Chapter 15-17: Compounding (NAPLEX) Flashcards
U.S Pharmacopeia: What are they?
U.S Pharmacopeia (USP) sets standards for compounding (preparation, strength, quality, and purity of human/ animal drugs - including manufactured and compounded drugs). USP 795, 797, and 800 are considered to be minimum acceptable standards for compounding for FDA.
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Notes: Hopsital pharmacist relies on The American Society of Health System Pharm (ASHP) for detailed guidance on implementing USP standards
List the different USP and what they entail
Non-Sterile Compounding
Non-Sterile Compounding is primarily used to:
- prepare dose or formulation that is not commercially available such as: changing a solid tablet to liquid for a patient who cannot swallow, compounding a 10% ointment when only 5% and 15% is available
- Avoid an excipient (d/t sensitivity/ allergies like gluten or red dye)
- Add a flavor
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Often include: meds that are PO, via tube, rectally, vaginally, topically, nasally or ear
Non-Sterile Compounding
Non-Sterile Compounding: Physical Space
Compounding space should be specifically designed for non sterile compounding. Non sterile compounding can be done in ambient air/ room air but must be separated from dispensing part.
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Adequate space + shelves needed and all equipement, containers, components must be off the floor. Space should be clean and well lit.
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There needs to be adequate plumbing and two types
of water:
1. Potable (drinkable - from the tap), for hand and equipment washing
2. Purified (e.g., distilled), for use in compounded formulations that include water, and for rinsing equipment and utensils.
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Sink should also be clean and have single use towels (sanitary method to dry hands)
Sterile Compounding
Sterile Compounding
Sterile compounding involves stringent procedures to ensure contamination-free products, particularly crucial for intravenous drugs. Contamination risks include microorganisms and foreign particles.
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Sterile compounding is use to prepare: Injections (IV, IM, SC), eye drops, Irrigations, pulmonary inhalation
USP Terminology
CSPs
compound sterile products (IVs or other drugs that require sterile manipulation)
USP Terminology
SVP
small volume parenteral (IV bags < 100mL)
USP Terminology
LVP
LArge volume parenteral (IV bag > 100mL)
USP Terminology
PEC
Primary engineering control - sterile hood that provides ISO 5 air for sterile compounding
USP Terminology
LAFW
Laminar Airflow Workbench - Type of sterile hood (PEC); parallel air steams flow in one direction
USP Terminology
C-PEC
Containment Primary Engineering Control - ventilated (negative pressure) chemo hood used for HDs
USP Terminology
BSC
Biological safety cabinet - chemo hood (class 2 or 3 for sterile HD)
USP Terminology
SEC
Second Engineering Control - ISO 7 buffer room where the sterile hood (PEC) is located
USP Terminology
C-SEC
Containment Secondary Engineering Control - Ventilated (negative pressure) buffer room for hDs (room where the C-PEC is located)
USP Terminology
SCA
Segregated Compounding Area - designated space that contains an ISO 5 hood but not part of a cleanroom suite (air is not ISO-rated)
USP Terminology
C-SCA
Containment Segregated Compounding Area - ventilated (negative pressure) room used for HDs; not in a cleanroom suite (air is not ISO- rated)
USP Terminology
CAI
Compounding Aseptic Isolator - “Glovebox” for non-HDs, a closed front sterile hood (PEC)
UPS Terminology
CACI
Compounding Aseptic Containment Isolator - Glovebox for HDs, a type of closed-front C-PEC
UPS Terminology
RABS
Restricted Access Barrier System - Glovebox/ closed front sterile hood (including CAIs and CACIs)
UPS Terminology
CSTD
Closed System Transfer Device - device preventing escape of HD/ vapors when transferring
USP Terminology
CVE
Containment Ventilated Enclosure - ventilated “power hood” for non-sterile products
Sterile Compounding: Air quality and HEPA filters
- Clean air is crucial in the compounding area to minimize contamination risks. International Standards Organization (ISO) establishes air quality standards based on particle count per volume of air. The lower the particle count, the cleaner the air.
- In critical areas like inside sterile hoods, air must meet at least ISO 5, meaning no more than 3,520 particles per cubic meter of air, with particles of 0.5 microns or larger counted.
-Air quality requirements vary depending on proximity to exposed sterile drugs and containers: Inside the Primary Engineering Control (PEC) must be at least ISO 5. Buffer areas containing PECs must be at least ISO 7. The anteroom, where hand washing and garbing occur, must be at least ISO 8 if opening into a positive-pressure buffer area (non-HD sterile compounding), or ISO 7 if opening into a negative-pressure buffer area (HD sterile compounding).
Regular room air, or “ambient” air, is unclassified and not rated by ISO (~ISO 9)
Sterile Compounding
ISO ratings in the different compounding areas and particles/m3
High-efficiency particulate air (HEPA)
High-efficiency particulate air (HEPA) filters effectively capture particles, including bacteria, viruses, fungi, and dust, with an efficiency of over 99.97% for particles as small as 0.3 microns.
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In vertical airflow biological safety cabinets (BSCs) or compounding primary engineering controls (C-PECs) the HEPA filter is positioned at the top, while in laminar airflow workbenches (LAFWs) or compounding primary engineering controls (PECs), it’s located at the back of sterile hood (horizontal airflow). A blower pushes air through the HEPA filter, trapping contaminants before entering the PEC. Compounding should ideally occur in the area directly receiving air from the HEPA filter, known as the direct compounding area (DCA), where the air is termed “first air.” HEPA filters require recertification every six months and whenever a PEC is relocated.
The dots in the image below show the relevant amount of particles in the air. Ambient (room) air is not rated; if it were, most room air would be about ISO 9 (look at pic)
Sterile Compounding
Air Pressure: What part requires negative vs positive pressure
Apart from maintaining ISO air quality standards, ensuring appropriate air pressure differentials between spaces is crucial. Differentials regulate air movement, either containing it within a space or allowing it to flow into adjacent areas. Positive air pressure is suitable for non-hazardous compounding areas like PECs and SECs, preventing contamination without toxicity concerns. However, for hazardous compounding, containment areas like C-PECs and C-SECs require negative pressure to confine toxic air. Non-sterile hazardous compounding in non-ISO-rated spaces necessitates negative air pressure rooms.
Types of Sterile Compounding Areas
- Cleanroom suite: one or more sterile hood (ISO 5 PECs) inside an ISO 7 Buffer Room (SEC) that is entered thru an adjacent anteroom
- Segregated compounding area (SCA) with an ISO 5 PEC: a sterile hood, often an isolator (glovebox) with a closed front, located in a segregated space with unclassified air
PECs for Non-Hazardous Sterile Preparations: PECs used for nonhaz compounding have HEPA filtered air and positive air pressure
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Talk about laminar airflow benchwork (LAFW)
It’s an open front PEC where air flows out in parallel lines from HEPA filter, typically from back of hood (ie horizantal laminar airflow). Laminar airflow keeps cleaner air in PEC from mixing with dirty air in buffer room
PECs for Non-Hazardous Sterile Preparations: PECs used for nonhaz compounding have HEPA filtered air and positive air pressure
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Talk about Compounding aseptic isolator (CAI)
it’s a closed front PEC often located in the segregated compounding area (SCA). The clsoed front keeps unclassifed room air from mixng with clean air in the PEC
Sterile Compounding
Talk about Secondary Engineering control
SEC is the room that contains PEC. SEC is sometimes called the buffer area (buffer of relativly clean air of ISO 7 around the PEC which is ISO 5)
Talk about the segregated compounding area
SCA is an option when a cleanroom is not able to be installed. It’s a designed area with unclassified air, such as a corner of that pharmacy. The max BUD for a CPS made in an SCA is 12 hours (room temp) and 24 hr (fridge)
The National Institute for Occupational Safety and Health (NIOSH) determines which drugs are hazardous. A drug is considered haz if it is:
- Carcinogenic
- Teratogenic
- Genotoxic
- Toxic to organ
- labeled by manufactures with special handling instructions
Safety Data Sheets (SDS): Talk about it
Series of safety documents required by OSHA to be accessible to all employees who are working with hazardous materials/ drugs.
Hazard Communication Program: Talk about it
Each facility must have desinated person responsible for creating worker safety procedures for handling hazardous drugs. This include a written plan for implementing safety measures, training, assessing competency, and maintaining documents.
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Pharamcies must maintain a list of all HDs stocked, which should be reviewed annually or when new drugs or doseage forms are introduced.
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Men and women capable of reproduction must provide written confirmation of their understanding of risk of handling HDs
Assessing Risk for Hazardous Drugs (HDs)
USP 797 and USP 800 have different definitions of risk. USP 797 focuses on the risk of contamination of sterile products, while USP 800 considers the risk of harm to workers exposed to hazardous drugs.
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USP 800 has extensive requirements for the safe handling of hazardous drugs, but some activities are considered lower risk, such as counting and packaging tablets. Pharmacies can conduct an Assessment of Risk (AoR) for lower-risk drugs and develop Stand Operating procedures (SOPs) to limit staff exposure. This includes using distinctive shelf bins, wearing appropriate gloves, dedicating counting trays and spatulas, and using sealable bags for prepared hazardous drug containers. If any manipulation of the low-risk hazardous drug is required, full USP 800 requirements must be followed. The AoR documents must be reviewed annually and documented.
When compounding hazardous drugs, both sterile and non-sterile compounds must be prepared in a Containment Primary Engineering Control (C-PEC) that is located in a Containment Secondary Engineering Control (C-SEC) or Containment Secondary Control Area (C-SCA). There are different types of C-PECs available:
- Biological Safety Cabinets (BSCs): These cabinets have vertical laminar airflow that flows down from a HEPA filter at the top of the hood. They provide negative air pressure to protect the worker from exposure to hazardous drugs. Class II or Class III BSCs are required for sterile hazardous drug compounding.
- Containment Ventilated Enclosures (CVEs): These are powder containment hoods with HEPA-filtered air and negative air pressure. They are used for non-sterile compounding only.
- Compounding Aseptic Containment Isolators (CACIs): These closed-front C-PECs, also known as gloveboxes, can be located in a buffer room (C-SEC) but are often placed in a C-SCA.
Non-Sterile and Sterile HD Compounding in the same space
While it’s prefer to keep non sterile and sterile compounding space seperate, exceptions can be made if requirements are met:
- C-SEC must maintain ISO 7
- if there are separate sterile amd non sterile C-PECs in the same C-SEC they must be 1 meter apart
Air Handling For Hazardous Drugs
What area/ things must have negative air pressure
C-PECSs, C-SCAs, and C-SECs must have negative air pressure
Air Handling For Hazardous Drugs
Air Changes: Air in space used for HDs compounding can get contaminated and needs to be regularly replaced. The air changes per hour (ACPH) is the # of times (per hour) that the air is replaced in the room..
What is the ACPH in these areas
1. Space where non sterile HDs are compounded
2. Sterile C-SEC
3. C-SCA
- Space where non sterile HDs are compounded: at least 12 ACPH
- Sterile C-SEC: at least 30 ACPH
- C-SCA: at least 12 ACPH
Compounding Staff Training: Inital and Continous
- Inital: includes didatic training, hands-on training which is observed by a desinated personin charge of compounding.
- Continous: on-going training. When work is new or different, the staff must recieve that new training.
Gloved Fingertip Test
The gloved fingertip test is required annually for compounding low- and medium-risk CSPs, or semiannually for high-risk CSPs. The compounder’s gloved fingertips are sampled using tryptic soy agar (TSA), which promotes microbial growth if contamination is present. After incubation for 2-3 days, any visible colony-forming units (CFUs) indicate glove contamination.
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Passing a gloved fingertip test
- inital: passing requires 3 consecutive gloved fingertip samples (with 0 CFU)
- Ongoing: at least one sample taken from each hand immediately after completion of media fill test with goal of < 3 CFUs
Media-Fill Test
The media-fill test is used to determine if a compounder is preparing CSPs in an aseptic manner. Test must be done initially and annually for low/med risk level compounding.
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Tryptic soy broth (TSB) is taking the place of the
drug in the preparation. TSB is a growth medium used by the organisms to replicate. A small Iv bad or vial can be used for the test. Multiple aseptic manipulations (transfers using the same syringe) are done and then the product is incubated and checked for bacterial growth. Turbidity/ cloudiness = contamination!.
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Passing test: if the liquid stays clear after 14 days of incudation.
Temprature Monitoring:
1. Buffer room (SEC)
2. Refrigerator
3. Freezer
- Buffer Room (SEC): The SEC should be checked once daily and maintained at a temperature of 20°C (68°F) or cooler.
- Refrigerator: The refrigerator should be monitored daily, unless it contains vaccines. In that case, monitoring should be done twice daily. The temperature range for the refrigerator should be between 2°C and 8°C.
- Freezer: If the freezer contains only compounded sterile preparations (CSPs) and no vaccines, the temperature should be maintained between -25°C and -10°C, as per USP 797 guidelines. However, if the freezer also stores vaccines, the required temperature range is -50°C to -15°C, according to CDC guidance.
Alongside personnel testing such as the gloved fingertip and media-fill tests, other tests ensure the compounding environment is free of contaminants. These tests include:
- Air sampling: preformed every 6 months
- Surface sampling: perfromed periodically; areas touched most frequently should be tested at the end of the day.
- Air pressure: preformed once daily (minimally or with every work shift, to confirm the correct differential pressure between 2 spacesand ensure that airflwo is unidirectional
- Humidity testing: once daily (minimally)
KEEP THE PEC RUNNING AND WHAT TO DO DURING OVER OUTAGE???
All PECs and C-PECs should ideally remain operational to maintain clean surfaces. In the event of a power outage, compounding must cease, and PECs require cleaning with germicidal detergent followed by disinfection with sterile 70% isopropyl alcohol before resuming activity. C-PECs necessitate a more complex sanitization process after power restoration. After power restoration, both PECs and C-PECs must be operational for at least 30 minutes before compounding resumes.
Clean the PEC continuously: Overview
The PEC undergoes frequent cleaning throughout the day and a final cleaning at day’s end before attending to the SEC and anteroom. Lint-free sterile wipes are utilized for cleaning, first with a germicidal detergent followed by 70% IPA disinfection. Pre-soaked wipes or a spray bottle can be employed, avoiding spraying inside the PEC. Cleaning involves unidirectional strokes with overlapping coverage, changing wipes regularly. PECs are cleaned from top to bottom, back to front . This means that the cleanest areas will be cleaned first, and the dirtiest areas will be cleaned last .
HAZARDOUS DRUG COMPOUNDING
CLEANING SPECIFICS: Sanitization
All areas and equipment handling Hazardous Drugs (HDs) require daily sanitation, involving deactivation, decontamination, and cleaning. Sterile compounding areas and equipment are disinfected last to prevent HD residue spread. Wetted wipes are preferred over spray bottles to avoid aerosolizing HD residue. Workers must wear appropriate PPE, including NIOSH-approved fit-tested respirators when opening containment devices. Commercial kits like Peridox RTU simplify the process, while bleach or peroxide can be used, but bleach may corrode stainless steel surfaces, necessitating neutralization with sodium thiosulfate or other agents. All HD-handling areas (receiving, compounding, administering, disposal) and reusable equipment must undergo routine deactivation, decontamination, and cleaning per USP 800 guidelines, with immediate decontamination required for spills.
Drug Exposure: what are the steps to take
Immediate action is crucial when a staff member experiences exposure, whether to a non-Hazardous Drug (HD), a workplace chemical, or an HD. The first 10 to 15 seconds post-exposure are critical. Urgent steps include removing the drug or chemical from the person promptly. Emergency protocols should be readily available in the pharmacy. Key actions to take include:
-Removing contaminated garments.
-Cleansing affected skin with soap and water.
-Flushing eyes with water or an isotonic eyewash for at least 15 minutes.
-Seeking medical attention as needed.
-Documenting the exposure in the employee’s record.
Respiratory Protection
When unpacking Hazardous Drugs (HDs) without plastic containment, staff should wear an elastomeric half-mask with a multi-gas cartridge and P100 filter until packaging integrity is confirmed. While an N95 respirator is sufficient for most HD compounding, it doesn’t protect against gases, vapors, or liquid splashes. Respiratory protection is necessary during direct HD exposure, such as:
-Cleaning up spills requiring more supplies than provided by a spill kit.
-Deactivating, decontaminating, and cleaning beneath the work surface of a C-PEC.
-Known or suspected airborne exposure to HD powders or vapors.
-Disposal of PPE contaminated with trace amounts of HDs.
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For respiratory exposure risks, wear either a fit-tested respirator mask with attached gas canisters or a powered air-purifying respirator (PAPR), which blows filtered air to the user. PAPRs are more comfortable but require a charged battery for proper operation.
Administering Hazardous Drugs
When administering Hazardous Drugs (HDs), appropriate Personal Protective Equipment (PPE) is essential. Two pairs of chemotherapy gloves are necessary for all HD administrations. A chemotherapy gown is required for IV HDs and recommended for other routes (e.g., oral). Closed-system drug transfer devices (CSTDs) should be utilized during drug administration if available, along with chemotherapy pins to prevent aerosolization during reconstitution and administration. Closed-system transfer devices are encouraged to contain HDs during transfers, reducing leaks and spills. Avoid manipulating oral HDs whenever possible; if necessary, do so in a plastic bag to contain particles.
Disposal: How should Personal Protective Equipment (PPE) be handled when dealing with Hazardous Drugs (HDs), and what are the disposal procedures for both trace and bulk antineoplastic waste?
All Personal Protective Equipment (PPE) used during handling of Hazardous Drugs (HDs) is considered contaminated with trace amounts. Outer chemotherapy gloves worn during compounding are disposed of in a yellow trace chemotherapy waste bin inside the C-PEC or sealed in a bag if discarded outside. Remove outer gloves before handling and labeling compounded HDs. Trace antineoplastic waste (e.g., empty vials, syringes, IV bags, gloves, gowns, pads) is discarded in a yellow container for incineration.Bulk antineoplastic waste, including unused or partially empty IV bags, syringes, and vials, is disposed of in a black container for incineration.
GARB FOR HAZARDOUS DRUG: General
Appropriate PPE is essential throughout HD handling processes, including receiving, storage, transportation, compounding, administration, sanitation, and spill control. Double ASTM D6978-rated (chemo rated) gloves are required for compounding and spill cleanup, while single gloves suffice for receiving and storage.
PPE for NON-sterile hazardous drug compounding includes:
■ Double gloves, a gown, a mask and
■ A disposable pad to protect the work surface
PPE for sterile hazardous drug compounding includes:
■ Head covers, a face mask and (if applicable) beard covers
■ Two pairs of shoe covers
■ A gown impermeable to liquids
■ Two pairs of ASTM D6978(chemotherapy)-rated gloves
■ A full-facepiece respirator or a face shield with goggles when there is a risk for spills or splashes
Garbing for Sterile Compounding: Garb is donned in the ante-area. The order in which the garb should be donned is from dirtest to cleanest
- Remove coats, rings, watches, bracelets, and makeup before entering the ante area. Artificial or long nails are not permitted. No makeup is allowed due to shedding.
- Don head and facial hair covers, face masks, and shoe covers upon crossing the line of demarcation. Use a second pair of shoe covers for compounding HDs. Verify hair coverage using a mirror in the ante area.
- Perform hand hygiene with soap and warm water, focusing on cleaning under fingernails and vigorously washing hands and forearms for 30 seconds. Dry with lint-free disposable towels.
- Don a non-shedding gown that fits snugly around the wrists and has a neck enclosure. Disposable gowns are mandatory for HD compounding and preferred for non-HD compounding. Launder reusable gowns before reuse.
- Enter the buffer area (SEC) and apply an alcohol-based surgical hand scrub for the recommended duration. Consider alternative options like povidone-iodine if allergic to chlorhexidine.
- Don sterile, powder-free gloves, with two pairs of ASTM D6978-rated gloves required for compounding HDs. Tuck one pair under gown cuffs and place the second pair over cuffs. Routinely sanitize gloves with 70% IPA during compounding.
- Ensure all garb is used when compounding with an isolator (glove box) unless the manufacturer states otherwise.
- When leaving the compounding area, dispose of all garb except the gown if not visibly soiled. The gown can be kept on the clean side of the ante area for reuse within the shift but cannot leave the area. Replace all other garb and repeat hand hygiene upon re-entering the compounding area.
Garbing for Hazardous Drugs: just know general stuff
Cylinder vs Conical Graduates: Measuring Volume
A graduate cylinder has the same diameter from top to bottom - which is more accurate than a conical graduate which has a wider mouth (making it easier for glass rod to mix) but the wider mouth has lower accuracy.
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Some important things to consider/ keep in mind mind:
- a graduate should not be used to measure volume less than 20% of the graduates capacity = higher error
- To read volume must be view at eye level
- The liquid can curve downward from both sides = this is called meniscus
- The bottom of the meniscus (at the center) is the true volume!
Syringes used for non sterile compounding
- syringes are more accurate for smaller volumes
- useful for measuring viscous liquids
- If patient needs a VERY accurate dose, should use syringe
- all syringe packages should be wiped off with isopro alcohol 70%
- Recapping needles can lead to needle stick injuries. So in general, DO NOT recap syringes! It is preferred to use syringes with safety features
Pipettes: talk about them
Pipettes are thin plastic/ glass tubes used to measure small volumes.
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A volumetric pipette draws up a set volume only, which is the amount a pipette can hold
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A mohr pipette is graduated and is used to measure different volumes
Weighing Equipment: Class III (Class A) torsion balance
Older and not as common. These have sensitivity requirments and need calcualtion for the minimum weighable quantity (the amount that can be weighed) is calculated based on the sensitivity requirement and the acceptable error rate (typically 0.05 or 5%)
Weighing Equipment: top-loading electronic balance (aka analytical scale)
More commonly used. This balance is simple to use/ has higher sensitivity
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When using, must remember to zero out (tare) the balance after placing a boat to ensure that you are only measuring the ingredients
List the 3 different types of mortars
- Glass Mortar: used for liquids (suspension/ solutions) that are oily and can statin
- Wedgewood mortars: have a rough surface + preferred for grinding dry crystals/ hard powder
- Porcelain mortars: smooth surface and are preferred for belding powder/ pulverizing gummy consistancy
Electric Mixing Equipment
Mixing can be done manually or with electric mixing equipment, which speeds up the process. Ointment mills, homogenizers, and grinders are used to mix ingredients. Ointment mills and grinders reduce particle size, increasing the surface area and rate of drug absorption. Ointment mills draw the preparation between rollers to grind and homogenize the ingredients. Homogenizers, similar to powerful blenders, are used to mix ointments and creams. They can be handheld and come in brands like Unguator, PharmaRAM, or Mazerustar Mixer. Electric grinders, similar to coffee bean grinders, can be used to grind hard tablets, but they should only be used for compounding purposes.
Heating Device: hot plates
A hot plate with a magnetic stirrer can save time by continuously stirring the mixture to dissolve and mix the ingredients. The stirrer has a rotating magnet under the ceramic plate, which moves the stir bar inside the glass to spin and stir the components. Hot plates can also be used without the stir bar for heating purposes, and a glass stirring rod can be used to mix contents manually.
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Hot plates provide direct heat to soften and melt ingredients, and they can be used with a water bath to carefully control the temperature and prevent burning. The water bath involves placing the container with the ingredients into a larger container filled with water, which acts as a barrier between the direct heat source and the ingredients.
Molds, tablet presses and capsule machines: Molds are used to prepare tablets, lozenage, and suppositories. Talk about how the process is to make tablets and capsules
Tablet
-A tablet press is two plastic or metal plates used to compress damp powder into tablets
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Capsule
- capsules can be soft gel or hard shells. The shells are made from gelatin (which is pork derived) or hypromellose (plant derived). Capsules sizes used for human ranges from 000 (largest) to 5 (smallest)
Surfactants - talk about it and it’ main purpose in compounding
Surfactants are used in preparations like salad dressings to prevent the separation of different phases, such as oil and water. When shaken, the oil and water in salad dressing quickly separate because of the high tension between their surfaces. However, adding a surfactant lowers this tension and keeps the phases from separating. Surfactants work by reducing the surface tension between the ingredients, making them more miscible and easier to mix together. They can form micelles, where the oil interacts with the lipophilic end of the surfactant and the water interacts with the hydrophilic end. Surfactants can also use other mechanisms, such as forming a film between the surfaces or creating an electrically-charged layer to keep the phases separate. In all cases, surfactants help with the preparation and stabilization of substances.
Types of Surfactants (part 1)
- Wetting Agents
- Emulsifiers
- Suspending Agent
1. Wetting Agents: susbtance use to lower surface tension between liquid and solid, allowing liquid ti spread more easily. They are used to wet fine powder before mixing it in to suspension, creating a thick paste
2. Emulsifiers: An emulsion is a mixture of two or more liquids which are not blendable (immiscible). Emulsifer is added to keep the liquid droplets dispersed throughout the liquid vehicle
3. Suspending Agent: A suspension consists of solid particles dispersed in a liquid, like amoxicillin powder in water. Suspending agents are added to prevent settling, but they don’t prevent separation for long. Before use, suspensions must be shaken to redistribute the solid. These agents can also be called dispersants or plasticizers, like sorbitol, which aids in shaping gelatin capsules.
How to prepare ointment
- Powders should be triturated well, using levigating agent (levigating agent must be miscible with base)
- The powder will be mixed into the ointment base, using geometric dilution
- Certain ointment will require heat in order to mix the components together well (aka fusion method) - a water bath used to heat ointment will help prevent overheating
BUD for Sterile compounded products based on categories
Sterile Compounding
Cleaning, Disinfecting, Sporicidal: when to clean each sites/ how often
Enviromental monitoring + cleaning: where and how often
Sterile Compounding
Personnel Training Schedule
