both 21 CFR 820 and ISO 9001 is the Quality Policy. Though it is jointly written by management and quality experts, the process of writing a Quality Process is a beneficial exercise for management as it has them focus on systems and how the company operates. This document…Details
A frequent term thrown around most manufacturing companies is GMP (also called cGMP). While most people seem to have a vague understanding of what Good Manufacturing Practices (GMP) are, many do not have a clear grasp of what the requirements are. To start with, GMP is a system that provides assurance to customers that products…Details
The concept of equipment calibration is an important one throughout FDA and ISO requirements. ISO 9001, section 7.6 discusses it in a broad sense, while ISO 17025, “General Requirements for the Competence of Testing and Calibration Laboratories”, is specifically about calibration. In 21 CFR 820.72, it’s stated that “Calibration procedures shall include specific directions and…Details
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50 mS solution now available
Mesa’s new 50 mS Conductivity Standard Solution allows the user to verify accurate readings during final bicarbonate testing using a NIST traceable standard as a qualified data point of 50 mS during meter verification and calibration.
Dialysis is based on the diffusion and ultrafiltration of fluid across a semi-permeable membrane. As blood flows past one side of a semi-permeable membrane, dialysate flows by the other side. Fluid and smaller solutes and pass through the membrane, but larger substances (e.g. large proteins and red blood cells,) are blocked by the membrane, mimicking the filtering process that takes place in the kidneys.
Hemodialysis works by removing waste and water from circulating blood by filtering it outside the body through a dialyzer which contains a semi-permeable membrane. Blood and dialysate flow in opposite directions, contributing to the concentration gradient that allows the maximum amount of urea and creatinine to be removed from the blood.
Dialysis solutions contain similar levels of certain minerals (e.g. calcium, potassium) as healthy blood. The blood of dialysis patients contains higher levels of potassium and urea than the dialysate so constant replacement of the dialysate through the dialysis process maintains this imbalance ensures that undesired solutes are removed from the patient’s blood. For bicarbonate, the level is set slightly higher than healthy blood to encourage diffusion. Individual patient needs dictate the concentrations of the components of dialysate, typically prescribed by a nephrologist.
To ensure patient safety, Mesa offers several digital dialysate meters to help the nephrology technician verify that the dialysis machine is functioning properly. The pHoenix, HYDRA and NEO-STAT test various parameters utilizing Mesa’s easy to use syringe style concept which is small in size and offers a host of advantages including a large, digital display, one-touch calibration and an auto-off battery saving feature.
In addition to these syringe style digital dialysate meters, Mesa offers its 90XL technician meter which can be used to test and calibrate all types of delivery systems and water purification systems.
Mesa Labs maintains a sophisticated calibration lab for all of its instrument products, including its line of digital dialysate meters.
Mesa’s in-house calibration is far more extensive than the user calibration options available to our customers. Mesa’s dialysate meters, in general, have two sets of calibration coefficients. A set that is exposed to the customer/user and is used to make minor adjustments to the accuracy of the device and a set that is exposed, in general, only to Mesa’s in-house calibration software.
Also, Mesa’s Calibration lab has the N.I.S.T. traceable standards at the facility to calibrate the meters to. A typical user doesn’t have access to N.I.S.T. traceable standards.
Lastly, if there is an issue with the function of the meter, Mesa has the OEM parts to correctly service, repair and re-certify a customer’s meter. Should an instrument or meter need repair, it can only be accomplished at our factory.