Contamination Control

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  • Created by: LBCW0502
  • Created on: 31-01-20 11:03
What are the three main factors to consider in the microbial contamination of pharmaceutical products?
Hazards (product spoilage, health hazards which need to be avoided), limits (sterile products/absolute, non-sterile products/needs limits), control (GMP, formulation, preservatives)
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Why are all pharmaceutical products not sterilised?
Make everything sterile, avoid making judgement calls (reason for not using approach – time consuming, cost, large investment, non-sterile products need to have different criteria to be fit for purpose, determine boundaries/contamination/organisms)
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How much risk is associated with the ingestion of medicines and application of topical products?
Low risk
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State features for control of contamination
Satisfactory quality, appropriate for intended use/fit for purpose, safe/efficacious/good quality, at the point at which the product is made and throughout design/manufacture/given to patient
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Give examples of guidelines which need to be followed
Good manufacturing practice – orange book, set of principles to assure product is what it should be (e.g. techniques, equipment etc). Pharmaceutical products – pharmacopoeia limits
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Why is it important to determine microbial contamination in formulations? (1)
Some products may grow more microbes compared to others, tablets (low risk), nutritious suspensions/high water content (high risk, encourages growth of microbes). Household products/cosmetics/food industry/pharmaceuticals – (microbial growth)
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Why is it important to determine microbial contamination in formulations? (2)
There are different ways a formulation may be affected by microbial contamination (pharmaceutical microbiology – product)
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Why are preservatives used?
Allows non-sterile products to be viable/commercial products, product still suitable to use
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What are the four main ways a pharmaceutical product can be spoiled?
Breakdown of the active. Breakdown of the formulation. Reduced acceptability. Degradation of preservative
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State features of breakdown of the API due to microbes (1)
No longer the dose we think is being delivered. Bacteria – enzymes break down API/low mwt products via sugars/organic acids, high mwt (polysaccharides, proteins). Lab experiments – many therapeutic compounds can be degraded
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State features of breakdown of the API due to microbes (2)
E.g. natural products - penicillin, opioids, alkaloids etc. Pseudomonas contamination of eye drops , degrade API, (eye drops – sterile product, delivery of product to eye/subject to microbial contamination)
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State features of breakdown of the API due to microbes (3)
Patients experience difficulty administering eye drops. Preservatives in eye drop – prevent microbial contamination of the eye. Pharmacopoeia specifies particular microbes to identify
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State features of breakdown of the formulation (1)
API might be fine, but breakdown of formulation prevents patient from receiving medicine in the correct form e.g. cracking/creaming of emulsions, viscosity changes, degradation of surfactants
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State features of breakdown of the formulation (2)
Degradation/thickening of suspending agents (no longer homogenous, suspensions), degradation of oil phases, pH changes, bacteria/sugar fermentation (metabolic route, change pH, affect drug)
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State features of reduced acceptability (1)
Metabolic waste products of bacterial metabolism (sensitive detection by patients), hydrogen sulphide gas, amines (bacterial waste products)
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State features of reduced acceptability (2)
Unpleasant taste/smell/appearance from amines in small amounts, returned medicines in pharmacy (blotches on tablets – patients store medicines in bathrooms, cycle of heat and humidity, followed by cooling
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State features of reduced acceptability (3)
Water condenses on surfaces of pharmaceuticals, promotes growth of microbes)
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State features of the degradation of preservatives
Preservative is no longer doing its job in the formulation, Pseudomonas can degrade phenol, overgrowth of organism (results in other problems mentioned). More water activity, more nutrition in product, more chance of product spoilage
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What are the four factors which contribute to hazards to health (for non-sterile products)? (1)
Type of organism. Health of patient. Number of organisms. Route of administration.
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What are the four factors which contribute to hazards to health (for non-sterile products)? (2)
Product may give no sensory evidence e.g. no breakdown of formulation, no lack of acceptability but supports an amount of bacteria which will affect the patient’s health
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Describe features of the type of organism (1)
Primary pathogens (microbes which are always infective e.g. Salmonella - found associated with pharmaceutical products)
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Describe features of the type of organism (2)
Opportunistic pathogens (exposed to in the environment, free living organisms, normal flora, mutations, S. aureus, can cause lung infections, immune response in patient)
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Describe features of the health of the patient (1)
Normal healthy adults (adequate resistance to microbes), any patient with severe/chronic disease tends to be immunologically compromised, vulnerable to infection, categories of patients (drug therapy can interfere with immune system
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Describe features of the health of the patient (2)
E.g. corticosteroids prevent hyperimmune response but may expose patient to being more vulnerable to infection, cancer chemotherapy, adverse effects on the immune system whilst treating cancer, don’t want to give contaminated medicines)
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Describe features of the health of the patient (3)
Wound dressings, risk situation, normal barrier for protection from infection is compromised – needs to be sterilised. Neonates - immune system underdeveloped, more vulnerable to infection
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Describe features of the number of organisms (1)
Probability of infection increases with number of organisms, number required to induce an active infection can vary amongst different microbes/strains
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Describe features of the number of organisms (2)
E.g. oral administration of infective dose of Salmonella (10 million or as low as 100 depending on pathogenicity of strain), e.g. 5 E.coli organisms result in people dying due to contaminated food, 60 Pseudomonas species can affect the eye
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Describe features of the route of administration (1)
Risk is lower via the oral route (ingest microbes everyday), no real recent examples where patients have been harmed by poor quality pharmaceutical products (consider events prior to controls being introduced e.g. BP, limits)
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Describe features of the route of administration (2)
E.g. thyroid tablets contaminated with organisms of Salmonella resulting in patients dying, breakdowns in systems
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Describe features of the route of administration (3)
Infusions (most dangerous product to make – high volume, IV route, fluid can promote microbial growth, straight into bloodstream/body, high risk) e.g. poor stop break systems but few recent examples
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Describe features of limits - pharmacopoeia (1)
Focus on numbers and types of organisms, total viable counts (limit of organisms acceptable), absence of specific organisms (linked to route of administration
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Describe features of limits - pharmacopoeia (2)
E.g. ingestion – want absence of E.coli, Salmonella, inhalation – want absence of S. aureus, don’t want particular opportunistic pathogens in particular ROA
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Describe features of limits - pharmacopoeia (3)
Make product as satisfactory within guidelines as much as possible (not at border limits)
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Describe features of limits - in house guidelines
Industry, hospital pharmacy (work well within the guidelines, stay away from thresholds, have monitoring systems to monitor quality of products, investigations if there are suspicious organisms, become active before product quality fails)
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What are the sources of contamination?
Raw materials, premises and environment, processing, personnel
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What are the types of product in pharmaceutical microbiology? (1)
Aseptically prepared (determine that there is no single organism in product, high risk).
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What are the types of product in pharmaceutical microbiology? (2)
Terminally sterilised (operate best processes, sterilise product in its final container, high confidence that there are no organisms present)
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What are the types of product in pharmaceutical microbiology? (3)
Microbiologically vulnerable non-sterile products (e.g. suspensions, oral solutions, high water content/nutrition, microbial growth promoted, need preservatives)
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What are the types of product in pharmaceutical microbiology? (4)
Powder/anhydrous form (water added when needed, no preservatives/used for limited time due to microbial growth and contamination)
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What are the types of product in pharmaceutical microbiology? (5)
All other products (e.g. tablets, capsules, don’t encourage microbial growth, administered via a low risk route e.g. oral route, could have preservatives)
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What are the formulation factors affecting microbial content?
Water content, nutritional value, pH, osmotic pressure, surface tension, (temperature), oxygen tension, storage
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Describe features of water content (1)
Significant, parameter – water activity, vapour pressure of product/vapour pressure of pure water, adding components to water/reduces vapour pressure, highest water activity – pure water
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Describe features of water content (2)
Water activity of 0.98 vapour pressure - microbes flourish in this environment, water activity of 0.95 pressure – relatively few bacteria grow but yeast/mould may grow slowly at a greater range, product will not spoil
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Describe features of water content (3)
Bacteria not as robust, solutions/suspensions more susceptible, syrups/sugars subject to osmophilic yeasts, contamination of product in jar – water condenses on surface of product, contamination/microbial growth on top surface of the product)
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Describe features of nutritional value
Significant, more nutrition, more risk, get non-exacting species, Pseudomonas can grow in simple salt solutions and grow in distilled water, issues with aromatic flavoured water
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Describe features of pH
Bacteria – like a pH around 7.4-7.8, reduce pH <4-5 most bacteria struggle, self-preserving formulation, some fungi/bacteria more tolerant in acidic environment
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State features of osmotic pressure
Increased pressure (reduce microbial growth)
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Describe features of surface tension
Low surface tension, lots of surfactants, encourages Gram negative bacteria over Gram positive bacteria, affects microbial profile
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Describe features of temperature
Around 37 degrees Celsius for bacteria, yeast (25 degrees Celsius), promotes microbial growth
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Describe features of oxygen tension
Anaerobes, aerobes, effects on microbial profile, affects decisions made for storage of product, production where oxygen is replaced by nitrogen, reduce aerobic organisms contaminating product
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State features of storage
Growth can occur immediately or after a half-life, microbial contamination can increase
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Other cards in this set

Card 2

Front

Why are all pharmaceutical products not sterilised?

Back

Make everything sterile, avoid making judgement calls (reason for not using approach – time consuming, cost, large investment, non-sterile products need to have different criteria to be fit for purpose, determine boundaries/contamination/organisms)

Card 3

Front

How much risk is associated with the ingestion of medicines and application of topical products?

Back

Preview of the front of card 3

Card 4

Front

State features for control of contamination

Back

Preview of the front of card 4

Card 5

Front

Give examples of guidelines which need to be followed

Back

Preview of the front of card 5
View more cards

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