Meeting USP 1231 for pharmaceutical purposes and standard methods
Whitehouse Laboratories, a US FDA regulated laboratory owned by AMRI, has added water and environmental monitoring analysis to its microbiology laboratory.
The Lebanon, NJ, US-based company says this addition offers clients the opportunity to have their water systems and environmental monitoring programmes validated and routinely analysed concurrently with their other analytical assessments.
'Whitehouse Laboratories has long positioned itself as a ‘one-stop-shop’ for analytical support of API to finished product packaging. The addition of this testing capability is a logical step in the realisation of this vision,' said Brandon Zurawlow, Associate Director of Container Testing & CCIT at Whitehouse Laboratories.
Water testing is performed to evaluate whether water systems are under acceptable levels of control, producing high quality water for manufacturing and cleaning purposes. Environmental monitoring testing evaluates whether environmental controls provide sufficient air and surface quality for the processes taking place, either sterile fill/finish, or aseptic processing.
Enumeration of micro-organisms is a critical component in water testing. The assessment of the microbiological quality of water used in manufacturing is a key indicator of system control. If micro-organisms are present in incoming water it can compromise the purification steps.
Early detection is also a necessity in preventing the formation of biofilms. Bioburden testing includes the quantitation of microbes such as aerobic plate count, yeast/mould count, heterotrophic plate count, total coliforms, coli, Enterococci, Listeria and Pseudomonas aeruginosa.
This new capability in the microbiology laboratory enhances the water analyses services already available at Whitehouse Laboratories, including heavy metals, nitrates, TOC, and conductivity.