Hand Hygiene and Garbing Procedures PDF

**INTRO VIDEO -- the previous module focused on the requirements for both the compounding space and the hood or primary engineering utilized for compounding. With this module, we are going to focus a lot on the requirements of the personnel within the compounding space including hand hygiene, garbin...

**INTRO VIDEO -- the previous module focused on the requirements for both the compounding space and the hood or primary engineering utilized for compounding. With this module, we are going to focus a lot on the requirements of the personnel within the compounding space including hand hygiene, garbing, cleaning, aseptic technique, and documentation requirements just to name a few. We will also begin practicing in the virtual cleanroom environment and completing skill assessments within that environment.** **Required Personnel Training and Competency Assessments** All compounding personnel and those who directly oversee them must undergo initial training and demonstrate competency in the following areas before performing job functions independently. The next sections will dive deeper into each of these topics. - Hand Hygiene - Garbing - Cleaning and disinfection - Calculations, measuring, and mixing - Aseptic technique - Achieving and/or maintain sterility (and apyrogenicity if compounding with nonsterile components) - Use of equipment - Documentation of the compounding process (e.g., mater formulation and compounding records) - Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class 5 area - Proper use of PECs - Principles of movement and materials and personnel within the compounding area **Personal Health and Hygiene Requirements for Sterile Compounding** Maintenance of the ISO classified air in sterile compounding areas is heavily dependent upon preventing personnel from contaminating the environment. The majority of clean room contamination is a result of the squamous cells shed from the human body. These cells shed at a rate of 10^6^ or more per hour and these cells are covered with microorganisms. Proper garbing and personal hygiene is essential to minimize the risk of contamination to the environment and/or CSPs. Certain individuals have a higher risk of contaminating the CSP and the environment. These individuals include personnel with: - Rashes - Recent tatoos - Oozing sores - Conjunctivitis - Active respiratory injections Personnel with any of these conditions must report them to the designated person responsible for evaluating whether these individuals should be allowed to work in the compounding area until their conditions have resolved. The designated person is the individual the compounding facility has selected to oversee the facility's compliance with compounding requirements. In addition to the physical conditions listed above, personnel may also increase the risk of environmental contamination based on clothing and other items that they bring into the environment with them. Food, drinks, gum, and mints must not enter anterooms, buffer rooms, or segregated compounding areas. Other unnecessary items must be removed by compounding personnel prior to entering the compounding area. At a minimum, individuals must: - Remove personal outer garments (e.g., coats, hats, jackets, sweaters, vests). - Remove all cosmetics due to shedding of flakes and particles. - Remove all hand, wrist, and other exposed jewelry and piercings that could interfere with the effectiveness of garbing or otherwise increase the risk of contamination of CSP. Cover any jewelry that cannot be removed. - Not wear earbuds or headphones. - Not bring electronic devices that are not necessary for compounding or other required tasks into the compounding area. - Keep nails clean and neatly trimmed to minimize particle shedding and avoid glove punctures. Nail polish, artificial nails, and extenders must not be worn. - Wipe eyeglasses with isopropyl alcohol, if worn. Exceptions to the above may be permitted by the designated person if it does not impact the quality of the CSP or environment. Any exceptions must be documented. **Hand Hygiene and Garbing Procedures** Hand hygiene and garbing are critical to maintaining the proper environment in a clean room or sterile compounding area. Any person entering an area where Category 1, Category 2, or Category 3 CSPs are prepared must wash hands and forearms up to the elbows with soap and water and be properly garbed before compounding. The physical act of putting on the garb is called "donning" garb and the act of taking off the garb is called "doffing of garb." The garb donning and doffing are completed in an order that reduces the risk of environmental contamination. Each facility should define the required garb, order of garbing, and storage of garb in its sterile operating procedures. When preparing Category 2 and 3 CSPs, all garb should be donned in a classified area. Donning and doffing of garb should not be completed in the same area simultaneously. Minimum garbing requirements for Category 1 and 2 CSPs: - Low-lint cover for head that covers hair and ears - Cover for facial hair, if applicable - Low-lint shoe covers - Low-lint garment with sleeves that fit snugly around the wrists and an enclosed neck (e.g., gown or coverall) - Sterile powder-free gloves - Low-lint face mask Any visibly soiled or damaged garb must be replaced immediately. All storage conditions of garb must be done in such a way as to minimize contaminations (e.g., splashing of a sink). If compounding category 1 or 2 CSPs the low-lint garment may be reused throughout the same shift by the same person if it is removed and stored in a classified area or adjacent to, or within, the SCA in a manner that prevents contamination. No other garb may be reused when exiting the compounding area and must be discarded or laundered before reuse. Each facility must define the proper disinfection procedures for reusing equipment such as goggles, respirators, and other reusable equipment in its standard operating procedures. For facilities compounding category 3 CSPs there are additional garbing requirements that must be continuously met. Facilities must always follow these requirements regardless as to whether or not a Category 3 CSP is being compounded on that given day. - No exposed skin in the buffer room (i.e., face and neck must be covered) - All low-lint garb must be sterile - Sterile sleeves must be used over gauntlet sleeves when using a RABs - No reuse of disposable garbing items, and laundered garb must undergo re-sterilization with a validated cycle. Gloves must be sterile and powder-free. Application of sterile 70% IPA to gloves must occur immediately prior to compounding and regularly throughout the compounding process. All gloves must be inspected for holes, punctures, and tears. If any of these defects are discovered the gloves must be replaced immediately. If utilizing a RABS or pharmaceutical isolator the sleeves and gloves must be changed according to the manufacturer's recommendations. This must be defined in the facility\'s SOPs. **Hand Hygiene** The sink utilized for hand hygiene can be located either outside of the classified areas or within the anteroom. If hand washing procedures are performed outside of the classified areas, alcohol-based hand rub must be used prior to donning garb. *Hand Washing Procedures* - Clean underneath fingernails under warm running water using a disposable nail cleaner. - Wash hands and forearms up to the elbows with soap and water for at least 30 seconds. - Dry hands and forearms up to the elbows completely with low-lint disposable towels or wipers. Hand dryers should not be utilized to dry hands. Scrub brushes should not be used during hand-washing procedures as they may cause additional skin flaking and generate particles. Disposable soap containers should also not be refilled to prevent contamination. *Hand Sanitizing Procedures* - Apply an alcohol-based hand rub to dry skin. - Apply product to one hand and rub hands together, covering all surfaces of hands and fingers, until hands are dry. - Allow hands to dry thoroughly before donning sterile gloves. **Hazardous Garbing** Garbing discussed up to this point is intended to prevent the compounder from contaminating the compounded sterile products. This section focuses on garbing for compounding of hazardous drugs (HDs). This personal protective equipment intends to also protect the compounder from exposure to hazardous drug residues and aerosols. Disposable garb utilized for compounding of hazardous drugs must not be reused and reusable garb must be decontaminated and cleaner after use. Minimum required garb for hazardous compounding: - Gown - Head cover - Hair cover - Two pairs of shoe cover - Two pairs of chemotherapy gloves Required PPE: Gloves - Must meet American Society for Testing and Materials (ASTM) standard D6978. - Must be powder-free. Powder can contaminate the work area and absorb and retain HDs. - Must be inspected for physical defects before use. Do not use gloves with pin holes or weak spots. Gloves must be changed if they become torn, punctured, or contaminated. - Outer chemotherapy gloves must be sterile when used in sterile compounding. - Should be changed every 30 minutes unless otherwise recommended by manufacturer's documentation. - Hands must be washed with soap and water after removing gloves. Gowns - Must be shown to resist permeability by HDs. - Facilities should select an appropriate gown based on the HDs being handled. - Coated gowns (i.e., polyethylene-coated polypropylene or other laminate materials) offer better protection than those made of uncoated materials. - Gowns must close in the back, have long sleeves, and closed cuffs made of elastic or knit. - No seams or closures that could allow HDs to pass through are permitted. - Gowns must be changed based on the manufacturer's information for permeation of the gown, or every 2-3 hours if the information is unavailable. - Gowns must be changed immediately following a spill or splash. - Gowns worn in HD areas must not be worn into other areas to prevent the spreading of HD contamination. Head, Hair, and Shoe Covers - Head, hair, and shoe covers protect the compounder from contact with HD residue. - A second pair of shoe covers must be donned before entering the hazardous buffer area and must be doffed when exiting this area. - Shoe covers worn in hazardous areas must not be worn into other areas to prevent the spreading of HD contamination. PPE Required in Certain Circumstances: Sterile Sleeve Covers - Sleeve covers protect the compounder from contact with HD residue. - Sterile sleeve covers must be used with a RABS when compounding category 3 CSPs - Disposable sleeves may be used to protect areas of the arm that may come into contact with HDs. - As with gowns the coated sleeve covers provide better protection than uncoated materials. Eye and Face Protection - Eye and face protection must be worn when there is a risk of spills or splashes of HDs. - Goggles must be worn when eye protection is needed. Eyeglasses or safety glasses with side shields do not adequately protect the eyes from splashes. - Face shields alone do not provide full eye and face protection. - Face shields in combination with goggles provide the best level of protection to the face and eyes. - Surgical masks should not be used when protection from drug exposure is necessary as they do not provide respiratory protection. - For most activities requiring protection from HD airborne particles, a fit-tested NIOSH-certified N95 or more protective respirator is sufficient. - N95 respirators, however, do not protect against gases or vapors and provide little protection against direct liquid splashes. - Some circumstances necessitate the use of a full-facepiece, chemical cartridge-type respirator or a powered air-purifying respirator (PAPR). These include the following: - Attending to an HD spill larger than what can be handled with a spill kit. - Deactivating, decontaminating, or cleaning underneath the work surface of a C-PEC. - Known or suspected airborne exposure to powders or vapors. Disposal of Garb Utilized in Hazardous Compounding Any garb utilized when compounding a hazardous drug must at a minimum be considered to contain trace quantities of hazardous drugs. Chemotherapy gloves and sleeve covers (if used) must be removed and discarded immediately into a waste container approved for trace contaminated waste inside the C-PEC or contained in a sealed bag for discarding outside the C-PEC. All other garb should be disposed of in a separate container marked as trace hazardous drug waste and disposed of per local, state, and federal regulations. **Garbing and Hand Hygiene Competency** After undergoing training on the proper process for garbing and hand hygiene, personnel must complete an initial garbing competency evaluation no fewer than three separate times before being able to compound any category of CSPs or have direct oversight of compounding. This garbing competency consists of the following: - Visual observation of hand hygiene and garbing procedures - Completion of gloved-fingertip and thumb sampling of both hands The three completions must be in succession and failure of any of the three initial evaluations requires them to be repeated until three are passed in a row. Each of the three gloved-fingertip evaluations must be completed immediately following a complete set of hand hygiene and garbing procedures. The gloved-fingertip sampling must occur after putting on a pair of sterile gloves and before applying 70% isopropyl alcohol to gloves as this could result in a false negative result. Glove must be applied in a classified area or segregated compounding area. Microbial growth exceeding action levels on gloved-fingertip samples or failure of the visual observation due to improper hand hygiene and garbing procedures results in failure of the competency evaluation. The visual audit and gloved-fingertip results must be documented and documentation maintained to provide a record and long-term assessment of personnel competency. Gloved-fingertip and thumb sampling results exceeding action levels are not required to have the organisms growing on the sampling identified. Minimum documentation requirements: - Name of person evaluated - Evaluation date and time - Media and components including manufacturer - Expiration date - Lot number - Starting temperature for each interval of incubation - Dates of incubation - Results and identification of the observer and personnel reading and documenting the results Gloved fingertip and thumb sampling procedure as outlined by USP 797: - Use one sampling media device per hand, containing general microbial growth agar (e.g., trypticase soy agar \[TSA\]) supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) as this agar supports both bacterial and fungal growth - Label each media device with a personnel identifier, right or left hand, and the date and time of sampling. - Using a separate media device for each hand, collect samples from all gloved fingertips and thumbs from both hands by rolling fingertips and thumbs over the agar surface. - Incubate the media device at 30 degrees Celsius to 35 degrees Celcius for no less than 48 hours and then 20 degrees Celcius to 25 degrees Celcius for no less than 5 additional days. Samples must be incubated in an incubator. Handle and store media devices to avoid contamination and prevent condensate from dropping onto the agar during incubation and affecting the accuracy of the CFU readings (e.g., inverted plates) - Record the number of colony-forming units (cfu) per hand (left hand, right hand) - Determine whether the cfu action level is exceeded by counting the total number of cfu from both hands Knowledge Check Questions **Cleaning and Disinfecting** Cleaning and disinfecting are important steps in preventing contamination of CSPs because surfaces in classified areas and SCAs are a potential source of microbial contamination. Cleaning removes visible solids from the surface such as dirt, debris, residual drugs and chemicals, and microbes. These agents generally contain a surfactant. Disinfectants destroy fungi, viruses, and bacteria present on surfaces using a chemical or physical agent. Sporicidal disinfectants destroy bacterial and fungal spores on a surface when used at a sufficient concentration for a minimum of the specified contact time. These are also expected to kill all vegetative microorganisms. The effectiveness of a disinfectant depends on the following factors - intrinsic biocidal activity - concentration of the disinfectant - contact time - nature of the surface disinfected - hardness of the water used to dilute the disinfectant - amount of organic materials present on the surface - type and the number of microorganisms present. Compounding facilities should select cleaning and disinfecting agents with careful consideration to compatibilities, effectiveness, and the safety of the users. Other factors such as antimicrobial activity, inactivation by organic matter, residues left behind, shelf life, preparation requirements, and suitability with surfaces being disinfected should also be considered. All cleaners, disinfectants, and sporicidal disinfectants utilized within the PEC must be sterile. Sterile water must also be utilized for any cleaners and disinfectants requiring dilution. It is also recommended to utilize sterile cleaners and disinfectants when cleaning areas outside the PEC. To minimize particle generation in the classified area, all cleaning and disinfecting supplies must be low-lint. Any supplies utilized in the PEC must be sterile with the exception of tool handles and holders, which must be cleaned and disinfected prior to use in a PEC. Cleaning supplies such as wipers, sponges, pads, and mop heads should be disposable. Reusable cleaning tools must be cleaned and disinfected before each use. Cleaning tools must be dedicated for use in the classified areas or SCA and should not be removed except for disposal. Cleaning supplies must be disposed of in a manner that minimizes the spread of contaminants into the air. Sterile cleaning and disinfecting agents and supplies may be reused for a time specified by the manufacturer or described in the facility\'s written SOPs. Surfaces within a classified area used to prepare Category 1, 2, and 3 CSPs must be cleaned, disinfected, and have a sporicidal agent applied based on the frequencies described in the table below. +-----------------+-----------------+-----------------+-----------------+ | Location | Cleaning | Disinfecting | Sporicidal | | | | | Agent Applied | +=================+=================+=================+=================+ | PEC -- all | Daily on days | Daily on days | Category 1 and | | interior | when | when | 2 CSPs - | | surfaces | compounding | compounding | Monthly | | | occurs and when | occurs and when | | | | surface | surface | Category 3 CSPs | | | contamination | contamination | -- Weekly | | | is known or | is known or | | | | suspected | suspected | | +-----------------+-----------------+-----------------+-----------------+ | Equipment | | | | | inside the PEC | | | | +-----------------+-----------------+-----------------+-----------------+ | Pass-through | Daily on days | Daily on days | | | chambers | when | when | | | | compounding | compounding | | | | occurs | occurs | | +-----------------+-----------------+-----------------+-----------------+ | Work surfaces | | | | | outside the PEC | | | | +-----------------+-----------------+-----------------+-----------------+ | Floors | | | | +-----------------+-----------------+-----------------+-----------------+ | The work | Daily on days | Daily on days | Monthly | | surface of the | when | when | | | removable tray | compounding | compounding | | | of the PEC if | occurs | occurs | | | applicable | | | | +-----------------+-----------------+-----------------+-----------------+ | All surfaces | Monthly | Monthly | | | and areas | | | | | underneath the | | | | | work surface of | | | | | the removable | | | | | tray of the PEC | | | | | if applicable | | | | +-----------------+-----------------+-----------------+-----------------+ | Walls, doors, | | | | | and door frames | | | | +-----------------+-----------------+-----------------+-----------------+ | Ceilings | | | | +-----------------+-----------------+-----------------+-----------------+ | Storage | | | | | shelving and | | | | | bins | | | | +-----------------+-----------------+-----------------+-----------------+ | Equipment | | | | | outside the PEC | | | | +-----------------+-----------------+-----------------+-----------------+ Cleaning using a germicidal agent will leave a residue on the surface that must be removed. This is generally accomplished by utilizing 70% sterile isopropyl alcohol after applying a one-step disinfectant cleaner or sporicidal disinfectant. In addition, sterile 70% isopropyl alcohol must be applied immediately before initiating compounding and at least every 30 minutes to horizontal surfaces of the PEC if compounding takes 30 minutes or less. Compounding should not be disrupted to apply sterile 70% isopropyl alcohol. If the compounding process takes greater than 30 minutes the work surface must be disinfected immediately following compounding. All cleaning and disinfecting must be completed by properly trained and garbed personnel following standard operating procedures outlined by their facility. Cleaning must always be performed in the direction of clean to dirty areas (i.e., when completing the monthly cleaning of the compounding suite the personnel should start cleaning the ceiling first followed by the walls and finally the floor). The same mop may be used for the buffer room and ante room but only if cleaned in that order. Mops used for cleaning areas where compounding of hazardous drugs occurs must be dedicated to those areas to prevent the spread of hazardous residues to other areas. Each facility must define in their stand operating procedure the frequency, method, and location of cleaning, disinfecting, and applying sporicidal disinfectants and this must be followed by all cleaning personnel. These SOPs should be based on the manufacturer\'s instructions for use and published minimum contact times. When sterile 70% isopropyl alcohol is used it must be allowed to dry. *Procedures for Cleaning and Disinfecting the PEC* - Remove visible particles, debris, or residue utilizing sterile water and sterile, low-lint wipes if necessary. - Apply either a sterile cleaning agent followed by a sterile disinfectant or apply a sterile one-step disinfectant cleaner to all equipment and interior surfaces of the PEC using a low-lint sterile wipe. - Ensure the contact time specified by the manufacturer is achieved. - Apply sterile 70% isopropyl alcohol to all equipment and interior surfaces of the PEC using a low-lint sterile wipe. - Allow the surface to dry completely before beginning compounding. *Procedures for Applying a Sporicidal Disinfectant in the PEC* - Remove visible particles, debris, or residue utilizing sterile water and sterile, low-lint wipes if necessary. - After cleaning and disinfecting, apply the sterile sporicidal disinfectant using a sterile low-lint wipe to all surfaces and the area underneath the work tray. Separate cleaning and disinfecting steps are not required for sterile one-step sporicidal disinfectant cleaners. - Ensure the contact time specified by the manufacturer is achieved. - Apply sterile 70% isopropyl alcohol to all equipment and interior surfaces of the PEC including under the work tray using a low-lint sterile wipe. - Allow the surface to dry completely before beginning compounding. Cleaning of Hazardous Drug Areas In addition to the cleaning and disinfecting requirements that occur in normal sterile compounding areas, all areas where hazardous drugs are handled and all reusable equipment and devices in these areas must also undergo deactivation and decontamination. Deactivation renders hazardous compounds inert or inactive and decontamination physically removes hazardous drug residues from non-disposable surfaces. The residue left over when deactivating a surface must be removed by decontaminating the surface using absorbent, disposable materials. While deactivation is preferred, there is no one process has been found to deactivate all currently available hazardous drugs. The ultimate goal is complete surface decontamination. Deactivating agents can lead to adverse effects such as hazardous byproducts, respiratory effects, and damage to surfaces. This should be considered when selecting agents for deactivation. For example, sodium hypochlorite is an effective deactivator of many hazardous drugs but it is also known to cause corrosion of stainless steel surfaces if not neutralized. When selecting a product for decontaminating hazardous drugs, facilities should consider surface compatibility and facility requirements. The manufacturer's instructions for the use of these products must be followed. It is also recommended to utilize surface wipe sampling to determine the effectiveness of the decontamination product and process. Contamination with the C-PEC can be reduced by wiping down products before introducing them into the C-PEC. The product labeling must not be altered by the wiping process. Decontamination is required: - Between compounding of different drugs (work surface) - At least daily - When spills occur - Before and after certification - Any time voluntary interruption occurs - The ventilation tool is moved - Monthly under the work tray Before accessing the area under the work tray the surfaces of the PEC should be decontaminated and cleaned. Respiratory protection may be required when cleaning and deactivating under the work tray as the containment airflows are compromised when opening the cabinets. Each compounding facility must establish standard operating procedures on cleaning, deactivation, and decontamination procedures, agents utilized, dilution of agents, frequency of cleaning, and documentation of cleaning requirements. All personnel must be trained in these procedures to protect themselves and the environment from contamination. Appropriate PPE should be worn by personnel to protect them from HD contamination and the cleaning agent being utilized. This includes at a minimum an impermeable disposable gown and two pairs of chemotherapy gloves. NEED TO REFER OVER TO THE SKILLS ASSESSMENT **Aseptic Technique** The term aseptic means free of living pathogenic organisms or materials. Therefore, aseptic technique defines the technique necessary when preparing sterile products so that they remain sterile or free of living pathogenic organisms or materials. Proper aseptic technique when preparing sterile products requires the use of the proper equipment to provide an ISO class 5 environment. The use of such a device does not ensure that products compounded within it remain sterile. The technique of the personnel using the hood has also impacts the quality of the final product. We will start our discussion on aseptic technique with a few definitions: *Critical site* -- any component or fluid pathway surface (e.g., vial septa, injection ports, opened ampules, needles, or hubs) that is exposed and at risk of direct contact with air, moisture, or touch contamination *Direct Compounding Area* -- critical area within the ISO Class 5 primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air *First air* -- Air exiting the HEPA filter in a unidirectional air stream that is essentially particle free *Zone of turbulence --* pattern of flow of air from the HEPA filter created behind an object placed within the laminar airflow workbench pulling or allowing contaminated room air into the aseptic environment The key to proper aseptic technique within the PEC is to not block or disrupt the flow of first air from the HEPA filter onto critical sites. Blocking of first air can lead to contamination of the critical sites and ultimately may contaminate the final product. The blocking of airflow can occur due to improper placement of products within the hood or due to placement of hands between the HEPA filter and the object during compounding. Each object placed within the laminar airflow environment disrupts the normal laminar flow. This area of disrupted airflow is what is called the zone of turbulence. The size of the turbulent air is dependent upon the diameter of the object placed within the laminar flow. The length of the turbulent air produced by an object is approximately three times the diameter of the object. This length can be extended to six times the diameter of the object when the laminar airflow is not accessible to all sides of the object. See the attached figure and the impact of item placement has upon the hood on the zone of turbulence **INSERT PHOTO OF ZONE OF TURBULENCE** The length of the zone of turbulence can lead to contamination if products are not placed properly with the PEC. When the zone of turbulence extends beyond the laminar airflow of the PEC it can expose critical sites to air less than ISO class 5 quality. Due to this the compounding personnel should place objects at least 6 inches from the sides and front open edge of the PEC. Other important principles for the proper use of the PEC: - The PEC should operate continuously and should not be turned off when not in use. If circumstances necessitate the hood being turned off, the hood must for a defined amount of time prior to use. The manufacturer's recommendations should be followed for this amount of time. - The hood should be properly cleaned from the dirtiest part to the cleanest part (back to front and top to bottom) following the requirements previously discussed. - Nothing should touch the HEPA filter (e.g., cleaners sprayed towards HEPA filters, breaking of ampules towards the HEPA filter, expelling fluid from syringes towards HEPA filter) - Coughing and talking should be directed away from the direct compounding area. - Only objects essential to sterile compounding should be placed within the PEC. All items placed within the PEC should be wiped down with sterile isopropyl alcohol prior to introducing them into the PEC. - The PEC must be certified every 6 months. Supplies In addition to the proper use of the PEC, proper garbing and hand hygiene is essential in addition to the proper use and handling of sterile supplies including vials, syringes, needles, and ampules. Garbing and hand hygiene requirements were discussed previously. This section will focus upon the proper handling and use of sterile supplies. Syringes Syringes are made of either glass or plastic, but primarily plastic syringes are used in pharmacies, hospitals, and clinics. The reason that glass syringes are sometimes used is that most drugs are more stable in glass, so glass syringes are most often used when medication is to be stored in the syringe for an extended period. Some medications may react with the plastics in the syringe, which would alter the potency or stability of the final product. Disposable plastic syringes are most frequently used in preparing sterile products because they are inexpensive, durable, and are in contact with substances for only a short period of time, which minimizes the potential for incompatibility with the plastic itself. Syringes are composed of a hub/tip, barrel, and plunger. Each syringe is sterile while it is still in its wrapper. To maintain the sterility of the product, the compounding personnel should not touch the syringe hub/tip or the plunger. They may touch the flat end of the syringe and the outside of the barrel. Many syringes have a locking mechanism at the hub, such as the Luer Lock, which secures the needle within a threaded ring. Some syringes, such as a slip-tip syringe, do not have a locking mechanism. In that case, friction holds the needle on the syringe. Parts Of A Syringe Diagram - Wiring Diagram **INCLUDE PHOTO SHOWING PARTS OF SYRINGE such as this** Syringes are available in numerous sizes, ranging from 0.5 to 50 mL. Insulin syringes measure volume based on units of Insulin. Calibration marks on syringes represent different increments of capacity, depending on the size of the syringe. Usually, the larger the syringe capacity, the larger the interval between calibration lines. To maximize accuracy, the smallest syringe that can hold a desired amount of solution should be used. Syringes are accurate to one-half of the smallest increment marking on the barrel. Ideally, the volume of solution should take up only one-half to three-fourths of the syringe capacity for Hazardous Drugs, which avoids inadvertent touch contamination caused when the syringe plunger is pulled all the way back or spilling of the Hazardous Drug. When measuring with a syringe, the final edge (closest to the tip of the syringe) of the plunger piston should be lined up to the calibration mark on the barrel, which corresponds to the volume desired.  **INCLUDE IMAG OF FINAL EDGE OF PLUNGER PISTON** The syringe package should be opened inside the PEC. The wrapper should be peeled apart and not ripped or torn to prevent particle generation within the PEC. To minimize particulate contamination, the discarded packaging or unopened syringes should not be placed on the direct compounding area work surface. Syringes may come from the manufacturer with a needle attached or with a protective cover (cap) over the syringe tip. The syringe cap should be left in place until it is time to attach the needle. For attaching needles to Luer Lock type syringes, a quarter-turn is usually sufficient to secure the needle to the syringe. To ensure an accurate volume is measured, any air bubbles should be removed from the syringe. This can be accomplished by: 1. Pull back slightly on plunger to removed fluid trapped in the needle 2. Hold the syringe with the needle pointing up and tap on the syringe to force air bubbles to the top 3. Depress the plunger to expel only the air **[Needles]** Two numbers, gauge, and length describe the needle size. The gauge of the needle corresponds to the diameter of its bore, which is the diameter of the inside of the shaft. The larger the gauge, the smaller the needle bore. The length of a needle shaft is measured in inches and usually ranges from 3/8 to 3 ½ inches. The gauges typically used in the pharmacy include 16 and 18 gauge. The components of a simple needle are the shaft and the hub. The hub attaches the needle to the syringe and is often color-coded to correspond to a specific gauge. The tip of the needle shaft is slanted to form a point. The slant is called the *bevel*, and the point is called the *bevel tip*. The opposite end of the slant is termed the *bevel heel*. PPT - Principles and Methods of Drug Administration PowerPoint \... **INCLUDE IMAGE OF PARTS OF A NEEDLE** No part of the needle should be touched. Needles should be manipulated by their overwrap and protective covers (needle cap) only. A needle shaft is usually metal and is lubricated with a sterile silicone coating so that latex vial tops can be penetrated smoothly and easily. For this reason, needles should never be swabbed with alcohol. Inside a Laminar Airflow Hood, airflow to the needle shaft or hub opening should not be blocked. Before using the needle, the compounding personnel should make sure the packaging and needle is intact and undamaged. Some needles are designed for special purposes and therefore have unique characteristics. For example, needles designed for batch filling have built-in vents (vented needles) to avoid the need to release pressure that might form in the vial. Another example is needles with built-in filters, which are intended for use with products requiring filtering, such as drugs removed from a glass ampule. When dealing with small volumes, it is important to account for the volume of the solution left in the hub of the needle. As much as 0.3 mL may be present in the hub of the needle, which could represent a significant amount of the dose for a pediatric patient. To avoid any sharps related injuries, compounding personnel should avoid recapping of needles. Personnel may dispose of needles in a proper sharps container still attached to the syringes or a safety needle may be utilized that allows for a guard to flip up into place to cover the needle after use. If it is necessary to recap a needle a scoop method should be utilized. The needle cap should be left on the surface of the direct compounding area and the needle should be used to scoop up the cap. The personnel may then push on the cap to secure it into place. Use of these methods help to prevent personnel injuries and product contamination. **[Vials]** **Medication vials are glass or plastic containers with a rubber stopper secured to the top, usually by an aluminum cover. Protective covers do not guarantee sterility of the rubber stopper. Therefore, before the stopper is penetrated, it must be swabbed with 70 percent sterile isopropyl alcohol and allowed to dry. The correct swabbing technique is to make one firm stroke over the rubber closure, always using a clean swab. (Back of the IV hood to the front of the IV hood.) One swab per one vial. If you have to swab the vial again, then use a new swab. Swabbing helps achieve sterility in two ways:** - **The alcohol acts as a disinfecting agent** - **The physical act of swabbing in one direction removes particles.** **When puncturing vials with a needle, the compounding personnel should avoid coring fragments out of the rubber stopper with the needle. A core is a piece of the rubber stopper that is pushed into the sterile liquid in the vial when the bevel tip and the bevel heel do not penetrate the stopper at the same point. To prevent core formation, the stopper should first be punctured with the bevel tip at a 45-degree angle and then pressed downward and toward the bevel as the needle is inserted.** **PICTURE SIMILAR TO THIS** **Vials are closed-system containers because air or fluid cannot pass freely in or out of them. To prevent the formation of a vacuum inside the vial (less pressure inside the vial than outside the vial), the user should normalize pressure by first injecting into the vial a volume of air equal to the volume of fluid that is going to be withdrawn. This step should not be done with drugs that produce a vapor when they are reconstituted, such as ceftazidime, or with cytotoxic drugs.** **[Reconstituting Vials]** **If the drug within the vial is in powder form, it must be reconstituted. The compounding personnel should inject the desired volume of sterile diluting solution (the diluent), such as sterile water for injection, into the vial containing the powder drug. The correct diluent is selected based on the package insert of the medication that is being reconstituted. An equal volume of air must be removed to prevent a positive pressure from developing inside the vial. (When injecting diluent, if you feel pressure on the plunger, ease back on the plunger to allow air into the syringe. This will help relieve pressure from the vial. This is particularly important when dealing with medications that can be harmful if aspirated into the air. The air should be allowed to flow into the syringe before the needle is removed from the vial, or a vented needle should be used, which allows displaced air to escape the vial through a vent in the needle. Care must be taken to ensure that the drug is completely dissolved before proceeding. Usually, gentle swirling adequately dissolves the drug contents. Some agents cannot be shaken because they will degrade the active ingredient.** **[Single-dose Vials vs. Multiple-dose Vials]** **Vials with drugs in solution are classified as either multiple-dose (also called multiple-use) or single*-dose*. Multiple-dose vials contain a small amount of a preservative agent, added to inhibit the growth of bacteria or other organisms that may inadvertently contaminate a product. Because of their toxicity, solutions with preservatives should not be used for epidural or intrathecal dosage forms and should only be used with caution in pediatric or neonatal preparations. Multiple-dose vials may be used over an extended period of time and contain multiple doses in the vial. Single-dose vials have no preservatives and are intended to be used one time only.** **[Ampules]** **Ampules are composed entirely of glass and, once broken (i.e., opened), become open-system containers. For this reason, it is not necessary to replace the volume of fluid to be withdrawn with air. Prior to breaking open the ampule the compounding personnel should ensure that all the fluids is moved to the bottom of the ampule. This may be done by:** - **Swirling the vial in an upright position** - **Tapping the top of the ampule head with a finger** - **Inverting the ampule then quickly swinging it back upright** Parts of \"one-point cut\" ampoule. **INCLUDE PHOTO OF AMPS WITH PARTS NAMED** **After ensuring all the fluid is in the bottom of the ampule the neck of the ampule should be swabbed with 70% isopropyl alcohol. The alcohol swab can be left around the neck of the ampule while breaking to project the compounding personnel's fingers from inadvertent cuts or a commercially available ampule breaker may be used. These ampule breakers are not sterile and must be sanitized before use. If there is a painted mark on the ampule head this is the pressure point. The compounders thumb on the dominant hand should be placed on this mark. Keeping the non-dominant hand still the compounder should snap the head of the ampule towards them to snap it off.** **To withdraw the solution from an ampule, it must be tipped at an angle and the bevel of the needle is placed in the upper corner space or shoulder of the ampule near the opening. This reduces the risk of aspirating glass into the syringe. Surface tension of the liquid prevent the spilling of the contents while it is tipped at an angle.** **The use of a filter needle or filter straw keeps glass or paint chips that may have fallen into the solution from being drawn into the syringe. To withdraw the solution, either use a filter needle/filter straw and then change to a regular needle before expelling the contents or start with a regular needle and change to a filter needle before expelling the contents. Either way, the filter needle must not be used for both withdrawing from the ampule or expelling from the syringe because doing so would nullify the filtering effect. If the syringe is used as the final container for dispensing, a filter needle should be used to withdraw the solution.** **Final Containers** **Flexible plastic bags made of polyvinyl chloride (PVC) are used frequently. They are easier to store, are less breakable than glass bottles, and eliminate the need to vent the container when removing fluid.** **PVC bags are available in several sizes and contain a variety of solutions. They may be packaged in plastic overwraps designed to limit fluid loss, prevent tampering, and help maintain sterility of the final bag. The protective overwrap should not be removed from a PVC bag until it is ready to be used. To minimize air turbulence in the critical area, the injection port of a PVC bag, which is covered by an outside latex tip diaphragm, should be positioned toward the HEPA filter or hung vertically from the bar when preparing an IV admixture.** **To add a drug to a PVC bag, the septum is wiped with 70% isopropyl alcohol, a needle is inserted into the injection port, and the appropriate volume of drug fluid is injected. A needle longer the 3/8 inch should be used because the injection port of the PVC bag has two diaphragms that must be punctured. The outside diaphragm is the outside latex tip; the inside diaphragm, which is plastic, is about 3/8 inch inside the injection portal. The injection should not be punctured more than three times. Anything over more than three punctures runs the risk of coring and/or leaking of the IV bag.** **IMAGE OF BAG (INJECTION PORT VS spiking port would need to be labeled)**  **Aseptic Manipulation Competency** Personnel must be able to successfully demonstrate their understanding and competency in the aseptic technique principles listed above. Personnel must complete an aseptic manipulation competency evaluation before being able to compound Category 1, 2, or 3 CSPs independently. This evaluation consists of visual observation of the individual's aseptic technique, media-fill testing, followed by a gloved fingertip and thumb sampling on both hands, and a surface sampling of the direct compounding areas. Ongoing assessment of aseptic competency depends upon the category of CSPs being compounded in the facility in which they work. Category CSP Frequency of reassessment ------------------ --------------------------------------- Category 1 and 2 Initially and at least every 6 months Category 3 Initially and at least every 3 months Media fill testing procedures utilize a sterile bacterial culture media that promotes bacterial growth. Any contamination of the fluids will result in visible turbidity during incubation. The procedure for testing is determined by the compounding facility and is meant to simulate the most challenging aseptic compounding procedures encountered within that facility. Certain factors that may contribute to the sterility of CSPs should be captured by the simulation. These include: - Number of aseptic additions or transfers - Number, type and complexity of manipulations - Number of personnel in the buffer room or SCA - Factors associated with the length of the process that can pose contamination risk (e.g., operator fatigue, quality of equipment) Either commercially available growth media or in-house prepared growth media may be utilized. Commercially kits are available to simulate either sterile-to-sterile conditions or nonsterile-to-sterile conditions. These kits typically contain a tryptic soy broth (soybean-casein digest broth) that promotes the growth of bacteria that are common contaminants of CSPs. Failure of the aseptic manipulation competency is indicated by visible turbidity in the growth media on or before the end of the incubation period, gloved fingertip and thumb sampling exceeding action levels, or surface sampling exceeding action levels. Microbial identification of the growth is not required for gloved-fingertip samples or the media fill results but may be necessary if surface sampling results exceed action levels. Results of the evaluation must be documented as well as any corrective actions taken as a result. As with the fingertip and thumb sampling these results are maintained to provide a record and long-term assessment of competency. Minimum documentation requirements: - Name of person evaluated - Evaluation date and time - Media and components including manufacturer - Expiration date - Lot number - Starting temperature for each interval of incubation - Dates of incubation - Results dentification of the observer and personnel reading and documenting the results Media-fill procedure as outlined by USP 797: - If all of the starting components are sterile to begin with, manipulate them in a manner that simulates sterile-to-sterile compounding activities, and transfer the sterile soybean-casein digest media into the same types of container closure systems commonly used at the facility. Do not further dilute the media unless specified by the manufacturer. - If some of the starting components are nonsterile to begin with, dissolve a commercially available nonsterile soybean-casein digest powder in non-bacteriostatic water to make a 3% nonsterile solution. Manipulate it in a manner that simulates nonsterile-to-sterile compounding activities. Prepare at least 1 container as a positive control to demonstrate growth promotion, which is indicated by visible turbidity upon incubation. - Once the compounding simulation is completed and the final containers are filled with the test media, perform a gloved fingertip and thumb sample on each hand and surface sample of the direct compounding area inside the PEC. Take the samples prior to disinfecting gloves and PEC. Handle and store samples to avoid contamination and prevent condensate from dropping onto the agar during incubation and affecting the accuracy of the cfu reading (e.g., invert containers). - Incubate the final containers at 20-25 degrees Celcius and 30-35 degrees Celcius for a minimum of 7 days at each temperature band to detect a broad spectrum of microorganisms. The order of the incubation temperatures must be described in the facility's SOPs. Final containers must be incubated in an incubator. - Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more closure units on or before 14 days. Action Levels for Gloved Fingertip and Thumb Sampling Gloved Fingertip and Thumb Sampling Action Levels (cfu, total from both hands) ------------------------------------- -------------------------------------------- After garbing \>0 After media-fill testing \>3 USP 797 USP 800 USP 1072 -- material on disinfectants