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
Express Pharma, first published as Express Pharma Pulse in 1994, is today India’s leading business fortnightly for the pharmaceutical industry. With the patronage of its readers, Express Pharma has grown to become the No.1 Business News Magazine for the pharmaceutical industry. The editorial contents include: news, views, analysis and interviews, under four main segments: Market (The business of pharmaceuticals), Management (Insight for managing pharma), Research (Expertise for drug development) and Pharma Life (HR issues with a pharma focus). Besides this, we bring out periodic specials like the quarterly Pharma Technology Review, Packaging Special and LABNEXT.