Keeping the IV Room Free of Contaminants: Part I

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:

• People:

• Processes

• Facility

• Equipment

In addition, controlling contaminants requires tight regulation of various air quality factors, such as:

• Airflow rates

• Airflow direction

• Pressure

• Temperature

• Humidity

• Specialized filtration

ISO Classifications

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:

• ISO Class 5: maximum of 3,520 particles per m³ of air

• ISO Class 6: maximum of 35,200 particles per m³ of air

• ISO Class 7: maximum of 352,000 particles per m³ of air

• ISO Class 8: maximum of 3,520,000 particles per m³ of air

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.

IV Room Training Procedures

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:

Didactic IV Room training

• Review video presentation on aseptic compounding

• Review video on USP <797>

• Review written facility standard operating procedures on pharmaceutical compounding

• Review owner’s manual for laminar flow hoods

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:

1. How long can a single-use vial be used after the initial needle puncture after exposure to ISO Class 5 air?
   1. 1 hour

   2. 6 hours

   3. 8 hours

   4. 24 hours

2. How often should anteroom storage shelving be emptied of all supplies, cleaned, and sanitized?
   1. Daily

   2. Weekly

   3. Monthly

   4. Annually

3. Each laminar flow workbench should be certified for air quality and performance at least ___?
   1. Weekly

   2. Monthly

   3. Semi-annually

   4. Annually

4. What item may be reused if it is removed at the cleanroom entrance, with the stipulation that it only be reused during the same shift?
   1. Hair cover

   2. Gown

   3. Shoe cover

   4. Face mask

Practical IV Room training

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:

• Appropriate attire, including garbing order, no jewelry, no makeup (including nail polish), and no electronics

• Hand hygiene

• Appropriate donning and disinfecting of sterile gloves

• Ability to assess and troubleshoot basic problems with the room’s engineering controls

• Ability to maintain quality controls

• Ability to identify and appropriately carry out routine cleaning procedures at the proper times (e.g. daily mopping)

• Ability to carry out cleaning procedures in the proper order (e.g. cleanest space to dirtiest space)

• Ability to use cleaning products in the proper order (e.g. germicidal agent followed by 70% isopropyl alcohol)

• Aseptic technique

• Ability to describe the airflow of the hood and the concept of first air (the undisrupted, unidirectional air that comes directly from the HEPA filtration source)

• Ability to use and empty waste containers

In addition, the practical training assessment should evaluate both:

• A media fill test, with a 14-day incubation and passing if the fill contains no turbidity at the end of the timeframe

• Glove tip sampling after handwashing, ideally completed 3 times with a passing score if the sample contains zero growth

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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References:

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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