One of the biggest risks of unwanted exposure to HDs is within the drug pressing process. Experimenting with the batches and perfecting the formulas for each batch, requires dedication and extra care. But the R & D areas are among the most prone to overexposure to hazardous drugs. The consequences might be fatal for the …
The importance of understanding your current situation is always a great starting point for any type of project. So our pharmacy project engineers are now conducting on-site visits for inspection and evaluation of your cleanroom areas in your facility.
Although most pharmacy personnel will say that the highest risk of exposure to hazardous drugs is during the compounding process, we feel that there is an even greater risk of exposure to hazardous materials during shipping and receiving. Under the current regulations as well as the upcoming USP <800> the hazardous materials are usually ordered …
In the last couple of years, we have recorded a serious upswing and increase in the use of automated IV preparation systems. Their popularity is directly linked to their ease of use since they combine barcode scanning and Digital image capture to ensure safer and more efficient compounding processes. With the increase of use of …
This StageThru800 is a negative pressure, isolated, Pass-through, CVE device that is intended to provide a significantly safer way for incoming shipments to be staged and prepped for entry into the hazardous drug compounding area. his equipment is designed to provide a protective barrier for the operator. It is not iso-classified. It is not appropriate for …
When renovating a cleanroom, or creating one from non-cleanroom space, understanding the details — of the site, building, planned research, and equipment — is essential. Cleanrooms are like race cars. When properly designed and built, they are highly efficient performance machines. When poorly designed and built, they operate poorly and are unreliable. The cost of cleanroom varies …
Compounding Capabilities during Cleanroom Renovations Read More »
Whether isolator or cleanroom-based working areas, if we’re talking about both sterile and hazardous sterile preparations we recognize the first source of contamination and exposure risk. The first known is actually outside of the cleanroom and is the pre-cleaning station. In the hazardous drug area, we like to see packages from shipping and receiving brought …
Exposure to Hazardous Materials during Shipping and Receiving Read More »
With two in house agreements with Premier, Inc. Aseptic Enclosures now allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier. The base of the supplying contracts covers a wide range of Primary Engineering Control Devices (I.V. Hoods, Isolators, Bio-Chemical Hoods, and Laminar Work Benches) in addition to Pharmacy Planning and …
Primary Engineering Control Devices for Premier, Inc. GPO Read More »
With two in house agreements with Premier, Inc. Aseptic Enclosures now allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier. The base of the supplying contracts covers a wide range of Primary Engineering Control Devices (I.V. Hoods, Isolators, Bio-Chemical Hoods, and Laminar Work Benches) in addition to …
Aseptic Enclosures is a Contracted Supplier of GPO Leader Premier, Inc. Read More »
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 technician is compounding and transferring materials. However, the revised version of …
Can an Isolator still be used without a Cleanroom Read More »
Aseptic Enclosures located in St Louis, Missouri manufactures a wide range of Air Filtration equipment for Aseptic processing and Containment applications.
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