Laboratory incubators used in microbiology laboratories and other research and development applications provide an environment for growing cultures under controlled conditions such as humidity, temperature, and CO2. Several regulations apply to operating a laboratory incubator so it is important to be certain that the laboratory equipment you buy is designed to meet your particular requirements.
Experts suggest that even before purchasing a laboratory incubator you should first consider what it will be used for and where it will be located. So instead of buying an incubator and then trying to make it fit your process or needs, turn the procedure around. This makes sense not only for assuring proper performance; it helps you pick a model that is most cost-effective for your needs.
Even the most obvious considerations are often overlooked. Among these are physical size and internal capacity – or otherwise stated “will it fit where I want to put it?” and “how many samples will I be incubating at any particular time?” Another question to be answered is “What temperature, CO2and relative humidity ranges will be required?”
Other considerations include proximity to an appropriate electrical outlet and availability of a water source if relative humidity tests are conducted. In such a case a drain should be nearby.
Useful bells and whistles are secondary glass doors that allow you to open the main door and view contents without disrupting the internal temperature, and internal electrical outlets to power shakers and agitators.
More important features are those that help you to comply with several official guidelines governing the use of incubators in a regulated environment. For example, United States Title 21 Code of Federal Regulations (CFR) parts 210 and 211 relate to Current Good Manufacturing Practice (CGMP). In the European Union it is EU Annex Volume 4. Metrology regulation is addressed under Title 21 CFR 606.60 covering equipment. Another is the International Conference on Harmonization (ICH) Guidelines.
Incubator manufacturers such as Norlake Scientific help laboratory personnel comply with these regulations through providing alarms, sensors, and data recording devices. Before the laboratory incubator is put into service, Installation Qualification (IQ) ascertains that the unit installation adheres to approved specifications and meets design criteria. Operational Qualification (OQ) verifies that it operates per design criteria over defined operating ranges and challenges. Performance Qualification (PQ) verifies that the equipment performs as specified during the actual incubation process, and that it is reliable and reproducible within a specified predetermined set of parameters. Upon request, Tovatech will recommend companies offering expert contract IQ, OQ, PQ validation and calibration services.
How does your company use laboratory incubators and what processes do you follow to insure regulatory compliance?