Remember that USP sets minimum standards and that it is up to each facility to assess situations and go beyond the minimum when needed. USP 2021 revision states that prior to introducing a “component” into the clean side of the anteroom that it must be wiped down with a sporicidal, EPA-registered disinfectant OR sterile IPA 70%. Note: The choice of product is given. In this brief post, we will discuss why sterile IPA 70% should not be considered as first line defense prior to introducing items into anterooms.
When items are delivered and stored in an uncontrolled environment (the general facility), they can be contaminated with just about any microbial organism. Not being cleaned and disinfected properly could lead to contamination of sensitive areas of controlled environments.
For example, if the item is removed from a refrigerated tote there is potential risk of contamination with gram negative rods, molds, fungus (all highly pathogenic organisms) due to moisture. Another example is risk of contamination from spores-forming organisms and molds, among other organisms, from items removed from corrugated boxes.
IPA 70% Should NOT be Considered First Line:
IPA 70% has limited germicidal coverage with varied dwell times and it does nothing to remove spores. Staff and SOPs should be aligned to mandate use of a sporicidal and EPA-registered disinfecting agents prior to introduction of any item into the anteroom. Otherwise stated, all components introduced into the anteroom should be cleaned and disinfected with a full spectrum [surfactant + germicidal + sporicidal] to reduce the possibility of introducing contamination of highly pathogenic organisms that may be easily spread to other areas.
Once cleaned (with dwell times observed) and introduced into the anteroom, under perfect circumstances, the compounder is free to take the product, wipe it down with sterile IPA 70% (to remove cleaning residues) and introduce it into the primary engineering control (PEC).
However, because the anteroom serves many functions, which can contribute to microbial contamination to the environment (staging, garbing, labeling, hand hygiene, etc.), if the item remains in the anteroom for some unspecified amount of time (e.g. staging for batches, etc.) then those items need to be wiped again with sterile IPA 70% at a minimum prior to introducing it into the buffer room. Other products may be used as well but at minimum Sterile IPA 70% should be used. Then, of course, as always, prior to introducing anything into the PEC, items must be wiped with sterile IPA 70%.
The key is that all items introduced into the controlled environment will be wiped down twice at a minimum. Initially with a [surfactant+germicidal+sporicidal] then again with sterile IPA 70%, understanding that at any time contamination is suspected, the item must be cleaned again.
Would you willingly swim with angry sharks? Sharks that are agitated and uncontrolled are unpredictable. Not many would take the risk by tempting fate.
Use of IPA 70% will remove most organisms but there is always a possibility of breakthrough contamination due its incomplete germicidal profile. It is the compounders responsibility to ensure quality of sterile compounded preparations by eliminating all known contributing factors that may lead to contamination.
Comments