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Behaviour and Practices in
Cleanrooms and Cleanzones
Tim Sandle
Microbiology solutions:
http://www.pharmamicroresources.com/
 Part 1: all grades of cleanrooms
 Part 2: all grades cleanzones
 Part 3: Aseptic Filling Suite
 in addition to Parts 1 and 2
Contents
A bench-mark...
Expected standard
GMP, audit and
inspection failure
Standards in cleanroom/zone behaviour and practices
will be assessed via specific micro audits
 Cleanroom
 a room designed, maintained and controlled
to prevent particulate and microbiological
contamination of drug products
Definitions:
 Cleanzone
 an area with a defined particulate and
microbiological cleanliness standard, usually
consisting of Laminar Air Flow protection.
 A cleanzone is designed to maintain asepsis or
sterility of the critical activity, product, test, or
material contained within it.
Definitions:
 Critical activity
 an activity that involves close proximity or
manipulation of exposed product, raw materials
or sterile equipment and components
 Laminar Air Flow (LAF)
 Uni-Directional Air Flow (UDAF) at a velocity
sufficient to uniformly sweep particulates away
from the Cleanzone
Definitions:
 Aseptic processing:
where the drug product, container, and closure
are subject to sterilisation processes separately,
as appropriate, and then brought together
 ‘Any manual or mechanical manipulation of the
sterilised drug, components, containers and
closures prior to, or during, aseptic assembly
poses a risk of contamination and thus
necessitates careful control’
Sterile Drug Products Produced by
Aseptic Processing [FDA]
 ‘Poor cGMP conditions…can ultimately pose a
life threatening health risk to a patient’
 ‘Even successfully qualified systems can be
compromised by:
poor personnel activities
poor operational activities
poor maintenance activities’
Sterile Drug Products Produced by
Aseptic Processing [FDA]
 ‘It is essential that operators involved in aseptic
manipulations adhere to the basic principles of aseptic
technique at all times…’
 Appropriate training should include:
 cleanroom behaviour
 aseptic technique
 microbiology
 gowning
 patient safety hazard posed by a non-sterile product
 Personnel training should be updated regularly
 Supervisors should routinely evaluate operators
Sterile Drug Products Produced by
Aseptic Processing [FDA]
All graded cleanzones (Grade A)
Microbiology sterility isolator (Grade A)
All graded cleanrooms (Grades B - D)
 Standards of behaviour and aseptic technique must be
transferable to all relevant situations
 this will be observed by an auditor/inspector
 if in doubt guidance must be sought
Scope of SOP...
 Everyone entering cleanrooms/zones must:
 be trained and competent, or
 must be ‘closely’ supervised
 Everyone has a responsibility to:
 be familiar/compliant with expected standards
 report substandard behaviour (e.g. gowning)
 report damaged room fabric, equipment, gowns
Any persons who pose an unacceptable risk to the product,
process or facility must be excluded immediately and
retrained
SOP responsibilities
Part 1: All cleanrooms
 Good practice:
 gowns/PPE changed if damaged, wet or
used for long durations
 check yours and others regularly
 target max duration = 4 hours
All cleanrooms: Behaviour
Time 
 Avoid rapid movements
– creates particles
– disturbs air flows
 Avoid aerosol production
  personnel =  contamination
 Aseptic technique must always be used wherever
applicable
 Fresh sterilised gloves must be worn immediately before
a critical activity and regularly sanitised
 but do not use disinfectant spray near product,
components, raw materials or env. mon. equipment
All cleanrooms: Behaviour
Minimise spread of contamination
during critical activities:
 avoid touching your person or other people
 avoid touching human contact sites such as:
 pens bin handles
 keyboards paperwork
 keypads desks
 doors plugs/switches
 chairs any unclean equipment
 telephones containers (disinfectant cans?!)
if you do make contact - sanitise gloves
All cleanrooms: Behaviour
 Sterile/sanitised implements
must be used for handling
product. If sterile their
sterility must be maintained
throughout the activity
 Minimise particles when
opening autoclave bags
All cleanrooms: Behaviour
50ml
syringe
Tubing
Lid
Container
 Items dropped on the floor
 floors are relatively dirty areas
 items must NOT be picked up during a critical activity
unless under exceptional circumstances
 if really needed the item must be thoroughly sanitised and
the operators gloves changed if they are completing the
activity
All cleanrooms: Surfaces
 Touching floors must be avoided at all times
 if having to kneel, sit or lie on the floor, either
 disinfect the floor before and after
 place a sanitised/sterile sheet on the floor first
 Aseptic items must not be placed on the floor, or any
other unsterile/unsanitised surface
 place on a suitable surface, or
 place on a sterile, or disinfectant wipe
All cleanrooms: Surfaces
 Items entering cleanrooms
 avoid material that cannot be effectively
sanitised
 avoid material that sheds excessive
particles
All cleanrooms: Practices
 Work areas must be kept clean,
neat and tidy to reduce cross-
contamination/mix-ups
All cleanrooms: Practices
 Items within cleanrooms must not
obstruct HVAC/LAF vents
All cleanrooms: Practices
 Standing water must be
cleaned up
 Status labelling
 e.g. cleaned, sanitised, disinfected or sterilised
 soiled disposable equipment must be discarded
 soiled reusable equipment must be removed
All cleanrooms: Practices
Part 2: All cleanzones
To avoid contamination and disruption of air flow:
 Control movements within, and adjacent to, cleanzones
 Talking must be avoided within, or adjacent to,
cleanzones
 Interventions must be performed slowly and deliberately
 Covers, curtains and doors surrounding cleanzones must
be opened with minimal distance/force
 Aseptic technique must always be used regardless of any
other protection present
Cleanzones: Behaviour
 ‘First Air’ principle:
 items being protected by air flow must receive clean ‘first
air’ - so all operator manipulations must be done
downstream of air flow
 Aseptic manipulations and operator gloves must
be restricted to within the protected zone during
a critical activity
Cleanzones: Behaviour
Vertical LAF

HorizontalLAF

Operation of cleanzone:
 Workareas must be clean, neat and tidy.
 Items present within the cleanzone must be minimised
and located so as not to disrupt or reduce air flow
protection
Cleanzones: Behaviour
 Cleanzone airflows must be
allowed to operate for at least
10 mins prior to use
 Cleanzone work areas must
be cleaned prior to use
Part 3: Aseptic Filling Suite
Gloves must be sanitised at regular intervals, but
especially when related to a critical activity:
Before leaving the final change/SW5
Entering the filling room/critical zone
Before opening cleanzone screens/doors
Before handling container/closure bags
Before handling a sterilised implement/surface
After touching any part of ones self or others
After touching a human contact site
After touching microbiological media
Aseptic Filling Suite: Behaviour
Use of disinfectant sprays
avoid excessive particles
spray away from env.mon. equipment including
particle counters (use Safe Zones in filling rms)
Use a jet spray for sanitising gloves
 deliver a pool into the palm of the hand
 spread across all surfaces
 allow to dry before commencing
Aseptic Filling Suite: Behaviour
Filling rooms
must not be used as short cuts, even when not
in use
must not be used to store items not required
for filling activity in progress
must have personnel numbers minimised
 Long 24” outer gloves are mandatory at all times
 Goggles to be worn during critical activities
Aseptic Filling Suite: Behaviour
 ‘Buddy system’ recommended for some aseptic
activities, e.g. Huber unloading
Aseptic Filling Suite: Behaviour
Grade A
‘CLEAN’
operator
Grade B
‘DIRTY’
operator
Single wrap Double wrap
N.B. The clean
operator must NOT
touch anything that
is not sterile
 When working in cleanzones the operator must hold
gloved hands:
 at working height
 at/above waste height
 under protective air flow
 avoiding touching anything unsterile
 Aseptic technique must be demonstrated at all times,
regardless of any other protection
Aseptic Filling Suite: Behaviour
 Facilities, utilities and equipment
 Liquid, moisture Storage
 Fabric HVAC/UDAF
 Interlocks/airlocks Documentation
 Specific activities
 Gowning Aseptic Technique
 Working in UDAFs Cleaning/disinfection
 Aseptic Filling
 General items
 Cleanroom behaviour
 Process flows/Personnel Housekeeping
 For all areas covered by this SOP
 For Correction & PREVENTION
NEW: microbiological audits
 Increase in activity/personnel = increased chance of
contaminating product/facility
 Behaviour and practices required at BPL are industry
practice and regulatory expectations
 You may well be observed by an inspector and will need
to demonstrate good standards
 Standards of behaviour and aseptic technique should be a
transferable skill applied to different situations. If in
doubt - ask.
 From NOW you must comply with this SOP
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Cleanroom sop slides

  • 1. Behaviour and Practices in Cleanrooms and Cleanzones Tim Sandle Microbiology solutions: http://www.pharmamicroresources.com/
  • 2.  Part 1: all grades of cleanrooms  Part 2: all grades cleanzones  Part 3: Aseptic Filling Suite  in addition to Parts 1 and 2 Contents
  • 3. A bench-mark... Expected standard GMP, audit and inspection failure Standards in cleanroom/zone behaviour and practices will be assessed via specific micro audits
  • 4.  Cleanroom  a room designed, maintained and controlled to prevent particulate and microbiological contamination of drug products Definitions:
  • 5.  Cleanzone  an area with a defined particulate and microbiological cleanliness standard, usually consisting of Laminar Air Flow protection.  A cleanzone is designed to maintain asepsis or sterility of the critical activity, product, test, or material contained within it. Definitions:
  • 6.  Critical activity  an activity that involves close proximity or manipulation of exposed product, raw materials or sterile equipment and components  Laminar Air Flow (LAF)  Uni-Directional Air Flow (UDAF) at a velocity sufficient to uniformly sweep particulates away from the Cleanzone Definitions:
  • 7.  Aseptic processing: where the drug product, container, and closure are subject to sterilisation processes separately, as appropriate, and then brought together  ‘Any manual or mechanical manipulation of the sterilised drug, components, containers and closures prior to, or during, aseptic assembly poses a risk of contamination and thus necessitates careful control’ Sterile Drug Products Produced by Aseptic Processing [FDA]
  • 8.  ‘Poor cGMP conditions…can ultimately pose a life threatening health risk to a patient’  ‘Even successfully qualified systems can be compromised by: poor personnel activities poor operational activities poor maintenance activities’ Sterile Drug Products Produced by Aseptic Processing [FDA]
  • 9.  ‘It is essential that operators involved in aseptic manipulations adhere to the basic principles of aseptic technique at all times…’  Appropriate training should include:  cleanroom behaviour  aseptic technique  microbiology  gowning  patient safety hazard posed by a non-sterile product  Personnel training should be updated regularly  Supervisors should routinely evaluate operators Sterile Drug Products Produced by Aseptic Processing [FDA]
  • 10. All graded cleanzones (Grade A) Microbiology sterility isolator (Grade A) All graded cleanrooms (Grades B - D)  Standards of behaviour and aseptic technique must be transferable to all relevant situations  this will be observed by an auditor/inspector  if in doubt guidance must be sought Scope of SOP...
  • 11.  Everyone entering cleanrooms/zones must:  be trained and competent, or  must be ‘closely’ supervised  Everyone has a responsibility to:  be familiar/compliant with expected standards  report substandard behaviour (e.g. gowning)  report damaged room fabric, equipment, gowns Any persons who pose an unacceptable risk to the product, process or facility must be excluded immediately and retrained SOP responsibilities
  • 12. Part 1: All cleanrooms
  • 13.  Good practice:  gowns/PPE changed if damaged, wet or used for long durations  check yours and others regularly  target max duration = 4 hours All cleanrooms: Behaviour Time   Avoid rapid movements – creates particles – disturbs air flows  Avoid aerosol production   personnel =  contamination
  • 14.  Aseptic technique must always be used wherever applicable  Fresh sterilised gloves must be worn immediately before a critical activity and regularly sanitised  but do not use disinfectant spray near product, components, raw materials or env. mon. equipment All cleanrooms: Behaviour
  • 15. Minimise spread of contamination during critical activities:  avoid touching your person or other people  avoid touching human contact sites such as:  pens bin handles  keyboards paperwork  keypads desks  doors plugs/switches  chairs any unclean equipment  telephones containers (disinfectant cans?!) if you do make contact - sanitise gloves All cleanrooms: Behaviour
  • 16.  Sterile/sanitised implements must be used for handling product. If sterile their sterility must be maintained throughout the activity  Minimise particles when opening autoclave bags All cleanrooms: Behaviour 50ml syringe Tubing Lid Container
  • 17.  Items dropped on the floor  floors are relatively dirty areas  items must NOT be picked up during a critical activity unless under exceptional circumstances  if really needed the item must be thoroughly sanitised and the operators gloves changed if they are completing the activity All cleanrooms: Surfaces
  • 18.  Touching floors must be avoided at all times  if having to kneel, sit or lie on the floor, either  disinfect the floor before and after  place a sanitised/sterile sheet on the floor first  Aseptic items must not be placed on the floor, or any other unsterile/unsanitised surface  place on a suitable surface, or  place on a sterile, or disinfectant wipe All cleanrooms: Surfaces
  • 19.  Items entering cleanrooms  avoid material that cannot be effectively sanitised  avoid material that sheds excessive particles All cleanrooms: Practices
  • 20.  Work areas must be kept clean, neat and tidy to reduce cross- contamination/mix-ups All cleanrooms: Practices
  • 21.  Items within cleanrooms must not obstruct HVAC/LAF vents All cleanrooms: Practices  Standing water must be cleaned up
  • 22.  Status labelling  e.g. cleaned, sanitised, disinfected or sterilised  soiled disposable equipment must be discarded  soiled reusable equipment must be removed All cleanrooms: Practices
  • 23. Part 2: All cleanzones
  • 24. To avoid contamination and disruption of air flow:  Control movements within, and adjacent to, cleanzones  Talking must be avoided within, or adjacent to, cleanzones  Interventions must be performed slowly and deliberately  Covers, curtains and doors surrounding cleanzones must be opened with minimal distance/force  Aseptic technique must always be used regardless of any other protection present Cleanzones: Behaviour
  • 25.  ‘First Air’ principle:  items being protected by air flow must receive clean ‘first air’ - so all operator manipulations must be done downstream of air flow  Aseptic manipulations and operator gloves must be restricted to within the protected zone during a critical activity Cleanzones: Behaviour Vertical LAF  HorizontalLAF 
  • 26. Operation of cleanzone:  Workareas must be clean, neat and tidy.  Items present within the cleanzone must be minimised and located so as not to disrupt or reduce air flow protection Cleanzones: Behaviour  Cleanzone airflows must be allowed to operate for at least 10 mins prior to use  Cleanzone work areas must be cleaned prior to use
  • 27. Part 3: Aseptic Filling Suite
  • 28. Gloves must be sanitised at regular intervals, but especially when related to a critical activity: Before leaving the final change/SW5 Entering the filling room/critical zone Before opening cleanzone screens/doors Before handling container/closure bags Before handling a sterilised implement/surface After touching any part of ones self or others After touching a human contact site After touching microbiological media Aseptic Filling Suite: Behaviour
  • 29. Use of disinfectant sprays avoid excessive particles spray away from env.mon. equipment including particle counters (use Safe Zones in filling rms) Use a jet spray for sanitising gloves  deliver a pool into the palm of the hand  spread across all surfaces  allow to dry before commencing Aseptic Filling Suite: Behaviour
  • 30. Filling rooms must not be used as short cuts, even when not in use must not be used to store items not required for filling activity in progress must have personnel numbers minimised  Long 24” outer gloves are mandatory at all times  Goggles to be worn during critical activities Aseptic Filling Suite: Behaviour
  • 31.  ‘Buddy system’ recommended for some aseptic activities, e.g. Huber unloading Aseptic Filling Suite: Behaviour Grade A ‘CLEAN’ operator Grade B ‘DIRTY’ operator Single wrap Double wrap N.B. The clean operator must NOT touch anything that is not sterile
  • 32.  When working in cleanzones the operator must hold gloved hands:  at working height  at/above waste height  under protective air flow  avoiding touching anything unsterile  Aseptic technique must be demonstrated at all times, regardless of any other protection Aseptic Filling Suite: Behaviour
  • 33.  Facilities, utilities and equipment  Liquid, moisture Storage  Fabric HVAC/UDAF  Interlocks/airlocks Documentation  Specific activities  Gowning Aseptic Technique  Working in UDAFs Cleaning/disinfection  Aseptic Filling  General items  Cleanroom behaviour  Process flows/Personnel Housekeeping  For all areas covered by this SOP  For Correction & PREVENTION NEW: microbiological audits
  • 34.  Increase in activity/personnel = increased chance of contaminating product/facility  Behaviour and practices required at BPL are industry practice and regulatory expectations  You may well be observed by an inspector and will need to demonstrate good standards  Standards of behaviour and aseptic technique should be a transferable skill applied to different situations. If in doubt - ask.  From NOW you must comply with this SOP Summary