title: Inspection qualification (IQ) and operational qualification (OQ) for a vacuum freeze-dryer--Part I. General discussion.
abstract: 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.
authors.forename: T A
authors.initials: TA
authors.lastname: Jennings
authors.forename: A
authors.initials: A
authors.lastname: Scheer
authors.forename: A
authors.initials: A
authors.lastname: Emodi
authors.forename: L
authors.initials: L
authors.lastname: Puderbach
authors.forename: S
authors.initials: S
authors.lastname: King
authors.forename: T
authors.initials: T
authors.lastname: Norton
mesh_terms: D005612:Freeze Drying / Q000295:instrumentation* / Q000592:standards; D013242:Sterilization; D013696:Temperature