Part Two – Compounding Pharmacies: Engineering Controls for Non-sterile Compounding

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This is the second article in a series of three that addresses the Oklahoma Pharmacy Law Book’s airflow and filtration requirements for containment hood systems within compounding pharmacies.

The first article in the series discusses the generic qualities of air flow within cabinets and hoods noted in the law book. It also identifies some of the organizations that establish performance standards for respiratory safety equipment such as cabinets, hoods and isolators.

The third article and final post in this series discusses the law book’s equipment specifications for compounding sterile products.

NOTE: Cabinets, clean rooms, hoods, and isolators have varied functionality and have differing roles in the compounding pharmacy. See your state’s pharmacy laws for guidance on the role these devices play in your practice. Click here for links to the pharmacy boards listed on the National Association of Pharmacy Boards (NAPB) website.

Compounding non-sterile hazardous drugs. In the law book, section 535:15-10-14 contains specific criteria for handling non-sterile hazardous drugs listed by NIOSH, the National Institute for Occupational Safety and Health.

In the table below, you will find three columns. The first column indicates the engineering control recommended in the Oklahoma Pharmacy Law Book for Non-Sterile Compounding (i.e., Class 1 Biological Safety Cabinet (BSC), Powder Containment Hood, or Isolator). In the second column you’ll find the NSF definition of a Class 1 BSC and HEPA Filter. The third column shows how Sentry Air Powder Containment Hoods meet or exceed these requirements.

Our pharmacy customers use our ductless hoods for weighing powder, filling capsules, compounding creams, and a variety of additional non-sterile compounding applications that require both containment and filtration.

IMPORTANT: Sentry Air Systems provides this information as a customer service. All information should be independently verified. The category of material being handled – for example, hazardous, sterile, non-sterile – and nature of the material – liquid, powder, gel, for example — require different types of engineered controls to protect products, people and the work environment. A certified industrial hygienist should be consulted to determine the best configuration of primary and secondary engineering controls for your pharmacy.

Oklahoma Pharmacy Law Book
NSF International
Definition
Sentry Air
Powder Containment Hoods
535:15-10-14(5)
“When asepsis is not required, a Class I BSC, powder containment hood, or isolator intended for containment applications may be sufficient.”
3.4.1 Class I – “A ventilated cabinet for personnel and environmental protection, having an unrecirculated inward airflow away from the operator that exhausts all air to the atmosphere after filtration through a HEPA filter.”
3.14.1 high efficiency particulate air (HEPA) filter* – A throwaway, extended/ pleated medium, dry-type
filter with the following:
– rigid casing enclosing the full depth of the pleats;
– minimum particulate removal of 99.99% of particles 0.3 μm diameter of (Type C)
– maximum pressure drop of 1.0 in w.g. (250 Pa) when clean and operated at rated airflow capacity
*NSF 2008 NSF/ANSI 49©  
The air flow provided by our ductless hoods, in a range of sizes, meets the Class 1 BSC standard:

√ inward airflow away from operator
√ exhausted through HEPA filtration
Filtration. Our ductless hoods can be equipped with a variety of filter types, including HEPA.
√ Throwaway filters
√ Rigid casing
√ Type C HEPA
√ Pressure drop
Sentry Air Systems manufactures a broad array of ductless powder containment hoods in standard sizes that range from 12” to 70” in width. Customized hoods are also available (e.g., custom size, material, cut-outs, multiple points of entry, increased air volume). For more information about these pharmaceutical containment hoods or any of our air purification products, please call a Sentry Air Systems Applications Specialist at 1.800.799.4609, email us at sales@sentryair.com, or fill out this formto receive more information or a quote.