Sterile compounding facility shutdown procedures for power loss events

• Once the power is restored, allow the PEC to run for 30 minutes (or for the timeframe stated by the manufacturer) to restore the ISO Class 5 environment.
• Fully clean and disinfect all interior surfaces of PEC with an appropriate cleaning agent after the designated run time and prior to resuming compounding activities.
• When an outage extends beyond 24 hours, consider recertifying the PEC(s).
• Investigate the power outage event, implement corrective actions, and verify the corrective actions have been effective. Document all aspects of the investigation, corrective action plan, and data collected to verify effectiveness. Retain documentation in a readily retrievable format and location.

Power or airflow outages to SECs only

When the power to the SEC(s) and/or HVAC system is disrupted (impacting airflow and air exchanges, pressure differentials, and/or temperature and humidity) while essential equipment including PECs remain functional:

Note the time of the power and/or HVAC system outage, pressure differentials at all doors, and temperature and humidity readings in all of the rooms

Notify DP or supervising pharmacist

Exit the SEC and restrict or halt movement into and out of the cleanroom suite and minimize movement between rooms in the cleanroom suite; post signage restricting movement into the cleanroom suite entry points

Contact the facilities department or external systems vendors for initial assessment

IF compounding must occur, reclassify the cleanroom suite as a Segregated Compounding Area (SCA). Until the issue is resolved and the cleanroom suite is returned to a state of control, compounding operations are impacted as follows:

• Nonhazardous CSP compounding: Can continue per Category 1 CSP requirements. Assign maximum BUDs of:
• Controlled room temperature: ≤ 12 hours
• Refrigerated: ≤ 24 hours
• Hazardous CSP compounding: Do not continue to compound hazardous drugs without the containment protection provided by the SEC

• Determine the disposition of CSPs and components inside the PEC at the time of the power disruption (see table below).
• Continue to monitor and record the pressure differentials, temperature, and humidity for each room every 30 minutes if restoration is expected within 1-2 hours from the loss of power and/or airflow, and nonhazardous compounding continues during that timeframe.
• If a power outage or airflow system downtime is expected to continue for more than 2 hours, relocate compounding operations during the outage if possible.
• Once the SEC environmental systems have been returned to normal function and pressure differentials at all entry/exits have been restored, document the time systems are restored and the pressure differentials, temperature, and humidity in all areas of the cleanroom suite. Continue to document pressure differentials, temperature, and humidity until they have returned to the required ranges.
• Before returning to normal compounding operations, perform remedial cleaning and air and surface sampling per the recommendations found in the table below:

• Since many facilities do not operate 24/7 and unplanned shutdowns may occur when personnel are not in the facility, the installation of continuous monitoring systems in all critical areas and devices should be considered. This includes pressure differential, temperature, and humidity monitoring for cleanroom suites and temperature monitoring in climate-controlled devices, such as drug storage rooms, refrigerators/freezers, and incubators.
• If a shutdown occurs during unstaffed hours, establish procedures to determine who is contacted and the steps to take. If continuous monitoring is not installed, a conservative approach should be taken, and the assumption made that excursion levels have been exceeded.

Climate controlled devices and equipment (refrigerators, freezers, incubators)

Critical drug storage areas and laboratory equipment, such as refrigerators, freezers, and incubators, should also be monitored over time during a planned or unplanned shutdown. Ideally, refrigerators and freezers should be monitored with glycol-based temperature measuring devices to avoid errant monitoring. Glycol-based devices more accurately reflect temperature changes within a refrigerator or freezer than non-glycol-based devices and can be programmed to show maximum and minimum temperatures for specific time periods (24 hours, etc.). Temperature measuring devices should be maintained according to the manufacturer's specifications, be calibrated and tested to NIST traceable standards annually, and operate on battery power with regular battery replacement.

Facility SOPs should establish acceptable operating minimum and maximum temperature ranges for all climate-controlled devices and medication storage locations within the facility. Ensure that the SOP includes the temperature excursion triggers that would require the relocation of products stored in these locations.

During a planned or unplanned shutdown of climate-controlled devices, the following recommended steps should be taken:

• Record the time of the shutdown
• Record the temperature of the device when the shutdown occurred
• Restrict or halt device access and post signage on the device(s)
• If the source of the outage or temperature excursion is unknown, contact the facilities department or external device technicians
• Monitor the device every 10 minutes and document the temperature changes over time
• When the device temperature exceeds or is soon expected to exceed the acceptable temperature deviation, relocate products to the alternative storage location that meets the required storage condition for the product
• If products were unable to be relocated before the temperature deviation occurred outside the acceptable range, quarantine all products, and determine if the temperature excursion (including duration) has degraded the quality of the product
• If incubators are affected and are being used to incubate surface, air, media fill, or gloved fingertip samples, notify the DP or pharmacy manager responsible for environmental and/or personnel sampling. These personnel must determine whether samples should be rejected and whether resampling needs to occur

If possible, implement technology to facilitate continuous monitoring of all critical devices. Doing so will eliminate questions regarding drug product safety, help during shutdown investigations, and establish greater control over the facility.

The importance of emergency protocols for sterile compounding

In the event of unexpected power loss or planned shutdowns in a sterile compounding facility, it is crucial to have well-defined shutdown procedures to maintain the integrity of CSPs and ensure the safety of patients and staff. By establishing clear operating ranges, implementing continuous monitoring systems, and having robust SOPs in place, facilities can effectively manage power and HVAC downtimes. These measures will help mitigate risks, maintain compliance with regulatory standards, and ensure that compounding activities can resume safely and efficiently once normal operations are restored. Preparing for these scenarios in advance will enable staff to respond promptly and appropriately, minimizing disruptions and maintaining the highest standards of sterility and safety.