Inspection qualification (IQ) and operational qualification (OQ) for a vacuum freeze-dryer--Part I. General discussion.
The principle objectives of this paper are (a), to develop the rationale for conducting an inspection qualification (IQ) and operational qualification (OQ) of a vacuum freeze-dryer; (b), to identify the key elements that require verification for completion of the IQ; and (c), to establish the necessary environmental and operational parameters necessary for the OQ of the vacuum freeze-dryer.
Jennings
T A
TA
Scheer
A
A
Emodi
A
A
Puderbach
L
L
King
S
S
Norton
T
T
D005612:Freeze Drying / Q000295:instrumentation* / Q000592:standards; D013242:Sterilization; D013696:Temperature