AbbVie
Comment nettoyer les équipements de production biopharmaceutique ?
Les installations et équipements de production biopharmaceutique doivent être nettoyés fréquemment pour garantir leur conformité. Une méthode efficace est le processus clean-in-place (CIP ou NEP, nettoyage en place) qui permet de nettoyer une installation sur site sans la démonter. Lorsqu’AbbVie Ireland a installé un skid CIP pour son nouveau lyophilisateur industriel, INDEFF a mis en place le matériel et le logiciel nécessaires pour contrôler le système et l’a intégré de manière transparente dans l’environnement de production.
AbbVie
How to clean biopharmaceutical production equipment?
Biopharmaceutical production facilities and equipment need frequent cleaning to ensure compliance. An effective method is the clean-in-place or CIP process – which allows for an installation to be cleaned on-site without dismantling it. When AbbVie Ireland installed a CIP skid for its new lyophilizer (an industrial freeze dryer), INDEFF implemented the necessary hardware and software to control the system and seamlessly integrated it into the manufacturing environment.
Interconnected cleaning system
AbbVie Ireland processes living organisms to create medicines. To prepare bulk product into a robust usable form without the risk of contamination, AbbVie uses a lyophilizer. As per FDA and EMA regulations, this freeze dryer requires cleaning, so a new CIP system was installed – controlled by Allen-Bradley Compact Logix PLC and AVEVA System Platform user interface.
The automated system handles the cleaning solution for the lyophilizer, cycles through wash cycles and rinse phases, and forms an interconnected communication system between the skid, waste collection, and the water for injection (WFI) system.
Included: smart audit and backup systems
AbbVie now has complete control over the cleaning process of its new lyophilizer, including full audit functionalities. With the integration of third-party software, the User Interface is fully locked down and secure from unauthorized access. As such, it is 100% compliant with FDA and EMA practices.
INDEFF’s engineers also developed a backup and restore method that exports all data to secure shared folders. This intelligent backup system provides more efficient and safer data transfer and frees on-site storage space.
On- & off-site system integration and validation
INDEFF designed the control philosophy and implemented the solution on a virtualized environment including full IO and process simulation. The control solution could then be safely validated during FAT with AbbVie’s project team at the INDEFF offices.
Our engineers designed a panel that houses the PLC hardware and connects to the instruments in the CIP skid. Connecting the devices and instrumentation on the physical skid was necessary to have an integrated control solution.
Following the smooth completion of a second FAT, INDEFF deployed a multi-functional team to reconnect the tied-off instrumentation and re-validate the static equipment. Once the quality requirements were all verified, a Site Acceptance Test was completed.
Goals
- Develop a control system for a new CIP skid
- Integrate the system into the production flow
- Ensure compliance with 21 CFR and Eudralex code of regulations
Challenges
- Integrate CIP controls with third-party equipment
- Thorough testing and validation to meet regulations
- Physical installation of skid instrumentation and devices
Results
- A new CIP skid that works flawlessly
- Full audit trail functionalities
- Intelligent backup system that protects critical data