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Posts: 2
Registered: ‎07-15-2013
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Re: USP 71 Sterility Testing and Extending BUD Webinar

[ Edited ]

Illinois wrote:

If I may ask a question of the panelists from today's excellent webinar: 

 

Please comment on the correctness or not of the following:  

USP <797> does not require end product sterility testing for low risk and medium risk CSPs when remaining within the chapter's BUD limits...    

 

And further,  if the above is true, is the primary reason because of the complexity of a USP<71> compliant sterility test and the likely unreasonalbleness of meeting that on a regular basis in a typical pharmacy scenario?


I'll let Eric answer as to the BUD question (I think a sterility test is a prudent idea even for low risk CSP - what happens if a control measure is out of compliance?  This now transforms it to a medium or high risk CSP and it has a completely different BUD).

 

I will comment on the "unreasonableness" of the sterility test.  We are seeing a general breakdown in control as pharmacies try to be much larger than the traditional role.  The concerns about the sterility test are only an indication of the general concern of the state of control in pharmacies in general.  Manufacture of sterile product, especially aseptic manufacture, is not a simple task and it one that poses a great risk to the patient.  Much has been made of the cost of pharma products - the level of control required in their manufacture is one of the contributing factors and is now becoming an expectation for the pharmacy. 

 

A recent review of Quality expectations from FDA in regards to the pharmacy can be found in the 2013 review of 483 observations for compounding pharmacies at http://microbiologynetwork.com/content/APR_2013-April_GMP-Compounding-Pharmacies.pdf

 

 

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Re: USP 71 Sterility Testing and Extending BUD Webinar

Hi Eric,

 

I had a question about BUD and risk-level for "batch" products.  If I transfer a quantity of medication from a single vial into an IVF bag to create a large volume of a more dilute concentration of drug, and then enter that IV bag 100 times to make 100 syringes I would consider this to be "medium-risk" compounding due to the number of entries into the IV bag.  However, if I use a dispensing pin to enter the large IV fluid bag a single time (after the drug has been added to the bag), would this be considered "low-risk" compounding?  In this scenario I would only be using two commercially manufactured packages of sterile products (the drug vial and IVF bag) with no more than two entries into any one sterile container (technically only entering the IVF bag once with the drug product and once with the dispensing pin)...

Are dispensing pins considered an acceptable method to minimize the number of entries into a container?

 

Thanks!

 

Jim

Expert
Posts: 1,166
Registered: ‎02-23-2010
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Re: USP 71 Sterility Testing and Extending BUD Webinar

[ Edited ]

Illinois wrote:

If I may ask a question of the panelists from today's excellent webinar: 

 

Please comment on the correctness or not of the following:  

USP <797> does not require end product sterility testing for low risk and medium risk CSPs when remaining within the chapter's BUD limits...    

 

And further,  if the above is true, is the primary reason because of the complexity of a USP<71> compliant sterility test and the likely unreasonalbleness of meeting that on a regular basis in a typical pharmacy scenario?




 

Illinois,

 

The first statement is correct and that also includes high-risk level CSPs but the second one is not.  USP 797 creates a safe harbor for routine compounding activities and assumes that all aspects of the chapter are adhered to making the need to do sterility testing, which is a 14 day test unnecessary since you are starting with sterile components and maintaining sterility during the compounding procedure vs. making something sterile from nonsterile components.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
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Posts: 1,166
Registered: ‎02-23-2010
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Re: USP 71 Sterility Testing and Extending BUD Webinar

[ Edited ]

KKain wrote:

Eric,

 

Can you elaborate on the necessity for sterility testing if terminal (heat/steam) sterilization is utilized?  We are having trouble finding a reference in the USP chapters.  Thanks,

 

Kelly


 

Kelly,

 

If you refer to a copy of USP Chapter <797> and look within the definition/discussion re: high-level CSPs (its in the beginning of the chapter), you will find language requiring sterility testing for 25 units or more of terminally sterilized CSPs.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,166
Registered: ‎02-23-2010
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Re: Sterility testing requirements for batch process

[ Edited ]

wendygw wrote:

Is sterility testing required for all batch processes?  More specifically, if we are batch processing IV's and assigning BUD as 48 hours room temp or 14 days under refrigeration, is sterility testing of the batch required by UPS 71?  Or does USP 71 sterility testing for batches only apply if we want to assign BUD beyond the guidelines set by 797?

Thanks,

Wendy Waldman, RPh


 

Wendy,

 

Sterility testing is required when the default BUDs are exceeded or you make more than 25 units of high-risk level CSPs or MDVs.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,166
Registered: ‎02-23-2010
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Re: USP 71 Sterility Testing and Extending BUD Webinar

[ Edited ]

cbuhrman wrote:

With regards to direct transfer testing...preparing prefilled syringes less than 1 ml fill amount in batches of less than 100.  Of the 10 syringes that would be used for testing--Would 5 syringes be injected into 1 vial of TSB and the other 5 syringes into 1 vail of FTM?  or would we use 5 vials of TSB and 5 Vials of FTM?

 

 


You don't want be using the direct inoculation method.  Please review the questions and answers posted earlier in this thread where Dr. Sutton and I answer the question.  Thanks.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
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Posts: 1,166
Registered: ‎02-23-2010
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Re: USP 71 Sterility Testing and Extending BUD Webinar

[ Edited ]

jtl009 wrote:

Hi Eric,

 

I had a question about BUD and risk-level for "batch" products.  If I transfer a quantity of medication from a single vial into an IVF bag to create a large volume of a more dilute concentration of drug, and then enter that IV bag 100 times to make 100 syringes I would consider this to be "medium-risk" compounding due to the number of entries into the IV bag.  However, if I use a dispensing pin to enter the large IV fluid bag a single time (after the drug has been added to the bag), would this be considered "low-risk" compounding?  In this scenario I would only be using two commercially manufactured packages of sterile products (the drug vial and IVF bag) with no more than two entries into any one sterile container (technically only entering the IVF bag once with the drug product and once with the dispensing pin)...

Are dispensing pins considered an acceptable method to minimize the number of entries into a container?

 

Thanks!

 

Jim


 

Jim,

 

No dispensing pins in my opinion are no different than needles, in fact might be worse because it creates a bigger opening for contamination to migrate into the stock bag.  Each time you connect and disconnect from a dispensing pin is a kin to using a needle.  You need to think of it in terms of aseptic connections are the same as aseptic punctures.  Hope this helps.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.