Inspection qualification (IQ) and operational qualification (OQ) for a vacuum freeze-dryer--Part II: Inspection qualification.
This paper demonstrates the importance of the inspection qualification (IQ). It was shown that the facilities were adequate to house the dryer and its associated instrumentation, and that the facilities had sufficient utilities to operate the dryer. The IQ established that the design and construction of the dryer was in agreement with the proposed hardware and design specifications. It was verified that the dryer was constructed in accordance with specifications set-forth by the equipment manufacturer.
Jennings
T A
TA
Phase Technologies, Inc., Conshohocken, PA, USA.
Scheer
A
A
Emodi
A
A
Puderbach
L
L
King
S
S
Norton
T
T
D004339:Drug Compounding / Q000295:instrumentation; D004345:Drug Industry / Q000592:standards; D005612:Freeze Drying / Q000295:instrumentation*