Contamination Control Flashcards
(30 cards)
Define non-sterile unlicensed medicines
Specials or extemporaneous dispensing
e.g. some eye drops, creams, ointments and oral liquids
Prepared in pharmacies or ordered in from specials manufacturer
Define sterile medicines
Not available in a licensed ‘ready to use’ formulation
Prepared in a licensed aseptic unit and sold in batch to external organisations such as NHS, e.g. BATH ASU
OR
Prepared in an unlicensed aseptic units for a specific patient e.g. in a hospital under section 10 exemption
Define asepsis
Absence of viable organisms
What is an aseptic area?
Highly controlled clean environment which has been specially designed, constructed and maintained to prevent microbial and particulate contamination of pharmaceutical products
What pharmaceutical products are made in an aseptic environment?
Products which cannot be end terminally sterilised
Products are often high-risk injectable products
Give some examples of aseptic products?
Some IV antibiotics
parenteral nutrition
Radio-chemicals
Patient controlled analgesia
Chemotherapy agents
Biologicals (monoclonals)
Gene therapy
Vaccines
Name the 4 grades of environment A-D
Grade A - site of aseptic preparation. and vials
Grade B
Grade C
Grade D - least clean - support operations
What is a clean room?
Minimise viable and non-viable contamination (particulates)
-filtered and circulated air
- controlled temp and humidity
- at positive pressure
Name the types of containment systems
Laminar flow hood/ hybrid laminar flow control (HLFC)
Cat II biological safety cabinet
Isolator
Pharmaceutical products are made in containment systems
The clean room background may be grade B or C but within the isolator it is grade A
What are the sources of microbial contamination in an aseptic suite?
1) people
2) workspace
3) starting material and consumables
4) storage
5) aseptic process
6) administration of product
How do people cause contamination?
People produce respiratory droplets which contain bacteria
People shed dead skin particles (skin squares), which carry bacteria
Shedding increases with movement
Training and competency of worker
How do work-spaces cause contamination?
Air quality
- non-spore forming gram-positive bacteria e.g. staphylococcus, streptococcus, micrococcus
- bacterial spores from dirt/soil, e.g. bacillus spp
- fungal spores e.g. penicillium, cladosporium, aspergillus, mucor, candida
- yeast - e.g. rhadotorula
Surfaces/ equipment
- Microorganisms can be transferred to a product from any surface
- surfaces in a clean room are hard, wipeable and rounded - no corners to collect dust
How to staring materials and consumables cause contamination?
Viable microorganisms in the starting materials or the consumables used for the aseptic process will be transferred to the product
How does storage conditions affect contamination?
Paper and cardboard harbour fungal and bacteria spores
Uncovered items will collect dust
Who is responsible for minimising risk?
All staff but especially the pharmacy manager to minimise the risk of contaminaation
How to minimise contamination? (PEOPLE)
People - sterile clothing (PPE), good fit , most be put on correctly, tuck in gloves and boots
good personal hygiene
no outdoor clothing
no infections/ skin lesions/ open wounds
no false nails
Regularly decontaminate hands
minimise movement (shedding)
light, temp, humidity
competency - optimise staff member
good work flow
training
How to minimise contamination? (WORKSPACE)
Filter air - HEPA filter
Maintain rooms at positive pressure
Perform aseptic operations in a BSC or isolator (Grade A) (BSC must be sited in a Grade B area)
All surfaces are hard, wipeable, rounded corners - minimal dust
Work areas must be clean, disinfected, dry and tidy
How does cleaning and disinfection rotation work in a clean room?
Cleaning process should be validated
use disinfectant in rotation
correct preparation and ‘in-use’ dilutions
correct contact time
regular use of Sporicide
Grade A and B areas - Sterile disinfectants
Regular monitoring required
What disinfectants should be used or grade A-D rooms?
Surfactants, hypochlorites, phenolics
example, amphoteric surfactant rotated with bleach daily and water every 3rd day to remove residues
for grade A, BSC or isolator - clean before and after every use
e.g. sterile neutral detergent at start and end of each session + alcohol + weekly bleach
How to minimise contamination in starting materials and consumables?
Starting materials - sterile products with a product license
Consumables - pre-sterilised by the manufacturer and packaged correctly
Remove from paper/cardboard packaging where possible
Sterility maintained by operator
How to minimise contamination in storage?
Products stored appropriately
- minimise time between prep and admin
max expiry - 7 days
store at 2-8 degrees where possible
Define transfer disinfection and how to minimise it
The transfer of components between different grades of environment without introducing contamination
wet all surfaces with sterile alcohol and a sporicide
wipe
transfer to hatch/airlock leave for 2 mins
remove from airlock
spray with alcohol
transfer to grade A working zone
Whats the difference between quality assurance and quality control?
QA - a proactive, process-focussed approach to prevent defects
QC - a reactive, product focussed approach to identify defects
Why is quality assurance essential for our aseptic products?
because it ensures consistent production of sterile, safe, and effective products—especially in high-risk areas like radiopharmacy or injectable manufacturing.
