whole blood and blood components
Download
Skip this Video
Download Presentation
Whole Blood and Blood Components

Loading in 2 Seconds...

play fullscreen
1 / 42

Whole Blood and Blood Components - PowerPoint PPT Presentation


  • 522 Views
  • Uploaded on

Whole Blood and Blood Components. Diane K. Hall Consumer Safety Officer CBER, OBRR, DBA September 16, 2009. Presentation Outline. Submission contents General Standard Operating Procedures (SOPs) Whole Blood and blood components Whole Blood and Red Blood Cells (RBCs)

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Whole Blood and Blood Components' - Jimmy


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
whole blood and blood components

Whole Blood and Blood Components

Diane K. Hall

Consumer Safety Officer

CBER, OBRR, DBA

September 16, 2009

presentation outline
Presentation Outline
  • Submission contents
  • General Standard Operating Procedures (SOPs)
  • Whole Blood and blood components
    • Whole Blood and Red Blood Cells (RBCs)
    • RBC Modifications
    • Autologous Donations
    • Plasma
    • Platelets
    • Cryoprecipitated AHF
general submission contents 21 cfr 601 12
General Submission Contents 21 CFR 601.12 *
  • Cover Letter
  • Form FDA 356h
  • Form FDA 2567 with Labels
  • Chemistry, Manufacturing and Control Section(CMC)
    • Appropriate SOPs
    • Validations and failure investigations
    • Quality Control (QC)
    • Records
    • Contractors’ names, addresses, registration numbers/CLIA approved
general sops
General SOPs
  • 21 CFR 606.100: Maintain SOPs for all steps followed in collection, processing, storage and distribution of blood and blood components
  • 640.4(h): Whole Blood storage temperatures during transport from collection site to processing site:
    • Cooling continuously towards 1-10C, or
    • Held in an environment maintained at a temperature range specified for that component in the directions for use for the blood collecting, processing, and storage system
general sops5
General SOPs
  • 606.160(b)(5)(iv): Validate shipping containers
  • 606.65(e): Supplies shall be used in a manner consistent with manufacturer’s instructions
  • If applicable, submit SOP for Sterile Connecting Device procedure **
whole blood 21 cfr 640 1 640 6
Whole Blood21 CFR 640.1 - 640.6
  • 640.2: General requirements
    • Manufacturing responsibility
    • Blood container
    • Reissue of blood
  • 640.3: Suitability of donor
  • 640.4: Collection of the blood
  • 640.5: Testing the blood
rbcs 21 cfr 640 10 640 17
RBCs21 CFR 640.10 - 640.17
  • 640.11: General requirements
    • Storage
    • Inspection
  • 640.12: Suitability of donor
  • 640.13: Collection of the blood
  • 640.14: Testing the blood
  • 640.15: Segments for testing
  • 640.16: Processing
rbc modifications

RBC Modifications

Red Blood Cells Washed

Red Blood Cells Rejuvenated

Red Blood Cells Frozen

Red Blood Cells Deglycerolized

considerations for rbc modifications storage and dating period
Considerations for RBC Modifications: Storage and Dating Period

Approved submissions have typically contained

  • Red Blood Cells Washed
    • Storage: 1-6C
    • Dating period: 24 hours from start of washing process
  • Red Blood Cells Rejuvenated
    • Storage: 1-6C
    • Dating period: 24 hours from start of washing process
  • Red Blood Cells Frozen Rejuvenated
    • Storage: <-65C
    • Dating period: 10 years for RBCs collected and stored in

CPD or CPDA-1 or 3 years for RBCs stored in CPD/

AS-1

rbc modifications storage and dating period
RBC Modifications: Storage and Dating period

640.17, 610.53(c)

  • Red Blood Cells Frozen (FRBC)
    • Storage: <-65C
    • Dating period: 10 years, or as specified in the manufacturer’s instructions
  • Red Blood Cells Deglycerolized
    • Storage: 1-6C
    • Dating period: 24 hours after removal from <65C storage or as specified in the directions for use for the blood collection, processing, and storage system approved by FDA
rbc modifications product qc
RBC Modifications: Product QC

Considerations for Red Blood Cells Washed

  • Approved submissions typically have contained
    • Two months of product QC
    • 4 units/month
    • RBC Percent Recovery ***
    • Residual Total Protein ***
    • Sterility testing (10 units) ***
rbc modifications product qc14
RBC Modifications: Product QC
  • Red Blood Cells Deglycerolized and Red Blood Cells Rejuvenated
    • RBC Percent Recovery ***
    • Determination of free hemoglobin ***
    • Monitor glycerol removal ***
    • Sterility testing (10 units) ***
autologous donations16
Autologous Donations
  • 640.3(b): Donor qualifications
  • 610.40(d): Infectious disease testing
  • 606.100(b)(20): Donor deferral
autologous donations labels
Autologous Donations Labels

21 CFR 606.121(i) and (j)

  • Information identifying the patient, e.g.
    • Name,
    • Blood Group,
    • Hospital,
    • Identification Number
  • Date of donation
  • If applicable, “FOR AUTOLOGOUS USE ONLY”
  • May use a tie tag attached to the container
autologous donations labels cont
Autologous DonationsLabels (cont.)

606.121(i)(4)

  • If donor fails to meet any Whole Blood donor suitability requirements, “FOR AUTOLOGOUS USE ONLY” label replaces the Blood Group label

610.40(h)(2)(ii)(B):

  • Components that have reactive infectious disease screening tests must be labeled with the “BIOHAZARD” legend
autologous donations labels cont19
Autologous DonationsLabels (cont.)

610.40(d)

  • If there is no cross over allowed and the units are not shipped anywhere else, then no infectious disease testing is required and the unit can be labeled, “DONOR UNTESTED”
  • If facilities cross over autologous units or ship to facilities that allow cross over, then all units must be tested for infectious diseases and labeled according to 606.121(i)
autologous donations labels cont20
Autologous DonationsLabels (cont.)

610.40(d)

  • If products are shipped to another facility that does not allow cross over, you must assure that the first donation in each 30-day period is tested.
    • Tested units: Label according to 606.121.
    • Untested units: Label as “DONOR TESTED WITHIN

THE LAST 30 DAYS”

plasma components

Plasma Components

Fresh Frozen Plasma (FFP)

Plasma Cryoprecipitate Reduced

Plasma Frozen Within 24 Hours After Phlebotomy

plasma 21 cfr 640 30 640 34
Plasma21 CFR 640.30 – 640.34
  • 640.31: Suitability of donors
  • 640.32: Collection of source material
  • 640.33: Testing the blood
  • 640.34: Processing
plasma components23
Plasma Components
  • 640.34(b), 640.54(a)(2): Separate plasma from RBCs and place in freezer within 8 hours of phlebotomy or within the timeframe specified in the directions for use for the blood collecting, processing and storage system.
  • 610.53(c)
    • Storage: <-18C
    • Dating period: 1 year from the collection date of Whole Blood
platelet components

Platelet Components

Platelets

Pooled Platelets-5d, Leukocytes Reduced

platelets 21 cfr 640 20 640 27
Platelets21 CFR 640.20-640.27
  • 640.21: Suitability of donors
  • 640.22: Collection of source material
  • 640.23: Testing the blood
  • 640.24: Processing
  • 640.25: General requirements
    • Storage
    • Quality control testing
    • Manufacturing responsibility
platelets
Platelets
  • 640.22(d) : Phlebotomy shall be performed by:
    • A single uninterrupted venipuncture
    • With minimal damage to and manipulation of donor’s tissue
platelets27
Platelets

640.24: Processing

  • Whole Blood temperatures during transport from collection site to processing site shall be maintained as close as possible to a range between 20-24C
  • Separate within 4 hours or within the timeframe specified in the direction for use for the blood collecting, processing, and storage system
platelets28
Platelets

640.25: Storage

  • 20-24C with continuous gentle agitation, or
  • 1-6C with no agitation

610.53(c): Dating period

  • 72 hours from the time of collection, or
  • 5 days, with approved containers
platelets29
Platelets

640.24(c) and (d)

  • The time and speed of the centrifuge should demonstrate that the manufactured product:
    • Is an unclumped product
    • Is without visible hemolysis
    • Yields a count of >5.5x1010 platelets per unit (75% of tested units)
  • The volume of original plasma used to resuspend the platelets shall maintain a pH of >6.2
considerations for platelets product qc
Considerations for Platelets:Product QC
  • Approved submissions have typically contained two consecutive months of product QC
  • 21 CFR 640.25
    • 4 units/month
    • pH
    • Platelet count
    • Plasma volume
platelets product qc
Platelets: Product QC

640.24(c), 640.25: Acceptance Criteria for

Platelets

  • pH: >6.2
  • Platelet yield: 5.5x1010 platelets/unit in >75% of tested units
considerations for pooled platelets 5d leukocytes reduced
Considerations for Pooled Platelets-5d, Leukocytes Reduced

Approved submissions have typically contained

  • Manufacturing: Use a process based on the manufacturer’s package insert that is capable of demonstrating the specified acceptance criteria
considerations for pooled platelets 5d leukocytes reduced33
Considerations for Pooled Platelets-5d, Leukocytes Reduced

Approved submissions have typically contained

  • Product QC
    • Two consecutive months of product QC
    • Statistically sound plan
    • Ensure products meet specifications stated in the manufacturer’s instructions
  • Acceptance Criteria
    • Acceptance criteria: manufacturer’s recommendations for product specifications
cryoprecipitate components

Cryoprecipitate Components

Cryoprecipitated AHF

Pooled Cyroprecipitated AHF

cryoprecipitated ahf 21 cfr 640 50 640 56
Cryoprecipitated AHF: 21 CFR 640.50 – 640.56
  • 640.51: Suitability of donors
  • 640.52: Collection of source material
  • 640.53: Testing the blood
  • 640.54: Processing
  • 640.56: Quality control test for potency
cryoprecipitated ahf
Cryoprecipitated AHF

640.54(a): Processing Plasma (cryo rich)

  • Separate plasma by centrifugation
  • Place plasma in freezer within 8 hours after collection or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system
  • Store plasma at <-18C until further processed
cryoprecipitated ahf37
Cryoprecipitated AHF

640.54(b): Processing Final Product

  • Separate the Cryoprecipitated AHF from the plasma by a procedure that has been shown to produce an average of >80 IU of AHF/final container
  • Do not add diluent prior to freezing final product
cryoprecipitated ahf38
Cryoprecipitated AHF

610.53(c): for Cryoprecipitated AHF

  • Storage: <-18C
  • Dating period: 1 year from the date of Whole Blood collection
considerations for cryoprecipitated ahf
Considerations for Cryoprecipitated AHF
  • Approved submissions typically have contained two consecutive months of product QC
  • 21 CFR 606.122(n), 640.56
    • 4 units/month
    • Fibrinogen
    • AHF potency
    • Acceptance Criteria
      • Fibrinogen: >150 mg
      • Mean AHF potency: >80 IU of AHF/final container
considerations for pooled cryoprecipitated ahf
Considerations for Pooled Cryoprecipitated AHF

Approved submissions have typically contained

  • Manufacturing
    • Use of Sterile Connecting Device **
    • Storage: <-18C
    • Dating period: 1 year from the oldest unit’s date of collection
  • Product QC and Acceptance Criteria
    • Same as Cryoprecipitated AHF
references
References

* Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

** Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices

***Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use”

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/default.htm

Eight-Hour Hold

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/MemorandumtoBlood

Establishments/default.htm

questions contact us
Questions - Contact us!
  • Mailing address:

Director, Division of Blood Applications,

OBRR, CBER, FDA

HFM-370

c/o Document Control Center, HFM-99

1401 Rockville Pike, Suite 200N

Rockville, MD 20852-1448

  • Telephone: 301-827-3543
  • FAX: 301-827-3534
ad