Aseptic Production Flashcards
What is Aseptic production ?
The assembling of sterile ingredients or products using sterile equipment and appropriate techniques within a clean room environment
State the most common flora found on walls and ceilings
Mould (they’re able to feed off plaster)
Walls and ceilings of a clean room should be ?
Smooth, Impervious and Washable
Generally walls of clean rooms are clad with what type of plastic ?
Laminated plastic
Why do aseptic clean rooms have a ‘false ceiling’
It contains air filtration systems and light fittings
In a clean room, Electrical wiring, pipework etc should be fitted within the walls rather than on the wall. TRUE or FALSE
TRUE
State requirements for Floors and drains in a clean room
- Floors should be flat, impervious to water, easy to clean
- Floor joints should be adequately sealed
- Floor to wall junction should be coved (curved laminated plastic)
- Floor surface must be able to withstand cleaning products
- There should be NO open sinks or drains in a clean room (handwash facilities will be exterior to the clean room)
State requirements for Doors, Windows and Fittings in a clean room
- Must be fitted flush with the walls to prevent dust collecting
- Doors must be well fitting to prevent entry of microorganisms
- Doors must be easy to open (usually no door handles, push plates used instead). If doors have handles they are flush fitted
- Windows for light only, not ventilation
- Fittings such as door plates must be easy to clean (often stainless steel used)
The EU guidance gives four grades of air. State them
Grade A: Cleanest possible air. For ‘high risk’ operations. e.g: Aseptic connections and filling. (Withdrawing a liquid from a vial using
Grade A environment has to be situated within a; Grade B: minimum background environment.
Grade B: Almost as clean as Grade A. Minimum background environment for grade A zones.
Grade C and D: Less critical stages of aseptic production. e.g: labelling and packing
Air supply (whatever grade) before it enters the clean room must be filtered. What filter is used to achieve this ?
HEPA filters
How many changes per hour are there in a clean room and what is this dependent on ?
20-35. Depending on room size, activity and number of operators
State the two types of air flow patterns
1) Unidirectional (ensures hyper clean and safe environments)
2) Non-directional (Grade C and D environments)
What does HEPA stand for
High-efficiency Particulate Air
HEPA filters trap particulate contamination. TRUE or FALSE
TRUE
HEPA filters are made up of pleated fibreglass filters. What does the glass spindles on the fibreglass ensure ?
Large surface area
HEPA filters exhibit
- Air passing through filter at a high flow rate
- High particulate holding capacity
- Low pressure drop across the filter
HEPA filters can remove particles in 3 ways. State them
What british standard must the HEPA filter conform to ?
1) Removal of large particles by; Inertial impaction
2) Removal of medium particles by; Interception
3) Removal of small particles by; Brownian diffusion
- Must conform BS5295
Clean rooms generally operate under negative pressure. TRUE or FALSE
FALSE. They usually operate under POSITIVE PRESSURE; 10-15 pascals above surrounding environment. Prevents ingress/entry of particles
When is negative pressure (10-15 pascals below surrounding environment)
used in a clean room
If products are deemed to be a risk to operators
A clean room suit is usually a room within a room. Multiple rooms have multiple pressure differentials.
LEARN
State the two types of Laminar airflow cabinets
Horizontal and Vertical
i.e; Air will blow horizontally or vertically at the operator.
Laminar Airflow cabinet is always situated in a positively pressured area. TRUE or FALSE
TRUE
Horizontal laminar airflow cabinets have an open front
LEARN
Where is the HEPA filter situated in an horizontal laminar airflow cabinet ?
At the back of the cabinet
Horizontal laminar airflow cabinets are for products with risk or no risk to the operator ?
Products with no risk e.g: TPN
Vertical laminar airflow cabinets are for products with risk or no risk to the operator ?
Products with some risk to the operator e.g: Cytotoxic drugs
Where is the HEPA filter situated in a vertical laminar airflow cabinet ?
At the top of the cabinet
Vertical laminar airflow cabinets are usually more difficult to work in as they do not have an open front. Instead they have a …
Perspex barrier
Horizontal and Vertical laminar airflow cabinets have to be situated in an environment with what grade of air ?
Generally Grade A air but Grade B may be used also
What is an alternative to Grade A and B air ?
Isolators
State the 2 types of Isolators
Type 1 (Positive pressure Isolator)
Type 2 (Negative pressure Isolator)
Isolators are self contained sealed units.
LEARN
State an advantage of a Negatively pressured isolator ?
It can be situated in a positively pressured room. Doesn’t need to be in a negatively pressured room to operate
Type 1 isolators are used for the production of what type of products ? Give examples
Non-harmful products e.g: TPN, Injections, eye drops
Type 2 isolators are used for production of harmful products such as ?
Cytotoxics, BCG vaccines
Type 1 isolators protect products from operator and aseptic process
LEARN
Type 2 isolators protect products from operator and operator from product
LEARN
What type of isolator is used for industrial/ large scale manufacture ?
Half-suit isolators
(generally used for making electronic components for the space industry)
- Can be type 1 or type 2
- Allows operator greater movement (operator comes from the bottom)
There is a specification for clean room clothing
LEARN
Why is Clean room clothing is worn ?
To prevent particulate contamination from the human body
State some specification required for clean room clothing
- Must not shed particles or fibres
- Must be washasble
- Must be sterilisable (usually autoclaving or radiation)
To maintain asepsis, we have to ensure ?
- Operators work efficiently and with good technique (Staff training, validation and revalidation)
- Appropriate disinfection of products
- Microbiological monitoring on a daily basis and this includes;
- Finger dabs
- Settle plates
- Surface testing
- Active air sampling
GMP applies to all aseptic processes.
- There must be a system in place to trace patients should a problem be identified
- Documentation should be kept up to date
- All processes should be validated (reviewed) regularly
LEARN
Give examples of 2 incidents where aseptic processes went wrong
1) Manchester Children’s Incident 1994
(2 children died after receiving TPN which was contaminated with Enterobacter cloacae)
2) Germany Incident 2010
(3 babies dies and 4 critically ill after receiving TPN contaminated with Enterobacter cloacae)
