Aseptic Production Flashcards Preview

Stage 2, Cycle 2 - Sterility and Asepsis > Aseptic Production > Flashcards

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 ?

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



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



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 ...

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 ?



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 ?

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



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



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)