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Advisor
Posts: 16
Registered: ‎07-05-2013
0

Terminal Sterilization

Aside from the cost and space involved with autoclaves and convection ovens, is there any downside to utilizing terminal sterilization of CSPs following aseptic technique?  Ideally we would like to decrease the amount of sterility testing required by keeping batches under 25 and utilizing sterilization for the limited number of sterile products we do make.  Is this a faulty line of thought?

 

The numbers from Eric's presentation involving nonsterile particles are startling:  1 particle per 1000 items with a filter vs 1 particle per 1,000,000 items sterilized.  Thanks for your input - this board has been very helpful.

 

Kelly

Expert
Posts: 1,152
Registered: ‎02-23-2010
0

Re: Terminal Sterilization

Kelly,

 

If you can terminally a compounded medication, it would be ideal from a patient safety perspective.  What medication are you autoclaving?  To minimize the cost of sterility testing, you could increase the size of the batch so you build economies of scale into your operation.  If you have a validated autoclave cycle, use BIs, and have an autoclave that can control and report temperature and pressure, there is a concept called parametric release that can be employed.  I suggest this cautiously since you need to do your due-diligence before jumping into using this process.  Food for thought.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 16
Registered: ‎07-05-2013
0

Re: Terminal Sterilization

We are autoclaving aqueous solutions and utilizing dry-heat for oil based injectables.  The problem we are running into is that we are unable to find a vial/stopper combo that can withstand the dry heat from the convection oven to perform terminal sterilization.  Thus, we are having to reverse the order of operations for oil based substances:

 

aspetic sterile preparation, place into a beaker that can withstand dry heat, cover the top, dry heat with convection oven, take back into ISO 5, then place into vials via filtration

 

Since the sterilization does not occur at the end, it is my opinion we still must perform sterility tests for these oil based substances.  Is my line of though correct on the process?  Thanks again for your input Eric. Your contribution to this site is very much appreciated,

 

Kelly

Expert
Posts: 1,152
Registered: ‎02-23-2010
0

Re: Terminal Sterilization

Kelly,

 

Thanks for your kind words.  It is important to realize that you are doing an aseptic procedure after the dry-heat oven cycle so you don't have the same sterility assurance as if you could terminally sterilize the CSP within the vial without additional aseptic manipulations.  If you haven't already done so, you should contact West Pharma, who makes stoppers and vials and see if they can help you solve your sterilization challenge.

http://www.westpharma.com/en/Pages/Default.aspx 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Occasional Visitor
Posts: 1
Registered: ‎11-15-2017
0

Re: Terminal Sterilization

We are currently using filtration sterilization for our high risk IT compounds.  We would like to add Terminal Sterilization with an Autoclave to our process.  Which autoclave should we use? Which drugs can withstand the autoclave process? Can you autoclave a BD syringe? How do you pay for the increase drug assays? I could go on for days/  

Dana