(09-24-2012, 10:02 AM)bvs science freak Wrote: Plz any one help me in this..
I've to present a paper on this..
Plz if any one know how to achieve sterile environment without Laminar air flow cabinets but sterility equal to LAF?
atleast some ideas or known informations about alternatives for laf ?
Thanks for all!
Barrier/Isolation Technology :An alternative to laminar flow/ Aseptic condition development:-
As a mean of achieving aseptic environment and to protect person from exposure to pathogenic microorganism during various microbial activities in lab or in research area, Barrier/isolation technology is used which is an alternative to laminar flow technology and clean room construction. It has been observed that 90 % of source of microbial contamination during product preparation in clean environment is people which are actually involved. Therefore this concept or knowledge is used scientifically and the personnel is removed physically from the area in which aseptic activities takes place. This is an alternative to laminar flow. Also it has been found that it increases the sterility assurance level than LF or clean rooms. This is known as Barrier or isolation technology. Earlier from last 40 year this technology was used in nuclear industry. Today it is rapidly being used in electronic, hospitals, pharmacy, home infusion markets and pharmaceutical industries also. The barrier/isolation workstation for sterile drug preparation is a closed environment that uses solid stainless steel walls rather than air movement to create a critical zone for handling of products. To view the operations, by compounding personnel, a hard clear plastic wall is used. The area is completely restricted, offering protection to both the pharmacist and the product from infection or contamination respectively. The solid barrier eliminates the procedural requirements of a "set back" and the also eliminate activity of placing materials within the work zone in a manner that does not block the laminar flow. This freedom of placement allows more efficient work flow and productivity equal to or exceeding traditional Laminar flows.
A HEPA filtration system can also be used to condition both entering and exiting air to remove initial & generated particles. In this system as air filtration system of the unit is not being used to provide a barrier, high velocity is not required, thereby reduce energy cost, heat loads and noise levels. Moreover, this pressure differential is used as a back-up if the security of the system is breached.
During the use of conventional laminar hood, the materials are directly introduced into the unit and the ways people interact with the product are crucial to ensuing aseptic preparation conditions. To eliminate these potential sources of contamination, the product is introduced in the workstation with a airlock system to separate the critical area and the outside area. This also easily allows addition of items to be introduced during operations. Glove ports are also used to manipulate the product without directly exposing either the product or the person.
Implications for Home Infusion
Quality of the product which is being handled is increased because personal performing activities are moved from the critical zone and are only able to manipulate the product using glove ports.
The number of workstations required depends up on volume and mix of product or microorganisms. Lead times for equipment are also reduced up to weeks only, allowing expansion to meet demand or microbial work load. Also using this alternative for laminar flow, installation and validation can be completed within a matter of hours. The in and out time of a clean room operation or laminar flow activities is more as compared to the advantages of barrier/isolation workstations.
The key to use of this alternative method for laminar flow is the Organizing and transferring materials into the workstation using a tray system. Also the Internal disposal systems for sharps and packaging materials as required for microbial activities can also enhance efficiency and safety.
In summary, barrier/isolation technology can offer a cost-effective alternative to laminar flow technology for providing a Class 100 environment. The Cost capital costs are less, operating costs is also less, as well as the investment in disposable supplies such as personnel protective clothing, and controlled expansion is also very less as compared to laminar flow or clean rooms. The operational advantages are that there is flexibility for location; also less heat and noise are generated in the working environment and the ability to turn the unit off when not in operation. This technology is not only alternative for laminar flow but also has many advantages with respect to product quality, efficiency, cost effectively and more importantly the safety of personnel’s against pathogenic micro-organism which are handled.