The Enterey Blog

Behind the Scenes of a Facility Maintenance Shutdown

Posted by Tita Tavares on Tue, Jan 10, 2012 @ 10:11 AM

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.

Facility Shutdown Behind the Scences 

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.

Industry example:
Read about Ben Venue's extension of their manufacturing maintenance process.


Click here for latest industry news.
Published by Murtaza Kapadia | Senior Manager, Enterey

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Next special article blog:
Agency Inspections Are On the Rise


Tags: Enterey, Facility Maintenance Shutdowns, Facility Maintenance, Manufacturing Process

The Importance of Scheduling Facility Maintenance Shutdowns

Posted by Tita Tavares on Fri, Dec 09, 2011 @ 11:30 AM

We’re all aware that we need to perform periodic recommended maintenance on our vehicles, such as oil changes for our cars every 3000 miles. What’s the worst that can happen if we skip these?  A potentially hefty repair bill at the mechanic shop if not caught in good time, or the worst case scenario – the annoyance of a breakdown on the side of the road.

 Facility Shut Down  

Similar to our cars, manufacturing facilities require periodic maintenance.  Most facilities are shutdown every 6-18 months to perform preventative maintenance or repair tasks on facility and utility systems.  What’s the worst that can happen if these are skipped?  There’s probably no significant damage to systems if caught in relatively short time.  But despite the low risk, there is a possibility of failure of equipment and systems when operating outside of the manufacturers’ recommended maintenance intervals.  These repairs can cost a significant amount of money, cause facility downtime, and most importantly potential contamination or loss of product. Most importantly, it will also require a resource draining assessment of the impact to manufacturing processes and products.  

Knowing this, the U.S. Food and Drug Administration requires that facilities and equipment be maintained and kept in good repair in 21 Code of Federal Regulations (CFR) Part 110.  One manufacturer, a pharmaceutical manufacturing facility in North Carolina, who ignored this warning learned the hard way when in November of 2007, they underwent an inspection by the FDA.  The inspector found environmental monitoring excursions in the purified water loop dating back to February and March of 2007 – eight months earlier. 

While the company noted that a modification to the purified water loop would correct the problem, the necessary parts had not been ordered or installed.  In fact, the company waited until June 2008, during the plant’s semi-annual plant maintenance shutdown, to install it.  In the meantime, production was compromised by this and other issues which they failed to address or rectify.

As a result of this and other significant violations, the FDA issued a warning letter and advised the company to take prompt action to correct all deviations. Failure to do so would result in regulatory action including seizure and/or injunction.

Had this company taken the necessary steps to schedule the maintenance and modification of their purified water loop during their annual or semi-annual plant maintenance shutdowns, they could have identified issues causing the environmental excursions, then successfully taken corrective action.  Their inspection would have gone smoother and they could have avoided receiving the dreaded “483 - FDA Warning Letter” and the prospect of fines, penalties and expensive repairs.

Most importantly, they would not have compromised their manufacturing facility with potential contaminants which could lead to risks for patients, loss of contracts, the destruction of inventory, and a public relations nightmare.

By scheduling periodic facility maintenance shutdowns, complete preventative maintenance designed to improve equipment life can be performed along with any modifications and system updates.  With the appropriate time afforded for a shutdown, operations can be expected to run at the greatest efficiency, eliminating or minimizing the need for unplanned facility downtime.

To ensure the longevity of your operations, schedule your facility maintenance shutdowns. You’ll sleep better knowing that all systems are on track.


Click here for latest industry news.

Published by Murtaza Kapadia | Senior Manager, Enterey


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Next week’s blog:
A Look at What Happens Behind the Scenes of a Plant Maintenance Shutdown


Tags: 483 FDA Warning Letter, Corrective Action, Facility Maintenance Shutdowns, Facility Maintenance, Regulatory