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Awareness SeminarsAwareness Seminars
Environmental MonitoringEnvironmental Monitoring
and HVACand HVAC
Tim SandleTim Sandle
TopicsTopics
 Why contamination is a problemWhy contamination is a problem
 Contamination sourcesContamination sources
 Contamination controlContamination control
 Understanding cleanroomsUnderstanding cleanrooms
 Environmental monitoringEnvironmental monitoring
Why is contaminationWhy is contamination
control important?control important?
Importance of contaminationImportance of contamination
controlcontrol
 This is not just toThis is not just to
have clean areashave clean areas
but due to the riskbut due to the risk
to the product.to the product.
 ContaminationContamination
refers to:refers to:
– Bacteria;Bacteria;
– Fungi;Fungi;
– Microbial toxinsMicrobial toxins
Importance of contaminationImportance of contamination
controlcontrol
 All BPL product manufacture startsAll BPL product manufacture starts
off with a number of micro-off with a number of micro-
organisms. Start pools, for example,organisms. Start pools, for example,
contain between 10 and 50 micro-contain between 10 and 50 micro-
organisms per mL.organisms per mL.
 Early processing must not increaseEarly processing must not increase
contamination.contamination.
Importance of contaminationImportance of contamination
controlcontrol
 Although micro-Although micro-
organisms areorganisms are
present in thepresent in the
product, theproduct, the
internationalinternational
standard for thestandard for the
pre-final filtrationpre-final filtration
is 10 / 100 mL.is 10 / 100 mL.
 Sterilising gradeSterilising grade
filters are validatedfilters are validated
using a highusing a high
concentration of aconcentration of a
small bacteria tosmall bacteria to
remove micro-remove micro-
organisms for aorganisms for a
population belowpopulation below
10 per 100 mL.10 per 100 mL.
Importance of contaminationImportance of contamination
controlcontrol
 Although sterilising grade filters canAlthough sterilising grade filters can
eliminate living micro-organismseliminate living micro-organisms
they cannot remove their toxins.they cannot remove their toxins.
 Many toxins are pyrogenic (fever), ofMany toxins are pyrogenic (fever), of
which endotoxin, from “water-liking”which endotoxin, from “water-liking”
bacteria, is the most prevalent.bacteria, is the most prevalent.
Importance of contaminationImportance of contamination
controlcontrol
 Once in the Aseptic Filling Suite, theOnce in the Aseptic Filling Suite, the
objective is to dispense a sterileobjective is to dispense a sterile
product.product.
 Therefore, even low levels ofTherefore, even low levels of
contamination become a concern.contamination become a concern.
Contamination sourcesContamination sources
There are several sourcesThere are several sources
of microbiologicalof microbiological
contaminationcontamination
ContaminationContamination
 Microbiological contamination is aMicrobiological contamination is a
key concern in manufacturing.key concern in manufacturing.
 Contamination can arise from:Contamination can arise from:
– PeoplePeople
– AirAir
– SurfacesSurfaces
– WaterWater
Contamination sourcesContamination sources
 PeoplePeople are theare the
BIGGESTBIGGEST
contamination sourcecontamination source
– People, when walking,People, when walking,
shed 1,000,000,000shed 1,000,000,000
skin cells per day.skin cells per day.
– Of these, 10% containOf these, 10% contain
micro-organisms.micro-organisms.
– Micro-organisms areMicro-organisms are
also spread fromalso spread from
sneezing, coughing &sneezing, coughing &
touchingtouching
ContaminationContamination
 Therefore, it isTherefore, it is
important to wearimportant to wear
cleanroom clothingcleanroom clothing
and to wear itand to wear it
correctly;correctly;
– And to behaveAnd to behave
appropriately.appropriately.
 There are differencesThere are differences
between Grade A – Dbetween Grade A – D
for clothingfor clothing
requirementsrequirements
Contamination sourcesContamination sources
 Second, to people,Second, to people,
waterwater is a keyis a key
contamination source.contamination source.
 It is a problemIt is a problem
because it not onlybecause it not only
allows contaminationallows contamination
to spread, it also helpsto spread, it also helps
micro-organisms tomicro-organisms to
growgrow..
Contamination sourcesContamination sources
 For example, theFor example, the
micro-organismmicro-organism
Escherichia coliEscherichia coli
((E. coliE. coli), which was), which was
found in the wash bayfound in the wash bay
in room P101 in thein room P101 in the
summer of 2007 cansummer of 2007 can
double its numbersdouble its numbers
every 20 minutes.every 20 minutes.
 So, 10 cells becomeSo, 10 cells become
over 2,500 in threeover 2,500 in three
hours.hours.
Contamination sourcesContamination sources
 Therefore, it isTherefore, it is
very importantvery important
that:that:
– Puddles are not leftPuddles are not left
on floors;on floors;
– Spillages areSpillages are
cleaned up ascleaned up as
quickly as possible;quickly as possible;
– Equipment shouldEquipment should
be dry before usebe dry before use
and checked that itand checked that it
is dry.is dry.
Contamination sourcesContamination sources
 For 2007-2008,For 2007-2008,
wet equipment iswet equipment is
the most significantthe most significant
contaminationcontamination
issue. In 2007 twoissue. In 2007 two
batches werebatches were
rejected because ofrejected because of
water-liking micro-water-liking micro-
organisms andorganisms and
toxins.toxins.
Contamination sourcesContamination sources
 The other contamination sourcesThe other contamination sources
are:are:
– AirAir, such as a faulty HEPA filter in a, such as a faulty HEPA filter in a
room or a piece of equipment blowingroom or a piece of equipment blowing
out dirty air into a room;out dirty air into a room;
– SurfacesSurfaces. Here the biggest risk is. Here the biggest risk is
transferring contamination from a lowtransferring contamination from a low
risk area to a more critical part of therisk area to a more critical part of the
process.process.
Contamination sourcesContamination sources
 Other common contamination issuesOther common contamination issues
include:include:
– Equipment that is clean is sometimes notEquipment that is clean is sometimes not
segregated from equipment that has not beensegregated from equipment that has not been
cleaned; or cleaned equipment is passedcleaned; or cleaned equipment is passed
through wet areas;through wet areas;
– Cleaning and disinfection needs to be carriedCleaning and disinfection needs to be carried
out efficiently at the required frequencies.out efficiently at the required frequencies.
 Applying detergent first;Applying detergent first;
 Correct technique;Correct technique;
 Contact times.Contact times.
We can monitor for thisWe can monitor for this
but…but…
Contamination controlContamination control
and risk assessment areand risk assessment are
the first things to addressthe first things to address
Contamination controlContamination control
 At BPL, the emphasis is first uponAt BPL, the emphasis is first upon
contamination control and riskcontamination control and risk
assessment to minimise the potentialassessment to minimise the potential
for contamination.for contamination.
 Where contamination cannot beWhere contamination cannot be
adequately controlled, and in orderadequately controlled, and in order
to monitor environments, monitoringto monitor environments, monitoring
is undertaken.is undertaken.
Contamination controlContamination control
 The way that contamination isThe way that contamination is
controlled is for manufacturing tocontrolled is for manufacturing to
take place in cleanrooms and for thetake place in cleanrooms and for the
design and function of thedesign and function of the
cleanrooms, and the processes, to becleanrooms, and the processes, to be
risk assessed.risk assessed.
 AA cleanroomcleanroom is a room which has ais a room which has a
specialised environment to controlspecialised environment to control
the level of ‘cleanliness’.the level of ‘cleanliness’.
CleanroomsCleanrooms
 Cleanrooms areCleanrooms are
gradedgraded A, B, C andA, B, C and
D depending uponD depending upon
what goes on inwhat goes on in
the room.the room.
 A is the ‘cleanest’A is the ‘cleanest’
state, and D is thestate, and D is the
‘least clean’ state.‘least clean’ state.
 ‘‘Clean’ is definedClean’ is defined
by the number ofby the number of
particles in the air.particles in the air.
CleanroomsCleanrooms
 The particles that areThe particles that are
looked for in the air arelooked for in the air are
very tiny and can’t be seenvery tiny and can’t be seen
with the naked eye:with the naked eye:
– 0.5 micrometers, which0.5 micrometers, which
indicate bacteria in theindicate bacteria in the
air;air;
– 5.0 micrometers, which5.0 micrometers, which
indicate skin cells orindicate skin cells or
flakes or other ’larger’flakes or other ’larger’
particlesparticles
CleanroomsCleanrooms
0.5 micron 5.0 micron
CleanroomsCleanrooms
 Product is filled at Grade A (under UDAF);Product is filled at Grade A (under UDAF);
 The background environment for the fillingThe background environment for the filling
suite is Grade B;suite is Grade B;
 VSA where final formulation and sterilisingVSA where final formulation and sterilising
filtration occurs, takes place at Grade C;filtration occurs, takes place at Grade C;
 Sterile Supplies, where final handling ofSterile Supplies, where final handling of
sterile components takes place at Gradesterile components takes place at Grade
C;C;
 Plasma stripping takes place at Grade D;Plasma stripping takes place at Grade D;
 Changing rooms need to be the sameChanging rooms need to be the same
grade as the area which they lead into.grade as the area which they lead into.
CleanroomsCleanrooms
 Cleanrooms are classified each yearCleanrooms are classified each year
to an international standard (ISOto an international standard (ISO
14644).14644).
 Once classified, certain physical andOnce classified, certain physical and
environmental standards need to beenvironmental standards need to be
met.met.
 The physical parameters areThe physical parameters are
controlled by an HVAC system.controlled by an HVAC system.
Cleanrooms: contamination controlCleanrooms: contamination control
 We control contamination at BPL by:We control contamination at BPL by:
– Filtering the air from outside Building 27Filtering the air from outside Building 27
before it enters the factory. The air isbefore it enters the factory. The air is
filtered for dust and many otherfiltered for dust and many other
particles in the air.particles in the air.
– At the point of air entering theAt the point of air entering the
cleanroom special filters are used calledcleanroom special filters are used called
HEPA filters.HEPA filters.
When HEPA filters are tested, it is importantWhen HEPA filters are tested, it is important
that they are assessed for leakage.that they are assessed for leakage.
Cleanrooms: contamination controlCleanrooms: contamination control
 To work efficiently, cleanrooms alsoTo work efficiently, cleanrooms also
need to have a set number of air-need to have a set number of air-
changes per hour to remove air-changes per hour to remove air-
borne contamination.borne contamination.
– An office might have 2-3 air-changesAn office might have 2-3 air-changes
per hour (a complete replacement of theper hour (a complete replacement of the
air volume in a room). A cleanroomair volume in a room). A cleanroom
needs to have, as minimum, 20 airneeds to have, as minimum, 20 air
changes per hour, and a changing roomchanges per hour, and a changing room
about 60.about 60.
Cleanrooms: contamination controlCleanrooms: contamination control
 Cleanrooms also need to demonstrate aCleanrooms also need to demonstrate a
‘clean-up’ time.‘clean-up’ time.
– This is the time taken for a room to return to aThis is the time taken for a room to return to a
set level of particles in the air after it has beenset level of particles in the air after it has been
used for an activity. This is required to takeused for an activity. This is required to take
place within 20 minutes of the room last beingplace within 20 minutes of the room last being
used.used.
 To stop the passage of contamination, theTo stop the passage of contamination, the
pressure differentials between certainpressure differentials between certain
areas are controlled so that potentiallyareas are controlled so that potentially
contaminated air moves away from acontaminated air moves away from a
clean area towards a less clean area.clean area towards a less clean area.
Cleanrooms: contamination controlCleanrooms: contamination control
 For the Aseptic Filling Suite, the airFor the Aseptic Filling Suite, the air
in a cleanroom is also required toin a cleanroom is also required to
move in a certain way and not blowmove in a certain way and not blow
any potentially contaminated airany potentially contaminated air
back towards critical areas.back towards critical areas.
– For filling activities, ‘uni-directional’ airFor filling activities, ‘uni-directional’ air
movement is required (air in a normalmovement is required (air in a normal
cleanroom is turbulent).cleanroom is turbulent).
Cleanrooms: contamination controlCleanrooms: contamination control
– Staff wear special cleanroom clothing,Staff wear special cleanroom clothing,
designed to reduce contamination (caps,designed to reduce contamination (caps,
face masks, gloves, boots and suits).face masks, gloves, boots and suits).
– Staff enter and leave clean areasStaff enter and leave clean areas
through air-locks.through air-locks.
Cleanrooms: contamination controlCleanrooms: contamination control
 Other factors:Other factors:
– Some rooms have certain requirementsSome rooms have certain requirements
for temperature and humidity.for temperature and humidity.
 Material control:Material control:
– Material entering the Aseptic FillingMaterial entering the Aseptic Filling
Suite needs to be sterilised, irradiatedSuite needs to be sterilised, irradiated
or disinfected.or disinfected.
– In other cleanrooms, the presence ofIn other cleanrooms, the presence of
dust and debris, such as fromdust and debris, such as from
cardboard, needs to be minimised.cardboard, needs to be minimised.
We can design clean areas, ensureWe can design clean areas, ensure
contamination control and risk assesscontamination control and risk assess
processes but…processes but…
We still need toWe still need to
demonstratedemonstrate controlcontrol
through monitoringthrough monitoring
Environmental monitoringEnvironmental monitoring
 EnvironmentalEnvironmental
monitoring ismonitoring is
undertaken in eachundertaken in each
BPL cleanroom.BPL cleanroom.
 The monitoringThe monitoring
looks for levels of:looks for levels of:
– Non-viable particlesNon-viable particles
in the air;in the air;
– Viable micro-Viable micro-
organisms.organisms.
Environmental monitoringEnvironmental monitoring
 BPL have ~215 cleanrooms andBPL have ~215 cleanrooms and
cleanzonescleanzones
– 35 cleanrooms in the filling suite35 cleanrooms in the filling suite
– 180 in other process areas180 in other process areas
 Microbiology take and examine overMicrobiology take and examine over
40,000 samples per year.40,000 samples per year.
Environmental monitoringEnvironmental monitoring
 Particle counting:Particle counting:
– 2 sizes of particle2 sizes of particle
are examined (0.5are examined (0.5
and 5.0 micron,and 5.0 micron,
based on thebased on the
‘Orange Guide’) in a‘Orange Guide’) in a
cubic metre of air;cubic metre of air;
– This is carried outThis is carried out
using an opticalusing an optical
(laser) particle(laser) particle
counter.counter.
Environmental monitoringEnvironmental monitoring
 Particles can be generated fromParticles can be generated from
people and equipment.people and equipment.
 Every batch fill is monitored forEvery batch fill is monitored for
particles and spot checks areparticles and spot checks are
undertaken throughout Building 27.undertaken throughout Building 27.
 The only way to achieve ‘real time’The only way to achieve ‘real time’
monitoring of the air – and to guessmonitoring of the air – and to guess
if the air contains bacteria – isif the air contains bacteria – is
through particle counting.through particle counting.
Environmental monitoringEnvironmental monitoring
 Viable monitoring usesViable monitoring uses
plates filled with aplates filled with a
growth medium calledgrowth medium called
agar.agar.
 At BPL we useAt BPL we use
something whichsomething which
mixes seaweed withmixes seaweed with
the contents of athe contents of a
cow’s stomach tocow’s stomach to
make a jelly whichmake a jelly which
bacteria like to growbacteria like to grow
on when incubated aton when incubated at
the optimalthe optimal
temperature and time.temperature and time.
Environmental MonitoringEnvironmental Monitoring
 Viable monitoring:Viable monitoring:
– Settle plates: gives anSettle plates: gives an
indication of how manyindication of how many
micro-organisms in themicro-organisms in the
air might settle onto aair might settle onto a
surface;surface;
– Active air-samples:Active air-samples:
these measure howthese measure how
many micro-organismsmany micro-organisms
there are in a cubicthere are in a cubic
metre of air when air ismetre of air when air is
sucked into a specialsucked into a special
device by a powerfuldevice by a powerful
mechanical force.mechanical force.
– Contact plates andContact plates and
swabs test how clean aswabs test how clean a
surface is.surface is.
Environmental monitoringEnvironmental monitoring
 In addition, in theIn addition, in the
filling suite, platesfilling suite, plates
are taken ofare taken of
people’s hands andpeople’s hands and
from their suits.from their suits.
Environmental monitoringEnvironmental monitoring
 The environmental monitoring programmeThe environmental monitoring programme
is undertaken by Microbiology.is undertaken by Microbiology.
– The programme examines different rooms atThe programme examines different rooms at
different frequencies using different numbersdifferent frequencies using different numbers
of samples, based on a risk assessment.of samples, based on a risk assessment.
– The aim is to answer the questions:The aim is to answer the questions:
 how many?; how frequent?; when doeshow many?; how frequent?; when does
contamination occur?; how frequently doescontamination occur?; how frequently does
contamination occur?; is the contamination a risk tocontamination occur?; is the contamination a risk to
the product?; is the contamination getting anythe product?; is the contamination getting any
worse?worse?
Environmental monitoringEnvironmental monitoring
 Data is assessed by looking at trends.Data is assessed by looking at trends.
– Action levels cannot exceed Orange GuideAction levels cannot exceed Orange Guide
levels, and they are set by examining pastlevels, and they are set by examining past
data.data.
– Each over action result, e.g. from poorEach over action result, e.g. from poor
cleaning, will take ~10 person hours to dealcleaning, will take ~10 person hours to deal
with (in taking repeat samples, assessmentwith (in taking repeat samples, assessment
and report writing).and report writing).
– There are about 1000 action level samples perThere are about 1000 action level samples per
year.year.
– Data is reviewed at the MEMR each month.Data is reviewed at the MEMR each month.
Thank YouThank You
Any questions?Any questions?

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Sterility assurance and microbiology awareness

  • 1. Awareness SeminarsAwareness Seminars Environmental MonitoringEnvironmental Monitoring and HVACand HVAC Tim SandleTim Sandle
  • 2. TopicsTopics  Why contamination is a problemWhy contamination is a problem  Contamination sourcesContamination sources  Contamination controlContamination control  Understanding cleanroomsUnderstanding cleanrooms  Environmental monitoringEnvironmental monitoring
  • 3. Why is contaminationWhy is contamination control important?control important?
  • 4. Importance of contaminationImportance of contamination controlcontrol  This is not just toThis is not just to have clean areashave clean areas but due to the riskbut due to the risk to the product.to the product.  ContaminationContamination refers to:refers to: – Bacteria;Bacteria; – Fungi;Fungi; – Microbial toxinsMicrobial toxins
  • 5. Importance of contaminationImportance of contamination controlcontrol  All BPL product manufacture startsAll BPL product manufacture starts off with a number of micro-off with a number of micro- organisms. Start pools, for example,organisms. Start pools, for example, contain between 10 and 50 micro-contain between 10 and 50 micro- organisms per mL.organisms per mL.  Early processing must not increaseEarly processing must not increase contamination.contamination.
  • 6. Importance of contaminationImportance of contamination controlcontrol  Although micro-Although micro- organisms areorganisms are present in thepresent in the product, theproduct, the internationalinternational standard for thestandard for the pre-final filtrationpre-final filtration is 10 / 100 mL.is 10 / 100 mL.  Sterilising gradeSterilising grade filters are validatedfilters are validated using a highusing a high concentration of aconcentration of a small bacteria tosmall bacteria to remove micro-remove micro- organisms for aorganisms for a population belowpopulation below 10 per 100 mL.10 per 100 mL.
  • 7. Importance of contaminationImportance of contamination controlcontrol  Although sterilising grade filters canAlthough sterilising grade filters can eliminate living micro-organismseliminate living micro-organisms they cannot remove their toxins.they cannot remove their toxins.  Many toxins are pyrogenic (fever), ofMany toxins are pyrogenic (fever), of which endotoxin, from “water-liking”which endotoxin, from “water-liking” bacteria, is the most prevalent.bacteria, is the most prevalent.
  • 8. Importance of contaminationImportance of contamination controlcontrol  Once in the Aseptic Filling Suite, theOnce in the Aseptic Filling Suite, the objective is to dispense a sterileobjective is to dispense a sterile product.product.  Therefore, even low levels ofTherefore, even low levels of contamination become a concern.contamination become a concern.
  • 9. Contamination sourcesContamination sources There are several sourcesThere are several sources of microbiologicalof microbiological contaminationcontamination
  • 10. ContaminationContamination  Microbiological contamination is aMicrobiological contamination is a key concern in manufacturing.key concern in manufacturing.  Contamination can arise from:Contamination can arise from: – PeoplePeople – AirAir – SurfacesSurfaces – WaterWater
  • 11. Contamination sourcesContamination sources  PeoplePeople are theare the BIGGESTBIGGEST contamination sourcecontamination source – People, when walking,People, when walking, shed 1,000,000,000shed 1,000,000,000 skin cells per day.skin cells per day. – Of these, 10% containOf these, 10% contain micro-organisms.micro-organisms. – Micro-organisms areMicro-organisms are also spread fromalso spread from sneezing, coughing &sneezing, coughing & touchingtouching
  • 12. ContaminationContamination  Therefore, it isTherefore, it is important to wearimportant to wear cleanroom clothingcleanroom clothing and to wear itand to wear it correctly;correctly; – And to behaveAnd to behave appropriately.appropriately.  There are differencesThere are differences between Grade A – Dbetween Grade A – D for clothingfor clothing requirementsrequirements
  • 13. Contamination sourcesContamination sources  Second, to people,Second, to people, waterwater is a keyis a key contamination source.contamination source.  It is a problemIt is a problem because it not onlybecause it not only allows contaminationallows contamination to spread, it also helpsto spread, it also helps micro-organisms tomicro-organisms to growgrow..
  • 14. Contamination sourcesContamination sources  For example, theFor example, the micro-organismmicro-organism Escherichia coliEscherichia coli ((E. coliE. coli), which was), which was found in the wash bayfound in the wash bay in room P101 in thein room P101 in the summer of 2007 cansummer of 2007 can double its numbersdouble its numbers every 20 minutes.every 20 minutes.  So, 10 cells becomeSo, 10 cells become over 2,500 in threeover 2,500 in three hours.hours.
  • 15. Contamination sourcesContamination sources  Therefore, it isTherefore, it is very importantvery important that:that: – Puddles are not leftPuddles are not left on floors;on floors; – Spillages areSpillages are cleaned up ascleaned up as quickly as possible;quickly as possible; – Equipment shouldEquipment should be dry before usebe dry before use and checked that itand checked that it is dry.is dry.
  • 16. Contamination sourcesContamination sources  For 2007-2008,For 2007-2008, wet equipment iswet equipment is the most significantthe most significant contaminationcontamination issue. In 2007 twoissue. In 2007 two batches werebatches were rejected because ofrejected because of water-liking micro-water-liking micro- organisms andorganisms and toxins.toxins.
  • 17. Contamination sourcesContamination sources  The other contamination sourcesThe other contamination sources are:are: – AirAir, such as a faulty HEPA filter in a, such as a faulty HEPA filter in a room or a piece of equipment blowingroom or a piece of equipment blowing out dirty air into a room;out dirty air into a room; – SurfacesSurfaces. Here the biggest risk is. Here the biggest risk is transferring contamination from a lowtransferring contamination from a low risk area to a more critical part of therisk area to a more critical part of the process.process.
  • 18. Contamination sourcesContamination sources  Other common contamination issuesOther common contamination issues include:include: – Equipment that is clean is sometimes notEquipment that is clean is sometimes not segregated from equipment that has not beensegregated from equipment that has not been cleaned; or cleaned equipment is passedcleaned; or cleaned equipment is passed through wet areas;through wet areas; – Cleaning and disinfection needs to be carriedCleaning and disinfection needs to be carried out efficiently at the required frequencies.out efficiently at the required frequencies.  Applying detergent first;Applying detergent first;  Correct technique;Correct technique;  Contact times.Contact times.
  • 19. We can monitor for thisWe can monitor for this but…but… Contamination controlContamination control and risk assessment areand risk assessment are the first things to addressthe first things to address
  • 20. Contamination controlContamination control  At BPL, the emphasis is first uponAt BPL, the emphasis is first upon contamination control and riskcontamination control and risk assessment to minimise the potentialassessment to minimise the potential for contamination.for contamination.  Where contamination cannot beWhere contamination cannot be adequately controlled, and in orderadequately controlled, and in order to monitor environments, monitoringto monitor environments, monitoring is undertaken.is undertaken.
  • 21. Contamination controlContamination control  The way that contamination isThe way that contamination is controlled is for manufacturing tocontrolled is for manufacturing to take place in cleanrooms and for thetake place in cleanrooms and for the design and function of thedesign and function of the cleanrooms, and the processes, to becleanrooms, and the processes, to be risk assessed.risk assessed.  AA cleanroomcleanroom is a room which has ais a room which has a specialised environment to controlspecialised environment to control the level of ‘cleanliness’.the level of ‘cleanliness’.
  • 22. CleanroomsCleanrooms  Cleanrooms areCleanrooms are gradedgraded A, B, C andA, B, C and D depending uponD depending upon what goes on inwhat goes on in the room.the room.  A is the ‘cleanest’A is the ‘cleanest’ state, and D is thestate, and D is the ‘least clean’ state.‘least clean’ state.  ‘‘Clean’ is definedClean’ is defined by the number ofby the number of particles in the air.particles in the air.
  • 23. CleanroomsCleanrooms  The particles that areThe particles that are looked for in the air arelooked for in the air are very tiny and can’t be seenvery tiny and can’t be seen with the naked eye:with the naked eye: – 0.5 micrometers, which0.5 micrometers, which indicate bacteria in theindicate bacteria in the air;air; – 5.0 micrometers, which5.0 micrometers, which indicate skin cells orindicate skin cells or flakes or other ’larger’flakes or other ’larger’ particlesparticles
  • 25. CleanroomsCleanrooms  Product is filled at Grade A (under UDAF);Product is filled at Grade A (under UDAF);  The background environment for the fillingThe background environment for the filling suite is Grade B;suite is Grade B;  VSA where final formulation and sterilisingVSA where final formulation and sterilising filtration occurs, takes place at Grade C;filtration occurs, takes place at Grade C;  Sterile Supplies, where final handling ofSterile Supplies, where final handling of sterile components takes place at Gradesterile components takes place at Grade C;C;  Plasma stripping takes place at Grade D;Plasma stripping takes place at Grade D;  Changing rooms need to be the sameChanging rooms need to be the same grade as the area which they lead into.grade as the area which they lead into.
  • 26. CleanroomsCleanrooms  Cleanrooms are classified each yearCleanrooms are classified each year to an international standard (ISOto an international standard (ISO 14644).14644).  Once classified, certain physical andOnce classified, certain physical and environmental standards need to beenvironmental standards need to be met.met.  The physical parameters areThe physical parameters are controlled by an HVAC system.controlled by an HVAC system.
  • 27. Cleanrooms: contamination controlCleanrooms: contamination control  We control contamination at BPL by:We control contamination at BPL by: – Filtering the air from outside Building 27Filtering the air from outside Building 27 before it enters the factory. The air isbefore it enters the factory. The air is filtered for dust and many otherfiltered for dust and many other particles in the air.particles in the air. – At the point of air entering theAt the point of air entering the cleanroom special filters are used calledcleanroom special filters are used called HEPA filters.HEPA filters. When HEPA filters are tested, it is importantWhen HEPA filters are tested, it is important that they are assessed for leakage.that they are assessed for leakage.
  • 28. Cleanrooms: contamination controlCleanrooms: contamination control  To work efficiently, cleanrooms alsoTo work efficiently, cleanrooms also need to have a set number of air-need to have a set number of air- changes per hour to remove air-changes per hour to remove air- borne contamination.borne contamination. – An office might have 2-3 air-changesAn office might have 2-3 air-changes per hour (a complete replacement of theper hour (a complete replacement of the air volume in a room). A cleanroomair volume in a room). A cleanroom needs to have, as minimum, 20 airneeds to have, as minimum, 20 air changes per hour, and a changing roomchanges per hour, and a changing room about 60.about 60.
  • 29. Cleanrooms: contamination controlCleanrooms: contamination control  Cleanrooms also need to demonstrate aCleanrooms also need to demonstrate a ‘clean-up’ time.‘clean-up’ time. – This is the time taken for a room to return to aThis is the time taken for a room to return to a set level of particles in the air after it has beenset level of particles in the air after it has been used for an activity. This is required to takeused for an activity. This is required to take place within 20 minutes of the room last beingplace within 20 minutes of the room last being used.used.  To stop the passage of contamination, theTo stop the passage of contamination, the pressure differentials between certainpressure differentials between certain areas are controlled so that potentiallyareas are controlled so that potentially contaminated air moves away from acontaminated air moves away from a clean area towards a less clean area.clean area towards a less clean area.
  • 30. Cleanrooms: contamination controlCleanrooms: contamination control  For the Aseptic Filling Suite, the airFor the Aseptic Filling Suite, the air in a cleanroom is also required toin a cleanroom is also required to move in a certain way and not blowmove in a certain way and not blow any potentially contaminated airany potentially contaminated air back towards critical areas.back towards critical areas. – For filling activities, ‘uni-directional’ airFor filling activities, ‘uni-directional’ air movement is required (air in a normalmovement is required (air in a normal cleanroom is turbulent).cleanroom is turbulent).
  • 31. Cleanrooms: contamination controlCleanrooms: contamination control – Staff wear special cleanroom clothing,Staff wear special cleanroom clothing, designed to reduce contamination (caps,designed to reduce contamination (caps, face masks, gloves, boots and suits).face masks, gloves, boots and suits). – Staff enter and leave clean areasStaff enter and leave clean areas through air-locks.through air-locks.
  • 32. Cleanrooms: contamination controlCleanrooms: contamination control  Other factors:Other factors: – Some rooms have certain requirementsSome rooms have certain requirements for temperature and humidity.for temperature and humidity.  Material control:Material control: – Material entering the Aseptic FillingMaterial entering the Aseptic Filling Suite needs to be sterilised, irradiatedSuite needs to be sterilised, irradiated or disinfected.or disinfected. – In other cleanrooms, the presence ofIn other cleanrooms, the presence of dust and debris, such as fromdust and debris, such as from cardboard, needs to be minimised.cardboard, needs to be minimised.
  • 33. We can design clean areas, ensureWe can design clean areas, ensure contamination control and risk assesscontamination control and risk assess processes but…processes but… We still need toWe still need to demonstratedemonstrate controlcontrol through monitoringthrough monitoring
  • 34. Environmental monitoringEnvironmental monitoring  EnvironmentalEnvironmental monitoring ismonitoring is undertaken in eachundertaken in each BPL cleanroom.BPL cleanroom.  The monitoringThe monitoring looks for levels of:looks for levels of: – Non-viable particlesNon-viable particles in the air;in the air; – Viable micro-Viable micro- organisms.organisms.
  • 35. Environmental monitoringEnvironmental monitoring  BPL have ~215 cleanrooms andBPL have ~215 cleanrooms and cleanzonescleanzones – 35 cleanrooms in the filling suite35 cleanrooms in the filling suite – 180 in other process areas180 in other process areas  Microbiology take and examine overMicrobiology take and examine over 40,000 samples per year.40,000 samples per year.
  • 36. Environmental monitoringEnvironmental monitoring  Particle counting:Particle counting: – 2 sizes of particle2 sizes of particle are examined (0.5are examined (0.5 and 5.0 micron,and 5.0 micron, based on thebased on the ‘Orange Guide’) in a‘Orange Guide’) in a cubic metre of air;cubic metre of air; – This is carried outThis is carried out using an opticalusing an optical (laser) particle(laser) particle counter.counter.
  • 37. Environmental monitoringEnvironmental monitoring  Particles can be generated fromParticles can be generated from people and equipment.people and equipment.  Every batch fill is monitored forEvery batch fill is monitored for particles and spot checks areparticles and spot checks are undertaken throughout Building 27.undertaken throughout Building 27.  The only way to achieve ‘real time’The only way to achieve ‘real time’ monitoring of the air – and to guessmonitoring of the air – and to guess if the air contains bacteria – isif the air contains bacteria – is through particle counting.through particle counting.
  • 38. Environmental monitoringEnvironmental monitoring  Viable monitoring usesViable monitoring uses plates filled with aplates filled with a growth medium calledgrowth medium called agar.agar.  At BPL we useAt BPL we use something whichsomething which mixes seaweed withmixes seaweed with the contents of athe contents of a cow’s stomach tocow’s stomach to make a jelly whichmake a jelly which bacteria like to growbacteria like to grow on when incubated aton when incubated at the optimalthe optimal temperature and time.temperature and time.
  • 39. Environmental MonitoringEnvironmental Monitoring  Viable monitoring:Viable monitoring: – Settle plates: gives anSettle plates: gives an indication of how manyindication of how many micro-organisms in themicro-organisms in the air might settle onto aair might settle onto a surface;surface; – Active air-samples:Active air-samples: these measure howthese measure how many micro-organismsmany micro-organisms there are in a cubicthere are in a cubic metre of air when air ismetre of air when air is sucked into a specialsucked into a special device by a powerfuldevice by a powerful mechanical force.mechanical force. – Contact plates andContact plates and swabs test how clean aswabs test how clean a surface is.surface is.
  • 40. Environmental monitoringEnvironmental monitoring  In addition, in theIn addition, in the filling suite, platesfilling suite, plates are taken ofare taken of people’s hands andpeople’s hands and from their suits.from their suits.
  • 41. Environmental monitoringEnvironmental monitoring  The environmental monitoring programmeThe environmental monitoring programme is undertaken by Microbiology.is undertaken by Microbiology. – The programme examines different rooms atThe programme examines different rooms at different frequencies using different numbersdifferent frequencies using different numbers of samples, based on a risk assessment.of samples, based on a risk assessment. – The aim is to answer the questions:The aim is to answer the questions:  how many?; how frequent?; when doeshow many?; how frequent?; when does contamination occur?; how frequently doescontamination occur?; how frequently does contamination occur?; is the contamination a risk tocontamination occur?; is the contamination a risk to the product?; is the contamination getting anythe product?; is the contamination getting any worse?worse?
  • 42. Environmental monitoringEnvironmental monitoring  Data is assessed by looking at trends.Data is assessed by looking at trends. – Action levels cannot exceed Orange GuideAction levels cannot exceed Orange Guide levels, and they are set by examining pastlevels, and they are set by examining past data.data. – Each over action result, e.g. from poorEach over action result, e.g. from poor cleaning, will take ~10 person hours to dealcleaning, will take ~10 person hours to deal with (in taking repeat samples, assessmentwith (in taking repeat samples, assessment and report writing).and report writing). – There are about 1000 action level samples perThere are about 1000 action level samples per year.year. – Data is reviewed at the MEMR each month.Data is reviewed at the MEMR each month.
  • 43. Thank YouThank You Any questions?Any questions?