Annex 1 Compliant Set-up of Autoclaved Parts
The revised EU GMP Annex 1 reinforces the distinction between biodecontamination and sterility. Indirect product-contact components and parts located in critical first-air zones must be sterile before production begins and remain sterile throughout operation. It explores the complete set- up process for autoclaved components, from preparation and sterilization to transfer, installation, and final positioning within an isolator. Key considerations include maintaining first-air protection, managing critical interfaces, and selecting appropriate manual or automated handling concepts. The approach demonstrates how the individual process steps are interconnected and how these interfaces can be addressed to support Annex 1 compliance.
About OPTIMA pharma
The Optima Pharma division designs, develops, and delivers filling and packaging solutions for pharmaceuticals requiring the highest levels of cleanliness and sterility. Its portfolio includes filling, closing, and process technology with a strong focus on safety and flexibility, as well as pharmaceutical freeze-drying systems and isolator technology. As a technology partner for turnkey projects in the pharmaceutical industry, Optima Pharma helps improve the lives of patients and healthcare professionals around the world.
Optima Pharma is part of the OPTIMA Group, headquartered in Schwäbisch Hall, Germany.
OPTIMA is a technology leader in the precise dosing, filling, packaging, and handling of sophisticated liquid and solid products. For more than 100 years, the company has been ensuring that valuable and sensitive products such as pharmaceuticals, hygiene and medical products, food, and cosmetics reach people worldwide who rely on them every day. Through flexible and customized solutions, OPTIMA supports customers across a wide range of industries.
More than 3,700 experts contribute to OPTIMA’s global success from its headquarters in Schwäbisch Hall and more than 20 locations in Germany and around the world. At the heart of everything OPTIMA does is its shared mission: “We care for people.”
