Steamsterilizer4 Demoreport PDF

PROCESS CONTROL & VALIDATION
Richmond B.V.
Lintelerweg 60A
NL-7556 PD Hengelo(Ov)
Tel +31 (0) 74 291 30 86

Fax +31 (0) 74 243 29 53
E-Mail mail@richmond-nl.com
Internet www.richmond-nl.com
Warning:
This report is for demonstration purposes only.

No conclusion may be drawn with respect to the
validity of the measurement results reported.
Validation report
Report reference RM07-0123
Customer/location University Clinic Hengelo
Subject Steam sterilizer no. 4
Date March 15 - 16, 2007

Validation report Date: 31-5-2010
ValidR Version 1.12b Page 2 of 45
Richmond BV UIN: 398
Contents
1. Summary ...................................................................................................................................... 3
2. Installation qualification: Steam sterilizer 4 .................................................................................. 5
3. Operational qualification: Steam sterilizer 4 ................................................................................. 8
4. Measurement: Leakage test ....................................................................................................... 10
5. Graph: Leakage test ................................................................................................................... 11
6. Measurement: Bowie & Dick test 3min/134................................................................................ 13
7. Graph: Bowie & Dick test 3min/134............................................................................................ 15
8. Measurement: Unloaded 4min/134 ............................................................................................ 17
9. Graph: Unloaded 4min/134 ........................................................................................................ 19
10. Graph: Unloaded 4min/134 ........................................................................................................ 21
11. Measurement: 50% load Instruments 4 min/134........................................................................ 23
12. Graph: 50% load Instruments 4 min/134 .................................................................................... 25
13. Measurement: 100% load Instruments 4min/134....................................................................... 27
14. Graph: 100% load Instruments 4min/134 ................................................................................... 30
15. Measurement: Mixed load containers/paper 4min/134 .............................................................. 32
16. Graph: Mixed load containers/paper 4min/134 .......................................................................... 34
17. Measurement: Worst case container/textile 4min/134 ............................................................... 36
18. Graph: Worst case container/textile 4min/134 ........................................................................... 39
19. Calibration: Default protocol Steam Sterilizers (120-130-140) ................................................... 41
20. Description of the validation system ........................................................................................... 42
21. Attachments................................................................................................................................ 45
1. Summary
This validation document reports the planning and execution of measurements and tests regarding the
validation the sterilizer mentioned in the assignment description.
The previous contents show the planned and executed validation tasks. The results and other details
are elaborated in the indicated paragraphs of this report. Per measurement they describe the process,
the load under test and the arrangement of the measurement sensors.
The measurement results and their graphical representations are added including the detected
deviations and further measurement details.
This summary holds the details of the validation assignment, the persons and organizations involved
with the validation. The justification of the applied standards are given as well as the used
measurement equipment and the persons responsible fort he interpretation of the result and the final
validation conclusions.
In the conclusion a summary is given of the validation results and eventual detected deviations and
where applicable comments from already held discussions on that and comparing them with previous
validation results or otherwise important circumstances.
Assignment
Subject of validation: Steam sterilizer 4

Location: University Clinic Hengelo
Principal: Mr. P. Principal, University Clinic Hengelo
Expert sterile medical devices:

Mr. E. Expert, University Clinic Hengelo
Reason for validation: Revalidation 2007

Applicable standard: ISO-EN 554 / ISO-EN 285
Assignee: Richmond BV
Assignment contract: our offer dated 02-02-2007
Performed by: Mr. V. Engineer

Date performed: March 15-16, 2007
Justification
The validation is set up and executed according to the following applicable European standards:
ISO-EN 285: Sterilizers – Steam sterilizers – Large sterilizers.
ISO-EN 554: Sterilization of medical devices. Validation and routine control of steam (Large
sterilizers).
ISO-EN 285 describes general specifications regarding steam sterilizers and with respect to validation
specific requirements for leakage test and indicating/recording instruments.
ISO-EN 554 describes the actual validation process and the requirements for the measurement
equipment used as well as the specific required measurement values and accuracies with regard to
the course of the sterilization process.
De actual execution of the measurements en the processing of the measurement results was done
with the help of IAVS-M2 validation measurement system with ValidR validation and reporting
software. This measurement system, developed by Richmond BV, Hengelo, the Netherlands,
complies with the requirements set by the standards and it performs most of the criteria verifications
automatically. A detailed description of this equipment and the accompanying calibration certificates is
given further on in this report.
Conclusions
1. The sterilizer complies with the involved standards and in relation to the combinations of process,
product, product packaging and load concerning the following processes:
Ster. Ster.
Nr. temp. time Load
(°C) (min.)
6 - - Leakage test
9 134 4 50% loaded Instruments 4min/134
10 134 4 100% loaded Instruments 4min/134
11 134 4 Mixed load containers/paper 4min/134
[Commentaar]
2. The sterilizer DOES NOT COMPLY with the involved standards and in relation to the combination
of process, product, product packaging and load concerning the following processes:
Ster. Ster.
Nr. temp. time Load
(°C) (min.)
7 134 4 Bowie&Dick test:
- Jacket temperature lower than theoretical temperature
8 134 4 Unloaded 4min/134

- Equilibrationtime too long
12 134 4 Worst case containers/textile 4min/134

- Deviation in temperature comparison Registration too large
(Sterilisation phase)
Remarks and suggestions
1. Recommende revalidation
According to the involved standards a revalidation is to be performed at latest in March 2008 , or
earlier when any intervention is done that could influence the combination of process, product,
product packaging and load.
2. It is advised to make written work instructions and use those in the daily routine of
loading/unloading of the sterilizer.
Signature
Drawn up on March 16, 2007 at Hengelo door V. Engineer:
Signature:
Report
The following paragraphs contain the specifications and measurement results for every part of the
validation and a description of the calibration and measurement equipment according to the
arrangement in the contents.
2. Installation qualification: Steam sterilizer 4
Machine data
Machine number : 4
Location : University Clinic Hengelo
Reason for identification : Revalidation 2007
Identification number : 6648GG6
Date identification : January 7, 2006
Date previous identification : n.a.
Changes after previous identification : n.a.
General Data
Trading name : Getinge

Type : HS 6613 DR-2
Purpose :
Year of manufacture : 2005
Manufacturer : Getinge
Supplier : Getinge
Registration number :
Date first used : May 2006
Description of sterilization method
(short characterization) : Steam sterlizer with air pressure compensation
If the sterilizers uses several different methods (depending on the cycle), these should all be
described clearly per cycle.
Control principle : Pressure / temperature controlled

Steering principle : Pressure / temperature steering
Main data
Inner dimensions :
Sterilizer chamber (H*W*D) : 670 mm * 670 mm * 1330 mm
Volume (H*W*D) : 670 mm * 670 mm * 1300 mm
Orientation of the chamber : Horizontal
Double jacket : Yes
Heating surface as % of the
chamber surface excl. doors : More than 50% %
Way of loading : Carts
Door principle : Sliding
: Vertical
: Single door
Door closing system : Steam
Steam
Steam supply : Own generator

Pressure : Min. 500 kPa
Feeding water : deminirilized/inverted osmosis/conductivity < 0.6
De gassing method : Thermic
Used additives
Trading name, type : no
Other additives
Trading name, type : no
Steam inlet : Left and right side wall
Inlet through jacket : yes
Filter : no
Filter Manufacturer name :
Filter Type :
Position condensate outlet : central in the floor
Air
Position air inlet : via steam inlet

Inlet type : Devider plate
Filter Manufacturer name : Getinge
Filter Type :
Vacuum
Vacuum pump present : yes

Pump manufacturer name: : Sterling LEMA 50AZ
Pump type :
Capacity : 51 m3 per hour at a pressure of
: 0.3 kPa and
: 2800 rpm
Control system
Control system type : Microprocessor

Fixed programs : yes
List of fixed programs : yes
If yes, state list : P1: Preheat programm
P2: Leakage test
P3: Bowie & Dick test
P4: Medical Devices 134 deg.C
Door unloading side block after
cycle error : yes
Protected against changes : yes
If yes, how :
Air leakage test possible : yes
Sterilisation temperature modifiable : no
Sterilisation time modifiable : no
Other variables modifiable : no
If yes, which ones :
Protected against free settings : yes
Protected with regard to sterilisation
temperature : yes
Bowie & Dick test possible : yes
Measure- and control system
Pressure control : yes

Temperature control : no
Pressure control : yes
Temperature registration : yes
Number of control sensors : 1 in condensate outlet
0 free in chamber
Number of steering sensors : 1 in condensate outlet
0 free in chamber
Number of registration sensors : 1 in condensate outlet
0 free in chamber
Sensors for control and registration
independent : yes
Control and registration sensor
In one case : yes
Principle of sensor : pt100
Registration system
Trading name registration system : Hewlett Packard

Type : DeskJet
Measurement range : Temperature 50 °C til 150 °C
Pressure 0,4 kPa til 400 kPa
Paper scale : Temperature 1.63 mm/°C
Time axis: 210 mm/Hour
Measurement frequency per channel : continuous per Minute
Direct readable instruments : Chamber temperature
chamber pressure
3. Operational qualification: Steam sterilizer 4
Performed by : V. Engineer
Job title : Validation engineer
Date & time : March 15, 2007
Steam pressure
Target value : min. 5 Bar

Actual value when not in use : 5.3 Bar
Position steam tap
Movable : yes
Fully opened : yes
External leakage : no
Position cycle water faucet
Movable : yes
Fully opened : yes
Position cooling water faucet
Movable : yes
Fully opened : yes
Position compressed air tap
Movable : yes
Fully opened : yes
Steamvalves
Leakage steam inlet jacket : no

Leakage steam inlet chamber : no
Steamfilter
Filter replacing interval : n.a.

Date last replaced : n.a.
Doorseal
Clean : yes
Damaged : no
Airfilter
Visible damage : no
Wet (or previously wet) : no
Filter replacing interval : 6 months
Date last replaced : Oct. 2006
Sterilizer chamber (including doors)
Clean : yes
Traces of corrosion : `no

Damage by loading trolleys : no
Filter in condensate outlet undamaged
and clean : yes
Loading trolley locking ok : yes
Trolley locking on sterilizer ok : yes
Water pools after cycle end : no
Steam inlet
Attachment ok : yes
Clean : yes
Free of water : yes
Other remarks
Noticable leakages : no
Odd noises : no
Registration
Correct operation : yes

Provided with correct paper : yes
Air leakage test
Start value : see resluts of leakage test

End value :
Duration of test :
Deepest Vacuum
Cycle phase : see results of measurements

Target value :
Actual value :
Registrated value :
Jacket pressure
Target value : see result of measurements during pre phase

: during sterilizaton phase
Actual value : during pre phase
: during sterilizaton phase
Chamber pressure
Target value : see results of measurements

Actual value :
Registrated value :
Sterilisation temperature
Target value : see results of measurements

Actual value :
Registrated value :
4. Measurement: Leakage test
General
Sterilizer name CSD4
Description Steam sterilizer 4
Performed by V. Engineer
Job title Validation Engineer
Date & time 15-3-2007 14:03:45
- Tested according: EN285 (LT): Sterilization - Steam sterilizers - Large sterilizers.
Conclusion
The validation system concludes the following:
- Compliance with the guidelines was found.
Operator remarks before the measurement

No peculiarities before the measurement
Results
Start time Duration Pressure Difference Recorded
(hh:mm:ss:) (hh:mm:ss:) at Start Pressure
(kPa) (kPa) (kPa)
Evacuate 0:00:00 0:06:06 101.3 -97.3
Stabilizing 0:06:06 0:05:00 4.0 0.1 4.2 ( 0.2)
Leakage test 0:11:06 0:09:57 4.1 0.0 4.2 ( 0.1)
Aeration phase 0:21:03 0:02:00 4.1 97.1 4.6 ( 0.5)
End of measurement 0:23:03 101.2
Operator remarks after the measurement

No peculiarities
5. Graph: Leakage test

Legend
── Pressure
Criteria and results

Descrition Applied Result
- Maximum pressure at start Stabilizing
- Duration stabilizing
- Duration leakage test
- Maximum pressure rise during leakage test
- Pressure reading at Stabilizing Start (X)
- Pressure reading at Leakage test Start (X)
- Pressure reading at Leakage test End (X)
End of report
6. Measurement: Bowie & Dick test 3min/134
Machine
Name : CSD4
Description : Steam sterilizer 4
Dimensions : 670 x 670 x 1300 (H x W x D, in mm)
Cycle
- Nominal sterilisation temperature 134 °C
- Nominal sterilisation time 0:03:00 uu:mm:ss
- Applicable guideline: EN554: Sterilization of Medical Devices. Validation and routine control of
sterilization by moist heat. (large sterilizers)
Conclusion
- Compliance with the guidelines was not found (see further in this report).
Product combination
Product Bowie & Dick test package
Package Sheets of 100% cotton; size 940 x 1180 mm.
Contents 32 sheets of 100% cotton , weigth 7090 grams
Load Size about 240 x 340 x 250 mm.
Thermocouple positioning
Tc. Nr. Type pt100 nr. Level X-Position Y-Position
1 H 1 1 3 4
In the drain
2 J 0 3 1 3
Heat conducting against the jacket
3 R 0 10 3 4
Free in the open space
4 P 0 4 2 3
In package heart
5 P 0 4 2 3
In corner of same sheet as couple 4.
6 P 0 4 4 3
In corner of same sheet as couple 4.
8 P 0 5 3 4
In top of package; under first textile layer
9 P 0 3 3 4
In bottom of package; above first layer of textile
10 R 0 6 3 4
2 cm above package
Thermocouple set
S/N 1080
Description CSD set 1, 1/2 inch feedthrough
Shielded set No
Number of couples 10
Thermocouple calibration protocol

Protocol Default protocol Steam Sterilizers (120-130-140)
Initial calibration Date & time 15-3-2007 13:57:26
First calibration Date & time 15-3-2007 13:57:26
Second calibration Date & time 20-3-2007 16:35:34

Place Bowie&Dick pakage in length of the sterilizer.
Wrap package once in white crepe en once in green paper
Time table
Duration
Start Pre phase 14:13:51 0:00:00 0:18:26
Start Sterilisation phase 0:18:26 0:03:01
Start Post phase 0:21:27 0:08:52
End of measurement 0:30:19
Equilibrationtime: 0:00:08
Temperature spread in sterilisation phase

Time in cycle 0:19:12 (uu:mm:ss)
Limit 2.0 (°C)
Measured value 1.8 (°C)
Hottest thermocouple 10
Coldest thermocouple 1
Deviations found during the measurement

- Time in cycle (hh:mm:ss) 0:16:33
- Value (°C) -0.1
- Measured by Thermocouple 2
Comparison validation system versus control and registration system

Sterilisation phase
Tc 1 (°C)
(pt100 0) Start (0:18:27) Middle (0:19:57) End (0:20:58)
ValidR 134.2 (0.0) 134.9 (0.0) 134.8 (0.0)
Control 134.7 (0.5) 134.7 (-0.2) 134.8 (0.0)
Registration 134.7 (0.5) 134.7 (-0.2) 134.8 (0.0)
Sterilisation phase
Pressure (kPa) Start (0:18:27) Middle (0:19:57) End (0:20:58)
ValidR 306.0 (0.0) 312.1 (0.0) 312.0 (0.0)
Control 311.6 (5.6) 312.0 (-0.1) 311.3 (-0.7)
Registration 311.6 (5.6) 312.0 (-0.1) 311.3 (-0.7)
Deviations in the comparison

- Deviation in pressure comparison Control too large (Sterilisation phase)
- Deviation in pressure comparison Registration too large (Sterilisation phase)
7. Graph: Bowie & Dick test 3min/134

Thermocouple information and curve selection

Code Type Level X Y Curve HC CC Spread
── Tc 1 0 H 1 3 4
── Tc 2 0 J 3 1 3
── Tc 3 0 R 10 3 4
── Tc 4 0 P 4 2 3
── Tc 5 0 P 4 2 3
── Tc 6 0 P 4 4 3
── Tc 8 0 P 5 3 4
── Tc 9 0 P 3 3 4
── Tc 10 0 R 6 3 4
── Pressure
---- Theoretical temperature

- Temperature >= nominal Sterilisation temperature (X)
- Temperature <= nominal Sterilisation temperature (X) + Temp. Band
- Spread in Temperatures (Sterilisation phase)
- Fluctuation per Thermo couple (Sterilisation phase)
- Jacket temperature >= Theoretical Temperature (TT)
- Equilibration time maximum (X)
- Sterilisation time >= nominal Holding time (X)
- Sterilisation time <= nominal Holding time (X)
- Temperature comparison Control (Sterilisation phase)
- Temperature comparison Registration (Sterilisation phase)
- Pressure comparison Control (Sterilisation phase)
- Pressure comparison Registration (Sterilisation phase)
- Calibration brief before the measurement
- Calibration brief after the measurement
End of report
8. Measurement: Unloaded 4min/134
Machine
Name : CSD4
Cycle
Conclusion
Product combination
Product n.a.
Package n.a.
Contents n.a.
Load n.a..
1 H 1 1 3 4
In the drain
2 J 0 3 1 3
Heat conducting against side wall; on first rib (not heated)
3 J 0 3 1 3
Heat conducting against side wall; on second rib (heated)
4 R 0 2 1 1
5 R 0 2 5 1
6 R 0 10 1 7
On pincher
8 R 0 10 5 7
9 R 0 10 1 1
10 R 0 2 5 7
Thermocouple set
S/N 1080
Shielded set No

Time table
Duration
Start Pre phase 14:17:56 0:00:00 0:17:51

Limit 2.0 (°C)

- Equilibrationtime too long
- Value (uu:mm:ss) 0:00:26
- Limit (uu:mm:ss) 0:00:15
- Time in cycle (hh:mm:ss) 0:22:16
- Value (°C) -0.5
- Measured by Thermocouple 2

Sterilisation phase
Tc 1 (°C)
ValidR 134.1 (0.0) 134.6 (0.0) 134.7 (0.0)
Control 134.2 (0.1) 135.2 (0.6) 134.6 (-0.1)
Registration 134.2 (0.1) 135.2 (0.6) 134.6 (-0.1)
Sterilisation phase
ValidR 306.6 (0.0) 311.6 (0.0) 312.2 (0.0)
Control 303.9 (-2.7) 311.3 (-0.3) 311.0 (-1.2)
Registration 308.2 (1.6) 311.3 (-0.3) 311.0 (-1.2)
9. Graph: Unloaded 4min/134


── Tc 1 0 H 1 3 4
── Tc 2 0 J 3 1 3
── Tc 3 0 J 3 1 3
── Tc 4 0 R 2 1 1
── Tc 5 0 R 2 5 1
── Tc 6 0 R 10 1 7
── Tc 8 0 R 10 5 7
── Tc 9 0 R 10 1 1
── Tc 10 0 R 2 5 7
── Pressure

End of report
10. Graph: Unloaded 4min/134


── Tc 1 0 H 1 3 4
── Tc 2 0 J 3 1 3
── Tc 3 0 J 3 1 3
── Tc 4 0 R 2 1 1
── Tc 5 0 R 2 5 1
── Tc 6 0 R 10 1 7
── Tc 8 0 R 10 5 7
── Tc 9 0 R 10 1 1
── Tc 10 0 R 2 5 7
── Pressure

End of report
11. Measurement: 50% load Instruments 4 min/134
Machine
Name : CSD4
Cycle
Conclusion
Product combination
Product Instruments
Package Containers
Contents Instruments
Load Half full
1 H 1 1 3 4
I the drain; through the sive, about 10 cm inside (and back upwards).
2 J 0 3 1 3
3 R 0 11 3 4
4 P 0 2 2 1
Attched to pincher
5 P 0 2 3 1
At the bottom of the net
6 P 0 2 3 4
On pincher
8 P 0 2 3 4
On sissers
9 P 0 4 5 7
Attached to metal handle
10 R 0 4 4 7
2 cm above container
Thermocouple set
S/N 1080
Shielded set No


Load 2 stacks of containers
Lowest 2 layers are half-length containers.

Upper layer: 2 half-size containers at the load side as well as the unload side.
At the bottom: form load side to unload side:

- OK bones, small
- Ok Instruments smaal
- Base net
- Base net
On top of that, at the load side:

- left: Jaw 38 Extraction 38
- rigth: Jaw surgery instruments
On top at the unload side:

- left: Jaw surgery extraction set
- right: Jaw surgery extraction pincer
Time table
Duration
Start Pre phase 14:21:42 0:00:00 0:22:42

Limit 2.0 (°C)

- No deviations were found.

Sterilisation phase
Tc 1 (°C)
ValidR 134.3 (0.0) 134.7 (0.0) 134.6 (0.0)
Control 134.4 (0.1) 134.7 (0.0) 134.7 (0.1)
Registration 134.4 (0.1) 134.7 (0.0) 134.7 (0.1)
Sterilisation phase
ValidR 308.4 (0.0) 311.7 (0.0) 311.8 (0.0)
Control 308.1 (-0.3) 310.9 (-0.8) 311.6 (-0.2)
Registration 308.1 (-0.3) 310.9 (-0.8) 311.6 (-0.2)
12. Graph: 50% load Instruments 4 min/134


── Tc 1 0 H 1 3 4
── Tc 2 0 J 3 1 3
── Tc 3 0 R 11 3 4
── Tc 4 0 P 2 2 1
── Tc 5 0 P 2 3 1
── Tc 6 0 P 2 3 4
── Tc 8 0 P 2 3 4
── Tc 9 0 P 4 5 7
── Tc 10 0 R 4 4 7
── Pressure

End of report
13. Measurement: 100% load Instruments 4min/134
Machine
Name : CSD4
Cycle
Conclusion
Product combination
Product Instruments
Package Containers
Load Full
1 H 1 1 3 4
2 J 0 3 1 3
3 R 0 11 3 4
4 P 0 2 2 1
Attached to kidney bowle
5 P 0 2 3 1
6 P 0 4 3 3
On stainless steel bowle
8 P 0 4 4 3
9 P 0 6 5 7
Attached to metal handle
10 R 0 6 4 7
2 cm above container
Thermocouple set
S/N 1080
Shielded set No


Loaded with 4 stacks of containers, 3 containers high.
Bottom 2 layers consist of full length containers.

Top layer consists of half width containers (8 pices in total).
At the bottom, fromload side to unload side:

- Base net
- Base net
- Base net
- Jaw set
In the middel, from load side to unload side:

- Teeth extracter
- Belly net
- Base net
- Base net
At the top, from load side to unload side, from left to right:
- Jaw surgery extraction pincer, Jaw surgery extraction pincer
- Jaw 38 extracter; Jaw extraction pincer
- Jaw surgery extraction pincer; Jaw surgery extraction pincer
- Jaw surgery 38, Instruments; Jaw 38, Instruments 38
Time table
Duration
Start Pre phase 14:23:39 0:00:00 0:29:11

Limit 2.0 (°C)


Check for dryness:
- NB: The crepe paper at the bottom of the bottom containers, is not completely dry (some drips of
water at the upper side).
Check for correct thermocouple placement: OK
Check for correct packaging: OK

Sterilisation phase
Tc 1 (°C)
ValidR 134.0 (0.0) 134.6 (0.0) 134.6 (0.0)
Control 134.2 (0.2) 134.7 (0.1) 134.7 (0.1)
Registration 134.2 (0.2) 134.7 (0.1) 134.7 (0.1)
Sterilisation phase
ValidR 306.3 (0.0) 311.6 (0.0) 311.8 (0.0)

Control 308.8 (2.5) 311.6 (0.0) 311.6 (-0.2)
Registration 308.8 (2.5) 311.6 (0.0) 311.6 (-0.2)
14. Graph: 100% load Instruments 4min/134


── Tc 1 0 H 1 3 4
── Tc 2 0 J 3 1 3
── Tc 3 0 R 11 3 4
── Tc 4 0 P 2 2 1
── Tc 5 0 P 2 3 1
── Tc 6 0 P 4 3 3
── Tc 8 0 P 4 4 3
── Tc 9 0 P 6 5 7
── Tc 10 0 R 6 4 7
── Pressure

End of report
15. Measurement: Mixed load containers/paper 4min/134
Machine
Name : CSD4
Cycle
Conclusion
Product combination
Product Instruments
Package Containers
Load Half full
1 H 1 1 3 4
2 J 0 3 1 3
3 R 0 11 3 4
4 P 0 6 2 1
In laminate packaging
5 R 0 6 3 1
2 cm aboce packaging witk couple 4.
6 P 0 4 3 4
Folded in jacket
8 P 0 4 4 4
Folded in jacket; under first layer.
9 P 0 2 3 7
Attached to kidney bowle
10 R 0 2 4 7
on the container
Thermocouple set
S/N 1080
Shielded set No


Loaded with 2 stacks of containers:
From load side to unload side, from bottom to top:

- Basket with laminate packaging
- Full heigth container 'Lapgal'
- Half heigth container 'OK Belly net'
Behind that:
- Basket with textile (coats)
- Two half heigth containers 'Base net'
Behind that:
- Basket with textile (coats) and 1 laminate packaging
- Two half heigth containers 'Base net' and 'Hip set'
Behind that:
- Basket with laminate packaging
- Two half heigth containers 'Base net' and 'Belly net'
Time table
Duration
Start Pre phase 14:26:38 0:00:00 0:28:20

Limit 2.0 (°C)


Check for dryness: OK
Check for Thermocouple placement: OK
Check for packaging: OK

Sterilisation phase
Tc 1 (°C)
ValidR 134.0 (0.0) 134.7 (0.0) 134.6 (0.0)
Control 134.2 (0.2) 134.8 (0.1) 134.7 (0.1)
Registration 134.2 (0.2) 134.8 (0.1) 134.7 (0.1)
Sterilisation phase
ValidR 305.7 (0.0) 312.0 (0.0) 311.7 (0.0)
Control 307.4 (1.7) 311.6 (-0.4) 311.0 (-0.7)
Registration 307.4 (1.7) 311.6 (-0.4) 311.0 (-0.7)
16. Graph: Mixed load containers/paper 4min/134


── Tc 1 0 H 1 3 4
── Tc 2 0 J 3 1 3
── Tc 3 0 R 11 3 4
── Tc 4 0 P 6 2 1
── Tc 5 0 R 6 3 1
── Tc 6 0 P 4 3 4
── Tc 8 0 P 4 4 4
── Tc 9 0 P 2 3 7
── Tc 10 0 R 2 4 7
── Pressure

End of report
17. Measurement: Worst case container/textile 4min/134
Machine
Name : CSD4
Cycle
Conclusion
Product combination
Product
Package
Contents
Load
1 H 1 1 3 4
2 J 0 3 1 3
3 R 0 11 3 4
4 P 0 2 3 2
On pincher
5 P 0 2 4 2
On sissers
6 P 0 6 3 3
Folded in the textile
8 P 0 6 4 3
In same sheet as couple 6
9 P 0 6 3 7
Folded in the textile
10 R 0 6 4 7
2 cm aboce packaging witk couple 4.
Thermocouple set
S/N 1080
Shielded set No


Loaded with 4 stacks of containers (2 high) with on top of that two baskets with cotton (sheets and
laminate).
From load side to unload side, from bottom to top:

- Textile
- OK Base net
- OK Base net
Behind that:
- Textile
- OK Base net
- Ok Base net
Behind that:
- Textile
- OK Base net
- Ok Base net
Behind that:
- Textile
- OK Bone net small
- Ok Base net
Time table
Duration
Start Pre phase 14:28:40 0:00:00 0:33:41

Limit 2.0 (°C)


Check for dryness: OK
Check for thermocouple placement: OK
Check for packaging: OK

Sterilisation phase
Tc 1 (°C)
ValidR 134.0 (0.0) 134.7 (0.0) 134.7 (0.0)
Control 134.2 (0.2) 134.7 (0.0) 134.7 (0.0)
Registration 134.2 (0.2) 130.0 (-4.7) 134.7 (0.0)
Sterilisation phase
ValidR 306.1 (0.0) 312.2 (0.0) 312.1 (0.0)
Control 306.5 (0.4) 311.8 (-0.4) 312.0 (-0.1)
Registration 306.4 (0.3) 311.8 (-0.4) 312.0 (-0.1)
Deviations in the comparison

- Deviation in temperature comparison Registration too large (Sterilisation phase)
18. Graph: Worst case container/textile 4min/134


── Tc 1 0 H 1 3 4
── Tc 2 0 J 3 1 3
── Tc 3 0 R 11 3 4
── Tc 4 0 P 2 3 2
── Tc 5 0 P 2 4 2
── Tc 6 0 P 6 3 3
── Tc 8 0 P 6 4 3
── Tc 9 0 P 6 3 7
── Tc 10 0 R 6 4 7
── Pressure

End of report
19. Calibration: Default protocol Steam Sterilizers (120-130-140)
Protocol
Name : DefSteam
Description : Default protocol Steam Sterilizers (120-130-140)
Results
Thermocouple set : 1080: CSD set 1, 1/2 inch feedthrough
(10 Thermocouples)
Measurement number : 2
Date and time : 20-3-2007 16:35:34
Performed by : V. Engineer
Job title : Validation Engineer
Initial : No
ITCS used : Yes
Approval for each point : Yes
Thermocouples
(The table shows recalculated digital values followed by the deviation from the intial and previous
calibrations).
Calibration temperatures in °C
Nr Code 120.0 134.0 140.0
1 0 35805.941 39976.350 41763.668
-0.2 -0.2 -0.2 -0.2 -0.2 -0.2
2 0 35776.152 39946.561 41704.091
0.0 0.0 -0.1 -0.1 0.0 0.0
3 0 35805.941 39976.350 41763.668
0.0 0.0 -0.1 -0.1 -0.1 -0.1
4 0 35776.152 39946.561 41733.880
0.0 0.0 0.0 0.0 0.0 0.0
5 0 35805.941 39976.350 41763.668
0.1 0.1 0.1 0.1 0.1 0.1
6 0 35686.786 39857.195 41644.514
0.2 0.2 -0.1 -0.1 -0.1 -0.1
7 1 0.000 0.000 0.000
--- --- --- --- --- ---
8 0 35835.730 40035.927 41823.245
-0.3 -0.3 -0.4 -0.4 0.1 0.1
9 0 35776.152 39946.561 41733.880
-0.1 -0.1 -0.1 -0.1 0.1 0.1
10 0 35746.364 39946.561 41733.880
0.0 0.0 -0.1 -0.1 0.1 0.1
Code Description Code Description

-1 Not calibrated 2 Inactive, defect detected
0 Calibrated 3 Deviation from initial calibration too large
1 Suppressed by user 4 Deviation from previous calibration too large
Temperature Metalblock oven and ITCS (°C)

Temp. 120.0 134.0 140.0
MBO 120.00 134.00 140.00
OTCS 120.00 134.00 140.00
20. Description of the validation system
The measurements in this report were performed with the Integrated Autoclave Validation System IAVS-
M2, equipped with the ValidR validation- and reporting software. The system and the software are
developed by Richmond BV, the Netherlands.
The system complies to the criteria of all applicable European guidelines regarding measurements
systems for thermometric validation of sterilization and cleaner/disinfectors. The system consists of the
following parts:
2
- An integrated Thermocouple scanner / AD converter / Amplifier TSA measurement system ([S/N
xxxxxxxxxx] ), responsible for central registration and processing of the measurement values for
temperature and pressure and also for controlling the metal block oven for the automatic calibration
of the thermocouples. For that, the measurement system contains amongst others a 16 channel
thermocouple scanner, a pressure transducer amplifier and a pt100 reference amplifier;
- An absolute pressure sensor in a temperature conditioned casing ([S/N xxxxxxxxxx]) with an
measurement tolerance not exceeding 0,7 kPA;
- An unshielded thermocouple set ([S/N xxxxxxxxxx]) with 16 (Type K) Thermocouples, mounted by
an airtight throughput with a total system measurement tolerance of 0,2°C;
- A thermocouple calibration oven (Metal block oven) ([S/N xxxxxxxxxx]) with a built in pt100
reference element with a measurement tolerance of 0,05°C;
- An Independent Temperature Control System ITCS (Type [Xxxxxxxxxxx], [S/N xxxxxxxxxx]) with a
measurement tolerance of 0,1°C;
- A portable Windows computer under Windows XP/ /Office2003 with ValidR Validation and reporting
software version 1.12 installed;
- An HP-DeskJet printer.
The ValidR validation and reporting software package has a user interface to set up detailed validation
protocols and thermocouple calibration protocols for all different combinations of process, product,
packaging and load configurations. Next to these measurement protocols text protocols can be designed
for the Installation and Operational Qualification activities as well as for other free text paragraphs of the
validation end report.
The validation part of ValidR instructs the validation engineer in how to prepare loads, the placements of
the thermocouples and the operation of the sterilizers/desinfector. This software part also controls the
measurement system according to the set up protocols; the measurement system performs the
measurements and checks the results against the applicable standards criteria, which are integrated in
the software.
The report part of ValidR collects all measurement results and the other textual paragraphs and merges
those together to a complete validation end report.
During the yearly maintenance cycle the validation system is extensively checked on correct functionality
and the system is adjusted (when necessary) within the required accuracies and always recalibrated.
The results of maintenance are logged in a logbook which is available with the system.
Calibration of the pressure sensor
The pressure sensor is calibrated once per year. The calibration results (correction values) are
programmed into the validation system so measurement results are always automatically corrected.
The attachments to this report hold a copy of the applicable calibration certificate of the pressure sensor.
Calibration of the independent temperature control system ITCS
The ITCS temperature meter is used to verify the temperature of the metal block oven during the
calibration of the thermocouples. The calibration results (correction values) are programmed into the
validation system so measurement results are always automatically corrected.
The attachments to this report hold a copy of the applicable calibration certificate of the ITCS
temperature meter.
Calibration of the thermocouples

st
The thermocouples are calibrated according to the applicable guidelines before (1 calibration) and
nd
after (2 calibration) the execution of the actual validation measurements. The calibration is done by
means of an automated thermocouple calibration process, which is integrated in the validation system
and the ValidR software.
st
Based on the 1 calibration results a “digital measurement value - to - temperature” conversion table is
generated. The actual recorded data during the validation is converted to temperature values based
upon linear interpolation within the calibrated table.
The thermocouple calibration process also compares every individual calibration value with the
previous value ánd with the initial calibration table, which is generated during maintenance. If a
thermocouple deviates more than 0.5°C with respect to the previous calibration and/ or more than
1.0°C with respect to the initial calibration, that thermocouple is supposed to be defect and it will not
be used in the validation measurements.
st nd
The results of the performed 1 and 2 calibrations are reported in combination in the report
paragraph concerned (see Contents).
Clarification on legends and abbreviations
Thermocouples have a type denomination in relation to their position either in the load (product) or
elsewhere in the sterilizer/desinfector chamber during validation. Validation standards demand specific
test criteria for the following different positions:
- type C Control couple In a product and with a pT100;
- type P Product couple In a product but not with a pT100;
- type H cHamber couple Not in a product but with a pT00;
- type R Room couple Not in a product and not with a pT100;
- type J Jacket couple On the jacket (heat conducting);
- type I Inactive couple Thermo couple is not used.
- With steam sterilization processes for medical devices and with washer/disinfectors the H-type
thermocouple (at the control pT100) is used for the comparison of the validation system with the
control and measurement system of the sterilizers/desinfector;
- With steam/hot-water sterilization processes for liquids (liquid sterilizers) and with hot-air
sterilizers the C-type thermocouple (at the pT100 in the product) is used for the comparison of the
validation system with the control and measurement system of the sterilizers;
- With H- and C-type thermocouples, so thermocouples placed at a pT100 sensor, the number of
the pT100 sensor concerned is noted with the couple.
The Level-, X- and Y- positions indicate the location of a thermocouple in the sterilizer/desinfector
chamber:
- The sterilizer/desinfector chamber is divided in 11 levels of height, each 5 positions wide and 7
positions deep;
- The level determines the height in the chamber: Level 1 is the bottom of the chamber, level 11 is
the top of the chamber, both actually used for positions outside the load. Levels 2 to 10 are
intermediate heights within the load with level 6 in the middle;
- The X-position determines the width in the chamber: X-position 1 is at the left (seen from the
load side to the unload side); position 3 is in the middle and position 5 is all right;
- The Y-position determines the depth in the chamber: Y-position 1 is at the front (at the load
side), position 4 is in the middle and position 7 is at the back (at the unload side);
- Examples: 1,1,1: On the bottom, left, at the front (load side);
1,5,1: On the bottom, right, at the front (load side);
1,5,7: On the bottom, right, at the back (unload side);
6,3,4: In the geometric heart of the chamber;
10,5,7: In the top layer of the load, right, at the back (unload side);
11,5,7: At the top (ceiling), right, at the back (unload side);
“ITCS” stands for the Independent Temperature Control System. Thermocouples are calibrated at a
reference temperature generated by the metal block oven (MBO); validation standards require an
accurate independent verification of that reference temperature by means of the ITCS.
21. Attachments
This is a table of the supporting documents for this report. The documents are sorted by number of the
individual tasks and identified by the paragraph number in the report. These documents are an
indispensable essential of this report.
Task
Identification Description
Nr.
5 Leakage test Process graph charge 21
6 Bowie & Dick test Bowie & Dick sheet
Process graph charge 24
7 Unloaded 4min/134 Process graph charge 22
8 50% loaded Instruments 4min/134 Process graph charge 26
9 100% loaded Instruments 4min/134 Process graph charge 23
10 Mixed load containers/paper 4min/134 Process graph charge 27
11 Worst case load container/textile 4min/134 Process graph charge 28
13 Measurement equipment Calibration Certificate Pressure sensor

13 Measurement equipment Calibration Certificate ITCS

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PROCESS CONTROL & VALIDATION

Tel +31 (0) 74 291 30 86

This report is for demonstration purposes only.

Report reference RM07-0123

Customer/location University Clinic Hengelo

Subject Steam sterilizer no. 4

Date March 15 - 16, 2007

Subject of validation: Steam sterilizer 4

Principal: Mr. P. Principal, University Clinic Hengelo

Expert sterile medical devices:

Reason for validation: Revalidation 2007

Performed by: Mr. V. Engineer

8 134 4 Unloaded 4min/134

12 134 4 Worst case containers/textile 4min/134

Remarks and suggestions

Drawn up on March 16, 2007 at Hengelo door V. Engineer:

2. Installation qualification: Steam sterilizer 4

Trading name : Getinge

Control principle : Pressure / temperature controlled

Steam supply : Own generator

Position air inlet : via steam inlet

Vacuum pump present : yes

Control system type : Microprocessor

Measure- and control system

Pressure control : yes

Trading name registration system : Hewlett Packard

3. Operational qualification: Steam sterilizer 4

Target value : min. 5 Bar

Position steam tap

Position cycle water faucet

Position cooling water faucet

Position compressed air tap

Leakage steam inlet jacket : no

Filter replacing interval : n.a.

Sterilizer chamber (including doors)

Traces of corrosion : `no

Correct operation : yes

Air leakage test

Start value : see resluts of leakage test

Cycle phase : see results of measurements

Target value : see result of measurements during pre phase

Target value : see results of measurements

Target value : see results of measurements

4. Measurement: Leakage test

- Tested according: EN285 (LT): Sterilization - Steam sterilizers - Large sterilizers.

Operator remarks before the measurement

Operator remarks after the measurement

5. Graph: Leakage test

Criteria and results

6. Measurement: Bowie & Dick test 3min/134

Thermocouple calibration protocol

Operator remarks before the measurement

Place Bowie&Dick pakage in length of the sterilizer.

Wrap package once in white crepe en once in green paper

Temperature spread in sterilisation phase

Deviations found during the measurement

Comparison validation system versus control and registration system

Deviations in the comparison

7. Graph: Bowie & Dick test 3min/134

Thermocouple information and curve selection

Criteria and results

8. Measurement: Unloaded 4min/134

Thermocouple calibration protocol