Take a look at what happens behind the scenes of a facility maintenance shutdown. Facilities that go without a maintenance shutdown could suffer system breakdowns at the most inconvenient time – like while processing a batch worth millions of dollars. If your facility’s heating, ventilation and air conditioning (HVAC) system breaks down during processing, your manufacturing environment can be compromised, which could then compromise your product.
From an equipment standpoint, if a fan should stop working or if belts are not properly aligned, it could damage your system -- at a significant cost – as well as impact the cleanliness of your facility.
Typically, during a facility shutdown, maintenance should be performed on the following systems: HVAC; water systems: reverse osmosis deionized water (RODI) and/or water for injection (WFI), compressed air/gas systems, steam systems and other utilities. This is a good time to test your backup generators and uninterruptable power supply (UPS) systems as well.
There are some other basic facility maintenance steps that should be planned during this downtime as manufacturing facilities all sustain a certain amount of wear and tear that may need repairs. Take a look at the walls and floors for any significant damage and schedule any needed repairs.
Use this opportunity to take a look at your process systems as well. They could require minor or major annual, semi-annual or bi-annual maintenance during this maintenance shutdown. With Biologics facilities, take a look at bioreactors, filtration systems, and chromatography skids, while at pharmaceutical facilities, it might be synthesizers and separation systems. In addition to required maintenance, you can also use this facility downtime to make any desired modifications or upgrades to systems.
Maintenance shutdowns are typically scheduled for two to four weeks’ time, although this will vary depending on the size of the facility and the demands of the manufacturing schedule. It is important that the maintenance activities are planned to ensure that the events go as smoothly as possible. To ensure all repairs are made during this important time, it is best to contact your service vendors in advance so they can schedule time to be available onsite during your shutdown.
Schedule your planning and coordination meetings as it is important to involve the different facility stakeholders. Arrange for planning meetings with the stakeholders to discuss any proposed projects and their impact to the shutdown. Develop a schedule of activities and ensure that it is communicated throughout the organization. Schedule daily coordination meetings to track activities as they occur and make updates to the shutdown schedule.
Allow time for a restart of your facility and process systems and be on alert for issues. Schedule the cleaning and environmental monitoring for the manufacturing areas as this will likely be required before the facility is released for manufacturing.
By planning your facility shutdown in advance, you can look forward to a smooth shutdown, longevity of your systems, smooth uninterrupted operations, maximum efficiency, and cost savings to your systems by preventing expensive repairs and facility downtime.
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What are the next steps?
Having read our first 3 blogs to become familiar with the FDA’s recent Guidance for Industry Process Validation: General Principles and Practices (January 2011), you now need to start thinking about where you and your company go from here to align your organization and process validation activities with the new guidance.
Recommended NEXT STEPS to help you:
1. Build your knowledge base early. A successful validation program relies on information and knowledge obtained early from product and process development. This knowledge and understanding is the basis for establishing your approach to controlling the manufacturing process through continued process verification to produce products with desired quality attributes.
2. Understand the sources of your variation and the impact this variation has on your process and product. Detect the presence and degree of variation in your process. Control your variation proportionate to the risk it poses to your process and product.
3. Develop and implement a Risk Management program. Establish procedures, train personnel, and document and manage your risks in a risk management plan to reduce, eliminate, or accept process risks.
4. Use a Lifecycle Approach. Process validation activities occur over the lifecycle of the product and process from Process Design (Stage 1) to Process Qualification (Stage 2) to Continued Process Verification (Stage 3). Science and process understanding will increase through the lifecycle.
5. Perform process monitoring to continually analyze your product and process data to ensure a state of control. This will eliminate the need for revalidation. Opportunities for process improvements can be identified, evaluated and implemented.
6. Use an integrated team approach to Process Validation. Include subject matter experts from various disciplines including process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing, and quality assurance. Project plans with full support of senior leadership are important to success.
7. Plan and conduct all studies using sound science, appropriately documented, and approved per established procedures throughout the product and process lifecycle.
8. Develop an ongoing program to collect and analyze product and process data as required per 211.180(e). The data should include process trends and quality of incoming materials, in-process materials, and finished products, and be statistically trended and reviewed by trained personnel. A statistician or person trained in statistical process control is recommended.
9. Identify gaps in your existing process validation procedures and implement a plan to revise them appropriately to meet the expectations in the new guidance.
10. Prepare to address questions and show documented evidence to demonstrate that your manufacturing processes have been validated and are in a state of control though continued process monitoring.
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