When I first started executing routine Environmental Monitoring, I often wondered: Why do we use saline solution in Grade A and DEB solution in other areas? One key factor influencing microbial recovery accuracy is the choice of swabbing solution. Two commonly used solutions—Dey-Engley Broth (DEB) and saline solution—serve distinct purposes in microbial monitoring. Here’s a…
Sterile cleanrooms demand precision, discipline, and adherence to protocols, but human factors can sometimes jeopardize the entire operation. Let’s shine a light on the bad behaviors that compromise sterility assurance and discuss how to prevent them. Common Bad Behaviors Observed in Cleanrooms: Improper Gowning Techniques Excessive Movements Touch Contamination Non-Compliance with SOPs Lack of Awareness…
When selecting cleanroom garments for use in sterile areas, several key criteria must be considered to ensure compliance with quality and safety standards. Here are the main criteria: Material Selection: Design and Fit: Electrostatic Discharge (ESD) Control: Contamination Control: Sterilization: Compliance with Standards: Cost-Effectiveness: Environmental Impact: These criteria help ensure that cleanroom garments provide a…
Pass boxes are an essential component of a cleanroom environment, preventing the transfer of contaminants from one area to another. Selecting the appropriate type of passbox will depend on various factors, such as the type and volume of materials being transferred, the level of contamination risk, and the specific requirements of the application. A passbox…
Regulators encourage the use of restricted access barrier system (RABS) or isolator technologies. Such settings minimize direct human intervention in a process, reducing the risk of microbial ingress from operators. Transition from a classic design based on grade-A or grade-B cleanrooms to an upgraded facility is not to be taken lightly. Such a project would…
How can the effectiveness of isolator systems and Restricted Access Barrier Systems (RABS) be evaluated in a specific production environment before and after implementation? Evaluating the effectiveness of isolator systems and Restricted Access Barrier Systems (RABS) in a production environment requires a detailed and systematic approach, both before the systems are put into place and…
A buoyancy test is required in cleanroom Laminar Airflow Systems (LAFs) to ensure proper airflow and contamination control. Cleanrooms are designed to maintain extremely low levels of airborne particles, and LAF systems play a critical role by providing a continuous, unidirectional flow of filtered air. The buoyancy test helps in verifying the following: Airflow Patterns:…
Clean Room Pressure Cascades When considering pressures cascades, consider a design concept to have a “clean corridor” or a “dirty corridor” design ,typically, low moisture drugs such as tablets or capsules are dry and dusty, therefore more likely to be a significant cross-contamination risk. If the “clean” area pressure differential were positive to the corridor,…
