Aseptic technique and Cleanroom Procedures

1. Aseptic technique and Cleanroom Procedures • Cleanroom is a room that is designed to be relatively free of airborne particulate matter • United States General Services Agency established in 1949 a standard of airborne particulate cleanness for cleanrooms. • In 2001, these standards were replaced by the ISO standards • According to the USP, to be compliant with the new 797 guidelines for the preparation of sterile pharmaceutical products, a cleanroom must meet at least ISO8 standard, the anteroom ISO7 and the immediate sterile preparation area or the Laminar flow hood area must meet ISO5 • ISO 5 means no more than 100,000 particulates 0.1 micrometer or larger per cubic meter. By contrast, room air is classified as ISO9 which is no more than 1,000,000,000 particulates per cubic meter. (a ten thousand fold difference)

2. Cleanroom • Usually consists of a storage area, an area for records, computers and printers, an anteroom for gowning and preparation for IV compounding takes place, and buffer area near the laminar flow hood, and the hood itself. • The hood is usually washed and disinfected with 70% isopropranol by a pharmacist at the beginning and end of the shift. Washing is from top to bottom of the hood and back to front in the direction of laminar flow. • HEPA filters remove over 99% of particles, including microorganism 0.3 microns or larger. When cleaning the HEPA filter grill do not spray the filter always spray the sterile gauze pads and clean the surface of the grill • If the HEPA Laminar flow hood is turn off for any reason then it must be turn on for at least 30 minutes before commencing any IV preparation.

3. Preparing to make an IV product • Enter the cleanroom with slow and deliberate movement. Remove jewelry and tie back loose hair. • Put on shoe coverings (booties) and then proceed to anteroom. • In anteroom, perform antiseptic washing of hands which includes washing hands and washing between fingers as well as using fingernail buffer pad to clean under the fingernails. Wash hands up to the elbows and rinse hands first allowing water to drip down to elbows. • Don surgical gown, hair cap, beard cover (if needed) and surgical mask if working with a hood with no front panel. • Gather syringes, needles, IV bags (with cover removed) • Perform second antiseptic handwash. • Donn powder free surgical latex gloves • Enter Buffer zone • Place all products into the laminar flow hood.

4. Remove all caps to vials. Swab each vial with alcohol swab from back to front once with swab. • Swab medication port of the IV bag that you will use. • All products should be 6 inches inside the hood. • Arrange materials in such as way as to not block any of the laminar flow air currents. • Once inside the hood, your hands should not leave the inside of the hood. If they do you will need to sanitize your gloves before returning to the hood area. • Always remember not to touch critical areas

5. The following are critical areas which must not be touched. • All parts of the needle. • The hub of a luer lok syringe • The ribs of the piston of the syringe. • The injection port of the IV bag. • The rubber entry port of the vial

6. Remember, touch is the number one cause of product contamination. • Human skin harbors many organisms: Staphylococci, Streptococci, Actinobacter, Candida, Tricophyton Rubrum fungi, Pseudomonas, etc. • Contaminated IV products can cause bacteremia and fungemia, septic shock and death. • I will demonstrate aseptic technique in class with reference to drug manipulation.

7. The Finished products • If you are a pharmacy technicians that will be performing IV admixtures. Always leave the following item for the RPH to check: • All vials used in the process • All syringes used in the process drawn back to the volume you used. • All information recorded in the IV prep log book: Patient’s name, medical record number, drugs, concentrations, volumes used, lot number and manufacturer’s expiration. • Assigned a pharmacy expiration date (usually 24 hours at room temperature)

8. IV products continued • ALL Intravenous products must be clear to the eye. Cloudiness or discoloration could indicate a physical or chemical incompatibility. • Cloudiness indicates a drug has “come out” or precipitated out of solution. One example of this is mixing phenytoin sodium (Dilantin®) in D5W solution. A cloudy haze forms in the IV bag on standing. • A second example is in TPN, addition of calcium gluconate in a solution of high phosphate can cause calcium phosphate to “come out” of solution • A third example is excessive shaking and agitation of a solution of mannitol. Mannitol’s needle like crystals can be seen after such agitation.

9. A great reference to use to determine drug-drug, drug-IV solution compatibilities is a book called, Trissel’s Handbook on Injectable Drugs® Common causes of physical and chemical incompatibilities are: • Drugs mixed in low pH solutions, like D5W • Drugs mixed in hypertonic solutions, like D5WNS • Drugs mixed in incorrect IV mediums. Such drugs are not compatibility in the PVC container of an IV bags; these drug are mixed in glass IV containers. A class example is nitroglycerin which is used for patients with acute MI. • Drugs mixed with other drugs that “complex” each other.

10. Routes of IV administration • As mentioned before, the most common routes of IV administration are IV push, Primary IV infusion, and IV piggyback. • In IV push, the luerlok of a syringe is attached directly to the patient’s intravenous access and slowly “pushed” in by pressing on the syringe barrel. It may also by given through a Y site on a primary IV line with a fluid running IV solution. • Primary IV infusion, the drug admixture is a large volume parenteral IV bag that is run through a dedicated IV line. • In IV piggyback, the drug admixture is a small volume parenteral that is infusion through a secondary line into a primary one through a Y site connection.

11. Other Parenteral routes • Epidural routes are IV catheters that are tunneled into a patient’s back near the spinal cord of the patient. Meant to deliver opiates and other pain medications to post op patients and obstetric patients. Solutions made for epidural use must be made from preservative free drug products. • Intrathecal injections are made into the spinal cord. The needle passes through the dura mater into the subarachnoid space. This method is used to administer spinal opiates at doses far below regular IV doses. It is also used to deliver chemotherapy with methothexate and in the delivery of a drug called baclofen to patients with severe cerebral palsy. • Some drugs given this way can be fatal. An example is the drug Vincristine.