Compliant Garbing Practices for Sterile Compounding
By Kate Douglass, MS, RN, CRNI

To protect the sterile compounding environment and ultimately the compounded sterile preparation, hand hygiene and garbing must be performed properly and in the correct sequence. USP has delineated the required processes in Chapter <797> for sterile compounding and in <800> for hazardous drug (HD) compounding; however, the chapters may not provide the granularity needed for practitioners.

1. Don a Hair Cover, Face Mask, and Beard Cover
When entering the anteroom on the dirty side, don a head cover, face mask, and beard cover (if necessary). A mirror placed on the dirty side of the line of demarcation (LOD) ensures staff can verify that both the face mask and hair cover are properly placed and all hair is captured. Face masks can be the tie or earloop type, but must cover the bridge of the nose and be pulled underneath the chin. Face masks must fit snugly so that they do not require adjustment. Always don the face mask so that the pleats on the outside of the mask face down. When the pleats are down on the outside, they are up on the inside, which increases the potential of the pleats to catch contamination. Cleanroom-grade masks, which have a better ability to contain moisture, have a shiny side, which faces outward. Always change your mask if it becomes wet.

2. Don Shoe Covers and Cross the LOD
The LOD must be visibly marked. This is best accomplished using a different color of wide sheet vinyl or poured epoxy to delineate the LOD, or by using different floor colors on the dirty and clean sides. Cleanroom tape can be used for this purpose, but it is considered a temporary solution. Locate a bench or stool straddling the LOD. Place the first shoecover on the foot closest to the LOD and place the covered foot onto the clean side of the LOD. Follow with the second foot.

3. Perform Hand Hygiene
Hand hygiene must be performed and nails must be cleaned with a disposable nail pick. Wet arms and hands up to elbows and lather for 30 seconds. Measure the 30 seconds objectively by observing the second hand on a clock. Washing hands while singing “Happy Birthday” is not objective, and results in various lengths of lather. Faucet operation must be hands-free, and can be accomplished with automatic faucets, foot pedals, or extended wings, which can be operated with one’s elbows.

4. Don Non-Shedding Gown
<797> requires gowns to close at the neck and have elastic cuffs. Use of the yellow isolation gowns is not acceptable, as these do not close tightly at the neck and are not made of low-linting material. For employee comfort, and to prevent the sleeves from migrating out of the gloves, it is helpful to purchase gowns that have an integrated thumb loop. If a thumb loop is not provided, staff can cut a hole or push their thumb through the gown material.

5. Don Sterile Gloves
<797> requires that an alcohol-based surgical hand rub with persistent activity is applied to all the surfaces of the clean hands and allowed to dry before donning sterile gloves in the buffer room. These functions are best performed in a designated space in the buffer room: either at a clutter-free gloving table, or each operator can use the top of the cart they may keep at their workstation. Under no circumstances should the deck of the LAFW be used to don gloves. Apply the alcohol-based surgical hand rub with persistent activity to all hand surfaces and allow to dry, put the thumb loops in place, and don sterile gloves. It is strongly recommended that staff use sized gloves (eg, 6, 7, 7.5, 8, etc, rather than S, M, L) so they can select gloves that consistently fit well and provide manual dexterity. Gloves must have long cuffs so that there is significant overlap of the glove cuff and the gown sleeve.

Kate Douglass, MS, RN, CRNI, is the vice president of CriticalPoint, LLC, and serves as the co-director of the annual USP <797> Compliance Survey.

Although USP details garbing requirements in General Chapter <797> Pharmaceutical Compounding—Sterile Preparations and <800> Hazardous Drugs—Handling in Healthcare Settings, additional clarification may be valuable to practitioners. As such, the following details key points in the garbing process, including step-by-step doffing instructions that are not widely available.

• This article, Part 1, includes best practices for hand hygiene and donning PPE in HD sterile compounding
• Part 2, which will be published in a future issue of PP&P, will include best practices for doffing PPE in HD sterile compounding

Donning Requirements

Donning garb for HD sterile compounding differs depending on whether the pharmacy performs HD compounding in an HD buffer room (ISO 7, negative pressure) or in a containment segregated compounding area (C-SCA; non-ISO classified, negative pressure room with at least 12 air changes per hour). The following steps note the differences as they apply.

A video of proper donning of two pairs of HD gloves is available at the CriticalPoint Web site at: https://www.criticalpoint.info/video/donning-double-hd-sterile-gloves/

Photos 2-5. Don Double Shoe Covers
USP <800> requires the use of double shoe covers when entering HD compounding locations so that upon exiting, the outer set can be properly doffed before entering the anteroom, thus decreasing the amount of HD residue tracked out of the HD compounding area (which is known to be contaminated with HD residue).

To begin, don two shoe covers, one at a time, on the foot closest to the LOD, then place that foot over the LOD and repeat with the second foot.

The use of a plastic, water-resistant shoe cover as the second (outer) shoe cover is strongly recommended. In surrogate testing performed at CriticalPoint, double standard shoe covers did not demonstrate the ability to prevent the absorption of HD drugs through the material, as residue was found on the inner shoe cover after the outer shoe cover was removed. By replacing the outer standard shoe cover with a water-resistant, seamless plastic shoe cover, HD residue was limited to the outside of the outer cover; and the standard shoe covers underneath tested negative for surrogate HD residue.

CriticalPoint is completing a second round of testing on this approach, with the results to be published in a future issue of PP&P.

Chapter <800> requires that gowns used for HD compounding be disposable, back closing, long sleeved, and have closed cuffs that are knit or elastic. These gowns must also be seamless or have taped seams to prevent HDs from passing through. Although <800> does not require coated gowns, the author recommends that only gowns that are polyethylene-coated polypropylene or other laminated material be used. During surrogate testing performed at CriticalPoint on a variety of coated and non-coated chemo gowns, non-coated gowns consistently allowed simulated HD mist and powder residue through the material.

When entering a C-SCA, don a chemo gown. Since the C-SCA is not an ISO-classified area, workers can don a single chemo gown that is suitable for sterile HD compounding, as described above. No regular gown is required underneath.

Photos 9-16. Don Two Pairs of Gloves Tested to ASTM Standard 6978-05
According to USP Chapter <800>, double gloves (two pairs) tested to ASTM Standard 6978-05 must be worn for both sterile and nonsterile HD compounding; when performing sterile compounding, the outer pair must be sterile. Because the outer pair of gloves is removed inside the C-PEC, the author strongly recommends that two pairs of sterile gloves be donned immediately prior to beginning sterile compounding. Prior to donning sterile gloves, an alcohol-based surgical rub with persistent activity is applied; gloves should not be donned until after hands have dried.

It is important to note that USP <800> does not specifically address the fact that staff should not move about any HD compounding environment without wearing some type of hand protection. Chapter <800> requires that ASTM-tested gloves be worn when handling HDs, but compounders should be reminded to wear gloves when entering the cleanroom if they are going to perform non-compounding activities. Per USP <797>, in non-hazardous operations it is acceptable to enter ISO 7 rooms without gloves on and don sterile gloves immediately before compounding. In HD environments, this is not appropriate, as all high-touch surfaces are assumed to be contaminated. Staff circulating in the HD buffer area or C-SCA who are not compounding are urged to don a pair of gloves tested to ASTM standard 6978-05. If that staff member later compounds, it is recommended that they remove those gloves, apply an alcohol-based hand sanitizer with persistent activity, and then don two pairs of gloves tested to the standard.

When donning double gloves for HD compounding, the first pair of gloves must be under the cuff of the hD gown and the second pair of gloves must be place over the HD gown. Begin by pulling up the sleeves of the gown. In this photo, the person is compounding ina  C-SCA so they are wearing a single gown. (If the compounding were to occur in a hazardous buffer room, the operator would pull up the sleeves of the hazardous gown, leaving the non-hazardous gown sleeves in place.)

Next, open two pairs of sterile gloves tested to ASTM 6978-05.

Don the first pair of gloves.

Use sterile paper to pull down the sleeves of the HD gown. Once the paper is used to pull down the first sleeve, that side is contaminated, so do not touch it with your sterile glove. Carefully turn the paper around and transfer hands, holding the sterile side and using the contaminated side to pull down the second sleeve, being careful not to contaminate the glove with the trailing edge of the paper.

Finally, don the second pair of sterile gloves, this time with the cuff over the HD gown.

Regular observation of staff practices is key to ensuring ongoing compliance to proper PPE practices.

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Photos 11-14. Remove the Inner Pair of Sterile Gloves
Remove the remaining pair of sterile gloves by grasping the outside of the first glove with the other gloved hand and pulling it off inside out, placing it in the palm of the remaining gloved hand. Slide your index finger underneath the remaining glove and carefully pull off the remaining glove inside out, making a packet of gloves. Dispose in the trace hazardous waste container.

If leaving the anteroom to move to non-classed space, cross the LOD, remove shoe covers, head, and face covers, and exit the anteroom. If entering the non-hazardous buffer room from the shared anteroom, put the non-hazardous gown back on and enter the buffer room, apply alcohol-based surgical hand rub with persistent activity, and don sterile gloves.

Kate Douglass, MS, RN, CRNI, is the vice president of CriticalPoint, LLC, and serves as the co-director of the annual USP <797> and <800> Compliance Studies.