Pharmaceutics III For Lab Sessions Aseptic Techniques IV

Pharmaceutics III For Lab Sessions Aseptic Techniques IV Preparation Dr. J. Domenech

Aseptic Technique • Aseptic technique: is the term used for all procedures and techniques to keep a sterile product from becoming contaminated.

Parenteral drug administration • Basic IV therapy: • IV route of administration is the most common route that parenteral dose are administered today. • Other parenteral dosage forms: • - IM • -SC • -ID • -Epidural • IV fluid is in a large-volume parenteral (LVP), usually > 100 ml.

IV PIGGYBACK & LVP • Hang on an IV pole approximately 36 inches higher than the patients bed. • The LVP is usually a simple solution of dilute dextrose, sod. Chloride or both. • Solution is infused continually to keep blood from clotting in the catheter and plugging the line.

Risks of IV Therapy • • • 1 - Infection (Human touch is the common source) 2 - Air embolus (low incidence due to use of air-in-alarm) 3 - Bleeding 4 - Allergic reactions 5 - Incompatibilities (precipitated, inactivated or adherence to the container) 6 - Extravasation 7 - particulate matters (Hair, lint or cotton fibers, undissolved drugs, rubber stoppers). 8 - Pyrogen 9 - Phlebitis.

Aseptic Preparation of Parenteral Products • Aseptic Technique: • Programs designed to ensure the aseptic preparation of sterile products. • The main elements these programs focus on are: • 1 - The development and maintenance of good aseptic tec. In the personnel • 2 - The development and maintenance of a sterile compounding are complete with sterilized equipment and supplies. • 3 - development and maintenance of the skills needed to properly use a laminar flow hood (LAH). • N. B. The proper use of a LAH and strict aseptic tec. Are the most important factors in preventing the contamination of sterile products.

Sterile Compounding Area • A Sterile compounding area should be cleaned daily and segregated from normal pharmacy operations, patient specimens, nonessential equipment. • E. g. cardboard into clean area should be avoided • Traffic flow should be minimized • Floors should be disinfected periodically • Trash should be removed frequently.

Sterile Compounding Area • Sterile products should be prepared in a Class 100 environment, which contains no more than 100 particles per cf that are 0. 5 micron or larger in size. • LAH are frequently used to achieve a Class 100 environment.

LAH • Two common types: • 1 - Horizontal LAH- Sweeps filtered air from the back of hood to the front. • 2 - Vertical LAH- HEPA filtered air emerges from top and passes through the work area. • This type used for: anticancer and dangerous biologicals so its called ( Biological Safety Cabinets) BSCs. • The critical principle of using LAHs is that nothing interrupts the flow of air between the HEPA filter and the sterile object. The space between HEPA filter and the sterile object is known as the critical area.

LAH • To maintain sterility, nothing should pass behind a sterile object in a horizontal LAH or above sterile object in a vertical LAH. • Materials placed within LAH disturb the patterned flow of air blowing from the HEPA filter. This ( zone of Turbulence) created behind an object allowing contaminated room air into the aseptic working area. • Its advisable to work with objects at least 6 inches from the sides and front edge of the hood without blocking air vents, so that unobstructed airflow is maintained between the HEPA filter and sterile objects.

Types of LAFH • 1 - Horizontal Flow LAFH: • Where air blows towards worker • Used for non-chemotherapy preparations Hepa Filtered Air Room Air

• 2 -Vertical Flow LAFH: • Air blows from top down to maintain sterility and protect the worker • Used to make chemotherapy and biologicals.

Correct placement of items in a laminar flow hood

Wrong placement of items in a laminar flow hood

Important Precautions During Procedure • 1 - All aseptic techniques should be performed at least 6 inches within the hood to prevent the possibility of contamination from room air entering the hood. • 2 - A laminar flow hood should be left operating continuously. • 3 - If hood is turned off it must run for 30 minutes to reestablish laminar air flow and then be cleaned prior to use. • 4 - Before use, all interior working surfaces of the laminar flow hood should be cleaned from back to front away from the HEPA filter. • 5 - Nothing ( cleaning solution, syringes aspirates, glass from ampoules and fluids) should be permitted to come in contact with the HEPA filter.

• 6 - Only products essential to product preparation should be placed in the laminar flow hood to minimize the potential for contamination ( no pens, papers or calculators). • 7 - Avoid eating, drinking, and smoking. • 8 -Talking or coughing should be directed away from hood. • 9 - A mask must be worn while working in the hood • 10 - Quality control (QC) and quality assurance (QA) should be implemented.

LAH Cleaning

USP 797 - New Standards • The primary structure of the new USP standards is based on 3 risk levels classified according to the potential for: • 1 - Microbial Contamination • 2 - Physical Contamination • 3 - Chemical Contamination. • There are specific standards for each risk level. • Standards regarding personnel training, environmental QC, verification of compounding accuracy, packaging and transport, adverse event repot, and storage.

Environmental QC • Work bench area: where compounding is completed • Buffer area= clean room: area immediately surrounding the work bench. Should not contain drains or sinks. • Ante area: Space beyond the buffer area where hand sanitizing and gowning occurs. • Include hands free facets and air dryers or low=shedding towels. • Supplies are unpacked and disinfected for storage in the ante room

Applications of Aseptic Technique: • Aseptic technique requires specific manipulations for: • Syringes • Needles • Vials • Ampoules • Removal of packaging • Assembling of sterile products • Hand placement

Aseptic Technique- Syringes and Needles 1 - Don’t use syringes whose gradations are greater than twice the volume being measured. 2 - To maintain sterility, neither the syringe tip or plunger should be touched. 3 - Insert the bevel tip first, then pressing downward and toward the bevel so the bevel tip and heel enter at the same point. 4 - Never touch any part of the needle 5 - Open needle package within hood to maintain sterility

Aseptic Technique- Syringes and Needles • 6 - It is important that when using needles and syringes in product preparation that they not be removed from the hood workspace • 7 - Needles and syringes must be properly disposed in a sharps container located near the hood to prevent injury to others • 8 - Never dispose of needles or syringes in regular trash.

Aseptic Technique- Vials • 1 - Swab rubber closure with 70% alcohol using firm strokes in the same direction in order to prevent contamination. • 2 - Insert needle to penetrate the rubber closure at same point with both tip and heel of bevel to prevent core formation. • 3 - Inject an equal amount of air for the volume of fluid to be removed to prevent vacuum formation. • 4 - Remove an equal amount of air for the volume of diluent added.

Aseptic Technique- Ampoules • • • 1 - Clean ampule neck with alcohol swab 2 - Leave swab in place 3 - Grasp ampule neck with thumb and index finger 4 - Use quick, firm, snapping motion away from body towards side wall of hood 5 - Don’t break toward the HEPA filter. 6 - To withdraw medication from ampoule Tilt ampoule Place needle bevel in corner space near opening Pull back syringe plunger

Aseptic Technique- Ampoules • 7 - To avoid glass contamination of ampoule solution • Use 5 micron filter needle to filter glass as solution is pushed out of the syringe • A filter needle can only be used in one direction, otherwise glass particles originally filtered are reintroduced.

Aseptic Technique - Removing Packaging • 1 - Any sterile component or supply (e. g. , syringes, needles, and ampules) should only be opened and/or removed from their packaging within the laminar-flow workspace. • 2 - When opening the wrapper on a needle, it should be peeled open. • 3 - Tearing paper introduces paper particles into the hood which could lead to product contamination.

Aseptic Technique - Assembling • 1 - Great care must be exercised to prevent any touch contamination of critical edges or component surfaces. • 2 - The syringe tip and plunger and all parts of the needle are critical surfaces. Aseptic Technique - Hand Placement • 1 - It is important that hand placement during any aseptic manipulation is such that laminar airflow is not interrupted around any of the critical sterile fluid pathways. • 2 - Great care should be taken to avoid contact with the syringe plunger, especially during multiple manipulations using the same syringe. Since the plunger enters the barrel of the syringe during repeated uses, contamination can be accidentally introduced into the barrel.

Practical Session