Compound Hood Amaris Medical
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Compound Hood

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A Compound Hood (Class II, Type B2 Biological Safety Cabinet) is a specialized containment device designed for safe handling and compounding of hazardous drugs including chemotherapy agents, meeting stringent USP <800> requirements. Featuring 100% exhaust to the outside, HEPA-filtered supply and exhaust air, negative pressure plenums, and hard-ducted connection to building exhaust systems, these cabinets provide maximum personnel, product, and environmental protection. Constructed of stainless steel with gas-tight seals, microprocessor controls, continuous airflow monitoring, and audible/visual alarms. Available in 4-6 foot widths. CRITICAL: Must be hard-ducted, NOT recirculating. Primary clinical applications include chemotherapy compounding in oncology pharmacies, hazardous IV admixture preparation, oral hazardous drug compounding, investigational drug handling, and clinical trial material preparation. Essential equipment for hospital pharmacies, cancer centers, and research facilities handling hazardous drugs, with absolute requirement for USP <800> compliance, annual certification, comprehensive training, medical surveillance, and strict adherence to containment protocols.
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Description

Compound Hood

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Compounding of Hazardous Drugs (Chemotherapy Agents):
  • Primary Use: Compound hoods (Class II, Type B2 Biological Safety Cabinets) are specifically designed for safe handling and compounding of hazardous drugs including chemotherapy agents, providing both product protection and personnel protection through 100% exhaust to the outside.
  • How it helps: Creates a complete barrier between pharmacy professionals and the toxic chemicals they handle daily, ensuring that life-saving chemotherapy can be prepared safely without exposing staff to carcinogenic drugs.
2. IV Admixture and Sterile Compounding:
  • Primary Use: Used in hospital pharmacies for compounding sterile intravenous medications, total parenteral nutrition (TPN), and other sterile preparations requiring ISO Class 5 clean air conditions combined with personnel protection.
  • How it helps: Ensures that IV medications are prepared in an ultra-clean environment, protecting vulnerable patients from infection while also protecting pharmacy staff from accidental exposure to potent drugs.
3. Preparation of Hazardous Pharmaceutical Products:
  • Primary Use: Essential for compounding hazardous non-chemotherapy drugs including certain antibiotics, antivirals, and hormone preparations that require containment to protect pharmacy personnel.
  • How it helps: Allows pharmacists to safely prepare a wide range of hazardous medications, from powerful antibiotics to hormone therapies, knowing they and their workspace are protected from contamination.
4. Antineoplastic Drug Compounding:
  • Primary Use: Primary containment device for preparing antineoplastic agents in oncology pharmacies, protecting pharmacists from exposure to carcinogenic, mutagenic, and teratogenic compounds.
  • How it helps: Protects the health of pharmacists who dedicate their careers to helping cancer patients, ensuring they are not harmed by the very drugs they use to treat disease.
5. Research and Development of Toxic Compounds:
  • Primary Use: Used in pharmaceutical research and development for handling experimental toxic compounds, investigational drugs, and potentially hazardous materials requiring containment.
  • How it helps: Enables scientists to safely work with experimental compounds whose effects may not yet be fully understood, protecting them while they develop the medicines of tomorrow.
6. Veterinary Chemotherapy Compounding:
  • Primary Use: Employed in veterinary oncology for preparing chemotherapeutic agents for animal patients, protecting veterinary personnel from exposure.
  • How it helps: Extends the same protections to veterinary professionals that human pharmacists receive, allowing them to treat animal cancer patients safely.
7. Clinical Trial Material Preparation:
  • Primary Use: Used for compounding investigational drugs and clinical trial materials that may have unknown toxicity profiles, requiring maximum containment.
  • How it helps: Ensures that the brave volunteers who participate in clinical trials receive properly prepared medications, while protecting the pharmacy staff who handle compounds with unknown risks.

SECONDARY & SUPPORTIVE USES

1. Radiopharmaceutical Compounding: Some compound hoods are used for preparing radiopharmaceuticals (with appropriate shielding), supporting nuclear medicine procedures.
2. Toxicology Laboratory Applications: Handling of toxicological samples and reference standards, protecting laboratory workers from hazardous materials.
3. Hazardous Waste Handling: Temporary containment for processing hazardous pharmaceutical waste, ensuring safe disposal of dangerous materials.
4. Research Laboratory Applications: General containment for work with potentially hazardous compounds, supporting scientific discovery while protecting researchers.
5. Academic Pharmacy Training: Teaching proper hazardous drug compounding techniques in pharmacy schools, preparing the next generation of pharmacists to handle hazardous materials safely.
6. Pharmaceutical Quality Control: Testing of hazardous drug products under contained conditions, ensuring medication safety and quality.
7. Decontamination and Spill Response: Safe area for cleaning and decontaminating equipment exposed to hazardous drugs, providing a secure location for emergency response.
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Product Type: Specialized containment device (Class II, Type B2 Biological Safety Cabinet) designed for safe handling of hazardous drugs with 100% exhaust to the outside.
  • Common Names: Compound Hood, Chemotherapy Hood, Hazardous Drug Compounding Cabinet, Class II Type B2 BSC, 100% Exhaust Biological Safety Cabinet.
  • NSF/ANSI 49 Classification: Class II, Type B2 (100% exhaust, hard-ducted).
  • Airflow Characteristics: 100% of air exhausted to outside; no recirculation within room.
  • HEPA Filters: Supply and exhaust HEPA filters (99.99% efficient at 0.3 microns).
  • Exhaust Connection: Hard-ducted to building exhaust system; cannot be thimble-connected or recirculated.
  • Construction: Stainless steel work surface and interior; gas-tight construction; negative pressure plenums.
  • Sash: Sliding or hinged tempered glass with proper airflow warning markings.
  • Work Area: Stainless steel with coved corners for easy cleaning and decontamination.
  • Lighting: Fluorescent or LED lighting within the work area.
  • Blower: Independent supply and exhaust blowers to maintain proper negative pressure.
  • Controls: Digital controls with airflow monitoring and alarms.
  • Pre-Filters: Removable pre-filters to extend HEPA filter life.

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Containment Level: BSL-2/BSL-3 containment; suitable for hazardous drugs (USP <800> compliant).
  • HEPA Filter Efficiency: 99.99% efficient at 0.3 microns for both supply and exhaust.
  • Airflow Velocity (Inflow): Typically 100-120 linear feet per minute (lfpm) at sash opening.
  • Airflow Velocity (Downflow): Typically 50-60 lfpm within the work area.
  • Exhaust: 100% exhausted to outside; negative pressure plenums prevent leakage.
  • Air Changes: Work area air replaced every 5-10 seconds.
  • Containment Testing: Must pass aerosol challenge tests (KI-Discus or equivalent) for certification.
  • Noise Level: <60-70 dB depending on model and blower speed.
  • Vibration: Low vibration design for delicate procedures.
  • Electrical Requirements: 115V or 230V, 50/60 Hz, dedicated circuit required.
  • Heat Load: Significant heat generation due to 100% exhaust; affects room HVAC requirements.
  • Light Intensity: 800-1200 lux (75-110 foot-candles) at work surface.

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Widths: 4-foot (1.2 m), 5-foot (1.5 m), 6-foot (1.8 m) standard.
  • Depth: 30-40 inches (75-100 cm) depending on model.
  • Height: 90-120 inches (230-300 cm) including exhaust plenum and ductwork.
  • Work Area Height: 20-30 inches (50-75 cm) sash opening.
  • Weight: 500-1000+ lbs (225-450+ kg) depending on size.
  • Construction: Heavy-gauge stainless steel; gas-tight construction; negative pressure design.
  • Sash: Tempered safety glass with counterbalance mechanism; alarm sensors.
  • Work Surface: Removable stainless steel trays with coved corners for spill containment.
  • Service Fixtures: Optional gas, vacuum, and electrical outlets within the work area (must be sealed).
  • Exhaust Collar: Hard-duct connection to building exhaust system.
  • Casters: Heavy-duty casters for positioning; leveling feet for stability.
  • Pressure Gauges: Magnehelic gauges or digital sensors for supply/exhaust monitoring.
  • Alarms: Audible and visual alarms for low airflow, sash misposition, and filter loading.

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Standards: NSF/ANSI 49 (Class II, Type B2), USP <800> compliant, OSHA standards for hazardous drugs.
  • USP <800> Compliance: Meets requirements for handling hazardous drugs including chemotherapy agents.
  • Personnel Protection: Excellent - 100% exhaust and negative pressure design protect operator.
  • Product Protection: Excellent - HEPA-filtered downflow protects products from contamination.
  • Environmental Protection: 100% exhaust through HEPA filters protects the environment.
  • Containment Testing: Must pass annual certification including airflow, HEPA integrity, and containment tests.
  • Electrical Safety: Compliant with UL 61010A or IEC 61010-1.
  • Alarms: Audible and visual alarms for airflow failure, sash misposition, and filter loading.
  • Negative Pressure: All contaminated plenums under negative pressure to prevent leakage.
  • Decontamination: Designed for gas decontamination (formaldehyde or hydrogen peroxide) before filter changes.
  • Interlocking: Blowers interlocked with building exhaust systems; cannot operate without exhaust.
  • Certification: Must be certified at installation and annually thereafter by a qualified technician.

5. STORAGE & HANDLING ATTRIBUTES

  • Installation: Professional installation required; must be hard-ducted to dedicated building exhaust system; requires structural support for weight; adequate clearance for ductwork.
  • Certification: Annual certification by qualified technician required for USP <800> compliance; includes airflow testing, HEPA filter integrity testing, and containment testing.
  • Decontamination: Must be decontaminated before filter changes, relocation, or disposal; performed by certified professionals using formaldehyde or hydrogen peroxide vapor.
  • Cleaning: Clean work surfaces daily with appropriate disinfectants (70% ethanol, peroxide-based cleaners). Follow USP <800> guidelines for deactivation, decontamination, and cleaning.
  • UV Lamp Care: Clean UV lamp regularly; replace annually or per manufacturer recommendation.
  • HEPA Filter Replacement: Performed by certified technicians during annual certification; requires decontamination first.
  • Pre-Filters: Some models have pre-filters that can be changed by trained staff; follow USP <800> guidelines for PPE during changes.
  • Alarm Testing: Test alarms weekly; document all tests; ensure all users know alarm meanings and responses.
  • Record Keeping: Maintain certification records, decontamination logs, maintenance records, and SOPs per USP <800> requirements.
  • USP <800> Compliance: Must have written SOPs, training records, medical surveillance program for personnel.

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Safe compounding of hazardous drugs (chemotherapy, antineoplastics) in compliance with USP <800> standards.
  • USP <800> Hazardous Drug Categories:
    • Antineoplastic Agents: Chemotherapy drugs requiring containment.
    • Non-antineoplastic Hazardous Drugs: Certain hormones, immunosuppressants, antivirals.
    • Investigational Drugs: Unknown toxicity profile requiring maximum protection.
  • Pharmacy Applications:
    • Chemotherapy Compounding: Preparation of patient-specific chemotherapy doses.
    • IV Admixture of Hazardous Drugs: Sterile preparation of hazardous IV medications.
    • Oral Hazardous Drug Compounding: Preparation of oral doses of hazardous drugs.
    • Clinical Trial Materials: Compounding investigational drugs with unknown hazards.
  • Oncology Pharmacy Applications:
    • Dose Preparation: Drawing up chemotherapy from vials into syringes or IV bags.
    • Batch Compounding: Preparing multiple doses of commonly used chemotherapy agents.
    • Intrathecal Chemotherapy: Special preparation for drugs administered into CSF.
  • Hospital Pharmacy Applications:
    • Hazardous Drug Storage: Temporary storage of compounded hazardous preparations.
    • Waste Handling: Safe containment of hazardous drug waste.
  • Research Applications:
    • Toxic Compound Handling: Research with potentially toxic investigational compounds.
    • Radiopharmaceuticals: With appropriate shielding for radioactive materials.
  • Veterinary Oncology Applications:
    • Animal Chemotherapy: Compounding chemotherapeutic agents for veterinary patients.
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • CRITICAL: USP <800> Compliance: Must meet all USP <800> requirements including facility design, engineering controls, work practices, PPE, and medical surveillance.
  • Never Use Recirculating Cabinets: Type A2 (70% recirculating) cabinets are NOT suitable for hazardous drug compounding.
  • Ductwork Integrity: Must be hard-ducted to dedicated exhaust; NEVER use thimble connections.
  • Negative Pressure: Ensure proper negative pressure relative to room; monitor continuously.
  • Pre-Use Checks: Verify airflow alarms functional; check sash height; ensure no obstructions.
  • PPE Requirements: Full PPE required including gown, double gloves, eye protection, and respiratory protection as needed.
  • Work Practices: Use aseptic technique within the cabinet; minimize rapid movements; work at least 4 inches inside the sash.
  • Spill Management: Have hazardous drug spill kits available; trained personnel for spill response.
  • Decontamination: Regular decontamination per USP <800> guidelines; documented procedures.
  • Medical Surveillance: Personnel must participate in a medical surveillance program per USP <800>.
  • Training: All users must have documented training on hazardous drug handling, USP <800> requirements, and emergency procedures.
  • Annual Certification: Absolutely required for continued safe operation and regulatory compliance.

2. FIRST AID MEASURES

  • Hazardous Drug Exposure (Skin): Remove contaminated clothing; wash affected area vigorously with soap and water for 15 minutes; seek medical attention; document exposure.
  • Hazardous Drug Exposure (Eye): Flush eyes with copious water or sterile saline for 15 minutes; seek immediate medical attention.
  • Hazardous Drug Spill Inside Cabinet: Close sash; leave cabinet running; follow USP <800> spill protocol; use hazardous drug spill kit; notify supervisor and biosafety officer.
  • Hazardous Drug Spill Outside Cabinet: Evacuate area; restrict access; follow institutional hazardous material spill protocol; use appropriate PPE; decontaminate area.
  • Needlestick/Sharps Injury (with hazardous drug): Wash area vigorously with soap and water; report immediately; seek medical attention; document exposure.
  • Inhalation Exposure: Move to fresh air; seek medical attention; document exposure.

3. FIRE FIGHTING MEASURES

  • Flammability: Cabinet contains flammable materials; some hazardous drugs may be flammable.
  • Extinguishing Media: For electrical fire, use COâ‚‚ or dry chemical (Class C) extinguisher.
  • Power Off: Disconnect power if safe to do so; note that exhaust must continue for containment.
  • Exhaust System: Building exhaust should continue during fire to maintain negative pressure.
  • Fire Response: Evacuate area; notify emergency responders of hazardous drug presence.

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