Seraplex sources its own inventory of Recovered Plasma for the manufacturing of Defibrinated and Delipidized Serums. Our Quality Assurance Department works alongside our manufacturing partners monitoring the quality of our defibrinated and delipidized serums. Our expertise in making serums allows us to accomodate your company’s individual Serum specifications.
Our serum is made from plasma sourced from US Registered blood centers. The plasma is tested and found negative for all FDA required viral marker tests. Pooled plasma is defibrinated and delipidized and the protein levels are adjusted the the customer’s specifications.
Each serum lot is manufactured to the customer’s specifications. Protein levels, pH levels, and other analyte levels can be adjusted to meet our costomer’s manufacturing needs. Serum is bottled in 3 liter containers and a certificate of analysis is supplied with each serum batch and includes a complete chemistry panel.
Delipidized – Defibrinated Plasma
Product # PS921
• Processed Plasma – Defibrinated anticoagulated plasma
• Produced in FDA Registered Plasma Processing or Medical Device Manufacturing Facilities
• Analyte Target Ranges
Total Protein 5.2 – 7.5 g/dL Uric Acid 2.5 – 7.2 mg/dL
Cholesterol < 10 mg/dL Calcium 8.5 – 10.4 mg/dL • Triglycerides < 10 mg/dL Phosphorus 2.5 – 4.8 mg/dL • AlkPhos < 100 U/L Potassium 3.5 – 5.1 mEq/L • Glucose 70 – 118 mg/dL Chloride 96 – 109 mEq/L • Creatinine 0.5 – 1.4 mg/dL Sodium 136 – 146 mEq/L • BUN 8 – 23 mg/dL pH 6.0 – 7.4 (Target to customer spec) • Preservatives None (can include 0.09% Sodium Azide if requested) • 0.2 μ Filtered • Microbial Testing: <10 cfu/mL • Storage: -15 to -25 C • Age at delivery: Three years or less from date of manufacture. • Certificate of Analysis, signed, included with each shipment, and includes Analysis for required analytes and hormones and test methods used Viral marker testing statement for plasma used in manufacture of product Each donor unit used in the manufacture of this product has been tested by an FDA accepted method at an FDA licensed laboratory and found non-reactive for the presence of HBsAg, antibody to HIV 1/2 and HCV, and Syphilis, and HIV-1 RNA and HCV RNA. • Labeling: Product name, lot number, volume, catalog #, storage temperature. • Packaging: 100 mL to Three (3) Liter HDPE containers • Appearance: Normal serum color (clear amber liquid), free of hemolysis, particulate matter, no fibrinogen, or offensive odor • Packing & 100 mL to 4 x 3 Liter containers per box in insulated boxes, shipped with dry ice Shipping to maintain temperature during transit. • Intended Use: For use in the manufacture of non-injectable (diagnostic) products. • Quality: Customer to be informed of any changes in the manufacturing or distribution which could influence the quality of the material supplied. • Ordering lead time: 2 months [/av_tab] [av_tab title='Product Specifications (PDF)' icon_select='yes' icon='8']
Seraplex has inventories of Defibrinated and Delipidized serum, but we can also manufacture specific lots based on your company’s individual specifications. Manufacturing lead times depend on volumes required and analyte specifications. Send us an inquiry at email@example.com or call (626) 792-9945 for more information.