You asked: How often must HEPA filters be certified quizlet?

The HEPA filter must be inspected and certified every SIX MONTHS to verify that the filter is in working condition.

How often should the air quality of a laminar flow hood be certified?

Laminar Flow Hoods or Clean Benches are used in critical environments to protect product from contaminants. In accordance with regulatory standards, Laminar Flow Hoods must be certified at time of installation and at 6-month intervals thereafter.

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Where is the compounding Hood also known as the CSP room located?

Garbing, CSP labeling and other procedures that release a high amount of particulates are done in the ante room, also called the ante-area. The ante room leads into the sterile IV compounding room (where the hood is located).

How long must a laminar airflow hood run before being used to ensure the quality of the sterile product?

Ideally, a laminar airflow hood should be left running at all times, except during cleaning. If it has been turned off, the LAH needs to run for 30 minutes before it can be used in the preparation of a drug. This provides the HEPA filter with enough time to clean the room air thoroughly.

Which ISO class of clean air is most appropriate for a direct compounding area?

The environment for all risk level compounding must be ISO Class 5 air quality. The most common example of this type of enclosure is a laminar air flow hood, in which air first passes through a microbial retentive HEPA filter then circulates over the critical site providing low-particulate, essentially sterile air.

How often must HEPA filters be certified?

The HEPA filter must be inspected and certified every SIX MONTHS to verify that the filter is in working condition.

How often do biosafety cabinets laminar flow hoods and clean benches need to be re certified?

All biosafety cabinets, laminar flow hoods, and clean benches must be re-certified on an annual basis, as well as after they are repaired and after they are moved to a new location. This service is offered through a Biosafety Office managed vendor and can be coordinated through Biosafety.

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How often must the pre filter of a BSC be replaced?

HEPA filters should be replaced every 3-5 years, depending on cumulative hours of operation, the cleanliness of the lab, and the materials being used in the BSC. Changing or cleaning the pre-filter on a regular basis extends the life of a HEPA filter.

What is the minimum PPE required when compounding hazardous drugs?

Gowns, head, hair, shoe covers, and two pairs of chemotherapy gloves are required for compounding sterile and nonsterile HDs. Two pairs of chemotherapy gloves are required for administering antineoplastic HDs.

How often must the air turn over in a buffer room designed for mixing sterile hazardous drug preparations?

Buffer room (with anteroom) for compounding sterile hazardous drugs. The buffer room must maintain a minimum of 30 air changes per hour (to meet ISO Class 7) and a negative pressure between 0.01 and 0.03 inches water.

How often must training be conducted for personnel doing high risk level?

USP <797> currently requires all employees that prepare CSPs to perform a media-fill activity, at minimum, once annually for lowand medium-risk compounding and twice annually for high-risk compounding.

When should you clean the laminar flow hood quizlet?

A hood should be cleaned at minimum, at the beginning of every shift, every 30 minutes during continuous compounding periods, and upon any major contamination.

How long must the blower run in a laminar airflow hood prior to use?

Let the blower motor run for at least one hour prior to first use to flush out any remaining shipping particles.

What is a containment segregated compounding area?

Containment Segregated Compounding Area (C-SCA): A type of C-SEC with nominal airflow (12 ACPH) and room pressurization requirements (negative pressure between 0.01 – 0.03 inches of water column) as they pertain to HD compounding.

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How often must surface sampling be performed in ISO Class 5’7 and 8 environments?

– Must be performed every 6 months AND whenever the PEC is relocated, the physical structure of the buffer or ante area has been altered, or major service to the facility is performed. – ISO Class 7: Not more than 352,000 particles (of 0.5 micron size and larger) per cubic meter.

What is the frequency needed to clean the work surfaces in the buffer room?

Table [3] of the USP chapter requires that cleanroom walls, cleanroom ceilings, and storage shelving be cleaned monthly. The text on page 16 of the chapter states, “In the buffer or clean area, ante-area, and segregated compounding area, walls, ceilings, and shelving shall be cleaned and disinfected monthly.”