Released August 2024

Aseptic Technique Vigilance: Beyond Compliance

In the world of pharmacy, particularly in highly clinical settings, the emphasis is often on regulation and compliance security. While compliance with our Standard Operating Procedures is essential, it is equally important to periodically observe the actual compounding process as it takes place. This observation helps establish whether our “state of control” in operator practices truly aligns with a culture of patient safety. Here, we will explore a few essential areas to focus on to polish aseptic processes in hospitals and infusion centers.

Disinfecting Objects Prior to Introduction into PECs

Disinfecting objects before introducing them into Primary Engineering Controls (PECs) is a fundamental practice that must be rigorously adhered to, especially during busy periods. Supervisors or lead technicians should continuously observe this practice to ensure consistency and thoroughness. Proper disinfection prevents contamination and upholds the integrity of the sterile environment.

Maintaining Hand Hygiene Throughout the Compounding Process 

Hand hygiene is a critical component of aseptic technique. It is imperative that gloves are changed every time an operator leaves the buffer zone and returns to the compounding area. This practice minimizes the risk of contamination and helps ensure the compounding process remains sterile from start to finish. Regular observation and reinforcement of this practice by supervisors can significantly enhance overall hygiene standards.

Simultaneous Compounding of Multiple CSP Types

Compounding multiple types of CSPs (Compounded Sterile Preparations) simultaneously can be a source of contamination if not managed correctly. It is essential to check if more than one CSP type is being compounded at the same time and ensure that proper separation and line clearances  occur between CSPs of different drug or concentrations and compounding protocols are followed. This practice reduces the risk of cross-contamination and helps maintains the safety, integrity, and sterility of each preparation.

Understanding Zones in the PEC

Operators must have a clear understanding of which zones in the PEC are designated as Direct Compounding Areas (DCAs). They should also know where to place wrappers and components to avoid contamination. Proper zoning within the PEC ensures that sterile items remain uncontaminated and that the compounding process adheres to aseptic principles.

Horizontal and Vertical Flow Dynamics

Understanding the difference between horizontal and vertical laminar flow dynamics is crucial for proper hand positioning and component placement. Horizontal flow moves air from the back to the front of the PEC, while vertical flow moves air from the top down. Proper technique involves placing hands and components in a way that does not disrupt the airflow and cause turbulence, which can lead to contamination. Training staff on these dynamics and observing their application can significantly enhance aseptic technique.

Workflow Management Hardware

Is your workflow management hardware (e.g., touch screen or scanner) within the PEC or on worst than ISO-5 air? If so, it can really be an issue with gloved-hand hygiene during compounding. It is also essential to ensure that the hardware does not obstruct the airflow or become a source of contamination. Assessment and adjustment of the placement of hardware can help maintain asepsis during compounding.

Impact on Preparation Time

Adhering to strict aseptic techniques can add to the preparation time of CSPs. It is crucial to evaluate how much time these practices are adding and to find a balance between efficiency and safety. For emergently needed CSPs that may save life, limb, or brain, policies should be in place to address immediate-use practices and the appropriate locations where emergent compounding may occur. Developing a clear policy for compounding in non-classified pharmacy areas during emergencies ensures that patient outcomes are enhanced and safety is not compromised.

Continuous Training and Communication

Regular discussions between technicians and designated persons (DPs) regarding aseptic technique in general: manipulations, holds, transitions between holds, connections, penetrations and use of specific compounding devices, should be common practice. These discussions foster a deeper understanding of aseptic techniques, standardize workflow process, and encourage the sharing of best practices. DPs should also enter the room daily to observe staff and ensure optimal working conditions. This presence demonstrates a commitment to maintaining a high standard of aseptic technique on the part of leaders.

Engaging Compounders

Engaging compounders in the process of fostering a culture of safety is vital. Encouraging them to share their best practices and experiences can lead to the development of work practices as well as effective and engaged teams. Creating an environment where compounders feel comfortable discussing challenges and solutions promotes continuous improvement. Rewarding compounders for contributions and giving them a voice fosters job satisfaction.

Regular Observation and Feedback

Supervisors and lead technicians should regularly observe compounding practices and provide constructive feedback. This ongoing observation helps identify areas for improvement and reinforces the importance of maintaining aseptic techniques. Providing regular feedback ensures that staff remain vigilant and committed to upholding the highest standards of patient safety. These conversations, whether to correct or praise an employee should be documented, filed and followed upon.

Conclusion

Polishing aseptic processes in hospitals and infusion centers requires a combination of strict adherence to protocols, continuous observation, and a commitment to fostering a culture of safety. By focusing on critical areas such as disinfecting objects, maintaining hand hygiene, understanding PEC zones, and balancing efficiency with safety, we can ensure that our compounding practices not only comply with regulations, but also protect patient health. Engaging staff in continuous training and communication, along with regular observation and feedback, will further enhance our aseptic techniques and contribute to a culture of patient safety.

About the Author

Luis Hernandez, RPh, BCSCP, is a certified sterile compounding pharmacist and the founder of Seven97 Training Solutions. Dedicated to advancing USP 797 pharmaceutical training, validation, and certification, Luis aims to promote and inspire excellence in aseptic processing, medication and patient safety, and regulatory compliance.

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