Guidelines for Immunization of Source Plasma Human Donors with Blood Substances

GUIDELINE8 FOR INMJNIZATION OF SOURCE PLASMA (HUMAN) DONORSWITH BLOOD SUBSTANCES Revised: Prepared June, by: 1980 Food and Drug Administration Bureau of Biologics Division of Blood and Blood Products Retyped 10/6/92 GUIDELINES FOR IXMUNISATION OF SOURCE PLASMA (BUMAN) DONORSWITR BLOOD BUBSTANCEB (Revised BLOOD GROUP SUBSTANCES 1. 2. Must be a licensed May be administered females product only to healthy who are either of childbearing. 1.0 mL subcutaneous "skin later test" the injection or may be males or else to June, 1980) in good health incapable physiologically or surgically a) Primary - no more than An initial followed subcutaneous intramuscular. 0.1 mL intradermal, to 0.9 mL either b) Booster same day by up or intramuscular. 1.0 mL by the only if same routes both the as - no more than the primary, following i) to be administered criteria are met: The serum hemagglutination 1:256 and one year titer is less than ii) More than immunization. has passed since the previous RED BLOOD CELLS 1. Cell Donor - Meets whole also: of hepatitis or blood donor criteria as specified in 640.3; 1. No history past reactive test for HBSAG. -10 2. NO history acupuncture, within the past 6 months of ear piercing, or tattooing. of previous used as red of 3. 4. No history Previously transfusions. cells donor three six for transfusion who without or immunieation have been followed having developed or at least for recipients, months at least hepatitis, jaundice, or reactive HBsAG tests: If a new previously should recipients which time unused red cells donor, the cells three during be used to immunize in an initial recipients no more than six month period, have monthly shall KBSAG tests If at and 8GGT or BGPT determinations. there is no clinical or other blood the end of 6 months, evidence diseases or laboratory transmissible may be considered of hepatitis in the recipients, for providing the donor red blood acceptable purposes. selected cells 5. for stimulation instances, histories in be In special documented which resulted donors blood without with properly of voluntary transfusions donations subsequent hepatitis 2. volume Total and of may found red acceptable. blood cells whole collections: blood drawn in any frequency than of no more 450 mL of -2. 8 week period, per year. Tests and no mOr8 than 2,250 mL whole blood drawn 3. Laboratory a. Each Donation: serological test for HBsAg syphilis tes must must limit8 be nonreactive; third generation SGPT within laboratory; - befOr8 C8llS be nonreactive; established typing. by SGOT or testing b. Initially Red Blood normal and ABO and Rh,(D) us8 as donor: don8 required, d8Sirabl8 for ph8nOtyping although is not often C, D, E, c, e, phenotyping and is for Xell other and Fy'; specificities recommended. 4. Preparation a. Coll8ction 1. Collected pyrogen-free of 2. under aS8ptiC conditions, in into sterile, ratio of Antigen containers anticoagulant. an appropriate an approved May be aseptically pyrogen-free, storages.* aliquoted Vials into sterile, or tubes for Singl8-dOS8 *BD red containers. BD/yellow stoppered vacutainers are not prepared as sterile stoppered nor vacutainers intended are Sterile, but are not of pyrogen-free for injection. Manufacturers -3. sterile, pyrogen-free Elkins-Sinn, cherry Product Hill, Code: Inc. vials suitable for injection: Nuclear Place Division MA 01862 New England 08002 452700 Atomlight NJ Radiopharmaceutical North Billerica, Neither of these vials contain anticoagulant. b. Gtorage 1. 2. Stored Frozen If stored frozen, at 1 - 6' C, or should 2 hours be washed prior after entry for to use, washing. and used within After c. Dating 1. If not a. washing - store at 1 - 6' C. Period stored exceed Must at 1 - 6' C and unfrozen, 45 days. submit sterility dating. data storage must to support requested 2. On all bacterial specifications except least which that blood aliquoted in an open system, according in Section a culture set the performed forth shall vial for to the 640.2(b), on at lot days. at test be performed from one single-dose is stored shall -Iunfrozen each bleed more than seven One culture be performed on day 8 for least On8 Single-dose culture the dating vial shall period. Cells from each lot be performed and an last additional date d. of on the Washing 1. of Red Blood Washing stored is desirable, liquid. is done, but not required, for RBC 2. If washing sterile, Sodium Chloride Injection 3. If USP must be used. Cells after are washed, entry for must be used washing. single-dose upside down, Red Blood 2 hours within 4. If washing is not performed, should be stored cells vial and only for of cells packed red blood should be aspirated immunization 5. Record Keeping purposes. in GMP and Source Plasma - As required Regulations. 6. Additional a. Testing of Red Blood Cell Recipients. phenotyped PI prior to who are Kell purpose of Must be ABO, Rh, Xell immunization. both positive producing red cells Kell Kell negative or Fy(‘*) and Duffy negative, or persons receive and Py"-' cells except must not for specific Only Anti-Kell or Anti-Fy'. ABO compatible may be transfused. for unexpected antibodies by methods that b. screening demonstrated hemolysing, should also agglutinating, be performed. and coating antibodies 1. Whenever presenoe those by antibody of unexpeated screening tests demonstrate other than the antibodies, stimulated deliberately through immunization cell the licensee, shall the prospective be red blood recipient they tissue received interrogated as to whether transfused they or a have cells part as for of have ever graft past been pregnant, recipient, injections This history or whether of red blood be made any reason. the permanent clearly 2. Recipient antibody 3. shall record and shall identify as possible should specificity Bureau the cause of immunization. be notified in writing of any he develops. of Biologics, report shall be basis elicited The Director, notified in a written on an annual antibodies of any unintended by red blood C. Women shall surgically 7. Immunization a. cell specificity immunization. unless not be immunized incapable schedule procedures physiologically or of childbearing. Immunization 1. De novo immunization for anti-Rho(D): The - 6- maximum nova within responding injected the 2. volume of packed red cells not Subjects to be used 8ltC88d not of 150 for & Rh,(D) any iIUUWnizatiOn 4 month period. shall 50 mL after packed receiving red cells a total shall be AU, of from dropped program. immunization than anti-Rh,(D): with other under protocol. r8d De novo other for atypical antibodies Any de nova blood cells for shall to a Bureau elicitation be of immunization antibodies performed approved will b. Immunization tests maximum donors shall (donors volume with be 4.0 than IND anti-Rh,(D) according All such of Biologics immunization basis. antibody protocol be considered on an individual with positive of donors with screening titers): The to pre-existing red Rh antibody blood cells (regardless This month, within to of packed be given of titer) pre-existing mL in up to a single 5 times red antibody injection. in volume but any may be shall six not month administered exceed period. C. Red cells as part of for a single cells 40 mL of packed blood immunization shall not procedure. on the be administered Red cell any plasmapheresis may be performed immunization same day as - 7 - plasmapheresis only as a totally , but only following procedure. plasmapheresis anb separate