Displaying items by tag: control
A cleanroom provides a controlled, isolated environment for handling contamination-sensitive substances or for protecting the exterior environment from dangerous substances in the controlled area. The density of sub-micron and larger airborne particle contamination inside a cleanroom is kept within tightly controlled limits by forcing clean, filtered air into the cleanroom.
We will look at several areas of concern to get a better idea of the overall picture of contamination control. These are the things that need to be considered when providing an effective contamination control program.
In isolator processes requiring manual control, workers can typically gain access to the products within the enclosure through the use of a half-suit or glove ports.
The dust and particles controlled in cleanroom are very small and invisible as shown below. Visible article is generally larger than 10 μm, which is removed out at the pre-filter stage. The cleanroom sub-micron particle, smaller than 1 μm, is the subject to control.
One of the things to be careful of in respect to cleanroom temperature and humidity control, is specifying them at too low or too tight of a tolerance. That translates again into the cost of construction and the cost of operating your clean room.
As the demand for complex cleanrooms in the life sciences grows, construction challenges mount. Making the right decisions during the building and commissioning phases of cleanrooms will help to ensure that they are successful, better integrated, more operable and sustainable. Generally speaking, teamwork among designers, operators, maintenance people and builders that focuses on project timelines will achieve the best results. The suggestions below will help drug and device manufacturers step back and better envision the whole facility during the build process.
As with cleanroom operations, cleanliness is a four-part equation: environment, process, tools, and people. How stringent clean manufacturing guidelines need to be is based on the products and customer requirements.
Controlling air temperature and humidity levels in all work areas is a good first step in clean manufacturing. It may eliminate the need to open windows, which would admit outdoor airborne dirt.
Clean rooms are “created” when clean room designers like Vernick & Associates bring together engineering design, fabrication, finish, and operational controls to convert a “normal” room to a “clean room” so that they can be used for manufacturing. These clean rooms must meet the requirements defined in the Sterile Code of Annex 1 of both the EU and PIC/S Guides to GMP and other standards and guidance as required by local health authorities.
Cleanrooms are designed to minimise the ingress of airborne particles (achieved through HEPA or ULPA filters) and to control what happens to particles generated within the cleanroom. Good air flow design — such as turbulent flow — helps to prevent particles from being deposited onto surfaces (particles settle by two primary mechanisms: gravitational sedimentation and turbulent deposition)1. The removal of these particles is achieved through the extraction of room air with the addition of clean air into the room (air exchange rates). The flow of particles in air from a less clean area can also be blocked from entering an area of a higher cleanliness level through positive pressure differentials.