White Papers and Educational Newsletter

Epoxy vs. FRP

In the subject of covering walls whether in cleanrooms, hospitals, or any application where the hygiene, cleanability and maintenance is important, there are two main choices: Epoxy paint or Fiber Reinforced Plastic/Polymer (FRP). Common residential/commercial solutions such as regular acrylic paint is of course out of the equation. A cleanroom (Or hospitals, labs, and certain healthcare settings) wall has…read more

PEC, C-PEC, and NAPRA requirements

PEC, standing for Primary Engineering Control, is an umbrella term for devices that provide ISO Class 5 environment during sterile non-hazardous compounding. The primary goal of a PEC is to protect the compound/product during the compounding process. This is achieved through passing unidirectional and ‘filtered to ISO 5’ air over the compounding process. PEC is not suitable for sterile hazardous compounding.

C-PEC, Containment Primary Engineering Control, refers to a PEC that protects the personnel and environment as well as the compound, hence the notion of containment. The triple protection is required during sterile hazardous compounding. The term C-PEC may also loosely refer to other containment devices that protect only personnel and environment. For example, non-sterile compounding (level A, B, and C), in which sterility is not required but protection of personnel and environment is still needed. A common case for this is…read more

Facilities and Engineering Controls for Non-Sterile Preparations: An Approach Comparison

This brief article aims to compare the required facilities and handling conditions as required by the United States Pharmacopeia (USP) and National Association of Pharmacy Regulatory Authorities (NAPRA) in regards to compounding of Hazardous Non-Sterile drugs.

Prior to going into details, we need to establish a reference to the definition of Hazardous Drugs (HD). Both USP and NAPRA refer to a public domain list by National Institute for Occupational Safety and Health (NIOSH). The Following excerpt is from 2016 revision. Currently a 2018 update to the list is being peer reviewed for public release. This publication is freely available online…read more