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Related Experiment Videos

Plateletapheresis: instrumentation validation.

E A Burgstaler1, A A Pineda

  • 1Division of Transfusion Medicine, Mayo Clinic, Rochester, MN 55905, USA.

Transfusion Science
|April 5, 2000
PubMed
Summary
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Plateletapheresis instrumentation validation ensures consistent product quality. This process confirms new equipment and techniques meet safety and efficacy standards for platelet products.

Area of Science:

  • Transfusion Medicine
  • Biotechnology
  • Medical Device Validation

Background:

  • Plateletapheresis instrumentation requires validation to ensure consistent product quality.
  • Validation is necessary for new or modified instruments/techniques, even with prior FDA approval.

Purpose of the Study:

  • To outline the requirements for plateletapheresis instrumentation validation.
  • To define when validation is needed, which products are validated, key parameters, and sample size.

Main Methods:

  • Validation is triggered by new processes potentially affecting product quality.
  • Key parameters monitored include platelet yield, white blood cell (WBC) content, and 5-day storage pH.
  • A minimum of 20 samples for variable parameters and five for less variable ones are recommended.

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Main Results:

  • A case study validated the Fenwal Amicus system for single apheresis platelet products.
  • Results showed 85% met plt yield requirements, all met plt concentration limits, and WBC content was below 1 x 10^6.
  • All products met the 5-day storage pH requirement (> or = 6.2).

Conclusions:

  • Process validation and ongoing statistical process control ensure consistent production of acceptable platelet products.
  • This approach provides assurance of product quality and safety in plateletapheresis centers.