Cleaning validation/verification is an FDA requirement at the conclusion of a pharmaceutical manufacturing run. Inadequate or incomplete cleaning validation analysis is one of the leading causes of internal investigations and regulatory citings. Current technologies keep production equipment off line as they are either too slow, not specific, inconvenient, or not sensitive enough. The need to perform fast analysis of a large number of samples to check for the presence of leftover API or cleaning agents, is a need of the global pharmaceutical manufacturing industry.
The FDA has required equipment cleaning since 1978 (cGMP guidelines for cleaning validation) to prevent contamination or adulteration of drug products. The guidelines do not specify which cleaning validation technology to use, it puts the onus on operations teams to ‘determine the specificity and sensitivity of the analytical method used to detect residuals or contaminants’. Users must ensure they deploy analytical technology that can detect residues from the manufacturing and cleaning processes at very low levels.
These performance requirements are often to the detriment of speed of analyses.
There are several different analytical approaches for cleaning validation. While some traditional lab-based techniques like HPLC have high precision and accuracy, they are relatively slow and require the sample to be transferred to an external quality lab and the production euipment sits idle until the results confirm cleanliness. Other techniques, such as TOC swab analysis, are more mobile, faster, and can even be handheld to deliver a result on the production floor, but sacrifice performance with speed.Read More On FDA Guidance Cleaning Validation
HPIMS provides significant manufacturing savings alongside trustworthy results, fast.Learn More
(Excellims) Electrospray Ionization HPIMS performs well versus HPLC for cleaning verifications. (It provides) more rapid analysis of samples with very good sensitivity and comparable resolving power (to HPLC systems).