PTCB HD cheat sheet

Primary engineering control (PEC): the device that captures and removes airborne contaminants at the point of generation (e.g., laminar airflow workbench, biological safety cabinet, compounding aseptic isolator).

ISO Class 5 air = ≤3,520 particles/m³ ≥0.5 µm; this is the required air quality inside a PEC used for sterile compounding.

Unidirectional (laminar) airflow within a PEC should be 0.2 m/s (40 ft/min) ±20% at the work surface.

External venting is required for a Class II BSC when hazardous drugs are compounded; a Class II Type A2 BSC must be thimble-vented or ducted when used for HDs.

A CACI or CACIs used for HDs must be a closed-system isolator that vents HEPA-filtered air and does not exhaust into the room.

Air changes per hour (ACPH): a C-SEC (buffer/cleanroom) needs ≥30 ACPH; a segregated compounding area needs ≥12 ACPH.

Pressure cascade: HD compounding rooms are negative pressure relative to adjacent areas (≥0.01 in. water column); non-HD sterile rooms are positive pressure.

HEPA filters remove ≥99.97% of particles ≥0.3 µm; certification of PECs and cleanrooms occurs every 6 months and after relocation or major service.

Cleanroom surfaces are cleaned and disinfected in a defined order: work surfaces and equipment first, then floors, moving from clean to dirty and top to bottom.

USP <797> requires cleaning (removing residue with a detergent/disinfectant) followed by disinfection (applying a sporicidal or appropriate agent) at the start and end of each shift and after spills.

Sporicidal agents (e.g., sodium hypochlorite, hydrogen peroxide/peracetic acid) must be applied at a defined frequency (e.g., daily or per policy) because they are inactivated by organic matter.

Aseptic areas are cleaned with low-lint, non-shedding wipes; mops and wipes used in HD areas are dedicated and not shared with non-HD areas.

Disinfectant contact (dwell) time must match the manufacturer's label; a surface is not considered disinfected until the labeled contact time elapses.

Isopropyl alcohol 70% is used on the work surface of the PEC immediately before compounding, applied with friction and allowed to dry.

Cleaning logs record date, time, agent, area, and initials; the log is an administrative control that supports compliance with USP <797>/<800>.

Spills of hazardous drugs are cleaned per the facility's HD spill kit procedure; contaminated waste goes into appropriate hazardous waste containers.

For non-hazardous sterile compounding, minimum PPE includes a low-lint gown, hair cover, face mask, and gloves; gloves must be sterile for direct contact with sterile components.

For hazardous drug handling, PPE includes two pairs of chemotherapy-rated gloves, a chemo-rated gown, a NIOSH-approved N95 or better respirator, and eye/face protection.

Chemotherapy gloves must meet ASTM D6978; they are changed every 30 minutes of HD contact or when torn, punctured, or visibly contaminated.

The outer pair of gloves is removed first and discarded as HD waste; the inner pair is removed and discarded next; hand hygiene follows.

A gown used for HDs must be a closed-front, long-sleeved, cuffed gown labeled as chemo-rated; it is removed inside the compounding area and discarded as HD waste.

PPE is donned in the anteroom before entering the buffer/cleanroom; sterile gloves are donned after hand hygiene and before touching sterile supplies.

Respirators require fit testing and a user seal check each time they are worn; facial hair at the sealing surface prevents a proper seal.

PPE for non-HD compounding is removed in the reverse order of donning, and hand hygiene is performed after removal.

Receiving: inspect shipping containers for damage, temperature excursion indicators, and tamper evidence before accepting; document discrepancies and quarantine affected product.

Temperature-controlled shipments: refrigerated products are 2–8 °C (36–46 °F); frozen products are −25 to −10 °C; controlled room temperature is 20–25 °C (68–77 °F).

Cold-chain products must be transported in validated containers with phase-change materials; product must not contact dry ice or gel packs directly.

Hazardous drugs are transported in sealed, labeled containers; transport containers for HDs must prevent breakage and leakage and be labeled per DOT/UN requirements.

Receiving documentation includes date, time, temperature reading, carrier, and initials; excursions are reported to the supplier and the product is quarantined pending disposition.

Final dosage forms (CSPs) are transported in sealed, tamper-evident containers; the label includes beyond-use date/time, storage requirements, and patient identifiers.

Transport of compounded sterile preparations must maintain temperature and protect from light per the CSP's stability; delivery is documented with time-out and time-in.

DEA-controlled substances received are counted, signed for by an authorized person, and stored in a secured, locked location; discrepancies are reported.

A CSP beyond-use date (BUD) is assigned from the time of compounding, based on the risk level, storage temperature, and whether the preparation is sterile and preservative-free.

USP <797> low-risk CSP BUDs (no preservative): 48 hours at room temperature, 14 days refrigerated, 45 days frozen; medium-risk: 30 hours, 9 days, 45 days.

A dispensed prescription label must include patient name, drug name and strength, directions, quantity, date, prescriber, pharmacy, and beyond-use or expiration date.

The final check of a CSP includes verification of the correct drug, dose, diluent, container, label, and visual inspection for particulates and container integrity.

Sterile products are visually inspected against a black-and-white background for particulates, discoloration, and leaks before release.

High-alert medications (e.g., insulin, heparin, chemotherapy) require independent double-checks and standardized concentrations before dispensing.

Unit-dose and repackaged dosage forms are labeled with the drug, strength, lot, expiration date, and repackager; repackaging records are retained.

Dispensing records for controlled substances include the drug, quantity, date, patient, prescriber, and the identity of the dispensing pharmacist.

USP <797> governs sterile compounding; USP <800> governs hazardous drug handling; both are enforceable in states that adopt them through boards of pharmacy.

Standard operating procedures (SOPs) must be written, reviewed, and updated at defined intervals; personnel must be trained and competency-assessed before independent compounding.

Personnel competency for sterile compounding is documented initially and at least every 12 months, including hand hygiene, garbing, and aseptic technique observation.

Environmental monitoring includes surface sampling and air sampling; results are trended and out-of-limit results trigger investigation and corrective action.

A medication error and adverse event reporting system is required; events are documented, reviewed, and used for quality improvement.

Controlled substances require a perpetual inventory, biennial (every 2 years) inventory, and secure storage; records are retained per DEA requirements (generally 2 years).

The pharmacy must maintain a policy for handling hazardous drug spills, including a spill kit, trained personnel, and documented cleanup.

Recall procedures require identification of affected lots, quarantine, notification of patients when appropriate, and documentation of the recall response.