Ensuring a clean product begins with ensuring a clean manufacturing environment and inputs. Purified water, Water for Injection (WFI), potable and other process waters are key materials and potential vectors for contamination. Water systems can harbor microorganisms and chemical impurities that can compromise product safety, sterility, and stability if left uncontrolled. Depending on the nature of their production, a manufacturer’s facility water monitoring program may consist of microbial counts, endotoxin levels, conductivity, total organic carbon (TOC), and sometimes specific chemical species. Scheduled testing at defined points of use and recirculating loops provides early warning of biofilm formation, system degradation, or process upsets.
A risk assessment should be performed and documented to identify the appropriate tests. Depending on the criticality, tests frequently run on facility water can include TOC, general microbial enumeration, specific pathogen screening, conductivity and endotoxins. Our experts are happy to share their ideas to help with your planning.
Coupled with your risk assessment and regulatory guidelines, a good starting point can be to perform repeat testing over a period of time without pre-defined pass/fail criteria (specifications). This will allow you to understand the baseline trends of your water before formalizing specifications. Much like Environmental Bioburden Monitoring, trends in water parameters can change with the seasons especially for municipal potable water.
While many organisms can cause issues if they get into water lines, some repeat offenders include Pseudomonas aeruginosa, Burkholderia cepacia complex and bile-tolerant gram negative bacteria.
Yes, Innovotech performs identity testing on microbes recovered from samples.
It depends on the tests being conducted. Sterile plastic sample containers are sufficient for routine microbe analysis. For TOC and endotoxin analysis where packaging poses a risk of contamination, our experts are happy to make sample container suggestions. All samples should be tightly sealed and shipped priority overnight in a Styrofoam cooler with an ice pack.
