Use of barrier technology for aseptic processes in the pharmaceutical sector

Abstract

Barrier technology plays an indispensable role in the production of sterile products in the pharmaceutical industry, being an important parameter to ensure the quality, efficacy and safety of drugs. This technology includes physical isolation systems, such as isolators and restricted access barrier systems, which minimize the risk of cross-contamination and exposure to external agents during the manufacturing and packaging processes. In Brazil, the National Health Surveillance Agency (ANVISA) regulates the production of sterile drugs. According to this regulation, operations in classified areas must be carried out under controlled conditions, with continuous monitoring of environmental parameters, such as particles, microorganisms and air flow. Considering the importance of the subject, this study aimed to present a theoretical framework on the use of barrier technology for aseptic processes in the pharmaceutical area. The methodological development involved a narrative review of the literature. Based on the findings, it was evident that the adoption of barrier technology must meet the regulatory requirements in order to reduce the need for manual interventions in critical areas, improving product protection and operator safety. The implementation of barrier systems enables greater control over aseptic processes. In addition, the technology contributes to compliance with international standards, aligning national production with the demands of the global market.