Document jgovV2DKRjkvdYky9580KvXpp

E. R. Squibb &. Sons, Inc. NewP.O. Box 191 Brunswick, New Jersey 08903 201-545-1300 CHARLES L. KROLL, Sc.D., director regulatory operations SQUIBB March 11, 1976 Department of Health, Education and Welfare Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20852 Attention: 3ureau of Drugs Gentlemen : MarchRe1f4e, re1n9c7e5 , is made to the regulations published on concerning the use of asbestos-containing or other fiber-releasing filters and particularly the requirements under 21 CFR 1 3 3 . 8 (j) (3) for reporting progress in the replacement if such replacement has not of be fibe en co r-rel mplet eas ed ing by M rilt arch er1s4 , 1976. We use a filter system for the terminal steriliza tion of technetium 99m eluates in our MINITEC (Technetium 99m) Generator, the subject of our New Drug Application 1 7 - 3 3 9 . ; This system employs a membrane filter preceded b y a filaer glass prefilter. We are currently evaluating a number of potential replacements for the fiber glass filter but so far have found none which do not either impede the flow, thus increasing the elution time exces sively, or permit the passage of additional alumina particles which could potentially clog the membrane filter. Sincerely, f eg <0072