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Hygiene & Cleanliness - Coggle Diagram

- - - - More than or equal to 1 living organism
      - Affects sterility of drug
      - Introduced through bare hands
    - - No living organisms. E.g. metal, dirt, pollen
      - From employee movements or uniforms
- - - - Specially designed for cleanroom
  - - - high efficient particle filtration
        
        Control concentration of airborne microbes and dust in cleanroom
    - - sub-micron filters
        
        eliminate bacteria in purified water for injection
  - - - Creates an environment in which
        
        pharmaceuticals, biologics, disposable medical devices
        
        can be manufactured without the risk of
        
        microbial or particulate contamination
      - level of air cleanliness regulated by standards
- - - - Prevent product cross-contamination
    - - Possible to show that cleaning between batches may be reduced/eliminated
      - Validation should be done to determine the no. of lots of the same product that can be consecutively manufactured before a more rigorous cleaning is necessary
  - - - Cover equipment or place in an area that is free from possible cross-contamination and designated for cleaned equipment
- - - - product
      - air
      - surfaces
    - - ensure gown is not compromised
        
        if compromised
        
        apparel becomes a contaminant not a barrier
  - - - shed 1 billion skin flakes per day
- - - - Light source minimizes risk of residue blending in with the background
  - - - 1) Pre-treat the swab in the sample solvent
        2) Swab the specified surface in a uni-direction firmly to cover the entire area
        3) Put the swab into a test tube with extractable solvent and extract the residue by sonication
        4) Filter the extract sample and analyze it using a suitable analytical method
- - - - includes
        
        Method of cleaning
        
        Manual
        
        involves the preparation of cleaning solution
        
        scrubbing of equipment or parts using
        
        brush
        
        single-use cloth
        
        pad
        
        Soak
        
        soaking utensils/ equipment parts in containers of detergent solution
        
        for extended period of time
        
        Generally used in combination with manual cleaning
        
        Spray
        
        using low/high pressure sprays
        
        good for cleaning hard to reach areas
        
        enhanced with the use of detergent
        
        mobile & used for general cleaning surfaces
        
        pressure range from 200 to 1000 psi
        
        Clean in place (CIP)
        
        full automated, self contained system
        
        high-pressure spray nozzles like spray balls are permanently installed in mixing / storage tanks
        
        Cleaning + sanitizing solution circulated for a specific time at specified temperature.
        
        no disassembly of equipment necessary
        
        Vacuuming
        
        using a electric motor to spin a fan
        
        drawing air and small particles to be push out into a bag/ contianer
        
        creates a negative pressure
        
        BUT
        
        1 more item...
        
        Cleaning sequences
        
        1) Pre-rinsing
        
        2) Apply detergent (specific conc, temp)
        
        3) Rinsing
        
        4) Apply sanitizer
        
        1 more item...
        
        Cleaning chemicals
        
        Detergents
        
        defined as
        
        a chemical/ formulation to remove undesired particles from a contact surface
        
        surface active ingredient have higher affinity to surface than to particles
        
        lift particles from the surface
        
        particles removed by wiping/ moping
        
        composition must be known
        
        Sanitizers
        
        chemical agent effective in reducing microbial contamination on product contact surfaces
        
        reduce non-spore forming microbial population by 3 logs/ 99.999% reduction
        
        within 30 second contact time
        
        Effecting against
        
        broad range of microbes
        
        in a short contact time
        
        1 more item...
        
        Sanitizers vs disinfectant
        
        Similarity
        
        both regulated by the Environment Protection Agency (EPA, USA)
        
        established rules to govern the products including
        
        3 more items...
        
        Differences
        
        Sanitizer need not eliminate 100% of organisms to be effective
        
        fungi and virus not included in sanitizing claim
        
        Types of sanitizers & disinfectants
        
        Phenol
        
        active ingredient found in household disinfectant
        
        effective against bacteria
        
        1 more item...
        
        Quaternary Ammonium
        
        widely used as disinfectant
        
        1 more item...
        
        effective against Gram +ve & Gram -ve
        
        1 more item...
        
        Alcohol
        
        IPA
        
        1 more item...
        
        Hypochlorites
        
        most common chlorine compounds in sanitizers
        
        1 more item...
        
        effective against fungi & bacteria
        
        1 more item...
        
        after 30 days, solution stored in PE container will lose 40 -50% of conc
        
        1 more item...
        
        disinfectant
        
        completely eliminate all organisms listed on the label
        
        within 10 mins
        
        organisms not limited to bacteria
        
        can include
        
        2 more items...
        
        Rotational Cleaning
        
        Usage of two or more disinfectant in rotation
        
        Purpose
        
        prevent development of bacterial resistance
        
        Cleaning tools
        
        Responsibilities
        
        whose job to clean and check
        
        Check cleanliness
        
        after cleaning
      - Require validation
        
        documentation that approved cleaning procedure will continually clean to a predetermined standard
- - - - Apply IPA to the folded wiper and wipe in parallel strokes with some overlap.
        
        Start each stroke at the cleaner end of the planned path
        
        Change the surface of the wiper or the wiper itself at the beginning of each stroke