Routine and intermittent cleaning and disinfecting of environments are essential to overall environmental control however, it would be incomplete not to address how to properly introduce items from uncontrolled environments into the controlled environments of the IV room. People and items brought into the environment are the largest contributing factor for excursions and loss of environmental control. Insufficient cleaning and disinfecting of items introduced into controlled environments will quickly lead to excursions and/or loss of environmental control.
When items are stored in an unclassified area (the general facility), they can be contaminated with just about any microorganism imaginable. Insufficient cleaning and disinfection can lead to contamination of critical areas that will quickly spread contamination throughout the controlled environment. For example, items removed from a refrigerated delivery tote carries risk of contamination with gram negative rods, molds, fungus (all highly pathogenic organisms) due to moisture or items removed from corrugated boxes are known to be contaminated with molds and other spores-forming organisms. Careful consideration must be made to cover all potential sources of contamination prior to introducing items into the controlled environment.
USP <797> sets minimum standards but it is up to each facility to assess needs to go beyond the minimum. USP <797> revision 2023 gives a choice of using either a sporicidal OR an EPA-registered disinfectant ORsterile IPA 70% prior to introducing a “component” into the clean side of the anteroom. However as addressed in a previous blog post (see link below), sterile IPA 70% would not be a good choice for first line cleaning and disinfecting due to its incomplete microbicidal and sporicidal profile. Best practice would be to align staff and SOPs to mandate the use of a one-step EPA-registered sporicidal disinfectant cleaner prior to introduction of any item into the anteroom as referenced in Table 4.
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 an item remains in the anteroom for some unspecified amount of time (e.g., staging for batch that will take place later, etc.), it should be wiped again with a cleaning agent (sterile IPA 70% at a minimum prior to introducing it into the buffer room). Then, as always, prior to introducing anything into the PEC, items must be wiped with sterile IPA 70%.
Minimum standards for cleaning and disinfecting controlled environments and items that are introduced into those environments are essential to environmental control, but often best practices must be put into placed to achieve the required control to provide safe quality compounded sterile products. It is the compounders responsibility to ensure quality of sterile compounded preparations by eliminating all known contributing factors that may lead to contamination.
Referenced Blog Post:
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About the author: Steve Milstead is a Board Certified Sterile Compounding Pharmacist (BCSCP) and the founder of Soigner Solutions (Soigner Universal, LLC). Collectively, Steve has over 20 years experience in sterile compounding of non-hazardous and hazardous preparations (including non-sterile to sterile using API). He is also experienced in non-sterile compounding and has fully developed and implemented all-inclusive compounding programs including USP <800> hazardous drug programs since the release of <800> in 2016. Steve received his Doctor of Pharmacy degree from McWhorter School of Pharmacy and holds two other degrees from Samford University and Université Sorbonne.
Thank you for visiting my site. For more information please visit www.SoignerSolutions.com or email me directly at smilstead@SoignerUniversal.com
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