Quality Assurance & Traceability
Our customers deserve products that are superior in quality and consistency.
We know Biopharm customers expect excellent and consistent product quality. Our Quality Assurance and Traceability program includes written standard operating procedures and documented traceability to NIST reference materials. Listed below are some examples of our quality assurance documentation and procedures.
Measurement of the electrical conductivity of an aqueous solution is a quick, easy, and practical way to gain information about that solution. Whether monitoring natural water for its total dissolved solids (TDS) or measuring a sophisticated pharmaceutical preparation, conductivity measurement is a widely used technique. A general discussion of the technology may be found in Standard Methods for the Examination of Water and Wastewater and other places.
Biopharm has manufactured conductivity standards since 1977. Our experience has led to many improvements in our products and production techniques. We have a dedicated conductivity lab where all of our standards are produced in a rigidly controlled environment. Written standard operating procedures are used to calibrate our conductivity instrumentation using NIST standard reference materials. We use instruments and contact-type dip cells manufactured by Yellow Springs Instrument Co., Inc. Temperature measurements and calibrations are traceable to NIST by way of ERTCO ASTM 63C-FC thermometers (0.1 degree graduations), and our balances are calibrated to National Voluntary Laboratory Accreditation Program (NVLAP) standards.
Our finished conductivity standards are filtered through a 0.2-micron filter to minimize bioburden. Each final container/bottle is rinsed with product at the time of fill. Bottles used to package standards of less than 20 μMho/cm undergo a “leaching” process to improve shelf life. Each lot receives a conservative expiration date based on documented shelf-life studies.
Biopharm Inc. manufactures a wide range of conductivity values so that you can calibrate your equipment near the value(s) at which you operate. We probably have a standard value close to your needs; if not, we will make exactly the value you need. Email or Call us today with your requirements!