Contamination Control in Practice

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Contamination Control in Practice

• Tim Sizer
• University of Leeds

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Cleaning and Disinfection

• Never separate
• Cleaning always precedes disinfection
• Effective cleaning and disinfection is essential
  to remove or reduce contamination
• particulates
• microorganisms
• protective films
• chemicals
• static electricity
• Necessary to satisfy regulatory requirements and
  written standards

Products People / operators Air
supply Packaging Paper Equipment

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WHY WORRY ABOUT CONTAMINATION?

• We have to comply with GMP
• cleaned thoroughly in accordance with a
  written programme
• Sanitation
• The Quality Assurance of Aseptic Preparation
  Services Chapter 12. Cleaning
• states
• 12.1.2 Clean areas must be regularly cleaned
  . according to a written procedure. A log
  should be kept of the areas cleaned, indicating
  the agents used.

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Accidental drug spills contribute to surface
contamination

• Case 1
• Floor contamination with fluorouracil and
  ifosfamide after the renovation and cleaning of a
  pharmacy.
• persistent contamination after two months of
  construction when the pharmacy area was not
  operational Connor, Anderson, Sessink,
  Spivey. (2002)

• Case 2
• Clean, but used BSC installed in a new prep room.
  
• Found contamination of cabinet and direct
  surroundings after installation Vandenbroucke
  Robays (2001)

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Meningitis Due to Iatrogenic BCG Infection in Two
Immunocompromised Children Stone, Vannier, et
al N. England J. Med 1995 333-561-563.

• 2 children (ages 3 5) with leukemia ?
  BCG-associated meningitis.
• Neither was receiving BCG, neither had hx of BCG
  vaccination.
• Infections may be due to accidental inoculation
  of BCG during admin of intrathecal methotrexate.
• The intrathecal chemotherapy may have been
  accidentally contaminated during the
  preparation..
• Failed to identify how contamination occurred
• Surface samples failed to grow any mycobacteria

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People cause contamination

People are responsible for 80 of particulates in
clean rooms A fully-clothed adult emits 9 x 106
particles in the size range 0.5 to 100 micron
(µm) every minute
Sitting quietly Moving
Walking 100,000 1,000,000
5,000,000 particles shed per minute
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Airborne Skin Squames
100 to 5,000 cfu every minute !
14 µm



2 m
7 minutes
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Opening your mouth causes contamination
Normal Breathing gt2 m/s
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• In pharmaceutical environments contamination is
  controlled
• partly by design construction
• partly by behaviour

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Storage Areas

• Risk reduction is achieved through a continuum
  of tasks and activities
• Starts with goods receipt and continues through
  to administration
• Items intended for aseptic preparation must be
  handled and stored appropriately
• Dust free environments or protected
• Minimal packaging
• Appropriate handling e.g. trays / gloves /
  bags
• Appropriate clothing and behaviour
• Caution Light Protection!

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Storage - refrigeration

• limits microbial growth
• increases viscosity
• slows degradation
• Problems
• Cleaning issues
• Unreliability
• Fluctuations in temperature
• Needs monitoring at all times

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Cleaning Materials Equipment

• Nothing should be taken into the cleanroom that
  will increase the particulate level or add
  contamination to the environment.
• All cleaning equipment brought into the cleanroom
  must be spotlessly clean
• Appropriate clothing must be worn
• Make-up must not be worn
• Paper of all types must be minimised

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Optimum Techniques

• Ensure thorough complete wetting
• Wiping essential to remove residues biofilm
• Using moist wipes
• Dry wipes more likely to shed bits, generate
  static
• Wet wipes likely to leave spread residues
• Damp wipes
• minimise shedding
• absorb liquids into fabric
• lifting and removing soiling

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Item Transfer - Spraying-In

• Wear ? gloves for spraying
• Gloves prevent hands contaminating items with
  microbes, chemicals and organic matter
• They protect operators from the same
  things
• Wear dedicated clothing for spraying
• Work in spraying booths with fume extract or
  drip trays
• Use correct technique

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Item Transfer - Spraying-In

• Aerosol is very important (droplet size) -
  2 reasons
• Wet all surfaces properly!
• Labels are high risk give particular attention
• Wipe stage is very important
• Attention to labels high risk

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Wipe stage is very important

• (QA of Aseptic Services - 4th Edn. 2005)
• Wiping to remove spores
• At least 2 decontamination stages (one to
  include wiping)
• Spray ? Wipe ? Spray
• systematically wipe from the cleanest end to
  the dirtiest i.e. from top to bottom of a bottle
• Use a fresh surface of the swab each time it
  comes into contact with item being disinfected
• The swab should then be discarded

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Contact Time

• Surface drying time must be considered This will
  be related to the ventilation system
• Disinfectant must stay in contact for sufficient
  time to enable penetration
• Disinfectant must be active during drying
  time
• Varies according to disinfectant
• alcohols - very rapid action
• hypochlorites - fast
• phenolics - slower
• Varies according to nature of contaminants

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Common Myths

• Disinfectants kill all known
  germs.dead!
• Disinfectants will solve all our cleaning
  problems
• We dont worry about cleaning, we
  disinfect

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Cleaning validation is

• the determination of the efficacy of cleaning
  procedures used in production premises or on
  equipment

Objective to show that after cleaning, the
production environment equipment return to
original state of microbiological and chemical
cleanliness.
Documented evidence that the cleaning procedure
will reduce contamination to an acceptable
level Validation enables routine monitoring to
be reduced to a minimum
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Conclusion

• CLEANING IS IMPORTANT - it saves lives
• It must be done well using
• trained, competent staff (who are
  adequately supervised and undergo
  regular validations)
• standardised, validated procedures
• It must be documented
• It must be monitored