CSPT Exam: Sterile Compounding Decisions and Practice Study Guide

Apply it

An order specifies potassium chloride 20 mEq as an infusion additive. The selected Hospira concentrate contains 2 mEq/mL, so the calculated withdrawal is 10 mL. Confirm the authorized diluent and final volume, dilute the concentrate, and mix completely. This vial is an additive requiring dilution; its drug identity does not make it a ready-to-administer infusion. Similarly, the cited methotrexate label supplies both preserved and preservative-free products at 25 mg/mL, so concentration alone cannot establish formulation suitability.

Apply it

Two heparin products have similar labels but different units per milliliter. Before withdrawing the calculated volume, compare the selected strength with the preparation record and complete the facility's required verification of the component and calculation.

Apply it

A technician preparing a route-specific formulation finds two injectable products with the same active ingredient. One matches the authorized formulation; the other has different excipients. Select the matching product and resolve any proposed substitution before compounding.

Apply it

A learning exercise specifies 250 mL of 5% dextrose injection. Calculate the dextrose content as 5 g per 100 mL multiplied by 250 mL, giving 12.5 g in the stated volume.

Apply it

A reference supports a drug at a stated concentration in glass under refrigeration. The proposed preparation uses a different concentration in a plastic syringe. Identify both mismatches before accepting the reference's storage period for the proposed product.

Apply it

Two components remain clear immediately after mixing, but no compatibility support exists for their concentrations. Do not treat appearance as authorization to proceed; obtain an assessment of the specific combination before preparation or release.

Apply it

A worksheet proposes Lactated Ringer solution as the mixing solution for ceftriaxone. Recognize the calcium-containing diluent as the decisive issue and stop the proposed mixture for correction before any component is transferred.

Apply it

A hypothetical CSP is aseptically compounded from sterile commercial components in an ISO Class 5 LAFW within a compliant Category 2 cleanroom suite. It has not undergone sterility testing and will remain at 2–8°C. These facts select a 10-day microbial ceiling. If exact-formulation stability supports only 7 days in its container, assign no more than 7 days from preparation start, assuming no shorter limit applies. Moving that LAFW into an unclassified SCA restricts preparation to Category 1's 24-hour refrigerated ceiling. In contrast, a qualifying pharmaceutical isolator in an ISO Class 8 room may support Category 2 or Category 3 preparation when the applicable equipment, placement, and category-specific requirements are satisfied.

Apply it

A technician needs both a dilution instruction and a spill response. Use product labeling or an appropriate compounding reference for dilution, and the hazardous-drug procedure together with relevant hazard information for exposure and spill controls.

Apply it

A technician adds the authorized potassium chloride quantity to an infusion container and immediately offers it for checking. Complete the specified mixing step and required verification before the preparation can proceed to release review.

Apply it

For a nonhazardous sterile admixture, a properly certified LAFW or CAI can provide product protection. For sterile hazardous-drug manipulation, choose a suitable externally exhausted Class II or Class III BSC or CACI with the required ISO Class 5 environment and room controls. A Class I BSC may control exposure during appropriate nonsterile work, but its inward room air can carry contaminants over exposed sterile components.

Apply it

A technician proposes using a horizontal airflow workbench for a hazardous preparation because it provides clean air. Identify the missing containment function and move planning to an appropriate hazardous-drug control arrangement before compounding begins.

Apply it

A proposed nonhazardous cleanroom suite has an ISO Class 7 positive-pressure buffer room receiving 30 HEPA-filtered ACPH from ceiling HVAC and an ISO Class 8 anteroom receiving 20 from ceiling HVAC. This arrangement meets the stated classification and air-change minima. If that same ISO Class 8 anteroom also provides access to a negative-pressure buffer room, it is inadequate: the anteroom must meet ISO Class 7 or better and its corresponding minimum of 30 total HEPA-filtered ACPH.

Apply it

A hazardous-drug containment room is designed to remain negative to the corridor, but the monitor shows pressure reversal. Recognize that the intended airflow relationship is compromised and initiate the facility's specified response before continuing affected work.

Apply it

An enclosure's fan operates normally, but certification identifies leakage around the filter perimeter. Treat the installed filtration system as deficient and follow the required corrective process before returning the affected equipment to compounding service.

Apply it

A room meets its required particle classification, but surface cultures show a concerning pattern. Investigate the microbiological findings rather than dismissing them because the separate nonviable particle assessment was acceptable during the same evaluation period.

Apply it

An airflow study uses an empty workbench, while routine work places a large device upstream of open components. Request evaluation with representative equipment and manipulations so the actual obstruction and its effect on critical sites can be assessed.

Apply it

An elevated viable air result occurs near a work area after an unusual maintenance event. Review the sampling details and associated activities, then investigate the possible contamination source instead of treating the number as an isolated administrative finding.

Apply it

Air monitoring is acceptable, but repeated surface samples from a frequently handled location show increased recovery. Investigate cleaning effectiveness and contact practices at that location rather than concluding that the acceptable air result resolves the concern.

Apply it

An ISO Class 5 air sample collected during compounding yields 2 CFU from 1000 L, equivalent to 2 CFU/m³ and above the air action level. A separate surface-sampling plate yields 4 CFU, exceeding the surface action level. Document the findings, attempt organism identification to genus, investigate airflow, personnel practices, cleaning, and recent changes, assess affected work, and verify corrective-action effectiveness. Successive surface counts of 0, 1, and 3 CFU do not exceed the numerical threshold but may warrant investigation as a rising trend. For Category 3 robotic compounding, a self-enclosed device established to meet the closed RABS definition qualifies for at least daily PEC surface sampling at the end of operations. Another robot described only as automated and enclosed has not established that criterion; retain the ordinary after-each-batch requirement.

Apply it

A hypothetical facility adopts limits of no more than 20°C and less than 60% RH, with an SOP requiring work to pause during excursions. Its logger records 23°C and 65% RH for 45 minutes while two Category 2 admixtures are prepared. Pause work, document the interval and affected preparations, investigate HVAC performance, and evaluate product exposure and environmental conditions before disposition. A separate refrigerator logger remaining at 4°C supports continued assessment against refrigerated storage criteria. For instrument verification, this facility's stated tolerances of ±0.5°C and ±3 percentage points RH would accept readings of 19.8°C and 49% RH against references of 20.0°C and 50% RH.

Apply it

A pressure alarm occurs during compounding shortly after maintenance. Follow the required operational response, preserve the alarm and maintenance details, and identify potentially affected work so the responsible personnel can assess impact and restoration of control.

Apply it

A delivery includes outer shipping cartons and individually packaged compounding supplies. Apply the facility's material-entry process before bringing items into controlled areas, and keep unnecessary outer packaging and personal belongings outside the designated compounding environment.

Apply it

A new employee obtains 1 CFU after an initial garbing evaluation: the zero-CFU criterion is not met, so initial qualification remains incomplete. A Category 2 compounder undergoing the ongoing 6-month assessment must demonstrate garbing under observation and have post-garbing samples collected before sterile 70% IPA is applied to the gloves. That person must also complete the separate scheduled aseptic manipulation assessment; passing the media fill does not replace the garbing assessment. If an established compounder has 4 CFU after a media fill, that result exceeds the post-media-fill action level. Investigate glove donning, touches during manipulation, sampling technique, and other plausible causes; document corrective training and reevaluation. If that facility's SOP suspends independent compounding until a satisfactory reevaluation, enforce that stated facility restriction.

Apply it

A Category 3 technician routinely makes repeated vial entries and assembles several sterile connections. Represent those challenging steps in the simulation rather than using one simple transfer. Incubate for the full two-temperature schedule. Turbidity appearing in one container on day 10 is a failed media fill even if every other container remains clear. Clear containers also cannot override unacceptable observed technique, post-fill fingertip results above 3 CFU total from both hands, or an ISO Class 5 surface result above 3 CFU per device.

Apply it

A scheduled compounder develops a weeping skin lesion before the shift. Report the condition before entering the compounding area so suitability for the assigned work can be assessed and an appropriate work arrangement established.

Apply it

A technician washes for only 10 seconds, dries the palms but leaves the forearms wet, and prepares to put on gloves while hand rub remains wet. The washing duration is inadequate, drying is incomplete, and sterile gloving is premature. Complete washing for at least 30 seconds, rinse and dry the hands and forearms completely, then apply hand rub over all hand and finger surfaces and allow thorough drying before gloving.

Apply it

Before transferring preservative-free methotrexate in an appropriate containment PEC, verify that both glove pairs are chemotherapy gloves and the outer pair is sterile and powder-free. Arrange the cuffs inner-under and outer-over the protective gown. Apply sterile 70% IPA to compatible outer gloves for aseptic disinfection and allow drying. If a glove tears or a splash is suspected, stop the manipulation safely, remove contaminated gloves using the exposure-control procedure, wash hands, and don replacement protection.

Apply it

At the SCA sink, dry washed hands and forearms completely with low-lint towels before applying alcohol-based hand rub. Rub all hand surfaces and allow complete drying before gowning. After gowning, complete the example procedure's hand-antisepsis step and allow hands to dry thoroughly before sterile gloving. If a glove tears during compounding, withdraw hands from the PEC before removing it. Replace it in the SCA using the documented hand-hygiene procedure, disinfect the replacement glove, and allow it to dry before resuming work. At the designated exit, remove used gloves and garb without transferring their outer surfaces to clean clothing or supplies, then perform hand hygiene.

Apply it

A compounder notices a glove puncture after handling a sharp. Protect the work and replace the compromised glove through the required procedure; applying disinfectant to the damaged glove cannot restore its physical barrier or establish safe continued use.

Apply it

A technician holds a large vial between the airflow source and an exposed syringe tip. Reposition the hands and materials to restore the protected airflow path before making the connection or performing the next aseptic manipulation.

Apply it

A technician moves from horizontal to vertical airflow equipment and places a large item directly above an exposed critical site. Reassess the vertical air path and reposition supplies to avoid blocking the site's protective airflow.

Apply it

A technician removes a vial cap, places the vial within the PEC, and sprays the stopper with sterile 70% IPA. Before access, the technician must also wipe the stopper to provide mechanical action and allow it to dry. If a gloved finger subsequently touches the prepared septum while repositioning the vial, repeat the sterile 70% IPA wiping and drying before puncture.

Apply it

A clinical area proposes saving leftovers from a single-dose vial for later patients because each entry will use a new needle. Reject that routine reuse plan; a new needle does not convert the product into a multidose vial.

Apply it

The nearby sharps container has reached its marked fill limit. Obtain an appropriate replacement before generating additional sharps rather than pushing another needle into the opening or temporarily placing the used sharp on the work surface.

Apply it

A technician performs successive 10-minute preparations after the initial sterile 70% IPA application. At 30 minutes, disinfect the horizontal work surface again before continuing and allow it to dry. For a separate uninterrupted 45-minute compounding process, apply IPA immediately before starting, complete the process without interrupting it at minute 30 for surface disinfection, and disinfect immediately afterward. If the PEC also has visible residue and is due for monthly sporicidal treatment, remove the soil, complete cleaning, disinfection, and sporicidal treatment with the applicable contact times, then apply sterile 70% IPA and allow drying before compounding.

Apply it

A selected surface disinfectant requires a stated wet contact period, but the surface dries much earlier. Correct the application using the specified method so the required exposure is achieved before treating the disinfection step as complete.

Apply it

A hazardous-drug work surface receives only the routine alcohol disinfection step. Identify the omitted chemical-residue control steps and complete the required hazardous-drug treatment sequence before considering the surface ready for its next intended use.

Apply it

A preparation needs 0.25 g of an ingredient labeled 50 mg/mL. Convert 0.25 g to 250 mg, then divide by 50 mg/mL to obtain 5 mL for the stated learning calculation.

Apply it

An authorized training preparation requires 180 mg from a stock solution labeled 60 mg/mL. Divide 180 mg by 60 mg/mL to obtain 3 mL, then verify the selected stock before measuring.

Apply it

A training formulation requires 500 mg in a final volume of 100 mL, using 10 mL of drug solution. The target concentration is 5 mg/mL; adding 100 mL of diluent would create a different final volume.

Apply it

A learning order specifies delivery of 150 mL over 90 minutes. Convert 90 minutes to 1.5 hours and calculate 150 mL divided by 1.5 hours, giving the specified rate of 100 mL/hour.

Apply it

A training procedure specifies a solution density of 1.20 g/mL. A 6.0 g net transfer corresponds to 5.0 mL. Use the stated density rather than assuming the solution has the same mass-to-volume relationship as water.

Apply it

Repackaging a sterile commercial injection into syringes for several patients requires an MFR because the preparation serves more than one patient. Preparing a sterile solution from nonsterile powder for only one patient also requires an MFR because of the starting ingredient. In contrast, an individualized single-patient admixture made only from sterile commercial ingredients does not trigger these MFR criteria.

Apply it

A component lot is later recalled. Use actual compounding records to identify affected preparations and their disposition rather than assuming every preparation made from the same master formulation necessarily used that particular component lot.

Apply it

A prescription adds phosphate and lipid emulsion to CLINIMIX E. First activate and mix the amino acid and dextrose chambers. Evaluate the total calcium-phosphate combination before adding phosphate, then use the appropriate port and product-specific aseptic addition instructions. Mix thoroughly. Discard an admixture showing precipitates or lipid separation; yellowish streaks or accumulated yellowish droplets indicate emulsion separation. The cited label specifies a 0.22-micrometer administration filter without lipid and a 1.2-micrometer filter when lipid is administered.

Apply it

A hypothetical authorized order requests 12 mg intrathecal methotrexate at the labeled final concentration of 1 mg/mL. Select the preservative-free 25 mg/mL product: 12 mg divided by 25 mg/mL equals 0.48 mL. Using preservative-free 0.9% sodium chloride, prepare a final volume of 12 mL, requiring 11.52 mL diluent under the stated volume assumptions. Verify the route and formulation before calculation or transfer and preserve clear intrathecal identification through release.

Apply it

A team proposes moving hazardous compounding outside its containment enclosure because a transfer device will be used. Retain the required engineering controls and evaluate the device as an additional protective measure within the complete safe-handling process.

Apply it

A proposed hazardous-drug transfer would substantially pressurize a vial before disconnection. Use the specified pressure-control technique and appropriate transfer arrangement within containment rather than proceeding with a connection likely to release liquid or aerosol when opened.

Apply it

A powder is nonsterile, but the proposed process only dissolves it in sterile diluent and transfers it aseptically. Identify the missing sterilization strategy before accepting the process as capable of producing a sterile finished preparation.

Apply it

Before filtering a solution into a sterile receiving system, confirm that the selected filter meets the pharmaceutical-use, sterility, depyrogenation, pore-size, and formulation-compatibility criteria. After use, perform the manufacturer-recommended integrity test. A bubble-point result outside the manufacturer's acceptance specification is a failure even when the filtrate looks clear. Withhold the CSP: either discard it or investigate the failure and, when justified by that investigation, refilter appropriately no more than once. Maintain downstream aseptic protection and assess relevant endotoxin risk separately.

Apply it

A proposed terminal heat process would exceed the supported temperature tolerance of the drug and container. Do not accept microbial lethality as the sole criterion; evaluate a validated preparation strategy that also preserves the product's required quality.

Apply it

A preparation made from nonsterile starting materials has an acceptable sterility result but an unacceptable endotoxin result. Keep it from release under the stated criteria; absence of recoverable organisms does not negate the separate endotoxin failure.

Apply it

A preparation expected to be clear develops unexplained cloudiness before release. Segregate it and obtain the required assessment rather than shaking it, filtering it informally, or dispensing it because the calculated ingredient quantities were correct.

Apply it

A hypothetical facility's release procedure requires a batch potency assay of 90–110% of the labeled concentration. A 1.00 mg/mL CSP assays at 0.88 mg/mL: 0.88 divided by 1.00 times 100 equals 88%, below the stated acceptance range. Withhold release and investigate component quantities, final volume, mixing, degradation, sampling, and analytical performance. An acceptable sterility result does not correct the potency failure. Conversely, an acceptable potency result does not satisfy required endotoxin testing.

Apply it

A preparation record specifies one route, but the printed label names another. Hold the preparation and resolve the discrepancy through the verification process before it leaves the compounding area, even if the drug and concentration match.

Apply it

A refrigerated preparation is found outside its specified range for an uncertain period. Record the available time and temperature information and place it on hold under the excursion procedure while its acceptability is assessed.

Apply it

A hazardous preparation is ready for internal delivery in its primary syringe only. Add the required protective secondary containment and hazard identification, and use the approved transport route rather than treating the syringe cap as complete transport protection.

Apply it

A needle used during hazardous-drug preparation must be discarded. Place it in the designated hazardous-drug sharps pathway required by the facility, preserving both puncture protection and the appropriate chemical-waste classification from the point of generation.

Apply it

CLINIMIX E with added lipid emulsion requires an administration set. One available set is labeled only latex-free; another has manufacturer specifications confirming that its set and lines are DEHP-free. The confirmed DEHP-free system meets this particular labeling requirement. The latex-free set cannot be accepted on that designation alone because its DEHP status remains unknown. Check specifications for the complete set and lines rather than assuming that a claim about one component covers the entire fluid pathway.