Plateletapheresis: instrumentation validation

Plateletapheresis instrumentation validation is required to document that a new or modified instrument or technique is capable of consistently produci ng acceptable products at the production center using their equipment, pers onnel, and counting techniques even though the instrument or technique may already have FDA or equivalent approval for use. To pursue the process of v alidation, several questions need to be addressed: when is it required, wha t products are validated, what parameters are monitored, and how many produ cts are required. Validation is required when a new instrument or technique (process) is used that could affect the quality of the product. According to the FDA, each apheresis system (e.g., Spectra LRS, Amicus) and each type of product (e.g., single, double, triple) need to be validated separately. Parameters to be validated vary, but usually platelet (plt) yield, white b lood cell (WBC) content (if products are labeled "leukoreduced"), and 5-day storage pH are monitored. The number of procedures monitored is also quite variable, but we use 20 samples for highly variable parameters such as pla telet yield and WBC content and five samples for less variable parameters s uch as 5-day storage pH. As an example, we validated the Fenwal Amicus (Bax ter Biotech) for single apheresis platelet products. With 20 samples, we fo und that: 85% of the products contained greater than or equal to 3 x 10(11) plt (requirement was at least 75% contain greater than or equal to 3 x 10( 11) plt); platelet concentration of all products was less than or equal to 1.515 x 10(6) plt/mu L (requirement was less than or equal to 2.435 x 10(6) plt/mu L), and WBC content was <1 x 10(6) WBC in ail products (requirement was all products contain <5 x 10(6) WBC). In addition, in five samples, th e 5-day storage pH was 6.89-7.25 (requirement was all products should be gr eater than or equal to 6.2 pH). Once validation is complete and acceptable, the process should be monitored on a regular basis using some form of proc ess control. Statistical process control programs are available that can as sist in documenting validation and ongoing process control. With the use of process validation and ongoing process control, the plateletapheresis cent er can assure that acceptable products are consistently being produced. (C) 1999 Elsevier Science Ltd. All rights reserved.