In this two-part series, we will explore strategies to keep the IV room free of contamination, with a focus on electronic checklists. In Part I, we will discuss training checklists for keeping the IV room clean. In Part II, we will discuss daily, weekly and monthly checklists for keeping the IV room pollutant-free.
Cleanrooms ensure that contaminants like dust particles are not present in products that are later administered to patients. To this end, the concentration of airborne particles is controlled to specified limits, and the particles are continually removed from the air supply. Contaminants can come from several different sources, including:
In addition, controlling contaminants requires tight regulation of various air quality factors, such as:
In the United States, the Food and Drug Administration (FDA) applies the International Organization for Standardization (ISO) classifications to meet the ISO 14644 requirements. The FDA’s standards classify any airborne particles at the threshold of ≥ 0.5 μm, with the in-operation maximum concentration limits differing based on the ISO classification number:
Maintaining these standards requires regular monitoring, as well as detailed procedures to ensure that the introduction, generation, and retention of particles are kept to a minimum.
The most important factor in keeping the IV room free of contaminants is ensuring that personnel are adequately trained and educated. This education should cover both the importance of keeping the IV room clean, as well as the proper procedures for doing so. The training should be fully documented and certified within the facility, ideally with a web-based tracking system. This allows for convenient tracking and reporting of training documentation as well as initial and ongoing staff competencies.
Ideally, training will include both didactic and practical components. A sample training checklist for the initial training is as follows:
Following the didactic training, the trainee should be given a written or electronic sterile compounding quiz. The trainee should not be allowed in the IV room unless s/he receives a passing score on the quiz. A quiz should be repeated at least annually, and/or as needed to reinforce training in the interim.
These tests may be administered in electronic form, which can make it easier to store and track results. The tests should include questions specific to IV room contamination protocols, such as:
Practical training protocols will vary widely depending on the facility. However, it is important that the trainee not be allowed to make a sterile preparation until the practical training has been completed and a practical training assessment has been passed. Relevant to avoiding contamination, the assessment checklist should include components ensuring the trainee’s:
In addition, the practical training assessment should evaluate both:
Appropriate training is the first step in ensuring that personnel will be able to maintain a clean, contaminant-free IV room. By ensuring proper protocols and documentation of training and regular testing, your personnel will be able to complete appropriate procedures, including daily, weekly, and monthly cleaning.
This series will continue with Part II, in which we will discuss daily, weekly, and monthly cleaning checklists.
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International Organization for Standardization. “Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness.” 1999. Retrieved from: https://www.iso.org/obp/ui/#iso:std:iso:14644:-1:ed-1:v1:en
Food and Drug Administration. “Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice.” 2004. Retrieved from: https://www.fda.gov/media/71026/download
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