By Tara S. Hundley, Anton Paar USA
For those of you who work with any analytical/lab or process instruments, you know that staying in compliance with global regulations has become burdensome in the past decade. Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the work flow as soon as possible; but to do so you need to know everything there is to know about equipment and instrument qualification. In the overall pharmaceutical manufacturing process, you may be just one cog on the gear of productivity, but without some help, you could go from cog to clog very quickly.
Validation is vital to pharmaceutical processes because it assures quality, consistency, and keeps your operations compliant with GMPs. The FDA provides guidance for proper cleaning validation, however challenges occur because interpretation of those procedures vary between facilities.
The U.S. Pharmacopeial Convention's (USP's) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years — and every pharmaceutical manufacturer waited to see what that meant in practice when the standards went into effect in December 2013.
LaboStar TWF ultrapure water purification systems from Evoqua Water Technologies are designed to provide ASTM Type I water from a tap water feed source. The compact design provides up to 1.2 lpm of ultrapure water, needed for many of today's laboratory applications.