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
