Cleanroom Isolator knowledge

Many pharmaceutical companies have raised concerns about the benefits of doing aseptic activities inside pharmaceutical isolators. However, many companies are purchasing isolator systems without considering all the issues related to their operations. This article will identify 10 t...

1. What is biological safety level? Biological safety level or biosafety level is a series of biocontainment precautions intended to protect personnel from potentially hazardous biological agents exposure in a research or manufacturing environment. Based on the agents or organi...

Laminar air flow and biosafety cabinet both are used in sterile manufacturing but both are different from each other. This article will help distinguish these two pieces of equipment. Basically, both the Laminar Air Flow and the Biological Safety Cabinets are simply protection devices b...

Isolators are very useful in sterile manufacturing where microbial contamination and cross-contamination is a major problem. An isolator is best defined as an arrangement of physical barricades that are integrated to the point where the isolator can be sealed. It can perform pressure-b...

The United States Center for Disease Control (CDC) has developed guidelines to classify laboratory applications conducted with potentially hazardous biological microorganisms. These levels range from Biosafety Level 1 (the least hazardous) to Biosafety Level 4 (the most hazardous). In addition...

Cleanroom Isolators In an industrial cleanroom environment, unidirectional air flow can provide a component or process with protection from airborne contaminants, but additional measures may be required to block these types of contaminants in certain applications. Barriers between t...

The answer is complicated. Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions. Usually, the certifier will conduct particle tests and airflow studies while a technici...