Germfree LFGI-3USP, Руководство пользователя

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GERMFREE, the LFGI and USP <797>
GERMFREE has strived to produce a primary engineering control that maintains a clean
and microbe free environment through a combination of design elements and
recommendations for good practice and technique.
USP <797> does not offer a great deal of guidance on the use of barrier isolators for the
compounding of sterile products and has left much to the manufacturer’s recommendation.
In light of this, GERMFREE will always err on the side of caution when making
recommendations on the proper use of the LFGI.
GERMFREE recommends the following regarding the general use of the LFGI in the
pharmacy environment:
1. The LFGI should be placed in a controlled environment. A room with a window that
opens to the out of doors or with high foot traffic is not appropriate for the compounding
of sterile products. This is recommended to reduce the overall bioburden in the surrounding
area. A classified environment or a room that conforms to a particular particle count is not
necessary. The LFGI is designed with a sealed airlock that maintains complete
environmental separation between the work area and the ambient room air. This sealed
airlock is then purged with HEPA filtered air to equalize or better the cleanliness level of
that contained air to the ISO Class 5 condition of the work area.
2. (For CACI Model- Handling Hazardous Drugs) Operators should wear a gown or coat
to protect themselves from accidental dermal contact with elements being compounded.
3. Operators should always wear gloves when handling compounding elements before and
after they are compounded in the work area. Studies show drug contamination on the
outside of vials.
4. Operators should minimize fingernail length and jewelry since they increase the chances
for glove puncture / tear.
5. All compounding elements should be wiped down before placement in the airlock to
reduce any surface contamination that may be present.
7. Operators should wipe down the exterior of waste or sharps containers that are used
inside of the work area prior to removal from the LFGI with alcohol.
8. Current standards of practice should prevail. For example, if you do not compound
antibiotics and TPNs concurrently in your Laminar Flow Workstation, do not compound
them at the same time in the LFGI.
9. Operators should be made aware that “first air” for the purposes of proper aseptic
technique is now located above the work area. This will change how they utilize the work
deck space.
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