Biological Safety Cabinets

non HD sterile compounding primary engineering control

LAFW to provide ISO 5 environment

non HD sterile compounding secondary engineering control

provide ISO 7 and 8 environments, temp/humidity control, positive pressure airflow with set ACPH

non HD sterile compounding engineering controls are designed to protect?

the product

HD sterile compounding engineering controls are designed to protect?

the product and personnel

categories of HD engineering controls

C-PEC, C-SEC, CSTDs (if there is a C in front then it is for hazardous materials)

distinguishing characteristics of C-PEC

vertical laminar airflow, physical barrier between compounder and product, exhaust air should be HEPA filtered and venter to outside of building

class 1 C-PEC

primarily protects personnel, no product protection, used for NS compounding, used with agents that pose low to moderate risk to compounders

class 2 C-PEC

provides product and environmental protection, subdivided into different types, utilizes filtered/vertical/unidirectional airflow to create ISO 5 environment, main BSC class used in pharmacies for sterile compounding

class 3 C-PEC

highest level of product and environmental protection, can achieve ISO 5 using laminar or turbulent air, exhaust is HEPA filtered twice, material is passed through ante-chamber

class 2 type A BSC

significant recirculation, can be vented into room which won’t work for sterile drug compounding

class 2 type B BSC

little to no recirculation, must be vented to outside

class 2 type A1 BSC

not suitable for volatile chemicals or radionucleotides

assumption about everything within the BSC

it is contaminated

how to preserve inward and downward airflow

BSC should run 24/7 (decontaminate before any planned shutdown), maintain appropriate sash height, avoid blocking front BSC intake vents

how to maintain ISO 5 environment

aseptic technique to avoid touch contamination, do not block 1st air (coming from above), identify sterile field

how to maximize HD containment inside BSC

use of a spill mat, wipe down drug vials before placing in BSC

syringes for HD should not be more full than?

¾ full, applies to both compounding and dispensing

how to prevent incidental spray of HD in vials

keeping needle in vial when reconstituting, verifying volumes while needle is still in vial, remove liquid from needle hub while needle is still in vial, avoid overpressurizing vials

HD drugs in ampules

be intentional and aware with splatter, remove entire contents using filter needle and inject any excess into a sterile vial

how to maximize HD containment outside BSC

cover injection ports with protective seals within BSC, attach and prime IV sets within BSC (before injecting hazardous dose), decontaminate any final containers/sets before removal from BSC, dispense in sealed bags (labeled and bagged within BSC)

Containment ventilated enclosure (CVE)

not a BSC, for NS compounding only, provides compounder protection only

what is preferred when HD NS compounding?

class 1 BSC