Displaying items by tag: design
From the time of Swiss watchmakers, who used bell jars to prevent dust from falling on their timepieces, to the development of high-efficiency particulate air (HEPA) filters for atomic energy production, manufacturers have worked to limit airborne contamination in their production environments. Today, ISO standards still emphasize air filtration and air distribution requirements, but the science of cleanroom design has necessarily gone beyond air filtration to include all components of the room, including floors, walls and especially doors.
When designing a clean room, there are many aspects to take into consideration. While regulations and guidelines such as USP chapters outline the minimum requirements for clean room design, they do not address all important elements. Many compounding pharmacies use the requirements stated in USP chapters <797> and <800> as the template for designing their clean room—often at the expense of a workflow that is operationally efficient and designed to minimize contamination risk. To help compounding pharmacies stay compliant and reduce risk without sacrificing efficiency, here are some of the aspects to consider when designing a clean room, as well as some recommendations that we at Eagle consider best practices.
In Cleanroom Design there are many factors to consider before a settling on a final design and beginning cleanroom construction:
When preparing to build a cleanroom for your business you want to make sure to think through several key factors early in the process to help you make sure to build the best cleanroom.
A modular wall system allows you to keep existing walls within your current lab and use wall cladding (overlay) that provides seamless internal walls and coved corners within the confines of the lab space.
Understanding environmental factors is an important element when designing and building a cleanroom. Not having proper airflow, temperature control, or understanding the various airborne contaminants can put your product, process, and personnel at risk. Some tips for when you design and build your cleanroom are:
Many pharmaceutical and medical device companies encounter the need to establish cleanrooms at one stage or another.
Cleanrooms are categorized based upon the number of particles or contaminants in a given cubic space air. The International Organization for Standardization (or ISO) has developed a series of Cleanroom classifications in which most Pharmaceutical cleanroom environments in the US are designed to meet. As we have talked about previously in What Are Cleanroom Classifications?
Cleanrooms are an important component of industrial manufacturing and laboratories, used extensively within the technology, pharmaceutical and medical industries. Accordingly, a cleanroom design must be created according to exact requirements that are spelled out in internationally recognized standards. This blog is a first in a series discussing the design and construction of cleanrooms and will cover these standards, the utility matrix that guides the design process, and the equipment included in the mechanical systems that support the cleanroom. Future blogs will discuss mechanical equipment in depth, examine how to maintain the quality of the air within the cleanroom and review the protocols that must be maintained during construction to insure the integrity of the finished cleanroom.
We are experts in cleanroom design and have extensive experience designing, manufacturing and installing modular cleanrooms for leading pharmaceutical, medical device companies. We are the engineering, manufacturing, and construction leader in the modular cleanroom industry. We would like to be your cleanroom design source for your cleanroom from start to completion.