PTCB CSDP cheat sheet

ISO Class 5 is the required air quality for the direct compounding area (critical zone); ISO Class 7 is required for the buffer/cleanroom surrounding a primary engineering control (PEC).

A primary engineering control (PEC) includes laminar airflow workbenches (LAFW), biological safety cabinets (BSC), compounding isolators, and containment isolators.

Horizontal airflow LAFWs direct HEPA-filtered air toward the operator; vertical airflow BSCs draw air down and away from the operator and are used for hazardous drugs.

HEPA filters remove at least 99.97% of particles 0.3 micron and larger.

Unidirectional airflow velocity at the PEC is typically 0.45-0.6 m/s (90 +/- 20 ft/min) for LAFWs and BSCs.

Pressure relationships: the buffer room must be at positive pressure relative to adjacent unclassified space; hazardous compounding uses negative pressure in the buffer and ante rooms.

Air changes per hour (ACPH): ISO Class 7 buffer rooms require at least 30 ACPH; the PEC provides the ISO Class 5 critical zone.

Certification of the PEC and room must be performed every 6 months and after relocation or significant service.

First-air rule: critical sites of sterile components must be exposed only to first air until they are joined in the final sterile product.

Critical sites include needle hubs, syringe tips, vial septa, ampule openings, and the sterile contents of the final container.

Garbing sequence for non-hazardous: remove outerwear and jewelry, don shoe covers, head/hair cover, beard cover (if needed), face mask, then perform hand hygiene and don sterile gown and sterile gloves.

Hand hygiene uses soap and water or an alcohol-based rub; sterile gloves must be donned without touching the exterior.

Swab all vial septa and ampule necks with 70% isopropyl alcohol and allow to dry before entry.

Ampules require a filter needle or filter straw to remove glass particles; replace with a regular needle before administration.

Syringe and needle selection: use a needle no larger than 20 gauge for reconstitution and a filter needle (5 micron) for withdrawing from ampules.

Single-dose vials should not be used for more than one patient; multi-dose vials must be dated when first opened.

NIOSH hazardous drug list includes drugs meeting criteria for carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, or genotoxicity.

USP <800> requires containment strategies: engineering controls (CSTD), PPE, and documented work practices for hazardous drugs.

Hazardous compounding uses a closed system transfer device (CSTD) and a negative-pressure containment isolator or Class II BSC.

PPE for hazardous drug compounding includes two pairs of chemotherapy gloves, a chemo gown, a NIOSH-approved respirator, and eye/face protection.

Spill kits must be available in areas where hazardous drugs are handled; use absorbent pads, chemo gown, and appropriate disposal.

Hazardous drug waste is disposed in yellow/black or designated containers per facility policy and EPA/DOT requirements.

Pregnant or breastfeeding personnel should be counseled on risk and may be excluded from hazardous drug handling per policy.

Non-hazardous drugs still require standard precautions and aseptic technique; risk assessment determines if HD precautions apply.

Sterilization destroys all microorganisms including spores; disinfection reduces pathogenic organisms but may not kill spores.

Autoclave sterilization typically uses 121 degrees C at 15 psi for 15-30 minutes (moist heat) or 134 degrees C for shorter cycles.

Sterile compounding typically uses filtration (0.22 micron) for heat-labile solutions or terminal sterilization for terminally sterilized products.

High-level disinfection is required for semi-critical items; low-level disinfection for non-critical surfaces.

Sporicidal agents (e.g., hydrogen peroxide, glutaraldehyde) are used for high-level disinfection and sterilization.

Hand hygiene is the single most effective infection-control measure; perform before and after gloving and after contact with contaminated items.

Clean and disinfect PEC surfaces at start of shift, before and after each batch, and after spills using 70% isopropyl alcohol.

Sharps must be disposed immediately in puncture-resistant, labeled sharps containers; do not recap needles.

USP <797> governs sterile compounding; USP <800> governs hazardous drug handling; USP <795> governs non-sterile compounding.

Beyond-use dating (BUD) depends on the risk level (low, medium, high) and storage temperature; low-risk CSPs at room temperature: 48 hours; refrigerated: 14 days; frozen: 45 days.

Medium-risk CSPs: room temperature 30 hours, refrigerated 9 days, frozen 45 days; high-risk: room temperature 24 hours, refrigerated 3 days, frozen 45 days.

Environmental monitoring includes air sampling (viable particle counts) and surface sampling; frequency per USP <797> risk level.

Media fill (gloved fingertip and thumb sampling) is required initially and at specified intervals for personnel who compound CSPs.

Documentation must include prescriptions, compounding records, lot numbers, expiration dates, and personnel training records.

The Joint Commission and state boards of pharmacy enforce USP standards; FDA oversees manufacturing, not compounding pharmacy practice.

Recall procedures require tracking CSPs by lot and patient to allow retrieval and notification.

Dose = (Desired dose / Have) x Quantity; use ratio-proportion or dimensional analysis for conversions.

Alligation method: (higher concentration - desired) : (desired - lower concentration) gives parts of each to mix.

Concentration percent solutions: % w/v = grams per 100 mL; % w/w = grams per 100 grams; % v/v = mL per 100 mL.

mEq = (mg x valence) / atomic weight; used for electrolyte calculations (e.g., KCl, NaCl).

Milliequivalent and millimole conversions require molecular weight and valence; verify with a second calculation.

Reconstitution: final concentration = total drug (mg) / total volume (mL) after adding diluent; account for powder volume displacement.

IV flow rate (mL/hr) = total volume (mL) / total time (hr); drop rate = (volume x drop factor) / time (min).

Always verify calculations with an independent double-check and confirm drug, dose, route, and rate against the prescription.

Verify the final CSP visually for particulates, color, clarity, and container integrity before release.

Check label against the original order: patient, drug, dose, route, diluent, volume, and expiration.

Confirm BUD assignment matches risk level and storage condition.

Document lot numbers and expiration dates of all components used.

Perform a final check of syringe/needle compatibility and that no coring or glass particles are present.

Use a second qualified person for high-risk or high-alert drug verification when required by policy.

Reject any CSP with visible particulates, discoloration, or compromised container closure.

Verify that the CSP is stored at the correct temperature and protected from light if required.