Cleaning validation/verification is a critical step in manufacturing process control, requiring fast analysis of a large number of samples to check for the presence of leftover API or cleaning agents.
Despite the high premium on speed, the current standard technique, HPLC, requires a substantial amount of time per sample. TOC, while faster, is non-specific and limited to aqueous samples. Ion Mobility, on the other hand, offers compound-specific detection in the ppb-ppm range combined with analysis times in seconds, not minutes, making it a prime candidate for efficient cleaning validation.
The core advantages of IMS for Cleaning Validation are:
Speed - answers in seconds, not minutes
Size - small enough for use at line
Specificity - pinpoint the API or detergent
Simplicity - no columns, no vacuum, or large amounts of solvent
Ease of method development - ideal for large numbers of APIs
Click the video below for an introduction to IMS for Cleaning validation:
With the recent upgrade to full 21 CFR part 11 regulatory compliance, the Excellims GA2200 CV offers an impressive array of feature that make it an ideal solution for cleaning validation:
A versatile ESI source, able to ionize non-volatile and thermally sensitive compounds in a variety of different solvents (swab extract and rinse samples)
IMS speed advantage with 30 s measurement time for ppb-ppm level samples with an RSD of 5-10%
A high resolving atmospheric drift tube (R > 70), allowing for specific identification and quantification of APIs and detergents
All features required for full 21 CFR part 11 compliance, e.g. restricted individual user access, different user levels, sample and method protection, electronic signatures and a comprehensive electronic audit trail
To learn more, please check out the materials below or contact our applications & sales specialists. We will be happy to organize an instrument demonstration using your samples.