Laboratories require a deep understanding of the specific needs, purposes and risks associated with each of them. Some of these requirements are specific to an industry (e.g. pharmaceutical, chemical), or to an activity (e.g. small volume manufacture of high potent products, work with biological agents).
Analytical and Quality Laboratories
In analytical and quality laboratories products and materials are tested against conformity to specifications and the absence of impurities. These laboratories form an essential component within the production and the supply chain.
The purpose of biosafety laboratories and suites is the containment of potentially harmful biological agents. The containment is achieved through a thoughtful combination of methods, facilities and equipment. The levels of containment go from BSL1 to the highest level of BSL4.
In cleanrooms the number of dust particles permitted per volume of air defines the classification of the clean room. All aspects of the people and materials flows, the mechanical systems and the room finishes are to be consistent with each other. The design and engineering needs to follow either “ISO 14644-1” – “FED STD 209E” – “BS 5295” or “GMP EU” classification.
Clinical and Medical Laboratories
These laboratories are equipped for diagnostic tests on tissue, blood and other patient samples. They can be subdivided into various processes such as pathology, serology, histology, virology, bacteriology and molecular biology with PCR-technologies.
Laboratories conducting microbiological, and cell or tissue culture work require incubators to protect these cultures from the environment. Parameters such as temperature, humidity, and O2 and CO2 levels need to be controlled.
Pilot production or small volume laboratories as a scale-up between R&D and commercial production, or for the production for clinical trials, form a category on their own. Such laboratories can be found in the pharmaceutical, biotech, and the science and technology sectors. Quite often special attention needs to be given towards containment and air quality.
Research & Development (R&D) Laboratories
This category covers a broad spectrum of laboratories with various risk qualifications and containment requirements such as: PBOEL, Bio Safety Laboratories, laboratories with radio-active risks etc. Also specialized laboratories for seed, crop, material, and life sciences research are part of this category.