Oven depyrogenation cycles must be routinely validated to ensure that the temperature distribution in various load patterns results in a 3 log reduction of endotoxin, should it be present on your metal and glass containers. Regulatory agencies expect pharmacies to demonstrate adequate depyrogenation by placing Endotoxin Challenge Vials (ECVs) or vials with known levels of endotoxin, throughout their worst case depyrogenation load patterns, and then assaying the ECV’s for remaining endotoxin. FOCUS Laboratories can help you validate your depyrogenation cycle with our ECV Box, which provides all the materials in the to easily perform your oven validations.
- What is ECV Box?
- Requested amount of ECV vials, and one control vial
- A Certificate of Analysis confirming the potency of your ECV vials
- Clear instructions on how to use the vials to confirm adequate depyrogenation
- Sample Bags, parafilm, and other supplies to process them
- Pre-paid shipping label to get the box back to us when you’re done
- We will document the temperature and condition of the ECV Vials upon receipt and enter the information into our LIMS, allowing you an opportunity to track progress through your secure portal.
- We will extract any remaining endotoxin from the inside of the ECV using our LAL free water, in controlled conditions of our qualified, mapped and monitored incubators.
- We will perform a kinetic endotoxin test on the extract and calculate the log reduction versus a control.
- Our Quality Unit will review the data, and if acceptable authorize release of the COA which will then be posted on your portal.
- We can deliver your pass/fail results within one week of receiving the vials back. If for any reason a vial does not pass, we will conduct a full Out of Specification investigation, and assist you in remediation if necessary.
- Scope?
- How?
We will keep your schedule and at the allotted time we will mail you a refrigerated cooler with:
Once you’ve processed your vials, place them and the unprocessed control vial back in the box with the ice pack, place the shipping label on the box, and return the kit back to us. We then take care of the rest:
While we can advise on how many ECV’s are required for your depyrogenation validation, ultimately it is your decision on how many vials to use as you know your process and equipment best.
Protocol development and risk assessment is the responsibility of the client. FOCUS is responsible for providing Endotoxin Challenge Vials and analysis, but determination of worse case load patterns, cold spots, and other protocol factors are the responsibility of the client.
Please call 610-866-7272 or email us at info@FOCUS-lab.com and a member of our Service Excellence Team will be in touch.
