7 09/2024 Annex 1 Text & Bild: ATEC PHARMATECHNIK GMBH Schulstraße 48-50 24966 Sörup The new Annex 1 of the GMP regulations requires a robust contamination control strategy in the preparation of primary packaging components. Stoppers, plungers and aluminium seals can be processed with the ATEC Component Processing System in compliance with these new regulations. In this article we want to point out a few of the requests from the Annex 1 and demonstrate solutions with the ATEC Component Processing System. The primary packaging components can be loaded from a lower clean room class into the clean room classification of the filling line using Rapid Transfer Port Technology. Once the components are loaded in the process vessel, the containment will not be changed during the complete process and the transfer of the components in the grade A environment of the sterile filling line. Using the process vessel as a transport and process containment all components are safely protected from the environment without any risk of recontamination. At the process station an automated recipe-based process is applied to wash, siliconize, sterilize, dry and cool the components. The process respects several requirements from the Annex 1 which are listed in the graphic on the right side: Using the process vessel as a transport and process containment all components are safely protected from the environment without any risk of recontamination. At the process station an automated recipe-based process is applied to wash, siliconize, sterilize, dry and cool the components. The process respects several requirements from the Annex 1 which are listed on the right side: All processes can be controlled by analytics of the components after the process. ATEC also offers laboratory services for the examination of the quality of stoppers as particle measurement or stopper dryness measurement. After the process the process vessel is pressurized to prevent any recontamination after sterilization. The components can be stored for several days in the process vessel before use at the filling line. For the transfer of the components at the filling line a transfer lift is used to position the process vessel at the Rapid Transfer Port of the filling line isolator or RABS. The complete transfer process can be automated which prevents further operator interventions through gloves in the isolator. ATEC offers a process that achieves good cleaning and sterilization of primary packaging components with a contamination free automatic transfer to the filling line. Annex 1 compliant Component Processing for sterile drug manufacturing CONTAMINATION CONTROL FROM NON-CLEAN ROOM AREA TO CRITICAL ZONE THE ATEC WAY OF AVOIDING CONTAMINATION IN CLEAN ROOM AND CRITICAL ZONES Bulk product sterilization with direct steam penatration Based on scientific principle 8.35 in Annex 1 Good engineered & validated process to reduce pyrogenes, particles & bioburden 8.2 in Annex 1 All surfaces with indirect product contact are sterilized 5.5 in Annex 1 Sterilization validation 2.5; 8.39 & 8.42 in Annex 1 Control of measuring points 8.50 8.51 in Annex 1 Sterilization monitoring & batch record 8.41; 8.45 & 8.52 in Annex 1 Reduction of process time Reduce energy and media consumption Unidirectional transfer process 4.11 in Annex 1 Automated Processes 8.9 in Annex 1 Automation at isolator 4.20 in Annex 1 Reduce human interventions 8.9 in Annex 1 The stoppers are processed, reduction of pyrogen, particle and microbial contamination. The stoppers are transferred into the critical zone without human intervention, free from contamination and in a sustainable way. Pressurization avoids recontamination after sterilization 8.46 Annex 1 The stoppers enter the clean room area without impacting the clean room environment. Transfer processes are minimized. Reduction of plastic waste! Analysis based cycle development for less media consumption. Optimization of media consuption! No interaction of bulk ware and clean room GO GREEN GO WITH Come by and visit us at Hall 3.1 Booth E25 Anzeige
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