GR Peshkar, Director, Pace Air Management, gives an outlook on the futuristic designs of smart cleanrooms for nuclear medicines, genetic, virology and bio — technology facilities
Advancements in medical science
- DNA codification/ genetic mapping/ stem cell developments/ production of cell and tissues/ genetherpy/ virology bone marrow transplanting
Needs and requirements
- India should be identified as a global hub for developing AIDS vaccines, stem cells, various vital tissues biosensors etc.
- Increase the necessity of more and more smart, clean rooms
- Design, maintain and operate smart cleanrooms which are technologically advanced, economical, viable and suits our existing and futuristic infrastructure
List of relevant tests:
- Air leaks through the walls around window, piping etc.
- Air filter leaks in gaskets and in the filter itself
- Filtration efficiency of different filters
- Fire proof material construction
- Wearing resistance of surfaces
- Air movement in the cleanroom
- Humidity temperature pressure etc.
The surface of perfect cleanroom material area:
- Has a smooth texture
- Has abrasion resistance
- Easy to clean
- Does not emit particles
- Does not store static charge
- Does not become electrically charged with in the laminar airflow of the clean room
- Is durable enough to accomplish the design table without wearing, fatiguing, bending or abrading
- Is non-magnetic and non-conductive when particles enter (these characteristics are specifically required)
- Should not be inordinately expensive
- Should be readily available
- Should be easy to form or otherwise fabricate with current manufacturing techniques
Finishes choosen to keep clean room free contamination and minimise the generation of particles within the room
- Specific chemical composition to exclude substances likely to interfere with the work in the room
- Low particle shedding
- Low out gassing
- Good impact resistance, including to local cracking and crazing due to hard body impact
- Resistance to microbial growth and survival
- Electrostatic characteristics that are comparable with rooms and help to create surface with low dust attraction, these are less likely to become dirty and so facilitate the maintenance of cleanliness
Containment of contamnation
- Active pharma products such as hormones, active radioisotopes must not reach the operator.
- Microbiology laboratories dealing with diseases producing micro organisms requires to ensure that the personnel working highly in them or the people passing near them are not infected.
- The technology associated with design of these containment rooms is similar to that used in cleanrooms and it is normal that containment rooms should also be cleanrooms.
w It is also common to find clean room with contamination facilities within them.
Containment rooms and cabinets
- Clean air is supplied to the room, but more air must be extracted.
- The air that is extracted must be filtered through a high efficiency hepa filter before being discharged to the outside.
- In a high risk area a class-III cabinet would be used.
- A pass through autoclave may be available to allow for the sterilisation of contaminated material.
- Rooms in which the hazards are high would contain the hazard with in class-iii type cabinet and provide a shower area between the air lock and the room.
Supply of liquid and gases to bio – cleanroom
- Not only the air is free of contaminations, but the other gases and liquids supplied to rooms are also free of contamination.
- In pharma products and radio pharma cleanroom there is a requirement for large quantities of water used to make up pharma and in semiconductors fabrication area pure water is used to wash silicon wafer during the manufacture and so also radio pharma, various gases for formation of isotopes are needed. This input must be provided with extremely low level of contamination.
Design guidelines for industries:
The following guidelines are given to aid in reducing these costs:
- Don’t over design/ design flexibility.
- Provide bulkhead mounting of the process equipment, where ever possible, in critical contamination – sensitive areas.
- Provide a cleanroom environment only where it is needed, and only to the level needed.
- Always examine process equipment design for freedom from vibration and electromagnetic interference.
- Define how the cleanroom is to be built, design utility distribution system to provide ready access for attachment to process equipment without the necessity for shutting down the system or cleanroom.
- Provides adequate flow rate to prevent stagnation and impurity pickup. Prevent pressure fluctuation during operating ‘runs’, even slight variations can have disastrous effects on the product. It is true not only on supply, but on the extract as well. It pertains to all systems of process utilities supply return such as: Gases supply and extract (exhaust liquid supply and drain)
Design methodlogy for radio pharma, bioclean and biotechnology applications
A simplified step wise approach can be summarised as follows:
- Analyse production stages
- Prepare process flow diagram
- Define activities associated with rooms
- Define environmental quality requirements
- Quantifying production, process and space requirements
- Prepare room association diagrams
- Define the accommodation needs
- Develop layout and scheme
- Prepare designs and specification
- Undertake the detailed design and construction process
PACE AIR MANAGEMENT
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