000			01881mam a2200349 a 4500
999			_c12641 _d12641
001			9928257323602122
005			20210225142537.0
008			921109s1993 ilu b 001 0 eng d
020			_a0935184384
035			_a(OCoLC)26935845
035			_a(WU)2825732-uwmadisondb
035			_a(EXLNZ-01UWI_NETWORK)999719950502121
040			_aACA _beng _cACA _dEET _erda
082	0	4	_222 _a610.28 _bD.C.D
100	1		_aDeSain, Carol.
245	1	0	_aDrug, device and diagnostic manufacturing : _bthe ultimate resource handbook / _cby Carol DeSain.
250			_aSecond edition.
264		1	_aBuffalo Grove, Ill. : _bInterpharm Press, Inc., _c1993.
300			_axv, 429 pages ; _c24 cm
336			_atext _btxt _2rdacontent
337			_aunmediated _bn _2rdamedia
338			_avolume _bnc _2rdacarrier
504			_aIncludes bibliographies and index.
505	0		_aBiomedical research/design -- Biomedical product development -- Regulatory requirements -- Facility qualification master protocol -- Documentation and document control -- Departmental organization/responsibilities -- Master validation protocol -- Quality assurance monitoring and control programs -- Clean rooms for aseptic processing -- Endotoxin testing and depyrogenation techniques -- Lyophilization -- Particulate monitoring and control for parenteral and implantable product manufacturing -- Physical sterilization techniques and validation -- Stability testing programs -- Disinfection programs -- Water purification and water quality testing -- Computer controlled process validation -- Safety programs.
650		0	_aPharmaceutical industry _xStandards.
650		2	_aDrug Industry _xstandards.
650		2	_aResearch Design _xstandards.
650		2	_aEquipment and Supplies.
942			_2ddc _cBK