By Erin Bakes, Chemistry Study Director
It is important for manufacturers to remember that the water they use must be validated to the suitable level of purity for their process. The United States Pharmacopeia (USP) states that it is the water user’s responsibility to ensure the water is validated to meet appropriate requirements. The problem is many manufacturers may not even know what purity specifications they need to meet—they need guidance.
By Alpa Patel, Department Scientist, Hospital Reprocessing, BS, RM(NRCM)
For many years Nelson Laboratories has been providing tissue process validation for manufacturers, tissue banks and organ procurement organizations (OPOs). Nelson Labs provides a full gamut of tissue testing services to the tissue industry.
by Sara Toole, Microbiology Department Manager, B.S. RM(NRCM) CQA (ASQ)
Tissue banks provide a great service for those in need. But, just like pharmaceuticals and medical devices, donated tissue needs to be rendered safe before it can be used on patients. The American Association of Tissue Banks (AATB) and the Food and Drug Administration (FDA) set the standards for procurement, processing and distribution of tissue. For skin donations, the tissue must meet criteria as determined by the AATB to be considered acceptable.
By Thomas Pace, Study Director, Nelson Laboratories
Recently, there has been an increased interest in understanding the potential for microbial growth in sterile dosage forms which require breaching the container or closure system long before dosage administration. A variety of approaches can be used to investigate the microbial growth within such products in order to determine their appropriate use instructions and label claims.