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- Title
Regulatory Review.
- Abstract
An alternative method to enter pre-sterilised containers into filling line EU Grade A zones without an in-process outer packaging surface bio-decontamination step, i.e. E-beam or vaporised hydrogen peroxide (vH202/VHP), has been characterised as no-touch-transfer (NTT). Proof of concept studies have verified that Grade A filling conditions are not compromised in the transfer process. The process of NTT is essentially a protective aseptic transfer process where pre-sterilised containers are only exposed to EU Grade A conditions in the aseptic processing environment. Within the NTT transfer process, there are both surface and airborne contamination risks to manage, with risk mitigation required following good manufacturing practice (GMP) and quality risk management (QRM) principles. Fundamentally, in the NTT process, no surface starts with a contamination level or is exposed to a lower grade of environmental cleanliness than the higher grade of environment the material is entering. A prerequisite of NTT is that the pre-sterilised container primary packaging is sterile on the outside. Sterility must be assured as an integral sterilisation process with the product containers sterilised inside the primary packaging as an assembly with secondary packaging. In addition, controls are required to manage assurance of sterility through the supply chain. This article explains how GMP and QRM principles are applied to NTT and lays out requirements for environmental classification, qualification and monitoring for GMP compliance.
- Subjects
BIOLOGICAL decontamination; HYDROGEN peroxide; ASEPTIC packaging; MEDICAL care; STERILIZATION (Disinfection)
- Publication
European Journal of Parenteral & Pharmaceutical Sciences, 2018, Vol 23, Issue 4, p147
- ISSN
1740-6277
- Publication type
Article