Industry

Drug Compounding

Primary Engineering Controls for USP 797 and 800 Compliance

Many people today depend on medications to stay alive and well. However, some patients don't simply rely one or two individual prescribed medications, but instead, need a combination of multiple medications in order to maintain their health. Compounding pharmacies exist to combine multiple drugs into one effective medication, which is chemically mixed to the exact strength and dosage required.

Pharmacist counting pills to be placed in a container.

Industry

Drug Compounding

Many people today depend on medications to stay alive and well. However, some patients don't simply rely one or two individual prescribed medications, but instead, need a combination of multiple medications in order to maintain their health. Compounding pharmacies exist to combine multiple drugs into one effective medication, which is chemically mixed to the exact strength and dosage required.

Compounding Pharmacy

At compounding pharmacies, specially trained pharmacists can personalize medicines for a variety of specifications. Some ways in which pharmacists may alter medications include strength, the form of dosage (e.g. liquid vs. tablet), or flavor. Also, compounding pharmacies are able to remove ingredients from medications that patients must avoid due to allergies or other sensitivities.

Millions of patients across the world have been able to take advantage of the services of compounding pharmacies in order to receive drugs that are perfectly tailored to their health needs. Not only does compounding make managing medication simpler, but it also can make medicine allergy-friendly or easier to consume. Pharmacists who specialize in compounding can also be beneficial to people who suffer from unusual or drug-resistant illnesses. They can analyze a person's medical needs and history to devise a completely unique and personalized treatment plan.

Compounding pharmacies can exist in a range of different locales and formats. Licensed pharmacists can compound drugs at a traditional pharmacy. Alternatively, licensed physicians can compound drugs themselves. Finally, the compounding process may be outsourced to a specialized facility that focuses on drug compounding. At these facilities, licensed pharmacists or employees who are supervised by licensed pharmacists compound drugs.

To help you with the compounding process, NuAire has created a range of pharmacy equipment that meets the U.S. Pharmacopeia's <797> standard for compounding sterile preparations and U.S. Pharmacopeia's <800> standard Hazardous Drugs—Handling in Healthcare Settings. You can rely on NuAire's powder weight stations to accurately and safely weigh powders and particles, even if they are hazardous. You can use Nuaire's primary engineering controls a compounding aseptic isolator (CAI), which provides a sterile, positive pressure work environment for compounding non-hazardous drugs, or a compounding aseptic containment isolator (CACI), which provides a sterile, negative pressure work environment that minimizes exposure to airborne toxins and other hazardous materials. NuAire also has biosafety cabinets (BSC), laminar airflow workstations (LAFW), containment ventilated enclosures (CVE), and custom robotic enclosures for use in a compounding pharmacy.

Sterile Hazardous Drug Compounding

application

Sterile Hazardous Drug Compounding

NuAire provides containment primary engineering controls (C-PEC) for the safe handling of sterile hazardous drug compounding for USP 800 compliance.

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Sterile Non-hazardous Drug Compounding

Application

Sterile Non-Hazardous Drug Compounding

Choose laminar airflow workstations (LAFW) or compounding aseptic isolators (CAI) for sterile non-hazardous drug compounding for USP 797 compliance.

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Non-sterile hazardous drug compounding

Application

Non-Sterile Hazardous Drug Compounding

Safely and effectively compound non-sterile hazardous drug powders in a containment ventilated enclosure (CVE) for USP 800 compliance.

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Compounding Pharmacy Medication Workflow

Application

Medication Workflow

Maximize your medication workflow solution in a primary engineering control (PEC) or containment primary engineering control (C-PEC) designed for scales, barcode scanners, computers, and more.

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Sterile Non Hazardous Compounding Products

Vertical Laminar Airflow Workstations

AireGard

NU-140

The AireGard™ NU-140 generates HEPA-filtered, ISO Class 5 vertical laminar airflow to provide product protection for sterile but non-hazardous drug compounding or non-hazardous work in microbiology.
Horizontal Laminar Airflow Workstations

AireGard

NU-240

The benchtop model AireGard™ NU-240 creates HEPA-filtered, ISO Class 5 horizontal laminar flow for sterile but non-hazardous drug compounding in pharmacies or non-hazardous work in research labs.
Horizontal Laminar Airflow Workstations

AireGard

NU-340

The console configuration AireGard™ NU-340 creates HEPA-filtered, ISO Class 5 horizontal laminar airflow for sterile but non-hazardous drug compounding in pharmacies or non-hazardous work in research labs.
Compounding Aseptic Isolator Restricted Access Barrier Systems

PharmaGard PR

NU-PR797

The NU-PR797 is a Compounding Aseptic Isolator (CAI) that provides a positive pressure environment for the sterile compounding of non-hazardous drugs and can be configured for your pharmacy’s workflow.

Sterile Hazardous Drug Compounding Products

Class II Type A2 Biosafety Cabinets

LabGard ES AIR

NU-543

LabGard NU-543 Class II, Type A2 Biosafety Cabinet with accessories telescoping base stand with leg levelers and exhaust transition.
The NU-543 is configurable for a broad range of applications and geographies with a choice of NSF listed access openings, an optional smooth interior, EN 12469 listed configurations, and a global supply chain.
Class II Type B2 Biosafety Cabinets

LabGard ES TE

NU-560

The NU-560 combines durable construction and an efficient motor with a control system providing the safety and monitoring appropriate for the demanding work done in a Class II Type B2 biological safety cabinet.
Compounding Aseptic Containment Isolator Restricted Access Barrier Systems

PharmaGard

NU-NR800

The NU-NR800 is a Compounding Aseptic Containment Isolator (CACI) that provides a negative pressure environment for the sterile compounding of hazardous drugs but recirculates most work chamber air, thereby reducing external exhaust volume and static pressure requirements to a more attainable level.
Compounding Aseptic Containment Isolator Restricted Access Barrier Systems

PharmaGard

NU-NTE800

The NU-NTE800 is a Compounding Aseptic Containment Isolator (CACI) that provides a negative pressure environment for the sterile compounding of hazardous drugs and exhausts all work chamber air without recirculation and requires connection to an external exhaust blower with adequate capacity.

Non-Sterile Hazardous Drug Compounding Products

Class I Containment Ventilated Enclosures

LabGard CVE

NU-813

The NU-813 Class I Containment Ventilated Enclosure (CVE)’s versatile design can be configured to compound non-sterile drugs in pharmacies or to provide personnel protection in microbiology labs.

Related Resources

White Paper

Minimize Exposure to Hazardous Drugs in the Compounding Pharmacy

Handling hazardous drugs in the compounding pharmacy, per USP chapter <800> guidelines, involves strategic workflow strategies with the goal of minimizing personnel and environmental exposure.
Webinar

USP Compliance: Safe Implementation of PECs Under USP 797 and 800

Jim Wagner reviews the impact of the changes to USP <797> with regard to PEC implementation & USP <800> requirements for containment.
White Paper

How to Perform a Hazardous Drug Risk Assessment in the Compounding Pharmacy

How to Perform a Hazardous Drug Risk Assessment in the Compounding Pharmacy.
Infographic

USP 797 and USP 800 PEC Requirements

Follow this flowchart for an easy method to identify what Primary Engineering Control (PEC) or Containment Primary Engineering Control (C-PEC) your pharmacy needs.
Webinar

Cleanroom Layout Design Under USP 800

Learn the necessary elements to establish a cleanroom layout under USP 800.
Infographic

10 Tips for Working Safely in the Pharmacy with Your Biosafety Cabinet

Proper Aseptic technique when working within a Class II Biosafety Cabinet (BSC) will minimize air turbulence and prevent splatter or unwanted spread of aerosols. Here are ten tips to help you work safely with your Biological Safety Cabinet when working in the compounding pharmacy.
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