ANNEX 1 UPGRADE
SUPPORTING COMPLIANCE VIA ENGINEERED UPGRADES
The Annex 1 Upgrade is Neoceram’s engineered response to evolving regulatory expectations for sterile manufacturing. It focuses on reducing aseptic interventions, simplifying installation and handling, and improving process control in critical environments, while integrating with existing filling systems.
REGULATORY CONTEXT
The revised EU GMP Annex 1 places increased emphasis on minimizing aseptic manipulations, limiting operator interventions in Grade A environments, and encouraging the use of preassembled and engineered solutions. Manufacturers are progressively inspected against these requirements, with expectations aligned across EU, FDA, and PIC/S frameworks.
The key points that concern handling and installation of direct/undirect contact parts:
[7.19] Activities in clean areas that are not critical to the production processes should be kept to a minimum, especially when aseptic operations are in progress… Movement adjacent to the critical zone should be restricted, and the obstruction of the path of the unidirectional (first air) airflow should be avoided…
[8.10] Where possible, the use of equipment such as RABS, isolators or other systems, should be considered in order to reduce the need for critical interventions into the Grade A zone and to minimize the risk of contamination. Robotics and automation of processes can also be considered to eliminate direct human critical interventions …
[8.15] Aseptic manipulations (including non-intrinsic aseptic connections) should be minimized through the use of engineering design solutions such as preassembled and sterilized equipment. Whenever feasible, product contact piping and equipment should be pre-assembled, and sterilized in place.
WHAT THE UPGRADE ADDRESSES
Reduction of operator intervention in critical areas
Simplified installation and removal of dosing systems
Support for preassembled and validated configurations
Improved repeatability and process control
Reduced setup time and line downtime
EASY FITTING ® - THE CORE OF THE ANNEX UPGRADE
Easy Fitting® is a preassembled handling and connection system designed to simplify the installation and removal of dosing pumps in sterile environments. By eliminating tools, screws, and direct contact with critical parts, it supports Annex 1 objectives while reducing setup time and operator intervention.
The Annex 1 Upgrade supports the transition from intervention-heavy handling to preassembled, simplified configurations.
Easy Fitting® is designed to reduce aseptic risks and optimize efficiency during installation and removal operations. By minimizing operator intervention and eliminating direct or indirect contact with product-critical parts, it supports Annex 1 expectations for controlled handling in Grade A environments.
Its ergonomic gripper and system-level approach, from RTP to the filling station, simplify maintenance and cleaning while integrating seamlessly into existing filling machines.
Easy Fitting® handling and connection system.
EASY FITTING ® / NAKED ® / X-CHANGE ® / SINGLE USE ®
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