Tools

LEADER 02212ntm 2200409 i 4500

001 on1453641890;

003 OCoLC;

005 20240830010646.0;

008 240830s1992 xx a b 000 0 eng ;

035 a| (Sirsi) o1453641890;

035 a| (OCoLC)1453641890;

049 a| EREE;

090 a| TP248.24;

100 1 a| Sendek, Stephen J.,e| author.?| UNAUTHORIZED;

245 13 a| An operational qualification study for the validation of a -20°C freezer as required by the Food and Drug Administration /c| by Stephen J. Sendek.;

264 0 c| 1992.;

300 a| 166 leaves :b| illustrations ;c| 28 cm;

336 a| textb| txt2| rdacontent;

337 a| unmediatedb| n2| rdamedia;

338 a| volumeb| nc2| rdacarrier;

502 b| M.S.c| East Carolina Universityd| 1992.;

500 a| Presented to the faculty of the School of Industry and Technology.;

500 a| Research Committee Chairperson: John Marshall.;

504 a| Includes bibliographical references: leaf 166.;

520 3 a| Federal regulations are quite specific for the manufacturing of biological products. These regulations require that the manufacturing process of biological products be controlled to assure probability that the finished product meets established specifications. The intention of this study shall be to validate an empty and fully-loaded chamber temperature distribution for a -20°C upright freezer. Specifically, this study will verify that the -20°C upright freezer conforms to the CFR 21, parts 210, and 600.;

650 0 a| Biotechnologyx| Law and legislation.=| ^A352019;

650 0 a| Biological productsx| Storage.=| ^A132664;

650 0 a| Biological productsx| Safety regulations.=| ^A132664;

650 0 a| Commercial freezersx| Testing.=| ^A1304793;

700 1 a| Marshall, John,e| degree supervisor.=| ^A754252;

710 2 a| East Carolina University.b| School of Industry and Technology,e| degree granting institution.?| UNAUTHORIZED;

949 a| ASK AT SPECIAL COLLECTIONS DESKh| JOYNER168o| jpmd;

994 a| C0b| ERE;

596 a| 1;

998 a| 6471579;

999 a| ASK AT SPECIAL COLLECTIONS DESKw| LCc| 1i| 6471579-1001l| JSCJTHDm| JOYNERr| Ys| Yt| JSCJTHDu| 8/30/2024x| ETDz| JSPECCOLLo| .STAFF. jpmd;

An operational qualification study for the validation of a -20°C freezer as required by the Food and Drug Administration / by Stephen J. Sendek.

Author/creator	Sendek, Stephen J. author.
Other author	Marshall, John, degree supervisor.
Other author	East Carolina University. School of Industry and Technology, degree granting institution.
Format	Theses and dissertations
Production	1992.
Description	166 leaves : illustrations ; 28 cm
Subjects	Biotechnology--Law and legislation. Biological products--Storage. Biological products--Safety regulations. Commercial freezers--Testing.

Summary	Federal regulations are quite specific for the manufacturing of biological products. These regulations require that the manufacturing process of biological products be controlled to assure probability that the finished product meets established specifications. The intention of this study shall be to validate an empty and fully-loaded chamber temperature distribution for a -20°C upright freezer. Specifically, this study will verify that the -20°C upright freezer conforms to the CFR 21, parts 210, and 600.
General note	Presented to the faculty of the School of Industry and Technology.
General note	Research Committee Chairperson: John Marshall.
Dissertation note	M.S. East Carolina University 1992.
Bibliography note	Includes bibliographical references: leaf 166.

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