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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Letter, May 23, 2012 - SOLX® System

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

Our Reference:  BN110059/0
 
Hemerus Medical, LLC
Attention: Ms. Lynn Jensen
May 23, 2012
Sent by email: ljensen@hemerus.com
 
Dear Ms. Jensen:
 
We are reviewing your October 28, 2011 new drug application (NDA) for HEMERUS LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX® Additive.  We have determined that the following information is necessary to continue our review:
 
Sterilization:
 
1.     Please clarify if the complete system is autoclaved and if the system is over-pouched/packaged when sterilized.
 
2.     Please provide how many systems are in each tray and trolley.  Please clarify how many systems are in a full load.
 
3.     Please explain if each tray is configured in the same way and do they have the same number of systems.
 
4.     Please provide a picture/diagram of how the system is configured in a trolley.
 
5.     Please explain how the system is coiled and packed for sterilization and if this is clearly defined in an SOP.
 
6.     Please provide a picture of the configuration of the system for sterilization (including how the tubing is configured along with the bags and filter).
 
7.     Please clarify if the systems are visually inspected for kinked tubes after sterilization during routine operations.
 
8.     With this method of sterilization, ---(b)(4)-- is a critical parameter.  Please explain how you ensure during routine production the (b)(4) is operating as it should.
 
9.     You stated that your sensors are calibrated every ---(b)(4)-- and that the sensors were calibrated before the validation.  Please clarify if the sensors were still within calibration after the validation and revalidation was completed.
 
10. Please provide the raw data of each run for the validation and revalidation.
 
11. Please indicate what organisms are being found on your product and in your facility.
 
12. Please provide the population and resistance of the bioburden on your product and at your facility.
 
13. Please provide the population and resistance of the BIs.
 
14. Are you performing periodic resistance testing?
 
15. In the validation and revalidation the minimum F0 values were ------(b)(4)----- minutes, respectively.  Please clarify if there were any BIs in those systems.
 
16. In Study LAB/VR/039/06, several thermal sensors did not reach (b)(4) when sterilization dwell time started.  Those locations could be indicative of a cold spot.  Locations ---(b)(4)---- did not have BIs at those locations.  Please address this concern.
 
17. The BIs used in LAB/VR/039/06 did not have a D-value for (b)(4) sterilization on the COA. Please explain how resistance can be evaluated.
 
18. Please clarify if you had any sterility failures of the final product.  If so provide a summary report of the investigation, root cause, and corrective and preventative action associated with these failures.
 
19. Please provide the firm’s sterility release criteria.  Will you be using parametric release?
 
20. During your validations, please clarify if there are any other changes (besides using the           ---(b)(4)---) from the actual system that is being validated.  For example, are all the other bags, connections, tubes, and etc. the same (material, dimensions, etc.).
 
21. The new bag arrangement is considered a new load configuration.  Additional runs need to be performed at the new load configuration for the Agency to be able to evaluate the effectiveness of your sterilization cycle.
 
22. In your validation, your cold spots have become hot spots and locations that you have not identified as cold spots are lagging behind the cold spots you have identify.  Please explain and provide data on how you selected your cold spots.
 
23. In the sterilization validations you provided the (b)(4) test method.  In the diagrams you indicate that the bags are cut off.  Please clarify if all bags are cut off and tested individually or pooled together.  How have you ensured all fluid pathways have been assessed for (b)(4)
24. You have also provided the product sterility test method. Please clarify how you ensured all fluid pathways have been assessed for sterility. Please also clarify if each bag is tested individually or if the complete system is tested.
 
----(b)(4)----------:
 
25. -----------(b)(4)--------------------------------------.
 
26. -----------(b)(4)------------------------------------------------------------.
 
27. -----------(b)(4)----------------------------------------------------------------.
 
28. -----------(b)(4)--------------------------------------------------------------------------------------------------------.
 
29. -----------(b)(4)--------------------------------------------------------.
 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission. 
 
Please submit your response to this information request as an amendment to this file by June 6, 2012 referencing the date of this request.  If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.
 
The action due date for this file is August 31, 2012.
 
If you have any questions, please contact me at (240) 507-8446.
 
Sincerely,
 
 
 
Sonday L. Kelly, M.S.
Regulatory Project Manager
FDA/CBER/OBRR