Flashcards in Aseptic Production Deck (44):
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 ?
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
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 ?
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
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.
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
Horizontal laminar airflow cabinets have an open front
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 ...
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 ?
State the 2 types of Isolators
Type 1 (Positive pressure Isolator)
Type 2 (Negative pressure Isolator)
Isolators are self contained sealed units.
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
Type 2 isolators protect products from operator and operator from product
What type of isolator is used for industrial/ large scale manufacture ?
(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
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