Compounding Sterile Preparations (CSPs) and Admixture Services in a Hospital Setting PDF

URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta...

URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta LECTURE Compounding Sterile Preparations (USP), especially USP , which sets (CSPs) and Admixture Services in a specific guidelines for the preparation of Hospital Setting compounded sterile preparations (CSPs). Compounding sterile preparations (CSPs) 1. Facility Design and Controlled and admixture services are critical Environment components of hospital pharmacy practice, particularly in providing personalized and The sterile compounding area must be safe medications to patients. These services carefully designed to maintain a controlled, involve the preparation, mixing, and contamination-free environment. The packaging of sterile medications, typically in facility includes cleanrooms, anterooms, liquid form, for intravenous (IV), and buffer areas, with controlled air quality intramuscular (IM), subcutaneous, or and airflow. intraocular administration. a. Cleanroom and Anteroom 1. Sterile Compounding  ISO Class 7 or better: The buffer Sterile compounding refers to the area where sterile compounding preparation of medications that must be takes place must meet ISO Class 7 free from contamination (microbial, standards for particle concentration. particulate, or pyrogenic). This is essential This includes laminar airflow for injectable drugs, eye drops, and workbenches (LAFWs) or biological infusions, where the risk of infection or safety cabinets (BSCs), where the air complications from contamination is high. is filtered to reduce particulate and The main objectives of sterile compounding microbial contamination. include ensuring sterility, accuracy of  Anteroom (ISO Class 8 or better): dosage, and stability of the final product. The anteroom serves as a transition space between the cleanroom and Minimum Requirements for Sterile the general pharmacy. Personnel Compounding Services don PPE in this room, and it acts as a barrier to prevent contaminants Sterile compounding involves the from entering the buffer room. preparation of medications in a sterile environment to ensure patient safety, b. HEPA Filters and Airflow Control particularly for drugs administered through  HEPA filtration: High-efficiency injectable, ophthalmic, or other routes particulate air (HEPA) filters are requiring sterility. In hospital and used to remove 99.97% of particles healthcare settings, sterile compounding ≥0.3 microns from the air. This must meet stringent standards to minimize ensures that the air in the sterile the risk of contamination, errors, and compounding area is free from adverse events. These minimum contaminants. requirements are outlined by regulatory  Airflow direction: Cleanrooms and bodies like the United States Pharmacopeia laminar airflow workbenches PROPERTY OF- TGBM,RPH  URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta LECTURE (LAFWs) maintain unidirectional place of drugs. The media is airflow (usually horizontal or incubated to detect any vertical) to keep contaminants away contamination. from the sterile product. Positive pressure is used in the buffer area c. Ongoing Training and Evaluation to push contaminated air away from the compounding space.  Regular re-evaluation of personnel competency through refresher 2. Personnel Training and Competency courses and ongoing assessments is required. Annual requalification for Sterile compounding personnel, including personnel engaged in low- and pharmacists and pharmacy technicians, medium-risk compounding is must be trained in aseptic techniques, common, while semi-annual proper use of equipment, and cleanroom requalification may be necessary for protocols. high-risk compounding. a. Initial Training 3. Aseptic Technique and Personal Protective Equipment (PPE)  Personnel must receive formal training in sterile compounding Proper aseptic technique is critical to procedures, including aseptic prevent contamination. Personnel must handling, cleaning, disinfecting, follow strict procedures when handling gowning, and gloving. sterile products and use appropriate PPE to  Training includes both theoretical minimize the risk of contamination. instruction (regulatory guidelines, contamination sources, etc.) and a. Aseptic Techniques hands-on simulation of aseptic compounding tasks.  Techniques such as hand washing, sterile gloving, and disinfection of b. Competency Testing work surfaces and equipment are mandatory before beginning  Gloved fingertip testing: This compounding. ensures that personnel can perform  Personnel must minimize hand and aseptic techniques without object movement to avoid contamination. After donning disruption of the first air (clean gloves, personnel touch sterile HEPA-filtered air) that passes over growth media with their fingertips the compounding area. to check for microbial contamination. Successful b. Personal Protective Equipment (PPE) completion without microbial growth is required.  Sterile compounding personnel must  Media fill testing: Personnel are wear appropriate PPE, including: tested periodically by preparing o Sterile gloves simulated CSPs using sterile media in PROPERTY OF- TGBM,RPH  URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta LECTURE o Sterile gown or low- c. Pressure Differentials particulate gown o Face mask and hair cover  Monitoring of pressure differentials (bouffant or hood) between the cleanroom, buffer o Shoe covers area, and anteroom ensures that o Eye protection or face positive airflow is maintained in shields (especially when sterile areas. This prevents handling hazardous drugs) contaminated air from flowing into the cleanroom. Personnel should avoid touching non-sterile surfaces, and gloves should be regularly 5. Sterilization and Disinfection disinfected with sterile 70% isopropyl Protocols alcohol during compounding procedures. The equipment, surfaces, and materials 4. Environmental Monitoring used in sterile compounding must be disinfected according to strict protocols to Environmental monitoring ensures that the ensure sterility. sterile compounding area remains free from contaminants, including microbial a. Sterilization of Equipment contamination and particulate matter.  Equipment that comes into contact a. Air and Surface Sampling with sterile products, such as syringes, vials, and filters, must be  Air sampling: Regular sampling of pre-sterilized or sterilized in-house the air in the compounding using techniques like autoclaving or environment (buffer area, filtration (for heat-sensitive anteroom) is required to monitor materials). the concentration of airborne particles and microorganisms. b. Surface Disinfection  Surface sampling: Surfaces in the compounding area (e.g.,  Surfaces and equipment in the workbenches, floors, and compounding area must be cleaned equipment) must be swabbed and disinfected before use. Sterile regularly to check for microbial 70% isopropyl alcohol is commonly contamination. used to disinfect work surfaces and tools, including the laminar airflow b. Temperature and Humidity Control workbench.  Compounding areas must be c. Routine Cleaning maintained at controlled temperature and humidity levels to  The entire sterile compounding reduce the risk of contamination area, including floors, walls, and and ensure the stability of sterile ceilings, must be cleaned on a products. routine basis. Different cleaning PROPERTY OF- TGBM,RPH  URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta LECTURE schedules (daily, weekly, monthly) with regulations and support quality are implemented depending on the improvement efforts. risk of contamination. 7. Sterility and End-Product Testing 6. Documentation and Record- Keeping Sterile compounded products, especially those prepared in bulk or those with a high- Accurate and thorough documentation is risk of contamination, may require sterility essential for sterile compounding services, testing before administration to patients. providing a record of each preparation and ensuring compliance with regulatory a. Sterility Testing standards.  Sterility tests may be required for a. Compounding Records certain CSPs, especially those prepared in high volumes or with  Every sterile compounded product high-risk methods (e.g., non-sterile must have an accompanying to sterile compounding). Products compounding record detailing: are incubated to check for microbial o Prescription information growth. (patient, drug, dosage) o Date and time of preparation b. End-Product Quality Checks o Name of the person preparing and verifying the  Visual inspection of all compounded product products is performed to ensure o Lot numbers of all there are no visible particulates or ingredients signs of contamination. o Expiration date and beyond-  Chemical testing may be performed use date (BUD) to ensure the correct concentration of active ingredients. b. Standard Operating Procedures (SOPs) 8. Beyond-Use Dating (BUD)  Written SOPs must be established for every aspect of sterile Beyond-use dates (BUDs) indicate how long compounding, including gowning, a sterile compounded product remains disinfection, environmental stable and safe for use. These are monitoring, equipment calibration, determined based on the type of and compounding procedures. preparation, storage conditions, and whether sterility testing was performed. c. Quality Assurance Documentation  Low-risk CSPs: Typically have a  Documentation of environmental longer BUD when prepared in an ISO monitoring, sterility testing, and Class 5 environment. staff competency evaluations is  High-risk CSPs: Must be used within critical to demonstrate compliance a shorter time frame unless sterility PROPERTY OF- TGBM,RPH  URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta LECTURE testing has confirmed a longer o Provide energy and calories. stability period. Dextrose is the most common form of BUDs must be clearly labeled on the final carbohydrate used in TPN product and documented in the solutions. compounding record. o The concentration of dextrose is tailored to meet 9. Regulatory Compliance the patient's caloric requirements and their Sterile compounding must comply with ability to tolerate glucose. regulations and guidelines issued by 2. Amino Acids (Protein Source): relevant authorities. In the U.S., these o Amino acids are essential for include: protein synthesis, tissue repair, and growth.  USP : Sets detailed standards o The concentration of amino for the preparation of compounded acids is adjusted based on sterile products. the patient's nutritional  FDA: For facilities engaged in needs and clinical condition. outsourcing compounding services 3. Lipids (Fats): or preparing bulk sterile products, o Lipid emulsions provide FDA oversight is necessary to ensure essential fatty acids and compliance with current good calories. manufacturing practices (cGMPs). o Lipids are typically administered separately Total Parenteral Nutrition (TPN) from the dextrose-amino acid mixture, but they can be Total Parenteral Nutrition (TPN) is a life- combined in a "three-in-one" saving intravenous therapy that provides all (3-in-1) TPN formulation that the essential nutrients required by a patient includes dextrose, amino who is unable to obtain nutrition via the acids, and lipids. gastrointestinal tract. TPN delivers a 4. Electrolytes (Sodium, Potassium, tailored mix of carbohydrates, proteins, Calcium, Magnesium, Phosphorus): fats, vitamins, and minerals directly into the o Maintain proper electrolyte bloodstream, bypassing the digestive balance and support system. TPN is commonly used for patients physiological functions such with gastrointestinal disorders, post- as nerve transmission and surgical complications, severe malnutrition, muscle contraction. or conditions that impair the absorption of o The specific electrolyte mix nutrients. depends on the patient’s electrolyte status, organ Key Components of TPN: function (e.g., kidney or liver), and clinical condition. 1. Carbohydrates (Dextrose): 5. Vitamins and Trace Elements: PROPERTY OF- TGBM,RPH  URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta LECTURE Essential vitamins (A, D, E, K, o peripherally inserted central C, B-complex) and trace catheter (PICC) or a tunneled elements (zinc, copper, catheter, because the high manganese, selenium) are concentration of nutrients included to prevent (especially dextrose) can irritate deficiencies and support peripheral veins. metabolic functions.  In rare cases, peripheral parenteral o These micronutrients are nutrition (PPN) may be used, but added as supplements to the this approach is limited due to lower TPN solution. tolerance for high dextrose 6. Water: concentrations in peripheral veins. o Water is included in TPN to maintain proper hydration Monitoring: and fluid balance. The total volume is tailored based on  Regular monitoring is essential to the patient’s fluid assess the patient’s response to TPN requirements. and to prevent complications such as electrolyte imbalances, infections Preparation of TPN: (from the central line), or metabolic disturbances like hyperglycemia.  Aseptic Compounding: TPN  Blood tests (electrolytes, glucose, solutions are compounded liver function tests, triglycerides) aseptically under sterile conditions and clinical assessments (fluid in the pharmacy, typically using balance, signs of infection) are automated compounders to ensure routinely performed to adjust the accurate mixing of the components. TPN formulation as needed. Due to the complexity of the mixture, sterility and precision are critical to avoid microbial contamination or dosage errors. Irrigations and Parenteral Admixtures  Individualized Formulations: TPN formulations are individualized Irrigations in a Hospital Setting based on the patient’s age, weight, medical condition, and nutritional Irrigations are sterile solutions used to needs. In some cases, the cleanse, hydrate, or administer therapeutic formulations may be adjusted daily agents to body tissues, cavities, or wounds. to reflect changes in the patient's In sterile compounding, irrigations must be metabolic status, laboratory results, prepared with the same care and aseptic or clinical condition. technique used for parenteral preparations to avoid introducing infections or Delivery Methods: contaminants into sensitive areas such as the eyes, bladder, or surgical sites.  TPN is delivered through a central venous catheter (CVC), such as a Types of Irrigation Solutions: PROPERTY OF- TGBM,RPH  URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta LECTURE 1. Bladder Irrigation:  Sterility: Like all sterile o Used to cleanse the bladder compounding, irrigations must be and prevent or treat prepared in an ISO Class 5 infections or blockages, often environment to maintain sterility. following urologic surgery. The risk of infection is high if o Sterile saline or other contaminated solutions are antiseptic solutions may be introduced into sterile body sites. used to irrigate the bladder  Isotonicity: Solutions used for through a catheter. irrigation must often be isotonic to 2. Wound Irrigation: avoid tissue damage or irritation. o Used to cleanse wounds or For instance, sterile saline (0.9% surgical sites to remove sodium chloride) is commonly used debris, reduce bacterial load, because it mimics the osmolarity of and promote healing. body fluids. o Solutions like sterile saline or specialized antiseptic solutions are commonly used for wound irrigation. Parenteral Admixtures 3. Eye Irrigation: o Sterile saline or specific Parenteral admixtures refer to the process ophthalmic solutions are of mixing multiple medications or used to cleanse the eyes or components into a single sterile treat conditions like chemical intravenous (IV) solution for administration burns, foreign bodies, or to patients. These admixtures can include infections. antibiotics, electrolytes, vitamins, or other o Sterility is paramount to drugs added to IV fluids. avoid introducing pathogens that could cause eye Examples of Parenteral Admixtures: infections. 4. Intraoperative Irrigation: 1. IV Antibiotic Admixtures: o During surgery, sterile o Antibiotics such as solutions are used to clean vancomycin, ceftriaxone, or surgical sites or body piperacillin-tazobactam are cavities. often added to IV fluids to o Common irrigating solutions treat infections. These include saline, lactated admixtures must be Ringer’s, or antibiotic- prepared aseptically to avoid containing solutions, contamination. depending on the clinical o The stability of the drug in scenario. solution and the compatibility of the drug Considerations for Irrigation Solutions: with the diluent (e.g., saline, dextrose) must be verified before compounding. PROPERTY OF- TGBM,RPH  URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta LECTURE 2. Electrolyte and Mineral drugs may interact or Admixtures: precipitate when mixed with o Electrolytes like potassium certain diluents or other chloride (KCl), magnesium medications, which can sulfate (MgSO4), or calcium compromise the efficacy of gluconate are often added to the treatment or cause harm IV fluids to correct to the patient. electrolyte imbalances. o For example, calcium and o Care must be taken to phosphate must be added ensure compatibility carefully to TPN solutions, as between different they can precipitate if the electrolytes and to prevent concentrations are too high precipitation or degradation or if the mixing order is of the components. incorrect. 3. IV Vitamin and Mineral Admixtures: 3. Stability and Shelf Life: o For patients requiring o The stability of the additional vitamins or trace compounded admixture elements, these can be must be evaluated to ensure added to the IV solution, that it remains effective and especially in TPN safe until it is administered formulations. to the patient. Certain drugs o Common vitamins include degrade over time, especially the B-complex vitamins (B1, if they are sensitive to light, B6, B12), vitamin C, and fat- heat, or specific pH levels. soluble vitamins (A, D, E, K). o Proper storage conditions (e.g., refrigeration, Considerations for Parenteral Admixtures: protection from light) are critical for maintaining the 1. Aseptic Technique: stability of the admixture. o All admixtures must be 4. Labeling: prepared in an aseptic o Each parenteral admixture environment under a laminar must be properly labeled airflow hood to maintain with all relevant information, sterility. including the names and o Personnel must wear concentrations of the drugs, appropriate PPE and adhere the volume of the solution, to strict aseptic techniques the patient’s name, the to prevent contamination preparation date, and the during the compounding expiration date. process. o Clear labeling helps to 2. Compatibility: prevent medication errors o Drug compatibility is a major and ensures the correct concern when preparing dosage is administered to parenteral admixtures. Some the patient. PROPERTY OF- TGBM,RPH  URDANETA CITY College of Pharmacy HOSPITAL PHARMACY UNIVERSITY Owned and operated by the City Government of Urdaneta LECTURE 5. Administration Considerations: o Parenteral admixtures must be administered via IV infusion, often using electronic infusion pumps to ensure accurate dosing over a specified period. o The rate of administration is critical, especially for drugs like potassium or magnesium, which can cause adverse effects if infused too quickly. PROPERTY OF- TGBM,RPH