1. Aseptic Preparation and Safe Handling Flashcards
Name 2 pharmaceutical products that require sterile production or to be sterile before use.
- Chemotherapy drugs and antibody preparations
- Total parenteral nutrition
- Intravenous additives
- Eye products
- Drugs used in clinical trials
- Some medicated dressings
What contaminants can present in non-sterile pharmaceutical products?
- Microorganisms (fungi and bacteria)
- Particulate matter (skin, hair, fibre, condensate)
- Pyrogens (endotoxin produced from G-ve bacteria)
Why are sterile pharmaceutical products more susceptible to contamination ?
Due to their nature and route of administration
What could happen to patients if they are administration with contaminated pharmaceutical products and why ?
Can lead to harm or death due to the ingress of micro-organisms, particulate matter or pyrogens
When can contamination of sterile pharmaceutical products occur?
Preparation and administration
Who can carry out manufacturing and give an example ?
Carried out by any suitable trained person.
e.g. trained assistance does not have to be a qualified or registered pharmacist
Who can carry out dispensing and give an example?
Carried out under supervision of a pharmacist. however in practice pharmacy technicians will prepare products under supervision
What is the recommended expiration date for manufactured products ?
MHRA licence allows extended expiry dates provided that theyre supported by stability data.
What are the benefits of basing expiry dates on stability of products ?
Longer shelf life and less waste
what is the recommended expiration date for dispensing products ?
7 days maximum which allows for stability
In what cases should dispensing product be prepared?
Single products
Dispensed under a prescription of a named person
Can small batched of products be dispensed ?
Yes but a maximum of 10 items can be infrequently prepared in anticipation of a prescription.
What conditions should be met when preparing a small batch of dispensing products ?
Limited shelf life
Full dispensing requirements eg label for named patients when dispensed
For manufacturing products can final checks and release of batch be done by the same person?
No, must be done by separate people
For dispensing products can final check and release be done by the same person?
Yes, can be done by the same person
Who can release final products in manufacturing ?
registered and recognised degree-qualified person
What is the pharmaceutical quality system (PQS)
Overall system of quality management designed to provide assurance of product quality as a result of the systems and processes in place
How are sterile environments maintained by airflow?
Air flow and pressure from highest to lowest, creating a positive pressure drop (10-15 Pa) to carry contaminates away from cleanest to dirtiest environments
What is the value of positive pressure drop?
10-15 Pa
What is the aim for a complete air change ?
20-30 complete air changes per hour
What does grade A clean zone contain ?
Laminar air flow cabinets and isolators. All aseptic manipulations carried out in critical zone grade A
What does grade B clean zone contain?
The aseptic preparation room
What does grade C clean zone contain ?
Change areas or inner support room
What does grade D clean zone contain?
Outer support room (grade A isolators be installed in grade C or D rooms)
what does the validation master plan include ?
All documentations and testing of design qualification, installation qualification, operational qualification and performance qualification
What is the definition of ANTT?
Aseptic non touch technique used to avoid any contamination with nay surface which will be in contact with the sterile fluid patch
Where is ANTT used ?
Used in near patient (wards, patient homes) and aseptic environments (aseptic units, operating theatres)
What is closed procedures defined as ?
Transfer of sterile ingredients or solution to a sterilised sealed container, either directly or using a sterile transfer device without exposing the solution to the external environment
In what zone should a closed procedure be carried out in
Grade A environment
What is sterility defined as ?
The absolute freedom from all viable forms of life (essentially microorganisms)
What is sterilisation defined as ?
The process of producing a condition of sterility
What is sterility defined as ?
The absence of viable contamination microorganisms
What do many products require before administration to patients ?
Requires to be both sterile and free from contaminates
What are the three main groups that contaminates are categorised in ? Give an example of each.
- Living- micro-organisms e.g bacteria and fungi
- Inert particulate matter- eg glass, rubber or dust
- Pyrogens- eg Lipopolysaccharide (from the outer membrane of gram-be bacteria )
What could result in the administration of pharmaceutical products that contain microorganisms ?
Cause harm or death to the patient
What effects could the administration of pharmaceutical products that contain particulate matter have on a patient ?
- Inflammation of blood vessels (phlebitis)
- Physical occlusion/blockage of blood vessels which could lead to thrombosis/embolism
What effects could the administration of pharmaceutical products that contain pyrogens have on a patients ?
Rapid increase in temperature/fever
What is the most important pyrogen ?
Endotoxin, specifically lipopolysaccharide (LPS) found in gram negative bacteria
Where is lipopolysaccharide (LPS) usually found on a bacterium? And what bacteria is it usually found in ?
The outer membrane of a gram negative bacteria
What is the pyrogens activity usually associated with ?
Lipid A portion of the LPS
True or false?
Many pyrogens withstand sterilisation and so can present even after sterilisation
True
Besides gram negative bacteria, what other microorganisms can pyrogens be produced from ?
Gram positive bacteria, mycobacteria, fungi, and viruses
What procedures and equipment are designed to maintain sterility and reduce the risk of contamination to both pharmaceutical products and operators ?
Personal protective equipment and standard operating procedures
Give an example of a potent pyrogen.
Lipid A of polysaccharide (endotoxin) from the outer membrane of gram negative. This can pose serious health risks when introduced to the body
Give an example of ophthalmic products
Eye drops
Eye lotions
Eye ointments
Why do products that are installed into the eye require to be sterile ?
Possibility of eye infections, especially if the corneal surface is already damaged
Why must eye products be article free ?
To prevent abrasive damage to the eye
Give an example of parenteral products
Products that are introduced directly yo the blood stream and therefore bypass a number of host defences
Eg,
- Intravenous infusions
- Intravenous additives
- Small volume injections
- Total parenteral nutrition (TPN)
What is the risks involved with administrating a pharmaceutical product that is not particle free and not sterile ?
Infection
Inflammation
Blockage of blood vessels
Why us TPN considered high risk?
Due to complexity of formulation and high risk of miscalculation and contamination
How can we reduce the risks associated with TPN
Use industry manufactured standardised pre-formulated bags
What products need to be sterile ?
- Ophthalmic products
- Parenteral products
- Non-injectable sterile solutions
- Dressings
What is meant by terminal sterilisation ?
Sterilisation is the final step in the manufacturing process once the products is steamed within the final container
What methods are included in terminal sterilisation ?
Steam
Dry heat
Gas/chemical
Ionising radiation
What is meant by aseptic processing ?
Procedure in which the drug/medicine, container and closure are sterilised separately then combined together to give the final product
Which method, aseptic processing or terminal sterilisation has a greater risk of microbial contamination and why ?
Aseptic processing because the drug/medicine, container and closure are sterilised exoneration then combined together to give a final product. There is no final step where the product is steamed. Difficult to obtain a high level of assurance that the final product will be sterile
When would aseptic processing be used ?
When drugs cannot undergo terminal sterilisation
What are the main sources of contamination during manufacturing ?
- Personnel
2. Air in the surrounding environment
What controlled parameters are required in clean rooms ?
- Air flow
- Microbial
- Particulate quality of the air
- Equipment surfaces
- Room surfaces
- Personnel
All requirements are monitored and must be met in order for a environment to be considered a clean room
Why are PPE used?
Used to protect the environment, products, patients and operators from contamination during the preparation of aseptic products
What are the considerations for the general design for a clean room ?
- Logical layout to minimise movement of personnel
2. Airflow and air supply
What is used to maintain air flow and clean air supply ?
HEPA filters
How much particles do HEPA filters remove and how large do these particles have to be in order to be removed by the HEPA filter ?
99.9997%
Removal of particles of size 0.3 micrometers or larger
True or false?
HEPA filters help protect from airborne contaminates by continuously sweeping away personnel derived particulates from immediate work areas using laminar air flow
True
What are the requirements for surfaces in a clean room environment ?
Smooth
Flat
Impervious
To minimise particulates and microorganisms from being trapped
What are the requirements fro wall and ceilings in a clean room environment ?
Junctions between walls and ceilings should be seamless and ledges/windowsills should be avoided
What aspects should a personal be trained in before sterile production ?
A) good personal hygiene B) clocking C) PPE D) Good aseptic technique and good manufacturing practice E) movement within manufacturing areas F) data and information sources
What is laminar flow defined as ?
The movement of air within a confined boundaries at essentially uniform velocity and along parallel lines
What is the air supply filtered with in laminar air flow ?
HEPA filters
How does laminar flow air help reduce contamination?
Sweeps away any airborne contaminates which have been generated by the operator during manipulations within the cabinet ate
What are the different displacements of air in LAFC ?
Horizontal (back to front)
Vertical (Top to bottom )
What would happen if there is physical obstruction to the air flow ?
Downstream turbulence, which increases the risk of contamination
Do products need to be free roam viable microorganisms before being introduced into the sterile air flow of the LAFC ?
Yes
What can be used to wipe down the product before introducing it into LAFC ?
Azowipes
What needs to be done before the usage of azowipes ?
Wearing nitrile gloves and avoiding excess usage and inhalation
How can you avoid contamination by yourself ?
Always work with your hands well inside the LAFC
Avoid quick, sudden movements as this creates turbulence which disperse particles from your body into the air. Slow movements create less turbulence
Close mouth
Leaving over causes particles to deposit on any equipment
What does aseptic non touch technique mean ?
Never touch critical sites
What is a critical site ?
Any part of a sterile product or equipment used in its preparation that must remain sterile to prevent contamination of the final product
Eg in injections do not rough the shaft or hub
What is the hypodermic needle used for ?
Used with a syringe to inject medication into the body or s part of a procedure for making medication in a SPU
What is the purpose of a bevelled end ?
Helps to easily penetrate the skin or septum of a vial
What direction should the bevel be facing when inserting the needle into the vial ?
Upwards
What is lure slip fitting ?
Needle slips easily on and off the syringe
What is lure locking fitting ?
The needle is screwed and locked onto the syringe to create a leak free seal
What is the risk of reusing needles ?
Transmit blood borne diseases such as HIV, hep b or c or AIDs
What should all syringes and needles have to deliver sterile medication ?
Protective packaging
Used by date
Batch/lot numbers
How can you maintain the sterility of needles and syringes ?
Handle using aseptic techniques
What is a low risk NSI?
One where the needle is clean and sterile
True or false ?
If you have a minor stick injury you do not need to report it
False, all NTI should be reported
What is the definition of sterility ?
Absence of viable micro-organisms
How is sterility of a product assured ?
Assured by the application of a suitably validated production process. Not all products can be tested for sterility
What are the three important factors when choosing a filters ?
Pore size
Inertness
Flow rate
What are the major mechanisms of filtration ?
- Sieving particles out that are larger than the pore size
- adsorption
3, deposition in filter bed
- retention in capillary films within the filter bed
