FDAs 2018 Compounding Policy Priorities Plan

 

 

Choosing Engineering Controls Under USP 800

 

The risks to health care workers handling hazardous drugs (HDs) under non-USP compliant conditions are often underappreciated. The development of the USP 800 chapter provides a framework of 18 sections that guide HD compounding practices to ensure the safety not only of patients, but also of the health care workers who prepare and administer these products.

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. Hoods, Isolators, Bio-Chemical Hoods, and Laminar Work Benches) in addition to Pharmacy Planning and Design services in order to meet USP Chapters <797> and <800> compliance.

HAPPY 4TH OF JULY

 

Dear Aseptic Enclosures visitors,

With great respect in our hearts, Let’s give our thanks to all who made our land free. We want to wish you all a very happy independence day.

 

Happy Fourth of July!

 

StageThru 800

 

The StageThru800 is a negative pressure, isolated, Pass-through, CVE (Containment Ventilated Enclosure) 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.

Schedule an on-site visit for an Aseptic Enclosures’ evaluation of your facility

 

Last chance to set up an on-site meeting with our Pharmacy Projects Manager. Joe Skorcz will be on tour in the Minneapolis area performing visits for Aseptic Enclosures’ pharmacy design evaluations.

XLTC800 for Tablet Pressing

 

Here in Aseptic Enclosures we have encountered a project where we were called upon to come up with a solution that will provide ISO class 5 conditions for compounding tablets. The issues we had successfully overcome were: increasing safety of the pharmacist, assuring sterility of the product, limit particulate emissions and avoid risks for potential cross contamination of products.

Pharmacy Planning and Design Projects

 

When it comes to clean room design, fabrication, installation, pricing, and customer service, we do clean rooms right.

Conatining Bloodstream Infections

 

DSM Montgomery ISO7 Sampling Room

 

 

Aseptic Enclosures were approached by DSM Montgomery, to design and develop an ISO 7 8×12 Sampling room. The sensitive instruments and procedures that are carried out, needed ISO 7 classification for particulate as well as protection from molecular, electromagnetic and magnetic contamination of the sampling procedure.