Plateletapheresis: instrumentation validation

Plateletapheresis instrumentation validation is required to document that a new or modified instrument or technique is capable of consistently producing acceptable products at the production center using their equipment, personnel, and counting techniques even though the instrument or technique may already have FDA or equivalent approval for use. To pursue the process of validation, several questions need to be addressed: when is it required, what products are validated, what parameters are monitored, and how many products 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 blood 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 platelet yield and WBC content and five samples for less variable parameters such as 5-day storage pH. As an example, we validated the Fenwal Amicus (Baxter Biotech) for single apheresis platelet products. With 20 samples, we found that: 85% of the products contained > or = 3 x 10(11) plt (requirement was at least 75% contain > or = 3 x 10(11) plt); platelet concentration of all products was < or = 1.515 x 10(6) plt/microL (requirement was < or = 2.435 x 10(6) plt/microL), and WBC content was < 1 x 10(6) WBC in all products (requirement was all products contain < 5 x 10(6) WBC). In addition, in five samples, the 5-day storage pH was 6.89-7.25 (requirement was all products should be > or = 6.2 pH). Once validation is complete and acceptable, the process should be monitored on a regular basis using some form of process control. Statistical process control programs are available that can assist in documenting validation and ongoing process control. With the use of process validation and ongoing process control, the plateletapheresis center can assure that acceptable products are consistently being produced.