Water Bath Incubator Validation and Qualification Service
Ellab is a provider of onsite cGMP water bath validation and qualification services.
These water baths may also be called water blocks or water buckets and may also be considered incubators. A water bath is a container filled with heated water that is designed to provide a consistent temperature to incubate samples in water over an extended period of time. The water bath has a water heater outside the water chamber in order to achieve uniform temperature throughout the chamber with increased heating efficiency.
Water bath incubators are used in laboratory settings all around the world. They are designed to create an environment that consists of stable temperature uniformity. Water bath incubators may also include general purpose water baths, stirring water baths, circulating water baths, reciprocal shaking water baths and refrigerated circulating baths.
Water Bath qualification must be performed to ensure that the water bath is capable of performing to satisfy all requirements including the quality attribute and process parameters.
Potential challenges with water bath qualifications are:
- Determine the water bath performs to the manufacture’s design specifications
- Determine the water bath can operate within the expected operating range
- Identify and improve, if necessary, temperature equilibration
- Calculate and document the minimum, maximum and average temperatures of the water bath
Bead Bath Incubator Validation and Qualification Service
Ellab is a provider of onsite validation and qualification services for cGMP laboratory bead bath incubators. These bead bath incubators can also be called chiller baths or buckets. The difference between these and standard water baths is that metal beads are used to fill the bucket. Often in validating these units the qualification performed includes validation protocol development, installation qualification and operational qualifications including temperature mapping. It is not as common to perform a performance qualification, but that is something we can adjust depending on your particular requirements. After the qualification is completed we can generate the report including summary repots.
Bead baths incubators are increasing in popularity. Some companies are replacing their water bath incubators with bead bath incubators. The dry thermal metallic beads help transfer heat uniformly through direct contact. These units are non-circulating, non-shaking devices. The beads can be used to replace the aluminum blocks in dry baths and ice in ice baths/buckets. These beads can be used from -80°C to 350°C. They are often run 24/7/365 which eliminates the warm-up period. These units typically do not require racks as the beads conform to the shape of the item being placed into the bath.