This document outlines standards of behavior and practices for cleanrooms and cleanzones. It defines key terms like cleanroom, cleanzone, critical activity, and aseptic processing. The document provides guidelines for behaviors in all cleanrooms and cleanzones, including proper gowning, minimizing contamination, and maintaining orderly work areas. It also outlines additional requirements for aseptic filling suites, such as proper glove sanitization procedures and using aseptic technique. The document states that compliance with these standards will be assessed through microbiological audits and is necessary to meet regulatory expectations for sterile drug production.
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Cleanroom and Cleanzone Behaviour and Practices SOP
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
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
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
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