Seamlessly Transition to a Cleanroom Suite

July 2022 - Vol.19 No. 7 - Page #18
Category: Cleanroom Design & Consulting

Transitioning from a compounding aseptic isolator (CAI) to a full cleanroom suite is an upgrade that requires many considerations. The build itself requires thoughtful attention to details such as placement of power outlets and cabinetry, as well as what build materials will best suit the facility’s compounding needs. Equally important is preparing staff for the new policies and procedures that will accompany this change.

After years of performing all sterile compounding in CAIs, Jersey Shore University Medical Center in Neptune, NJ (see the SIDEBAR) upgraded to a new state-of-the-art full cleanroom suite.

To safely meet patient needs and to align with current regulatory requirements, a fully-functioning, USP <797> and <800> compliant cleanroom suite was designed and built over the course of 5 years. Construction occurred in adjacent rooms while compounding was still being performed in the isolators. Once the NJ Board of Pharmacy granted approval to begin using the cleanroom, the isolators were decommissioned, and the team transitioned completely to the cleanroom. Compounding isolators are still in use in a pediatric and ICU satellite.

St. Patrick’s Day 2022 marked a successful year of compounding in the new workspace, but luck had little to do with the success. The transition from CAIs to cleanroom suite requires conscientious planning, thorough education and training, and continuous evaluation and modification of practices.

Preparing for a Cleanroom Environment

In order to ensure a successful transition, it was necessary to train staff in the required practices and appropriate behaviors needed in the cleanroom environment prior to construction. These practices include hand hygiene, garbing, and the appropriate transfer of materials into and out of ISO classified environments.

Hand hygiene and garbing are arguably the most important practices for minimizing contamination of CSPs. Requirements for these practices differ in the level of strictness depending on where compounding occurs. The current version of USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations states full garbing is required when compounding in a CAI “unless the isolator manufacturer can provide written documentation based on validated environmental testing that any component(s) of PPE or personnel cleansing are not required.”1 The manufacturer of the CAIs in use at JSUMC provide statements in their operation manuals noting all components of standard garb are not required. However, in advance of the transition to a cleanroom, the team was required to utilize full hand hygiene and garbing, including shoe, head, and facial hair or face covers as if they were already compounding in a cleanroom. This made these components of the overall process routine by the time the cleanroom was in full use.

Advanced preparation and practice should also be used for cleaning and disinfecting. When using CAIs, compounding materials had been disinfected with sIPA just prior to being introduced into the transfer chamber. To train the team in the new practices employed in the cleanroom, a more robust cleaning and disinfecting process was established (see FIGURE 1). At JSUMC, it was determined that the best practice for moving materials into the cleanroom is a two-step process:

  1. All materials are first wiped down with a low lint wipe presaturated with an EPA-registered one-step disinfectant cleaner in the workroom, then transferred into the buffer room.
  2. Once inside, the items are wiped down again with sIPA just prior to being introduced into the ISO Class 5 environment of the LAFW.
     

Click here to view a larger version of this FIGURE.

Ingraining these procedures on a daily basis proved invaluable, as they were then seamlessly transferred to the new cleanroom environment.

Just as the compounding team was being trained in new techniques and workflows, pharmacy leadership also had to learn new cleanroom processes to ensure compliance with all regulatory requirements. The sterile compounding supervisor sought education, training, and guidance from a variety of resources including live, multi-day educational programs, webinars from Pharmacy Purchasing &Products, and personal communication with a number of experts in the sterile compounding industry.

Developing SOPs

The transition to the cleanroom requires a structured approach which can only be accomplished by developing detailed SOPs for each aspect of the sterile compounding process. The JSUMC SOP manual had to be completely overhauled, as many of the processes changed significantly. Once SOPs are developed, they must be continually refined as the team gives feedback on more efficient processes. The new SOP manual at JSUMC was reorganized into broad categories:

  • Regulatory Requirements
  • Facilities Management
  • Team Members
  • Materials
  • Compounding
  • Cleaning
  • Hazardous Drugs
  • Emergency Compounding

Although many of the previous versions of SOPs were easily translatable for use in the cleanroom, several had to be revised or created from scratch, including:

  • Hand Hygiene and Garbing: Detailed SOPs were developed that describe each step of the hand hygiene and garbing processes in the correct order they are to be performed.
  • Differential Pressure Monitoring: While differential pressure monitoring for CAIs is a best practice to ensure that the equipment is performing properly and maintaining an ISO Class 5 environment, the requirements differ for cleanroom suites. Thus, SOPs were developed that describe the use of continuous monitoring devices. SOPs were also required to detail the team’s response to out of limits alerts and changes to assigned BUDs based on the length of time acceptable differential pressures were not maintained.
  • Environmental Monitoring: For CAIs, surface sampling is straightforward since only the transfer chamber and main compounding chamber must be sampled. For the cleanroom, SOPs were developed to define the increased EM required, including a surface sampling map of the more than two dozen sites to be sampled.
  • Cleanroom Access: An SOP explicitly describing who may enter the cleanroom and under what circumstances had to be developed. This SOP also outlines the hand hygiene and garbing requirements for non-compounding individuals.
  • Cleaning: New SOPs were developed to describe:
    • The selection of cleaning products
    • The individuals responsible for cleaning the PECs, buffer rooms, and anteroom
    • The frequency of cleaning
    • The step-by-step cleaning procedures for each PEC and all ISO classified spaces

SOPs also had to be developed for new technologies that were introduced to the cleanroom for the first time:

  • Cameras: As we had previously not utilized this technology in the cleanroom, SOPs were created to describe the appropriate use of cameras in the new anterooms and buffer rooms. Integral to the training and ongoing quality assurance programs, the cameras are used to review team members’ adherence to cleanroom techniques and practices. Leadership reviews video recordings as a tool to provide personalized feedback to each team member.
  • Pass-Throughs: Likewise, new SOPs were developed for the appropriate use and care of the integrated pass-throughs in both the non-HD and HD buffer rooms.

Workflow

With a change in the compounding setting, there is typically a corresponding need for changes in workflows and staffing. Prior to the cleanroom installation, the compounding teams operated on the day shift as two separate groups—an Adult Compounding Team and a Pediatric Compounding Team. Due to differences in staffing levels, the evening shift operated as a single team. Once the cleanroom was put into use, the team approach was revamped to become an Inside Team (those compounding inside the buffer rooms) and an Outside Team (those handling the medications and materials being transferred into and out of the cleanroom). Staffing levels were increased on the evening shift to support this new approach.

To effectively communicate between the buffer rooms and the workroom, an intercom system was integrated into the construction. However, the team quickly realized that in addition to the intercom, a more efficient means of communication was needed. Hand-held walkie talkies were then purchased and incorporated into the workflow to speed communication.

The line of demarcation (LOD) in the anteroom was originally designed to be incorporated into the flooring material. However, as the team began using the room, it became apparent that a more logical location for the LOD was needed. Cleanroom grade vinyl tape was used to mark the new LOD to provide a more efficient flow in the hand hygiene and garbing procedures.

HEPA-filtered pass-throughs with interlocking doors have been essential to the efficient exchange of medications, materials, and supplies into and out of the buffer rooms.

While there is always a pharmacist inside the buffer room to check all phases of sterile compounding, large glass windows were installed between the cleanroom and the workroom. This allows for visual observation of team members’ behaviors and activities, such as cleaning, from outside the controlled areas. In addition to the cameras inside the rooms, these windows allow for ongoing monitoring, training, and re-education as part of the overall quality assurance program.

Process Improvements

Once the cleanroom is in use, it is important to consistently review processes and procedures to ensure that they help maintain a safe and efficient workflow. As the first year progressed at JSUMC, it became apparent that certain areas of the new process needed improvement. To ensure that team members performed the hand hygiene and garbing steps completely and in the correct order, a numbering system was instituted (see FIGURE 2). Each step of the process was numbered with a laminated placard hung on the cleanroom wall.

Education and follow-up knowledge assessments using Google Forms have become an integral part of the ongoing training and process improvement. When it became apparent that the PECs were not consistently cleaned in the proper manner, a Google Form was created. The form contains a link to the relevant SOP, a stepwise description of the cleaning process, and a schematic diagram of a hood showing the order of cleaning.

Next Steps

As successful as the first full year of use has been, JSUMC’s cleanroom remains a work in progress. The team is not satisfied with meeting the minimum requirements and competencies. Rather, patient safety is the ultimate goal, which requires a high level of proficiency in all aspects of the sterile compounding process. In striving for this proficiency, several objectives have been identified and steps outlined to achieve these aims:

  • Providing ongoing education by engaging outside consultants on a variety of topics, including cleaning and environmental monitoring techniques.
  • Increasing the number of sterile compounding team members to allow the cleanroom to be in operation 24/7.
  • Creating a video-learning series for hand hygiene and garbing, sterile compounding techniques, and cleaning practices using our own facility and equipment to make the learning more relevant and effective.

Conclusion

One full year of compounding in the cleanroom suite has been a successful and rewarding endeavor for the sterile compounding team at JSUMC. However, the pathway to that achievement began long before the facility’s inauguration. A team’s dedication to patient safety and willingness to learn new processes and continually improve is intrinsic to ensuring ongoing success.


Michael Winstanley, RPh, BCSCP, is the sterile compounding supervisor at Jersey Shore University Medical Center.

 

Jersey Shore University Medical Center (JSUMC) is a non-profit research and academic medical center located in Neptune Township, NJ, serving the diverse populations of central and southern New Jersey. JSUMC is the region’s first university-level academic medical center, and the only Level I Adult and Level II Pediatric Trauma Center in Monmouth and Ocean counties. JSUMC is home to the K. Hovnanian Children’s Hospital. JSUMC is part of Hackensack Meridian Health and is the network’s second largest medical center. JSUMC is affiliated with several medical schools including Hackensack Meridian School of Medicine and offers an ASHP-accredited PGY-1 Pharmacy Residency Program.

The pharmacy department’s sterile compounding program serves the needs of a broad variety of individuals across inpatient and outpatient settings. In addition to routine sterile compounding for inpatients, compounded sterile preparations (CSPs) are provided to patients in adult, pediatric, and neonatal ICUs, outpatient oncology and infusion therapy patients, a busy Multiple Sclerosis Center, and a new Leukemia/Bone Marrow Transplant Center.

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