FAT REPORT FOR FEDEGARI STERILISERS

Date of FAT : 21.04.08 to 23.04.08 at FEDEGARI, Italy.

For Cipla Ltd. For Fedegari Autoclavi S.p.A.

Rajesh Dessai Mr. Lorenzo Del Rio - Sales Manager

Praveed Khairat Mr. Franco - Production Manager

FAT of following sterilizers performed

Model Description
XFOD3 Dry Heat sterilizer
FOAF8 Terminal sterilizer (air-steam mixture)
XFOF5 Saturated Steam sterilizer

A) XFOD1 :DRY HEAT STERILIZER

Sr.No. Activity Observation Action to be taken
1. Overall dimension of m/c & Satisfactory. ---
chamber
2. Checked P & ID of M/c Satisfactory Fedegari will recheck the P & ID &
GA before shipment.

Some Labelling of m/c Total labeling will be completed

parts missing. before shipment.
3. Loading system (trolleys and Edges found little Fedegari will polish edges for
racks) rough. smoothness before shipment.
4. HEPA filters New filters not To be installed on site. Fedegari to
installed install the filter and comply the
tests for class 100.
5. Port for DOP testing Port Provided ---
6. Particle count testing Port provided
6. Documentation Drawing checked To amend all the drawing is as built
version.
7. Load Depyrogenation W.r.t. temperature profile it is
sterilization cycle satisfactory.
satisfactory.
8. Heat distribution study Satisfactory. Meets our ---
(Empty chamber) criteria for sterilizer
validation.
9. Manometers (diff. Perssure Pressure differential Old HEPA filters used for testing as
across HEPA) was not satisfactory new HEPA filters can get damaged
across filiters. during handling at FAT. New HEPA
filter to be installed at site and
Delta-P to be checked
Fedegari has not As per fedegari, limit to be set by
specific limit for Cipla based on the data to be
manometer reading. studied on 2 years of use.

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C) FOAF4: TERMINAL STERILIZER (AIR-STEAM MIXTURE) UNIT V,
Sr.No. Activity Observation
1. Overall dimension of Satisfactory.
m/c & chamber
2. Checked P & ID of Manual bleed valves: Ball
M/c valves provided.
Block valves provided (ball
valves)
Pressure switch not fitted on
compressed air line.
No manual valve provided at
Air filter inlet.
All simplex probes are
provided.
Labelling of m/c parts
WFI provided for spray
cooling of the load.
Air detector calibration.
3. Loading system Available for inspection.
4. Loading of temp. Two probes provided for
sensors steam control at the top &
bottom of the chamber
which can’t used for
monitoring in independent
chart recorder due to
technical constraint of
fedegari.
5. Documentation Drawing checked. Some
minor changes required
6. Vacuum leak test Satisfactory
7. Chamber pressure Satisfactory
lake test
8. HPHV cycle Satisfactory
9. Air+steam Mix cycle Satisfactory
10. Heat distribution Satisfactory. Meets our
study (Empty criteria for sterilizer
chamber) validation.
Action to be taken
---
Sanitary bleed valve to be provided
Sanitary bleed valve to be provided
for DI water line.
Pressure sanitary switches to be fitted.
1.Blind flange to be provided for
valve V 154 & VPZ.
2. Fedegari to conduct WIT for filter
without manual valve In case of
failure, fedegari to advice further.
To provided duplex probes as per EU
requirement. Cost 2500 EURO.
Fedegari to do it free of charges.
To be completed before shipment.
DI water shall be provided for spray
cooling as well as chamber CIP.
Changes in P & ID. Considering the
cost of WFI and cost of heat
exchanger for cooling.
User to consider heat exchanger for
initial heating of DI water if required.
Calibration valve to be fitted at the
time of installation.
Satisfactory
To relocate 2 of the product
(controlling) probes (Duplex) close to
T9 & T10 for monitoring.
To amend all the drawing in as built
version.
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D) XFOF5: SATURATED STEAM STERILIZER UNIT V,

Sr.No. Activity Observation Action to be taken
1. Overall dimension of Satisfactory ---
m/c & chamber
2. Checked P & Id of Manual bleed valves: Ball valves Sanitary bled valves to be
m/c Provided. provided
Block valves not provided Not included in scope of
supply since we have
valves at the utility user
points.
No manual valve provided at Air 1.Blind flange to be
filter inlet. provided for valve V 154 &
VPZ.
2. Fedegari to conduct WIT
for filter without manual
valve
Labelling of m/c parts To be completed before
shipment.
Air detector calibration. 1.Calibration valve to be
fitted at the time of
installation.
2. Training to be given at
site during commissioning
3. Loading system Satisfactory ---
4. Loading of temp. Two probes provided for steam & air To relocate 2 of the
sensors control at the & bottom of the product (controlling)
chamber. probes (Duplex) close to
T9 & T10.
5. Documentation Drawing checked To amend all the drawing
in as built version.
6. Vacuum leak test Satisfactory ---
7. Chamber pressure Satisfactory ---
lake test
8. HPHV cycle Inefficient cooling of chamber. Jacket cooling to be
Temp. in the chamber observed provided. Separate utility
above 115 deg. C at the end of the line is needed for jacket
cycle and it had taken 5 hours to get cooling.*
cooled upto 85ºC.
9. Heat distribution Satisfactory. Meets our criteria for To be repeated after
study (Empty sterilizer validation. provision for jacket
chamber) cooling.
Fedegari has to provide OS Thema4 backup for all the sterilizers.

*Additional cost for modification of XFOF5 sterilizer i.e. jacket cooling to be paid by Cipla.
Cost for the same EUR. 10500. Fedegari will take additional one month for this modification.
Other m/c shall be shipped as per the schedule.

Training given to us on operation, maintenance, program creation, modification, safety and

precaution of all 3 autoclaves and 1 DHS.

Pralhad Nehe Pradipta Swain

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