U.S. Valdiation Services - Fe...

Page 1

HOME SERVICES PRODUCT CAREERS CONTACTS

Validation Approach
Fermentor
Installation Qualification Installation Qualification

Facility Qualification The common requirements outlined in the "General" sect

product contact surfaces must be stainless steel or appro
Utility Systems
Tanks which undergo SIP must be supplied with clean ste
steam piping is 316L stainless steel.
Equipment
If the fermentor is large and is hard piped in place, the in
with specifications, materials and installation details show
{ Generic Equipment IQ
{ Generic Equipment OQ
IQ Acceptance Criteria
{ Generic Equipment PQ
{ Autoclave
{ Depyrogenation Oven
Depyrogenation Tunnel If the fermentor is large and is hard
{ Post Installation
Washers system is in agreement with specifica
{ review of
Stopper Processor installation details shown on the Pan
{ PandIDs
{ Ampule/Vials Filling Machine marked.
{ Stoppering Machine
{ Capping Machine
{ Lyophilizer
Operational Qualification
{ Tablet Presses
In addition to the common requirements outlined in the "
{ Tablet Coater
protocol will outline the following tests. Not all tests will b
{ Capsule Filling Machine
fermentor.
{ Checkweigher
{ Tanks
Not more than 1 psi (0.07 bar) is lost in ten minutes afte
{ Cleaned-In-Place Tanks
barg)
{ Blenders and Mixers
{ Spray Granulator
Thermocouples show that the temperature can be raised
{ Mill and Micronizers
maintained at that setpoint. Thermocouples show that th
{ Controlled Temperature Units
to the set point, and maintained at that setpoint.
{ Liquid Nitrogen Freezers
{ Biosafety Cabinet
Calibrated fermentor instrumentation show that the grow
{ Isolator (Glove Box)
CO2) can be can be raised to their setpoints, and mainta
{ Fume Hood
be can be lowered to their setpoints, and maintained at t
{ Fermentor
The agitator performs properly; the speed can be control

Empty Vessel Steam Sterilization.

Thermocouples are arranged throughout the vessel, inclu
difficult to penetrate locations.
Temperature uniformity within the chamber during steam
thermocouples, must be less than ± 1.0°C of the mean c
include the penetration thermocouples in valves and pipin
Steam, during dwell in the empty chamber study, is satu
temperature:pressure relationship (see attached graph).
thermocouples in valves and piping in the calculation.

http://www.validationworld.c... 17/11/2010 3:51:15 PM

 U.S. Valdiation Services - Fe... Page 2

OQ Acceptance Criteria

Not more than 1 psi (0.07 bar) is lo

Pressure Hold Test
pressurization to 10 psig (0.7 barg)
Thermocouples show that the temp
set point, and maintained at that se
Temperature
Control
Thermocouples show that the temp
set point, and maintained at that se
Fermentor calibrated instrumentatio
parameters can be can be raised to
Growth Parameter maintained at those setpoints.
Control (pH, O2,
CO2) Fermentor calibrated instrumentatio
parameters can be can be lowered t
maintained at those setpoints.
Agitation Rate The agitator performs properly; the
Thermocouples are arranged throug
entry points, valves and difficult to

Temperature uniformity within the c

sterilization, as shown by the therm
1.0°C of the mean chamber temper
Empty Vessel
Steam Sterilization Do not include the penetration ther
in the calculation.

Steam, during dwell in the empty ch

shown by the temperature:pressure
graphs). Do not include the penetra
and piping in the calculation.

Performance Qualification

Empty Vessel Sterilization:

Bacillus stearothermophilus biological indicators are such
value and the log of the population is at least 6 (e.g., D =
106 is preferred for steam strips.
Biological indicators enumerate within specifications per U
average number is not less than 50% of the number of v
strain per carrier stated on the label, and not more than
Positive control biological indicators are positive after inc
days.
The sterilization cycle provides a minimum cumulative F0
dwell, at each temperature sensor (except the drain tem
All biological indicators placed are inactive after incubatio

Sterilization: Vessel with Media (if appropriate).

Bacillus stearothermophilus biological indicators are such
value and the log of the population is at least 6 (e.g., D =
106 is preferred for steam strips. Spore ampules are not
Biological indicators enumerate within specifications per U
average number is not less than 50% of the number of v
strain per carrier stated on the label, and not more than
Positive control biological indicators are positive after inc
days.
The sterilization cycle provides a minimum cumulative F0

http://www.validationworld.c... 17/11/2010 3:51:15 PM

 U.S. Valdiation Services - Fe... Page 3

dwell, at each temperature sensor.

All biological indicators placed are inactive after incubatio

Sterile Integrity Testing.

The vessel, with sterilized media,, is placed in normal ope

PQ Acceptance Criteria

Bacillus stearothermophilus biologic

product of the 'D' value and the log
(e.g., D = 1.5, population = 104).
strips.

Biological indicators enumerate wit

Monograph (the " average number
number of viable spores of the spec
Sterilization: on the label, and not more than 30
Empty Vessel
Positive control biological indicators
at 50-55°C for seven days.

The sterilization cycle provides a m

minutes, at end of cycle dwell, at e
(except the drain temperature sens

All biological indicators placed are i

55°C for seven days.
Bacillus stearothermophilus biologic
product of the 'D' value and the log
(e.g., D = 1.5, population = 104).
strips. Spore ampoules are not ava

Biological indicators enumerate wit

Monograph (the " average number
number of viable spores of the spe
Sterilization: on the label, and not more than 30
Vessel with Media
(if appropriate) Positive control biological indicators
at 50-55°C for seven days.

The sterilization cycle provides a m

minutes, at end of cycle dwell, at e
(except the drain temperature sens

All biological indicators placed are i

55°C for seven days.
No contamination seen in media-fil
Sterile Integrity under active conditions for a period
fermentation.

home | contacts | disclamer © 2009 U

Phone: 617-306-6767 50 Green

http://www.validationworld.c... 17/11/2010 3:51:15 PM