When Sterile Compounding Which Length Needle Will You Normally Use

EFFECTIVE DATE: 5/88 REVIEW DATE: 12/04

POLICY EDITION: 4 REVISION DATE: 12/01

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WISHARD MEMORIAL HOSPITAL POLICY MANUAL

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DEPARTMENT: Pharmacy Services POLICY NO: 731-562

TITLE: Aseptic Technique SUBJECT: Aseptic Technique

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PURPOSE

To establish an educational training program on proper aseptic technique for Pharmacy Employees involved in the preparation of parenteral products.

POLICY

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All pharmacy employees involved in the preparation of parenteral products shall be trained on utilizing proper aseptic technique. Employees will be inserviced on aseptic technique annually. Employees will demonstrate competency in aseptic technique procedures and knowledge.

SPECIAL INSTRUCTIONS

ASEPTIC PREPARATION OF PARENTERAL PRODUCTS

As the use of parenteral therapy continues to expand, the need for central­ized hospital intravenous admixture preparation has grown as well. In addition, demand by practitioners for aseptic preparation of other compounded products, such as sterile irrigations and ophthalmic solutions, has also increased. Recognizing this need, many hospital pharmacy departments have devoted increased resources to programs for aseptic preparation of sterile products. In conjunction with the use of sterile equipment and supplies, an understanding of laminar air flow principles, the proper use of the laminar air flow hood, and development and maintenance of skillful manipulative technique by personnel are essential for the compounding of products that are free of microbial and particulate contamination.

This program will review the clean room concept, including laminar air flow principles; proper use of the laminar air flow hood; appropriate attire and aseptic technique; use of syringes, needles, vials, and ampuls; and basic IV admixture compound­ing procedures.

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By definition, sterile products are free of all living microorganisms. In addition, parenteral solution must be relatively free of particles and free of pyrogens, which are usually bacterial toxins capable of causing a fever. The goal of using specific clean room equipment and procedures in conjunction with proper aseptic tech­nique is to allow the manipulation of sterile products without contamination with microorganisms, pyrogens, or particles.

Room air typically contains many thousands of suspended particles per cubic foot, most of which are too small to be seen with the naked eye, including contaminants such as dust, pollens, smoke, and bacteria. To provide a safe environment for sterile dosage form preparation, there are several steps which should be taken to reduce the number of particles in the air.

A sterile compounding area should be cleaned daily and segregated from normal pharmacy opera­tions, patient specimens, nonessential equipment, and other materials that produce particles. For example, the introduction of cardboard into the clean environ­ment should be avoided whenever possible. Traffic flow into a clean area should be minimized. Other more sophisticated aspects of clean room design include special filtration or treatment systems for incoming air ultraviolet irradiation, air-lock entry portals, sticky mats to remove particulates from shoes, and positive room air pressure to reduce contami­nant entry from adjacent rooms or hallways.

Sterile products should be prepared in a “Class 100” environment, containing no more than 100 particles per cubic foot that are 0.5 micron or larger in size. Thus, laminar flow hoods are utilized in the hospital setting to achieve a “Class 100” environment. Developed in the early 1960, laminar flow hoods are available in a variety of sizes and styles. There are two common types of laminar flow hood, horizontal flow and vertical flow.

Horizontal flow hoods operate, first, by drawing contaminated room air through a prefilter by means of an electrical blower within the food (Fig. 1). The prefilter, similar to a furnace filter, removes only gross contaminants and should be cleaned or replaced on a regular basis. Prefiltered air is then pressur­ized within a plenum to assure that a consistent distribution of air flow is presented to the final filtering apparatus. Constituting the entire back portion of a hood’s work area, this “high efficiency particulate air”, or HEPA, filter removes 99.97% of particles that are 0.3 micron or larger, thereby eliminating airborne microorganisms. The underlying principle of the laminar flow hood is that the constant flow of twice-filtered, laminar sheets or layers of “aseptic” air, at a rate of approximately 90 linear feet per minute across the work surface, physically sweeps the work area and prevents the entry of contaminated room air.

Laminar flow hoods which utilize a vertical flow of filtered air are also avail­able. In vertical flow hoods, HEPA filtered air emerges from the top and passes downward through the work area. Because exposure to some antineoplastic (anticancer) drugs may be harmful, they are usually prepared in biological safety cabinets, which utilize vertical air flow, to maintain sterility and protect the operator. The advan­tage of biological safety cabinets is that the risk of exposure to airborne drug is minimized by containing air flow within the hood. For more information on biological safety cabinets, see the American Society of Hospital Pharmacists’ videotape entitled “Safe Handling of Cytotoxic Drugs.”

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The critical principle of laminar flow hood utilization is that nothing must interrupt the flow of air between the HEPA filter and a sterile object. The introduc­tion of a foreign object between a sterile object and the HEPA filter presents the possibility that contaminants from the foreign object may be carried onto the sterile object. To maintain sterility, nothing should pass behind a sterile object in a horizon­tal flow hood, or above a sterile object in a vertical flow hood.

Furthermore, materials placed within the laminar flow hood disturb the patterned flow of air emanating from the HEPA filter. This “zone of turbulence” created behind an object could potentially extend outside the hood, pulling or allowing contaminated room air into the aseptic working area (Fig. 2). When laminar air flow is accessible to all sides of an object, the zone of turbulence extends approxi­mately 3X the diameter of that object. When laminar air flow is not accessible to an object on all sides (for example, when placed adjacent to a vertical wall), a zone of turbu­lence is created that may extend 6x the diameter of the object (Fig. 3). For these reasons it is advisable to place and work with objects as far into the hood as is practically feasible without blocking air vents, and to maintain unobstructed air flow between the HEPA filter and sterile objects. Also, when working in the hood, the hands should be positioned so that air flow between the HEPA filter and sterile objects is not blocked.

The following are general principles for proper laminar flow hood operation:

1. All aseptic manipulations should be performed at least 6 inches within the hood to prevent the possibil­ity of reflected contamination from the worker’s body or “backwash” contamination resulting from air patterns developing at the laminar flow hood-room air interface.

2. A laminar flow hood should be left operating continuously. If turned off, howev­er, the machine should not be used for a specified period of time when reactivat­ed, such as 30 min., depending on the hood manufacturer’s recommendations.

3. Before use, all interior working surfaces of the laminar flow hood should be cleaned with approved disinfectant such as cavicide and clean wipes. Cleaning should be performed from back to front (away from the HEPA filter in horizontal flow hoods), so that contaminants are moved out of the hood. The hood should be cleaned often through­out the compounding period. Some materials are not soluble in alcohol and may initially require the use of water in order to be removed. In addition, Plexi­glas sides, found on some types of laminar flow hoods, should be cleaned with warm soapy water or hydrogen peroxide as in the APreparing Parenteral Products@ to avoid damage.

4. Nothing should be permitted to come in contact with the HEPA filter. This in­cludes cleaning solutions, aspirate from syringes, or glass from ampuls, which should not be broken directly toward the filter.

5. A laminar flow hood should be positioned away from excess traffic, doors, air vents, or anything that could produce air currents capable of introducing contami­nants into the hood.

6. Jewelry should not be worn on the hands or wrists when working in the laminar flow hood since it may introduce bacteria or particles into the clean work area.

8. Actions such as talking and coughing should be directed away from the laminar flow hood working area, and any unnecessary motion within the hood should be avoided to minimize the turbulence of air flow.

9. Only those objects essential to product preparation should be placed in the laminar flow hood. Do not put paper, pens, labels, or trays into the hood.

10. Laminar flow hoods should be tested by qualified personnel annually, whenev­er the hood is moved, or if filter damage is suspected. Specific tests are employed to certify air flow velocity and HEPA filter integrity.

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