Contract Sterilization - Our company is a contract manufacturer

J

Jnks_Meddev

#1
Hello Everyone,

Anyone going through similar situation? Sterigenics had an unplanned shut down in Chicago and our team has plenty of sterilization lots that are stuck.

Thanks!
 
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Golfman25

Trusted Information Resource
#4
This wouldn't have to do with a provider in the Chicago area would it? I think in the case of an unplanned shutdown, some type of emergency procedures/disaster recovery stuff should be in play.
 
J

Jnks_Meddev

#5
sorry, I had misinformation. Just found out that this is related to the Chicago situation.
 

Golfman25

Trusted Information Resource
#6
So for those unfamiliar, a major sterilization provider was forced to shut down by the state. It's a major disruption to medical part providers. One of our customers was lucky enough to start the change process months ago.

I would think contingency plans, if available, should be operative until it can all be sorted out. Not sure what hoops it would entail moving to another location or another provider.
 
J

Jnks_Meddev

#7
Just an update to everyone - Since this was an unplanned shutdown as "sterigenics plant" is no longer in compliance with the ISO 11135 requirements. since this is a site specific failure and the companies are stuck between the state EPA and federal EPA the resolution might take 90days or more.

A new sterilization company will require revalidation and might take a minimum of 3 months. Currently our products that are stuck in the sterigenics facility have been released via single batch process at a different sterigenics location that has the same exact process - location change brings in 30 days FDA reporting (PMA requirement). A 510(K) indicates that any changes in sterilization methods require a special 510(K).

Batch release at a different location is a deviation - this can take a bit of time and can cost more.Our customers need to approve the deviation plan and get our sterilization expert to communicate with the customers to inform them we're on top of everything. Simultaneously we will be setting a course for the future.
 
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Golfman25

Trusted Information Resource
#8
Just an update to everyone - Since this was an unplanned shutdown as "sterigenics plant" is no longer in compliance with the ISO 11135 requirements. since this is a site specific failure and the companies are stuck between the state EPA and federal EPA the resolution might take 90days or more.

A new sterilization company will require revalidation and might take a minimum of 3 months. Currently our products that are stuck in the sterigenics facility have these released via single batch process at a different sterigenics location that has the same exact process - location change brings in 30 days FDA reporting. Batch release at a different location is a deviation - this can take a bit of time and can cost more.
Our customers need to approve the deviation plan and get our sterilization expert to communicate with the customers to inform them we're on top of everything. Simultaneously we will be setting a course for the future.
Just a word to the wise and probably above your pay grade. Other locations (of both same and different companies) that do the same process will likely be reviewed by the "authorities" and the lawyers. This may be a roller coaster for a while. Good luck with it.
 
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