Twice a year, many critical environments - such as compounding pharmacies and cleanrooms - undergo particle certification. To obtain room certification, either a minimum sample volume (as written in the EC GMP Annex 1) should be taken, or the sequential sampling technique (as identified in both FS209E and ISO 14644-1) should be used. However, since this particle certification usually occurs only every six months, many critical environments are unaware of their particle counts during the remainder of the year.
February 12, 2019
February 08, 2019
Flow rate is important to consider when selecting a particle counter for a critical environment. The flow rate of a particle counter is the rate at which a pump draws air through the sample chamber, measured in cubic feet per minute (cfm). Two common flow rates for particle counters are 1 cfm and 0.1 cfm. Depending on the application, each flow rate can be valuable.
January 25, 2019
Compliance with USP 797 and USP 800 are critical for maintaining a sterile cleanroom for CSPs. Proper environmental conditions, as outlined by USP 797 and USP 800, help to ensure the effectiveness and quality of medications.
In most hospital pharmacy cleanrooms, standard operating procedure includes sampling of air quality for viable particles (i.e. particles that include or are composed of microorganisms). These tasks are traditionally executed with an air sampler containing agar strips or simply by placing agar contact plates on surfaces throughout the facility. These samples are then left to incubate and are then analyzed to determine the environment’s air quality.
Hospital pharmacies are unique because of the critical role they play in maintaining patient health and safety. Pharmacies that perform compounded sterile preparations (CSPs), in particular, must meet specific clean room standards to ensure sterile conditions are maintained. While there are many established environmental requirements in these spaces, some pharmacy managers are choosing to go the extra mile in exchange for added peace of mind.