Showing results for 
Search instead for 
Do you mean 

Reply
Highlighted
Occasional Contributor
Posts: 6
Registered: ‎10-03-2012

Sterility & Endotoxin Testing in Small Batch CSPs

Hello-

 

I work in a Phase I clinical research unit where we occasionally have to prep small batches of high risk CSP's. Typically N=6-12 doses per batch. Typical it is a single dose event for a given drug product. Occasionally 2 or 3 dose dates may occur for the same product, but usually it is a one time dose date, and then we will never make this product again.

 

We are trying to determine when/if sterility & endotoxin testing are required. I reviewed your slides from your 2010 webinar, and one of the slides indicated sterility testing is not required if the dose is adminstered within the USP <797> specified BUD. However, one section of <797> indicates "All high-risk level CSPs that are prepared...in multiple dose vials for administration to multiple patients...shall meet the sterility test before they are dispensed or administered."

 

One approach we have taken is to do a validation prep using the same equipment, lot # of materials, etc and perform sterility and endotoxin testing. Passing results are obtained prior to preparing the clinical batch. The clinical batch is administered within the limits of the BUD (assuming the filter passes its integrity test), and sterility/endotox is confirmed post dose. Is this approach appropriate? Or is it even necessary given our small batch sizes and single dosing event for the CSP?

 

Thanks!!

Occasional Contributor
Posts: 6
Registered: ‎10-03-2012
0

Re: Sterility & Endotoxin Testing in Small Batch CSPs

Hi - does anyone have any input on this topic? Thanks!

Expert
Posts: 1,166
Registered: ‎02-23-2010

Re: Sterility & Endotoxin Testing in Small Batch CSPs

Lori,

 

Your statement: "One approach we have taken is to do a validation prep using the same equipment, lot # of materials, etc and perform sterility and endotoxin testing. Passing results are obtained prior to preparing the clinical batch. The clinical batch is administered within the limits of the BUD (assuming the filter passes its integrity test), and sterility/endotox is confirmed post dose." is very appropriate and should be required by all personnel compounding.  Medications prepared by aseptic processing is at the risk of contamination because of us.  Processes, systems and employees working with meticulous aseptic technique will reduce but not eliminate contamination. 

 

We need to do more employee media fills, environmental monitoring and use compounding methods that have been aseptically verified using a growth media. Only then will we have a greater confidence that we are doing right.

 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Occasional Contributor
Posts: 6
Registered: ‎10-03-2012
0

Re: Sterility & Endotoxin Testing in Small Batch CSPs

Thanks for the reply. Yes, all staff does perform media fills and finger tip sampling. My main question was regarding the small batch sizes that we prepare - is sterility/endotoxin testing required of small batches (N=6-10 doses)?

Expert
Posts: 1,166
Registered: ‎02-23-2010

Re: Sterility & Endotoxin Testing in Small Batch CSPs

If you are not exceeding the default BUD in the chapter, it is not required. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.