Importance of risk assessment for aseptic transfer in pharmaceutical compounding

Abstract

Aseptic transfer is a critical contamination control issue, carried out over a series of stages. If any stage is performed in an uncontrolled  manner then microbial contamination of a product can occur. Contamination risks can arise from a number of sources, including incoming
materials, air and personnel. To address these risks appropriate controls include controlled environments, personnel gowning and  behaviour, and the use of disinfectants. This article considers the key risks and risk mitigation strategies using a case study of aseptic transfer
within a pharmacy unit for the purpose of preparation or compounding of a medicinal drug product.

Introduction

Aseptic transfer applies to various aspects of pharmaceuticals and healthcare, covering everything from the inoculation of agar plates in a microbiology laboratory to the transfer of items into a cleanroom as part of sterile products manufacturing or pharmaceutical compounding. Across this range of applications the overriding
requirement is asepsis, to either render the material free of microbial contamination (through bioburden reduction) or to prevent adventitious contamination, from operators or the environment, affecting the quality of the product or materials.

This article focuses on the best practices for aseptic transfer within a pharmaceutical facility or pharmacy specialising in drug compounding. Compounding is a process whereby the facility combines, mixes, or alters ingredients of a drug to create a medication suitable for the needs of patients. This can range from the larger scale production of intravenous bags of nutrient fluid for babies to the preparation of individual cytotoxic drugs.

With these activities microbialcontamination in the environment can result in product adulteration and, in turn, in a potential infection of the patient. In order to minimise the possibility of cross-contamination, a risk-centric approach is required. This is
a topical subject in light of several high profile product contamination events which have occurred worldwide (some with serious consequences for patients). […]

A courtesy of ‘Clean Air & Containment Review’ – www.cleanairandcontainment.com