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| TechnoPharm 2013: Six tips for orderly upgrading cleanrooms Cleanroom technology plays a decisive role in many fields, but particularly in the pharmaceutical industry. A good reason for focusing on cleanrooms again at TechnoPharm in the Exhibition Centre Nuremberg from 23–25 April 2013. With the Cleanroom Village, supported by TÜV SÜD Cleancert, and the CleanRoomCongress organized by the International Association for Pharmaceutical Technology (APV) and Concept Heidelberg, cleanroom experts at Europe's leading Trade Fair for Life Science Process Technologies find a practical platform for sourcing information on the planning, construction and operation of clean and ultra-clean rooms in production, research and laboratories. How can you modernize pharmaceutical production smoothly, efficiently and above all with GMP-compliance in mind? Answers to such questions are provided by the CleanRoomCongress, which takes place at TechnoPharm in the Exhibition Centre Nuremberg from 24–25 April 2013. House owners know that despite good planning, unforeseen things can always happen that make the building project more expensive than planned. The situation is no different when modifying or extending cleanrooms. Modernization of pharmaceutical production is usually even more complex than a new building on a green-field site. This is certainly the view of Dr. Johannes Krämer, Director Engineering at CSL Behring, who will speak on GMP-compliant protective measures during upgrade works to cleanrooms at the congress at TechnoPharm in Nürnberg (24 April 2013, 2:30 p.m. – 3:10 p.m., NCC Mitte). In the run-up to the exhibition, the expert on project management in the pharmaceutical sector gives tips on the reliable and problem-free way to take cleanrooms into operation after upgrading. Tip 1: Assess the potential risks before carrying out upgrade works. Good planning counts. It is advisable to list the individual upgrade measures in a risk analysis in good time before the actual implementation, e.g. in an FMEA (Failure Mode and Effect Analysis). This assesses the potential risks for every measure and, if necessary, defines protective measures. Here the client should be aware that not only contamination with dust or germs can create a risk for the cleanroom and its operation. There are other potential risks that may occur due to upgrade measures like building work, welding and installation. These risks also have to be recognized and assessed. Tip 2: It's better to plan a day more for preventive protection of your cleanrooms than risk subsequent production shutdowns due to repeated cleaning measures. Important: If dust is expected to be produced, the inlet and outlet ducts and the filters of the HVAC system should be adequately protected or temporarily sealed. Otherwise increased particle contamination can occur over a long period of time when the HVAC system is restarted, because this could constantly blow in particles. Tip 3: Don't forget to thoroughly protect floors, ceilings and walls. For critical areas expected to be exposed to high contamination, it is helpful to protect them from the rest of the cleanroom during the implementation of the upgrade measures by installing simple partition walls. Laying out packaging material laminated with aluminium provides low-cost but effective protection for floors in heavily frequented areas during the upgrade works. If a large amount of dust is expected, it may help to use a ventilator to specifically extract particles where they are produced. Tip 4: Make sure you provide suitable access control. The access control system in staff and material air locks is usually taken out of operation when upgrade works start. Temporary access controls must be provided here during the upgrade activities to make sure only authorized and trained persons wearing suitable protective clothing gain access to the cleanrooms. This can be achieved, for example, by fencing off the building site and installing an electronic access control system. Your risk analysis should therefore also include possible risks due to the access of external personnel during the upgrading. It cannot be assumed that such persons are always thoroughly familiar with the rules for GMP-compliant behaviour in cleanrooms. Besides security instructions in advance, suitable training courses with the relevant GMP content should be carried out. Tip 5: Carefully plan taking cleanrooms into operation after the upgrading and proceed step by step. This starts with activating the access control for staff and material air locks to ensure that only production staff and, if applicable, external personnel wearing suitable protective clothing can enter the cleanroom. Depending on the level of dust contamination, the cleanroom should first be cleaned generally, followed by thorough cleaning at a later stage. Protective measures, especially against dust, should not be removed until general cleaning is completed. It is advisable to first switch on the HVAC system again now, before the defined cleaning and disinfection measures are carried out. Tip 6: Bear in mind that upgrade works during running production also involve risks. For example, if it is necessary to dismantle a filling plant or even carry out demolition work in adjacent areas, the particles created can be kept out of the actual production area by using suitable partition walls and an air extraction system. The vibrations are, however, transferred via the building and deviations may occur in sensitive filling systems, e.g. weight dosers. In particular, particles could still be released from the cleanroom ceiling and pass into the cleanroom air, despite thorough cleaning. So apart from dust and germ contamination, vibrations or even smoke and waste gases from welding work are also risks. An FMEA is also advisable here so that protective measures for unacceptable risks can be defined at an early stage. Personal details Dr. Johannes Krämer studied energy and process engineering and obtained his doctorate in Essen. Since 1999, Krämer has worked for CSL Behring, a world-leading manufacturer of plasma derivatives for treating patients with serious and rare illnesses. He took over the post of Director of Plant Engineering in 2004. Since March 2008 he has been responsible for all engineering at CSL Behring in Marburg, which includes planning and handling investment, engineering support, maintenance, energy supply, media supply, facility management, environmental protection, industrial safety and location security. He will give his presentation on "GMP-compliant protective measures during upgrading cleanrooms & protection of running production" at the CleanRoomCongress, which takes place parallel to TechnoPharm in the Exhibition Centre Nuremberg. write your comments about the article :: © 2013 Construction News :: home page |