Document np4ygbgGN48aow0MngvRg3rMw

m W PHS PKLN 045S EST 411379 VC IF D 3394 90.19.73 HEARING CLERK FOOD AND DRUG ADMINISTRATION ROOM S-9S n.oo REi DEPARTMENT OF HEALTH, EDUCATION AND WELFARE FOOD AND DRUG ADMINISTRATION (91 CFR PARTS 191,19(5,133) PROPOSED RULEMAKING ON ASBESTOS PARTICULES IN FOOD AND DRUGS AS PRINTED IN FEDERAL REGISTER, VOL. 39, NO. 199, FRIDAY, SEPTEMBER 99, 1973 DEAR SIR* THE ABOVE-MENTIONED MEMORANDUM ON "ASBESTOS PARTICLES IN FOOD AND D R U G S " COVERS THE PRINCI9AL PUFSTION OF A POSSIBLE HEALTH RISK THROUGH PARENTERAL DRUGS CONTAINING ASBESTOS PARTICLES. THIS SUBJECT HAD BEEN DISCUSSED IN A MEETING OF AN EXPERT COMMITTEE OF THE BUNDESVERBAND DER PHA.RMA7EUTISCHFN INDUSTRIE, THE WEST-GFPMAN PHARMACEUTICAL MANUFACTURERS * ASSOCIATION. THE PARTICIPANTS WELCOMED AND SUPPORTED FDA FFFORTS t o A I M a t ASBESTOS-FREE SOLUTIONS FOR PARENTERAL APPLICATION. HOWEVER, THE USE OF ASBESTOS-FILTERS IN THE MANUFACTURE OF PARENTFPAL DRUGS CANNOT BE AVOIDED COMPLETELY, ESPECIALLY AS CONCERNS HIGHLY CONCENTRATED AND HIGHLY VISCOUS SOLUTIONS OR CFRTAIN SERA AND VACCINES. FOR OTHER SOLUTIONS IT MAY ALSO BE CONVENIENT TO USE ASBESTOS-CONTAINING FILTERS IN ORDER TO REMOVE POSSIBLE PYROGENOUS PARTICLES. IT THEREFORE SEEMS TO US IMPOSSIBLE T0 GIVE UP ASBESTOS-CONTAINING FILTER PADS IN GENERAL. WHEREVER POSSIRLE, EINAL FILTRATION WITH ASBESTOS-FREE NON FIBRE RELEASING FILTERS IS LONG SINCE CARRIED OUT IN PHARMA CEUTICAL TECHNICS ACCORDING TO GOOD MANUFACTURING PRACTICES. FOR THIS PURPOSE ONE GENERALLY USFS THOSE FILTERS WHICH RELIABLY REMOVE FIBRES WHICH ARE NOT TOLFRATED ACCORDING TO THE PROPOSED METHOD HSM 79-109E7 (1979). IN OUR OPINION IT IS THEREFORE NOT NECESSARY To CONFIRM THIS BV FINAL FILTRATION GUARANTEED EFFECT THROUGH AN ADDITIONAL METHOD OF TpsT. WE DO HOPE HAVING CONTRIBUTED WITH OUR COMMENTS TO THIS FOR THE PHARMACEUTICAL INDUSTRY HIGHLY IMPORTANT SUBJECT. RESPECTFULLY YOURS, BUNDESVERBAND DER PHARMAZEUTISCHEN INDUSTRIE E.V. DIRECTION (DR. MAPRIS) (DR. AUTERHOFF) ++ 4! 1379 VC IF D DHEW RHS PKLN