Engineering Controls

Aseptic Enclosures is a Contracted Supplier of GPO Leader Premier, Inc.

Aseptic Enclosures is a Contracted Supplier of GPO Leader Premier, Inc. 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. …

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Can an isolator still be used without a cleanroom?

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 …

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