Work Area Dimensions:
Compliant with USP 797, USP 800 and Validated to CETA CAG-002-2006 Performance Standards
COMPOUNDING ASEPTIC CONTAINMENT ISOLATOR
Compounding Aseptic Containment Isolators: USP 797 and USP 800 Regulations for Compounded Sterile Preparations
USP 797 provided the first official and enforceable requirements for preparing CSPs -Compound Sterile Preparations. USP 797 is the U.S. Pharmacopeia's (USP) General Chapter '797 for Pharmaceutical Compounding Sterile Preparations'. According to the organization these requirements set “practice standards to help ensure that compounded sterile preparations are of high quality”. Chapter fundamentally changed the way that facilities that prepare compounded sterile preparations approach their work.
USP 797 applies to the diverse range of facilities that prepare Compounded Sterile Preparations
Chapter 797 applies to all facilities that prepare CSPs. This includes hospital and health-system pharmacies that prepare compounded sterile preparations including main hospital pharmacy operations and satellite pharmacy units. USP 797 also applies to clinics, hospital care units as well as other facilities that handle the compounding of sterile preparations. As facilities change their procedures to meet USP 797 and, they are finding that barrier isolators can provide an ideal alternative to a more costly cleanroom.
The Food and Drug Administration states that a barrier isolator is: "a decontaminated unit supplied with HEPA filtered air that provides uncompromised continuous isolation of its interior from the external environment, including surrounding cleanroom air and personnel." Installing a Compounding Aseptic Containment Isolator provides cleanroom conditions within a contained workspace. Compounding Aseptic Containment Isolators provide an ISO Class 5 (Class 100) environment for product preparation, with work occurring inside a closed, pressurized work space, accessible only via a sealed gloves system.
GENERAL STANDARDS FOR USP 797 AND USP 800
Compounding Aseptic Containment Isolators:
Germfree’s Compounding Aseptic Containment Isolators are an ideal solution for providing a clean work environment in the pharmacy industry when compounding sterile preparations.
As there no true uniform industry standards for manufacturing isolators, there are significant design differences among manufacturers. A well-designed isolator that will significantly reduce microbial contamination should meet a range of minimal standards.
Germfree’s LFGI Series meets or exceeds these standards:
GRx Rapid Exchange Glove System with full case.
GRx Rapid Exchange Glove System
GRx Rapid Exchange Glove System Clear Acrylic Basic Case
Stopcock for Air, Gas or Vacuum
Duplex Electrical Outlet Installed In Work Area Center
Additional Pair Smooth Sleeves
Replacement GOS for two part glove/sleeve with 4 O-rings
Additional 2-Door Airlock with timed HEPA Purge and sliding tray
Additional Sharps and Waste Discharge Tubes
Sharps and Waste Discharge Tubes
Stainless 9" x 14" Garbage Can
Sealed Data Port
Passage of 4 cables possible with individual adjustable diameters between 0.16"- 01/27"
Window for Airlock
Telescopic Stainless Steel Cleaning Handle with pivot head
Lint Free Mop Heads
Operator Training DVD
COMPOUNDING ASEPTIC CONTAINMENT ISOLATOR DIAGRAMS
AIRFLOW PATTERNS FOR COMPOUNDING ASEPTIC CONTAINMENT ISOLATORS