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Risk Considerations for Installation of a New Autoclave in a Pharmaceutical

Manufacturing Facility

Article · June 2015

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Reference: Sandle, T. (2015): Risk Considerations for Installation of a New Autoclave in a
Pharmaceutical Manufacturing Facility, Journal of Validation Technology, 21(1): 1-10
Online: http://www.ivtnetwork.com/article/risk-considerations-installation-new-autoclave-
pharmaceutical-manufacturing-facility

Risk Considerations for

Installation of a New Autoclave in
a Pharmaceutical Manufacturing
Facility | IVT
By
Tim Sandle, Ph.D.

May 6, 2015 11:00 pm PDT

ABSTRACT
This paper addresses some of the risk considerations that must be evaluated when
replacing a steam sterilizing autoclave within a pharmaceutical processing facility. It
demonstrates the application of Failure Modes and Effects Analysis (FMEA) for
assessment of risk as part of quality risk management. Formal risk approaches
normally share four basic concepts including risk assessment, risk control, risk
review, and risk communication. Risk management is fundamentally about
understanding what is most important for the control of equipment or design quality
and then focusing resources on managing and controlling these aspects. Before risks
can be managed, they need to be assessed. FMEA is a widely used risk assessment
tools. Steps to perform FMEA are identified; questions to be asked are listed.
Criteria for risk assessment must be defined. Either a numerical scoring system or
marker phrases such as “high,” “medium,” “low” may be utilized. Three areas are
evaluated: Severity of the hazard, likelihood of occurrence, and likelihood of
detection. Tables for classifying these aspects are provided. A team approach to risk
assessment is recommended. The risk assessment process is demonstrated using the
example of a steam sterilizing autoclave replacement.

INTRODUCTION
This paper addresses some of the risk considerations that must be evaluated when
replacing a steam sterilization autoclave within a pharmaceutical processing facility.
A cast study format is utilized. In outlining the key risk considerations, the paper
demonstrates a risk assessment approach – Failure Modes and Effects Analysis
(FMEA).
 An autoclave is a pressure chamber used to sterilize equipment and supplies by
subjecting them to high pressure saturated steam (1). Autoclaves are used within
pharmaceutical facilities to eliminate microbial cells and spores from within a given
device. Autoclaves commonly use steam heated to 115–134°C (250 273°F). To
achieve sterility, a holding time of at least 30 minutes at 115°C, 15 minutes at 121°C
(250°F) or 3 minutes at 134°C (273°F) is required (2).

The validation and verification of the sterilization process is well monitored in the
pharmaceutical industry. Operators must ensure that autoclaves comply with
various regulatory guidances and regulations. Nonetheless, the purchase of a new
autoclave and the assessment requires evaluation. An additional dimension is added
when one autoclave is being used to replace another, as with the case study discussed
here. To make such an evaluation, a formal risk assessment is required under the
auspices of quality risk management.

Risk management and risk assessment principles should be applied as early as

possible during the design and construction of steam sterilization devices. The most
critical functions in a steam sterilization device are the steam sterilization of direct
and indirect the product contact parts. A second important aspect relates to air
removal. All of the trapped air must be removed from the autoclave before
activation. Trapped air is a very poor medium for achieving sterility during the
sterilization cycle.

Formal risk approaches normally share four basic concepts, which are listed below:

 Risk assessment
 Risk control
 Risk review
 Risk communication.

This paper considers the application of FMEA, failure modes and effects analysis,
to the replacement of a steam-sterilizing autoclave in a pharmaceutical
manufacturing facility.

FAILURE MODES AND EFFECTS ANALYSIS

(FMEA)
Risk management is fundamentally about understanding what is most important for
the control of equipment or design quality and then focusing resources on managing
and controlling these aspects to ensure that risks are reduced and contained. Risks
relate to a situation, event or scenario where a recognized hazard may result in
harm. Before risks can be managed, they need to be assessed (3).

Risk assessment involves identifying risk scenarios. In relation to cleanroom and

clean air design, this should ideally be a prospective exercise rather than in reaction
to a failure. This process involves determining what can go wrong in the system and
all the associated consequences and likelihoods. To achieve this, some kind of risk
assessment tool is required (4).
 Three key definitions are outlined in ICH Q9(5). These help to contextualize what is
meant by “risks.”

 Risk: The combination of the probability of occurrence of harm and the severity of
that harm
 Harm: Damage to health, including the damage that can occur from loss of product
quality or availability
 Hazard: The potential source of harm.

For engineering systems, one of the most widely used tools for risk assessment is
Failure Modes and Effects Analysis (FMEA) (6).

FMEA is a highly structured approach and can be undertaken through the following
steps:

a) Setting the scope

b) Defining the problem

c) Setting scales for factors of severity, occurrence and detection (see below)

d) Process mapping

e) Defining failure modes

f) Listing the potential effects of each failure mode

g) Assigning severity ratings to each process step

h) Listing potential causes of each failure mode

i) Assigning and occurrence rating for each failure mode

j) Examining current controls

k) Examining mechanisms for detection

l) Calculating the risk

m) Examining outcomes and proposing actions to minimize risks.

STARTING THE RISK ASSESSMENT PROCESS

Before commencing a risk assessment, it is important to define the size and the scope
of the assessment while remaining focused on what is to be achieved, to select the
appropriate team (often an interdisciplinary team is best); selecting and reviewing
the appropriate risk management tool; deciding upon any numerical scale to be used,
and prioritizing the different problems to be addressed.

These steps can be broke down as follows:

 Gathering data through an audit and analysis
 Constructing diagrams of work flows
 Pin-pointing areas of greatest risk
 Examining potential sources of contamination
 Deciding on the most appropriate sample methods
 Helping to establish alert and action levels
 Taking into account changes to the work process / seasonal activities
 Using some type of scoring system so that the risk can be ranked and the level of
risk determined.

In doing so the following questions should be asked:

 What is the function of the equipment?

 What are its performance requirements?
 How can it fail to fulfill these functions?
 What can cause each failure?
 What happens when each failure occurs?
 How much does each failure matter? What are its consequences?
 What can be done to predict or prevent each failure?
 What should be done if a suitable proactive task cannot be found?

These reflective questions help to structure the risk assessment activity.

RISK CRITERIA
It is important to establish the risk assessment criteria as part of the risk assessment
exercise. This is necessary in order to place risks in proportion to one another and
against a universal scale. Without this, it cannot be determined whether one risk is a
greater or lesser problem compared with another, or if a given risk could potentially
result in patient harm.

FMEA may utilitze either a numerical scoring system or marker phrases such as
“high,” “medium,” “low’ for quantitation. Marker terms are used in the following
case study.

These terms are applied to three aspects. These are the severity of the hazard; how
likely the hazard is to occur; and whether there are any mechanisms in place to
detect the hazard should it occur. Here:

 Severity is the consequence of a failure, should it occur

 Occurrence is the likelihood of the failure happening based on past experience
 Detection is based on the monitoring systems in place and on how likely a failure
can be detected. Sometimes, a good detection system is described as one that can
detect a failure before it occurs.

When these three are cross-compared, the overall risk can be established. The best
means to do this is through the use of risk filters. These are illustrated in Tables 1
and 2 below.
 Before looking at the risk filter tables, it is necessary to define each of the terms used
to establish the overall risk.

Severity of Impact
 High = Patients safety will be impacted
 Medium = Potential patient safety issues
 Low = No impact on patient

Likelihood of Occurrence
 High = 1 failure per year
 Medium = 1 failure every 5 years
 Low = 1 failure every 10 years

For documentation, the likelihood is as follows:

 High = No Documentation
 Medium = Incorrect Documentation
 Low = Documentation present and correct

Probability of Detection
 Low = Will not be detected by in-place systems
 Medium = Only one mechanism for detection by existing systems
 High = More than one mechanism for detection by existing systems

RISK CLASSIFICATION AND RISK FILTERING

Record the risk classification based upon the impact and likelihood from the table
(Table 1). This is established through the use of a filter (or matrix).

TABLE 1: CLASSIFICATION OF RISK

Risk Priority
Record the risk priority based upon the risk classification and probability of
detection from the table.
TABLE 2: RISK PRIORITY

Risk Process
In formulating the risk assessment a group was assembled consisting of
engineering, validation, microbiology, and the end-users. The process began by
identifying the key risk factors and potential failure modes. These were described as
“functional details.” Once these were defined, these primary categories were broken
down into sub-steps that are termed “sub-functional details.”

Once these were selected and agreed, the steps were grouped together. The group
then proceeded to assess the risk for each step, using the FMEA schema outlined
above. This consisted of:

a) Considering the relevance of each sub-functional detail. For example, whether it

could potentially impact upon product quality
b) The possible risk scenarios were considered
c) The severity of impact was then assessed as either “high”, “medium” or “low”,
using the definitions outlined above
d) The likelihood of impact was then assessed, using the same descriptors
e) With the severity and likelihood assessed, the risk class was determined using
Table 1 above.
f) The probability of detection was assessed next
g) Knowing the probability of detection allowed the overall risk priority to
be determined using Table 2 above.
h) The penultimate step was to consider whether any controls or risk mitigation
factors were in place
i) The final step was to reach a conclusion in relation to risk management.

The risk assessment process is outlined in Appendix I using the example of a steam
sterilizing autoclave replacement.

Equipment preparation
The defined loading of the autoclave with equipment to be sterilized in an important
sub-functional detail is in autoclave operation. The relevance of loading an autoclave
incorrectly significantly impacts product quality. Here the risk scenario is an
incorrect sterilization of the load. In this case:
 a) The severity of impact would be high;
b) The likelihood of impact could be medium.

This produces, according to Table 1, a high risk class.

The probability of detection would be low, because the activity is operator dependent
and there are no system aspects that prevent an incorrect load from being prepared.
Therefore, using Table 2, the risk priority is high.

However, in terms of risk mitigation and risk management, a clear SOP can be put in
place and operators can be trained in order to lower the possibility of an incorrect
load being prepared. In addition:

 Photos of the loads can be prepared during the Operational Qualification

 Schematics may be included in the SOP
 Worst-case loads can be verified during both the Operational Qualification
and Performance Qualification.

This example is included in Appendix I. Other sub-functional steps were derived

using similar processes.

RISK EXAMPLE
Appendix I contains an example of risk assessment for a replacement steam-
sterilizing autoclave. The table is arranged in a fashion to facilitate the risk
assessment steps described above where functional and sub-functional steps are
outlined. The case study was designed around a particular device and should be
regarded as illustrative. Users embarking on a similar process may take note of the
items covered. However, they should construct their own risk schematic and reach
conclusions that are relevant to their own particular circumstances.

CONCLUSION

The final assessment of the FMEA risk exercise was that the new autoclave can be
fitted and that the risks are adequately controlled. It was noted that although the
new autoclave has newer control systems technology, the steam sterilization
principles together with the load/ test cycles remain in line with the autoclave that is
being replaced.

The FMEA risk assessment methodology was appropriate to the task. An alternative
approach could have been to use a numerical risk assessment. However, the use of
descriptor words like “high,” “medium,” and “low” proved adequate in relation to the
activity.
 REFERENCES

1. Sandle, T. (2013). Sterility, Sterilisation and Sterility Assurance for

Pharmaceuticals: Technology, Validation and Current Regulations, Woodhead
Publishing Ltd.: Cambridge, UK, pp93-110
2. Hugo WB (1991). A brief history of heat and chemical preservation and
disinfection. J. Appl. Bacteriol. 71 (1): 9–18
3. Sandle, T. (2011): Risk Management in Pharmaceutical Microbiology. In Saghee,
M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility
Assurance in Pharmaceuticals and Medical Devices, New Delhi: Business Horizons,
pp553-588
4. Sandle, T. and Lamba, S. S. (2012) Effectively Incorporating Quality Risk
Management into Quality Systems. In Saghee, M.R. Achieving Quality and
Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide, New Delhi:
Business Horizons, pp89-128
5. ICH Q9: Quality risk management. International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human Use ICH,
Geneva (November 2005)
6. Sandle, T. (2003). The use of a risk assessment in the pharmaceutical industry – the
application of FMEA to a sterility testing isolator: a case study, European Journal of
Parenteral and Pharmaceutical Sciences; 8(2): 43-49

FMEA KEY

BI - Biological Indicator

IQ - Installation Qualification

O&M - Operation and

Maintenance OQ - Operational

Qualification

PQ - Performance Qualification

PC - Personal Computer

SOP - Standard Operating Procedure

SAT - Site Acceptance Test

UPS - Uninterruptable Power Supply

APPENDIX 1
PROdECT• R EPLACEMEMT OF T IE STEAM S TERTL RING AUTOCLAVE — RTgH ASSEgBM E JT

6EVERT TY PROBABTL QTY CONTROLS eisx

LTKELI HO iD
NB OECD ! REt EVAHCE
BC ERARFO 8
Of
;p@y CLA89 OF OVERALL PR g RfTY
PLAC E MANAGEMENT
DETECTION

Manufacture not pen'ormed according to a zeagnized

Mediu SAT
Equipment ' cGM P High Low High
In spection

equlxalen\.
COI4100I U
r o ge cree\eo'
EOP not in placeHigh Low *’ ' High ñupgli8r brain ing.
System

BOP followed *’ ' U Suppilet'’ era ini'ng:

H'gh Law Medium Medi urn T•ei ning
m and SOP sign of..

Asset Asset eeg'st'aton

Equiont •oquifomn a not éen1ifieo
mph Loin
Mzintensnce .'
regigtgr Form

Equipment procedur e not High Low 9d!Ukligh

Eg uipmen1 ; cGM P
L@book
Low '^High SOP
Lpgbnok

OperaGons Medium HighHigh Medfum SOP Registr ation and

Oper at+ns kleoium Medium SOP

business
Operat'ons Spara Parts And Cri•ical
ñ1edi urn SOP
Business Critical @nsumnoies not tg vipmen1
Madiu
Operahnns .dentifieri so not Hfgh Low Medium Medfum SOP
 CONTROLS
Risc WEE

g|g

Low

MerPu
Huh LoW
ct+eck dunng IQ.

LoW

EplgntFig
LoW

Low
durlng TQ.

LowHuh Bgck up d
c ac-k during IQ.

LowHuh
eRouecz. neeuceuenz or me sTenu sTeniLizmo >uzocuve - met asses8mew

FUNCTION
CONTROLS
0ETA\LB runcuo s 8EVEWTY
LTKELTNOOD
DET*lL8 SELfVAMCE OC OF IMPACT RRIORJW " ’“"

EnY|r£+rjmen1al 6us•ness not Ie* Autooave H iph Med•u Hg Low

coniroiieo ma
Requirements Tticel antrd system O eziracton ar+d
if necess
Netefiai tyoe
Generated SNP, into oean rooms. Low Low GAT
Pences
The utilities durin 10.
supglieddond all.be desjgnfip
Utility allowslwilisalon ‹g..be.1 sag.0 st
Oqeralions conditions to be nigh Low
R@uirements Medau SQL.
athieved. IO/ SAT
4ervlces are not
Operations Utility

ROqulMment8 wti redo iy +J‹gh High Low SAT

OperafJng Opgra1ing Mediu

High Low High Low SAT
9qec#itatons
dufing OO

Tesfs must as
Operatons
repeated before
Lc'w
performed aflet
operatlonal tests
are completed
 eeoenv

Embmm
Low Hlgh

Low Hlgh

ezia gOP O

Ugéty'
ImmW m
 . AB*6EBGM*ER T OF. RIBE
RUB• 8fYEREFY tKfHMOOD CONTROL8
FUNCTIONS PRO8ABILW
OETATL6 DET@LS RELEVANT E IN PLACE MMAOEMENT
DETECT ION '”’

Safely ebbs.
EQiJiQffiOh I Operation
Equf prr+ant Is not
MQdiu m Med um SAT end s T we k
sare to operate to ensure @Fely.
PU\ñ/ER rid

Mediu Trainings Tainng8Wgn

Setup Incorrect k1edIum N480ium Loa
SOP
EPRON ooes not Checks maoe
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Recovery Cfltlcai version of the Medium Low Low High Low Change any changes/ or
deviañoJns noted
SATrha es
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SOP
Pnavious wrsion
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Recovery fiscal g Up
' ioeded efter
power restoration ! Checked Qur1ng
AT/
MP High
Madiu
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9AT ano aodeo Ie
Devlces fisllure Maintenanw
/hedvle
BAT/
TampefabJre SAT and added tc
Sensors Hign Low Mgin1enanc
uhedole
Unloading dear opens altar a Bowie Dick Test SAT ZOP
lnletlocks @N P Me0lum LOW LOW hTigfl Low
! SOp/ecCs
PR€MECT: ftEPLACEMEMT OE TNE 6TEAM 6TERILIZING AUTOCLAVE — RIBA

sue- CONTROLS RISK

BWVERIT¥ PROBAB
DETWL6 : g6K
OF
LIfiELIMO IL1TY OVERALL m ence MANAGEMENT
S'CENARIO6 IMPACT D CLA86 OF
DETECTTOM

Bolh d@rs SAT/

“ " Mod‹um Low Low I•Iigh LA
GOP SOP cnecKs
. oqens after nycJe I-ligh Ch ddunng
SOP
Equiprnoot interlocks Low Low SATandr«pwar
Algnrifhms used SOP cnecks
. In the calmlaton Functonal
cGJ•tP Low speti catio
Algorithm
Low n/ SET
S 's cil icalJnei
raview end CAT
does not function SOP/
Oparalor
System Screen OgereG#n . as ssecifiad in Meo•um Mqintgnpnc IT and norme‹
navigation
’ manual
Secunty levels CherEsddunng
SOP/ 5ATandemap
no w ue a me Meo‹um Low Low High Lo'•v
training ouñngTr ning

Toa rasutrs on ñheckea dufing

tne printed report Madium Low Low High Low sAT and set•up
Cystem Generation e/ Trgining/
SOP
' TWO vaues usa0
t f0r ke dspey Chem-ted during
Control Report
Maintenant
System Genereticri @p•0rtg pre 1gken Med‹um Low Low High e/ Trgining/
’ at diherant times SOP

the sob are.

PROJECT: REPLACEMENT OF THE BTEAM BTERt LIZI MG AUTOCLAVE -- VIBE A8BE8gMENT

BEVERFFY ” PROBABTLFFY CONTROLS | RISK

RELEVANCE OF
LIKEMNOOD
c LAM of RALL TN PLACE MANAGEMENT
” *"’ DETAILS 6CENARIO6 OC IMPACf PRIORITY
DETECTION
Regan And ' CnecMo dMng
ToftDot TneoaauWm Low SAT and setup
Dala M8di um Low Low high
eshiveo. e
during s

ReDonAno corrupted of System SET grid set-up

chlanged when Low Hiph Low
Daa Medrum Low Maintenaon during system
retdeved a’ Training -intengnne

Mxwggunng
GorrLot RePort And System SAT and aat-up
Medi um Low Low High M.aintenann our ing system
e/ Training maintenance
Chezltad dudng
Regort And Syatam , SAT and aat-up
Data Elem um to ouring system
Archiving rnzln •nante

Regort Ana The software is System ! SAT and set-

Data riol availabla frs Medfum how Low High up Maintenarin during
Arriving reztieva of dala system e/ {ya ning
maintenance

The Intoirect pererneters ere loaded in to the Training/i SOP.’

Gonb'0f Ntadiu SAT arrd set-up during Training and SOP cJ eased
$@MP Higft Low HJgh Low O&M’s

Medium Low Refer to supplier

Low TOP/
Cl&M’s gng $OP
O&M’s
 PRO SECT. REPLACEMEN T OF TNE BTEAM BTERTL RING AMTOCLAVE -- RI9E AS6EBBM EMT

LIGE LIHODO CONTROLS eisx

ruHcnons RSS IN MANAGEMENT
RELEVANCE OF
SCENAR DG OF TM PAGT PLACE
Tne
parameters
required to Plefer to suppllet
mod fram one Training/
phase
IGMP Medium Low Low GDP? O&I\4’s and... SOP

reo e sc+een.
GovneP T raining/
Refer to suppiler
The counter Medium Low Low High Low SDP?
Cl&M’s gnd SOP
ooes
GOlJfit8f/ n t IQg all Egg
i C0ñhB Low
M8di u
LOW S09/
Ref8£ to 6uQ 1i6f
be counsel does O&k4's and .90.P.
i failed cydes T
Tne ooes raining/
npt •cQrd jhe c'orrec1 time (G MT}, M8diiJ FMror lv guppllar
Nigh Low High Law
the ct+ase m
0&M’8
O&Ns ago..TOP
parameters in
the cYcle to abon
Eg uipmantOperational OperayonSequence 6AT/ oooumenNo ouing SAT and PQ
Low High

Tne umperawfe
in me cnamoer
commiaaion\ng,
! Eg uipment TemperaMre SAT? SAT 6 PQ
l Operg1inn (gis1zibulipn
Low Low
HTM zo1 a re
PROJECT: REPLACEMENT OF TNE 6TEAM 6TERILIZIMG AUTOCLAVE — RIBA Ag6E&9MEMT

FUNCTTOM
xua-
Y U NC• TJOP48 BWVERIT¥ PROBAO RISK
DETAILS LTKELtHOO4g' IL1TY OVER TN PLACE MANAGEMENT
0ETAtc8 OF OF IM PAGT
RELEVANCE C 6 OF sutoclaw
DETECTION
There is
uneven Mediu
Opefaban , heat dis•ribrzâoJn High Low High Low PQ {Bawie
Gommiseion*ng,
Die-k
Tasls}
CPiWk8d dutiKig
' Air is ref
Au1oclave
Opefabon SGM P ' removed from the Medium Law Low High WT/ PO

Laak Rate Taste

Dqeration Med‹um Low Le+w High Low SAT/PO ounng
Opetaoon
SAT6P'Q
Chmkedand
: Ste8+ii dON DOI
Equipment High Medium High High Medium agalnst arrent
Opeeflpn PQ Yalidat8d load

' Penetration
t TI+are are lnigh Ciean
Equipment Stgam
OperafioJn
, paraculates In me High fdedium Hign Meo'um
Equipment

r a oe cnenX:g'o
and donumantad
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Operefien Rerr*cval “” Arran I validated load prolires.
: Loads
runcTou FUNOIOH8
DETAiLB

Htgh

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PROJECT : REPLACEMENT OF THE 4TE fg SIERJLNTNG AUTOCLAVE •• R\8K Ag9E8B¥ENT

SEVERIW OWERALL CONTROLS R‹88

LTKELTHOOD ¥ADAO5lN5NT
DETA\Lg

loads (OQ)
Equiprr+ant Snhemanns to be ’
orientation innloded in the
incorrect causing Nigh COP .
Quality !I4eñ’8C4IYe EU [G\CI8 M8OiUW fdIgh None 6. Is \o De put Into :
n=m 'vol end failure) ihe loed to veriry
Eq+Jipment That there is
L0ad‹ng drainage srzfliuient air

steam penetrallon'
Madium MedJu
{Not
fin8I1h•e Mediu Low Nlgh None
m
steritizing

9tep 2 \Nrong title sheeted Lgw MediUm Npne

step) tame.
T na system
abons the cycle
Sep2 Equi pWM I with critical
'* Low Low Low Madium None asme. Name
Opetaoon
 oz' cLaae WNAOEMENT

Eg Iprnarit
Madlum Not

Eplpment FBI ma of

Operagon

OQ. No UPS.
SECT: MCEMEW OF THE BE 8TE W AUTOCMVE •• WK A86EB8MENT

GMñeI
LoW LoW Low

Smp2
Hlgh High

Bmp2
High
PR0dEC7 : REPLACEMENT OF THE 9TEAht 4TERILIZ4N 0 ALtTDCMVE •• RISK
AS6EBgMENT
COMTROL8
su6•
LtMC/QNS LIKELIHOOD
DETA\Lg DETAI LB RELEVAi'tCE OF I4 PLACE MMAOEMENT
OF IMPACT
IMPACT

independent fhs OQ. Oata will

be ctienkad for
Data not
I•Iigh Medium Low eacn oa1cn.
ioggeo (cGMP] is
¥W@e0 to
Opefabon the s fern,

Wu8iPig gI8fM9 Of I•Iigh '° Lo none venneo •n to Oo

venfeo in the
SET eno OQ.
Thg panty I

Datd not
6tep 2
Product Mediu
tortecoy onlo hllgh Low High Nve
a lion
on.Iy. Tfie two
the
printed raport

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 noJecr: Reevceuew oF one sJcnu szeniLizinc >uzocvve -- nisr aasessMew

FUNCThD N
sua- coNTRoLs us g
DETAILS LTKEL BLOOD MANAGEM ENT
OE7AIW RELEVANCE OF CLAS6 OF
8CENARW TM
OF IMRACT DETECT TOM
The software will
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