Potent Compound Containment Monitoring Program
In recent year’s drug discovery and development has been producing compounds of
increasing potency, they show their pharmacological effects at very low doses. These
extremely potent substances are very hazardous, drugs like steroids, hormones,
anti-cancer drugs, as well as drugs like beta-lactam and cephalosporins, which are
known to produce allergic reactions in susceptible populations can cause serious
adverse events at very low levels.
To protect the patients from the occurrence of such adverse events, it is very
important that their manufacturing operations are properly isolated to avoid
cross-contamination in other pharmaceutical products being manufactured in the same
or adjoining facilities.
All pharmaceutical companies are now using state-of-the-art containment systems and
even establishing dedicated manufacturing facilities for such products. Despite the
best of their efforts, cross-contamination can still occur through the movement of
staff, documents, materials, and failure of air handling systems.
The acceptable approach towards containment monitoring is to carry out regular
air sampling and swab sample analysis for detection and quantification of trace
levels off the potent drugs in the adjoining areas and general manufacturing
blocks.
It is recommended that sampling and analysis using validated methods should be
carried out every month for at least three months, then every three months for
the first year, then every six months for the second year and subsequently at
least once every year, to establish the effectiveness of the containment
procedures used in the facility.
We had Arbro has been supporting numerous clients for their containment
monitoring programs. We have established and validated analytical procedures for
quantifying numerous beta-lactam, cephalosporin, and other potent drugs at
ultra-trace levels in slab and air samples using LCMSMS.
We also carry out on-site swab sampling and air sampling using established and
validated sampling procedures as part of your containment monitoring program.