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AAI: Pharmaceutics > Manufacturing Of Sterile Pharmaceutical Products > Flashcards

Manufacturing Of Sterile Pharmaceutical Products Flashcards

1
Q

Sterile pharmaceutical products must be free of…

A

Living microorganism e.g. bacteria, fungi, viruses

  • patient at risk of infection
  • risk of degradation of therapeutic agent/formulation

*Particles - can block capillaries

*Pyrogens - substances that raise body temperature causing fever

  • can withstand sterilisation
  • mainly lipopolysaccharide (endotoxin from the outerwall of gram-negative bacteria)
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2
Q

What medicinal products must be sterile?

A

Injectable formulation

Ophthalmic preparation

Solutions for nebulisation

Solutions for wound/bladder injection

Dressings, sutures, implants

Surgical materials

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3
Q

Techniques of sterile production

A

Terminal sterilisation

Aseptic sterilisation

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4
Q

Terminal sterilisation

A

Product is manufactured, sealed in final container + sterilised

  • low risk of microbiological contamination
  • used for sterilisation of raw materials + surfaces
  • not always possible ( if drug is thermosensitive)
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5
Q

Aseptic technique

A

Medicine, container + closure are sterilised separately then combined in sterile environment e.g. Sodium Cromoglicate Eye Drops BP

  • high risk of microbiological contamination in final product
  • sterility assurance + control are crucial
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6
Q

Sterilisation processes accepted by BP

A

Moist heat (steam)

Dry heat

Ionising radiation

Gaseous sterilisation

Filtration

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7
Q

Which sterilisation processes are terminal?

A

Terminal = Biocidal processes (micro-organisms are killed)

  • Moist heat (steam)
  • Dry heat
  • Ionising radiations
  • Gaseous sterilisation
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8
Q

Which sterilisation processes are aseptic?

A

Aseptic = micro-organisms (and particles!) are physically removed from the product

  • Filtration
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9
Q

What is Moist Heat (steam) process?

A

Sterilisation by saturated steam under pressure in an autoclave

  • 121 degrees for 15 min or 134 degrees for 3 min
  • efficient - organisms are killed by denaturation/hydrolysis of essential cell constituents
  • used to sterilise bottled aqueous solutions, containers, dressings, instrumenta
  • items must be packed to allow steam penetration + post sterilisation protection
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10
Q

What is the Dry Heat process?

A

Sterilisation in a hot air oven

  • 160-180 degrees for 2 hours
  • less efficient than steam (kill microorganisms due to oxidative processes)
  • used to sterilise glass bottles + metal surgical instruments
  • Advantage = destruction of pyrogens (250 degrees)
  • Items must be packed to allow contact with heat and post-sterilisation protection
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11
Q

What is the Ionising Radiation process?

A

Sterilisation using accelerated electrons/gamma rays

  • damage DNA of microorganism (biocidal)
  • used for heat-sensitive products (can accelerate degradation of plastics or aqueous drug solutions)
  • used for sterilisation of ointments, instruments, sutures etc.
  • BUT…UV radiation is not suitable for the sterilisation of pharmaceutical products (not as efficient at killing micro-organisms as ionising radiations)
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12
Q

What is the Gaseous Methods process?

A

Sterilisation using toxic gas e.g. ethylene oxide/ formaldehyde

  • biocidal activity due to chemical modifications of proteins + nucleus acids
  • used to sterilise powders + instruments
  • sterility assurance is lower than with heat processes
  • the toxic gases are mutagenic + carcinogenic = protection of staff
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13
Q

What is the Filtration of solutions process?

A

Sterilise heat sensitive injectable or opthalmic solutions

  • pore diameter of filters: 0.22 micro moles
  • removal of particles (can’t use for suspension formulations)
  • different types of filter depending on solution properties
  • Requires working in laminal flow cabinet which provides a sterile environment
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14
Q

What is a Laminar airflow cabinet?

A

Provides continuous, unidirectional flow of clean filtered air

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15
Q

How to sterilise aqueous pharmaceutical product?

A
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16
Q

How to sterilise non-aqueous pharmaceutical products?

A
17
Q

How to ensure product sterility?

A

Sterility control

Sterility assurance

18
Q

What is Sterility control?

A

Incubation of the whole or portion of the product with a nutrient medium to verify abscence of contamination

  • Legally required
19
Q

Limitations of sterility tests

A
  • Product is destroyed
  • Few samples of each batch are tested
  • Not reliable
  • Do not detect presence of viruses

Unsuitable for personalised medicines produced for individual patients

Offer no guarantee of sterility for all products of a batch

20
Q

What is Sterility Assurance?

A

Working in a clean environment

Follow GMP/GWP rules

Use contamination free-starting materials

Suitable packaging + storage

Validation + in-process control of sterilisation

Crucial to guarantee sterility and patient safety

21
Q

Cleaning procedures

A
  1. Regular cleaning/disinfection
    • floor + horizontal surfaces cleaned + disinfected everyday
    • ceiling + walls cleaned + disinfected @ once a month
  2. Design of premises
    • smooth surfaces + rounded coving to prevent accumulation of dust + easy cleaning + disinfection
    • separation of storage + prep areas from aseptic production areas
    • different routes for staff + materials
    • unidirectional flow of sterile products
    • supply of filtered air @ positive pressure
  3. Suitable clothing
    • sterile trouser suit, hat enclosing hair, facemask, gloves, overboots
    • non-shedding materials
    • non-reusable
  4. Strict changing procedures
    • passage from outside to clean area via dividing step over sill
    • outer garments removed in the ‘black area’
    • hands washed in a sink with elbow/foot operated taps
22
Q

Disinfectants

A

Remove microorganism from objects/surfaces

23
Q

Antiseptic

A

Active against microorganism on living tissue

24
Q

Preservatives

A

Added to pharmaceutical, cosmetic, food products to avoid microbial spoilage

25
Q

In-process control of procedures

A

Biological indicators

Chemical indicators

Physical indicators

26
Q

Biological indicators

A

Heat sterilisation - Ampoules containing spores of a heat resistant bacteria placed in autoclave/oven

Aseptic filtration - Filtration of culture of a non-pathogenic bacteria of 0.3 mM through 0.22 mM pore size filter

Incubation to verify absence of bacterial growth in the medium

Limitations: incubation time!

27
Q

Chemical indicators

A

Chemical indicators - Melt when the T° is reached or change colour when irradiated

  • Highlight a failure in the process but do not confirm this has been completed successfully
28
Q

Physical Indicators

A

Heat sterilisation: temperature record (+ time T° was maintained for autoclaving)

Aseptic filtration: integrity of the filter

  • Bubble point pressure test for membrane filters
  • Retention of particles of known dimensions for HEPA filters

AAI: Pharmaceutics (7 decks)

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