Displaying items by tag: control
Check out our list of Dos and Don’ts in a cleanroom, a summary of cleanroom best practices for making the controlled environment function at peak performance. These are good resources for new cleanroom operators or those unsure about what steps to take in a cleanroom environment.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects.
Proper cleanroom cleaning procedure and maintenance protocol is an immediate, low-cost measure to enhance overall cleanliness, consistency, and contamination control within cleanrooms. This guide provides a framework for cleanroom management, protocol standards, specifications, and processes for general manufacturing and biomedical applications. Because each cleanroom class can require slightly different supplies and protocol, this overview connects best practices with application specific techniques for gowning, wipedown, and particle control. This guide should serve as a resource for understanding broad-line cleanroom consumable needs, but not as a replacement for expertise tailored to your application.
Clean Rooms are workplaces where contamination is controlled. The Clean Rooms are said to provide a conducive environment (for research, development and manufacturing of equipment or processes) with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors.
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.
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.
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.
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.
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.
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.