aseptics Flashcards
what does aseptic mean and why is it used ?
Free from contaminating organisms e.g. fungi or bacteria (sterile environment)
Aseptic technique is a procedure used by medical staff to prevent the spread of infection:
Sterile environment
Sterile equipment
Sterile manipulation techniques
what does enteral mean?
Enteral
Of or relating to the intestines (e.g. administered by mouth, orally, via tube)
what does parenteral mean ?
Parenteral
Introduced other than by way of the intestine (e.g. Intravenous, intramuscular, subcutaneous
what products are made by aseptic techniques and why
Chemotherapy (cytotoxics)
Methotrexate
Herceptin (trastuzimab)
Many many more…………………..
Radiopharmaceutical (used for imaging)
Technetium 99
Total parenteral nutrition (TPN)
Adult
Neonatal
Risks to patients are greater when injectable medicines are prepared in clinical areas, such as wards and operating theatres, than when they are prepared in pharmacy under appropriate standards
what patients is it targeted for?
Immunocompromised
Via a disease state
Via a drug regimen
Stage of development (neonatal)
Hospitalised patients
Inpatients on longer treatments
Versatility of dose and administration
Safety of staff
Safety for patients
what are the key legislations
-the medicines act
-orange guide
-farewell report
Breckenridge Report 1976
what does medicine acts 1968 cover ?
Medicines Act 1968 covers:
Administration, licences and certificates relating to medicinal products including clinical trials, retail pharmacy, general sales of medicines, prescription only medicines, labelling of medicinal products, British Pharmacopoeia and other publications
and section 10 and manufacturers license
what is stated in the section 10 - prep
- Max. 7 day expiry
- Items prepared of directly supervised by a pharmacist
- Product preparation for specific patient in accordance with a prescription
- Products released by any appropriately trained pharmacist
- Local/regional audit
what is stated in the manufacturers license
- Expiry based on stability data
- Items prepared by a suitably trained person following procedures (no direct supervision)
- Can prepare items for use as stock (i.e. batches)
- Pharmacist releasing items must be registered with MHRA (“Qualified Person” QP)
- MHRA inspection every 2-3 years
what does this legislation cover?
Rules and guidance for Pharmaceutical manufacturers and distributors (orange guide)
Promotes Good Manufacturing Practice (GMP)
Recommends steps which should be taken by manufactures to ensure that their medicinal products are of the nature and quality required for administration to humans
Compliance with the principles and guidelines of GMP is a legal requirement within the European Economic Area
What does GMP mean?
GMP is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:
Be of consistent high quality
Be appropriate for their intended use
Meet the requirements of the marketing authorisation (MA) or product specification
what does this consists of?
Breckenridge report
IV drugs usage increased during 1970s and they predominantly made up on the wards
Reports of contamination and incompatibilities
As a result, the preparation of IV injections and infusions are the responsibility of the hospital pharmacy department
But not all are restricted to preparation in the Pharmacy department, e.g., IV antibiotics are made up by nurses
Farwell report
In 1994 two children in Manchester died whilst receiving parenteral nutrition
Cause : Transfer of micro-organisms from a sink into transfer tubing that had been used for a week to prepare PN in the hospital pharmacy
Recommendation : Ensure standards of practice are in place in pharmacy aseptic units
what is the definition of contamination
Contamination – “Any effect or action that has a negative impact on product’s integrity making it unfit for use”
-bacteria
-fungi
viruses
toxins
chemicals
dust
what can contamination effect ?
Chemical composition pH Sterility (microorganism contamination) Pyrogenicity Biological or therapeutic potency Physical appearance Particulate matter
What is the purpose of a laminar flow cabinet
Provide a unidirectional stream of filtered air (protecting the product from contamination)
what is the 2 types of laminar flow cabinet?
Horizontal – for dispensing of non-hazardous products (parenteral nutrition)
Vertical – Products which are hazardous to the operator (product contained within the cabinet thereby protecting the operator)
what is horizontal laminar low cabinet used for?
for dispensing of non-hazardous products (parenteral nutrition)
what is vertical laminar low cabinet used for?
Products which are hazardous to the operator (product contained within the cabinet thereby protecting the operator)
how does the airflow work in the laminar flow cabinet?
Stage 1. Dirty room air enters the air cleaner
Stage 2. Air is processed through a Pre-filter where some particles are absorbed
Stage 3. Air is purified through a final HEPA filter with efficiency up to 99.97% on particulates down to 300 nm in size
Stage 4. Clean air is discharged into the work area creating a positive pressure laminar flow hood
what is the function of isolators
Differ form laminar flow
Are completely enclosed
Increased safety from toxic or radioactive products
what are the 2 types of isolators?
Positive pressure (pressure higher inside the isolator) Negative pressure (pressure lower inside the isolator)
what does HEPA filters do? ( high efficiency particulate air)
Removes aerosols, viable and non-viable particles from air
Provides air cleanliness to controlled workspace
Protect external environment
Only removes particles (liquid or solid) and not vapours or gases
MPPS (most particle penetrating size) < 0.1 µm diameter
These particles are trapped (they stick to the fibres) through a combination of four mechanisms
Interception
Impaction
Diffusion
Sieving
how many clean rooms are there?
There are 4 classes of clean zones
The grade is defined by the type of product and the part of the process which needs to be protected from contamination
what are the 4 clean rooms called?
A – High risk operations
B – Background environments for zone A
C & D – Clean zones for less controlled stages of manufacturing
what are the 3 types of environmental monitoring/testing
Physical Tests
Microbiological Tests
Chemical Tests
what does physical testing consist of?
Gauge checking for pressure and filter Status of rooms Pressure and filter status of laminar air flow cabinets (LAFC) Glove leak test in isolators Isolator leak test Integrity of the filters Particle count Room air change rates LAFC/isolator velocity
what does microbiology tests consists off
Settle plates Contact plates Swabs Finger Dabs (touch plates) Active air samples
what does chemical tests consists off
Surface swabs for chemical residues
Surface wipes for chemical residues
microbiology test :
what is a settle plate test?
-These are agar plates that placed within the clean room or with an isolator/laminar flow where the operators are working, and is trying to detect microbes that are in circulating in the air in main working room. Any microbes that land on the plate will grow when incubated
