Cleanroom start-up and shutdown (SU/SD) interrupt process flow and carry heightened contamination risks. Whether your SU/SD is scheduled or due to an unplanned event, having a detailed plan in place can help you maintain control over the cleanroom environment and facilitate a smooth return to operations. This guide covers the essential steps in planning, assessing risks, implementing controls, and minimizing contamination.
- Planning for a Cleanroom SU/SD
Careful planning is the foundation of a successful SU/SD process. Start by creating a checklist of tasks and responsibilities specific to your facility’s needs to create an official SOP that can be acted on in an emergency. Here are a few steps to consider:
- Define Procedures: Clearly document each step of your SU/SD protocol, including timelines, roles, and requirements. Detailed planning is essential to avoid last-minute challenges.
- Assign Roles: Designate tasks for each team member, from surface cleaning to environmental monitoring, ensuring they are trained and ready.
- Stock Supplies: Make sure you have enough cleaning agents, gowning materials, and inspection tools on hand for emergencies. During this time, machines that are not frequently started/stopped are more prone to experiencing technical difficulties. Ensure the long term health of your machines by using this time to your advantage.
- Clear Visual Communication: Ensure effective communication for all involved by using clear signage to indicate access restrictions, even if it’s as simple as paper notices on doors. Include contact information for the person responsible for the shutdown and update timelines as frequently as possible to keep everyone informed.
- Understanding the Risks of Cleanroom SU/SD
Shutdown and start-up processes inherently disrupt normal operations, making cleanrooms vulnerable to contamination. Risks include:
- Increased Particle Load/Uncontrolled Airflow: When HVAC and filtration systems are paused, dust and particulates can settle on surfaces and equipment. Plan for a full cleaning before systems come back online. Reinforce to leadership the unique opportunity a shutdown provides for deeper maintenance.
- Human Error: Personnel might unintentionally introduce contaminants if they aren’t diligent about gowning protocols. SU/SD often involves new faces or vendors in the cleanroom, making strict adherence to protocols even more essential.
- Environmental Factors: Temperature and humidity fluctuations during shutdowns can promote microbial growth. Consider using commercial-level solutions like silver ion sprays or UV-C lights for added microbial protection.
- How to Mitigate Contamination Risks
When working at an operation at the size of a cleanroom, plans need to be proactively implemented and approved to be functional enough to reduce contamination risks during SU/SD. Here are some base strategies to stay on top of it:
- Surface Cleanliness: Deep clean floors, walls, and equipment both before shutdown and after start-up. If time is an issue, cleaning surfaces at the end of the shutdown can help reduce EM hits in the coming days.
- Equipment Calibration: Cleanrooms don’t often have downtime where you can freely plan to work on less pressing tasks. Use any time you have to reasonably test and calibrate systems (air filtration, equipment, water & hookups, EM) to help avoid additional SU/SD in the future due to equipment failure.
- Monitor the Floor: 80% of contamination comes in at the floor level. Mitigate this risk by placing contamination control mats like Dycem at all critical entry points to trap contaminants from foot and wheel traffic. Antimicrobial protection in these mats can help protect from microbes.
- Strict Gowning Protocols: Ensure staff follow proper gowning procedures, wearing clean and appropriate garments to reduce contaminants from skin and clothing. If necessary, increase gowing requirements to protect against unforeseen events. If outside workers are entering the space, it’s a good time to revisit or monitor your training/notices for gowning protocol to see how effective current processes are.
- Regular Environmental Monitoring (EM): Conducting particle counts and microbial testing during SU/SD to ensure environmental conditions remain within required limits can be challenging if major systems are going to be offline. Avoid shutting off your EM systems (unless they are what’s under construction) as they will always provide you with data points for the new scenario.
- Reliability Programs to Decrease SU/SD Risk
Reliability programs are essential for maintaining consistent contamination control. Proactively integrating these programs into the workflow can help cleanrooms minimize the disruptions that SU/SD events pose:
- Preventive Maintenance: Schedule regular equipment and HVAC inspections can prevent unexpected shutdowns and give you information on how often inspections need to (not required to) take place based on the inspection results.
- Training and SOP Development: Train personnel regularly on contamination control best practices and ensure standard operating procedures (SOPs) are followed consistently. A training portal and accurate recording keeping keep the staff and facility up to standards. Remember, standards are the minimum that needs to be met, its required to meet the standard, its impressive when they’re surpassed.
- Continuous Environmental Monitoring: This one is a given. If you aren’t using EM full time, then you should absolutely use EM during shut down periods to monitor for changes. Use continuous monitoring systems that track particle counts and other contaminants, even during shutdown periods if possible.
- Risk Assessments: Regularly evaluate your cleanroom’s risk factors, adapting reliability programs as needs change or new risks arise.
- Why SU/SD Processes Happen
No two SU/SD are the same, Understanding the reasons for SU/SD can help in planning and minimizing disruptions while also giving you warning signs to look out for. Common causes include:
- Scheduled Maintenance: Routine maintenance on equipment, HVAC systems, and other infrastructure. Again, pack in as much maintenance as possible. Routine shut downs around the month of December mean that vendors will fill up fast. Plan 3 to 6 months in advance of this to make sure you can get the teams you need on site.
- Cleaning and Decontamination: Deep cleaning or disinfection processes, especially for facilities that work with sensitive products can take long periods of time. These types of shut downs need extra cleaning materials on hand, not only for the purpose of the shut down, but also for the cleanup after the shutdown in complete.
- Unexpected Repairs: Equipment failure or environmental issues that require immediate attention. You can’t plan for an emergency but you can plan to be prepared.
- An ounce of prevention is worth a pound of cure, don’t get caught with your bunny suit around your ankles!
- Process Changeovers: When switching to a new product line or process, a shutdown might be necessary to prevent cross-contamination and decontaminate the area. This is common in what industries.
- Key Measures for SU/SD Processes
Now that you have a plan in place, are prepared for the unexpected and know the warning signs, we are ready for the actual SU/SD an effective plan and mitigation measures in place, the following steps will support successful SU/SD transitions:
- Surface Cleanliness Verification: Perform a comprehensive cleaning of all floors, walls, and equipment to eliminate contaminants before start-up. Verify this has been completed.
- Check Air Filtration Efficiency: Test air filtration systems to ensure ISO air standards are met before resuming operations. Shutting down air handlers puts a large strain on them when they turn back on.
- Contamination Control Mats: Use Dycem mats or similar products at entry points to prevent contaminants from entering clean areas.
- Proper Gowning Protocols: Confirm that all personnel are correctly gowned before entering controlled environments and trained on how they need to garb into the type of cleanroom.
- Equipment Sanitization: Sanitize all machinery and tools according to protocol to minimize contamination risk. This may not always be necessary based on the production in the cleanroom but if time allows, it’s a good step to add.
- Environmental Monitoring: Conduct particle and microbial testing to verify cleanliness levels before production starts is a MUST. Having to shut down again because EM wasn’t completed can ruin an entire production batch.
- Material Flow Management: Follow strict contamination control protocols for materials entering and exiting the production area during the SU/SD. Changes in process are no time to start getting sloppy.
- Limiting Ingress and Egress: Minimize contamination risks by controlling entry and exit points for materials and personnel. To further reduce traffic in the environment, incorporate trash collection and disposal into the exit tasks of team members, eliminating the need for additional individuals to enter the space.
By developing a thorough plan, understanding SU/SD risks, implementing mitigation strategies, and using reliability programs, you can maintain cleanroom standards during shutdown and start-up processes. With these measures in place, you’ll protect your cleanroom environment and ensure a seamless return to safe production.
References
- https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/bringing-a-cleanroom-online.pdf?sfvrsn=690f9a8e_1
- https://cleanroomtechnology.com/cleanroom-shutdown-a-necessary-evil–204497
- https://www.wolterskluwer.com/en/expert-insights/unexpected-power-loss-and-shutdown-procedures-in-a-sterile-compounding-facility