Summary
Summary Preparation of sterile products
- Institution
- University Of East Anglia
Industrial pharmacy - 1st semester Includes bullet points, key diagrams and images
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Preparation of Sterile Products Sterility is the absence of viable microorganisms. The sterility of a product
cannot be guaranteed by testing; it has to be assured by application of
validated procedures.
Particles and bacteria:
Clean air technology and laminar flow cabinets/isolators-HEPA (high
efficiency particulate air) filters block 0.5micron particles. Cabinet in a
dedicated clean room and personal must be protected too with cytotoxics
Contamination by operator- Wash hands sterile gloves, appropriate
clothing and set techniques
Stop contamination from product and disposables- store products
appropriately and spray and wipe all products entering the environment
Disinfection- process of removing microorganisms, potentially
pathogenic, from the surface of objects
High level disinfection- destruction of all microorganism bot necessarily
spores
Intermediate level disinfection- destruction of all vegetative bacteria but
may exclude some viruses or fungi but little or no sporicidal activity
Low level disinfection- killing most vegetative bacteria, fungi and viruses
but not spores
Antisepsis- destruction or inhibition of microorganisms on living tissue
therefore preventing or limiting infection
Classes of microbial safety cabinets:
Class I- has a front aperture so the operator can carry out tasks. Aim to
protect the worker. Airborne contamination is controlled by an inward
airflow and filtration (protecting the user)
Class II- protects the user and products. HEPA filters where 70% of air is
recycled filtered air
Class III- aseptic manipulation. Air locks either side for transfer of
materials in and out of isolator
Cleaning:
Wet cleaning- for floors using disinfectant but recycles dirt. 3 bucket
system for rinsing dirty mop, second rinse and disinfectant solution.
Adhesive method- replacable or washable tacky mats to clean shoes or
trolleys
Sprays- alcohol or hydrogen peroxide. Useful for difficult areas but safety
issues
Alcohols- bactericidal, fungicidal and virucidal but not sporicidal.
Disinfectant and antiseptic 60-90% alcohol. IMS is ethanol with small
amount of methanol (70%). IMS less toxic than IPA (isopropyl alcohol),
inexpensive but poor penetration
Chlorinated disinfectants- sodium hypochlorite or sodium
dichloroisocyanurate (NaDCC). HOCl dissociates making it ineffective so
NaOH added. Concentration usually 1000ppm and is sporicidal but
corrosive.
Quaternary ammonium cations (QUATS or QUACs)- cetrimide or
benzalkonium chloride. Very effective against gram +, not very toxic and
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