Pharmaceutical production in Puerto Rico: Albany furnishes cleanroom airlocks of Merck
Lippstadt, 16 January 2012 The production of medication requires surroundings free of particles as already the smallest of parts could contaminate the pharmaceutical products. In order to ensure such surroundings the pharmaceutical group Merck implemented several cleanrooms at its production plant in Puerto Rico. The engineering company Daldrop + Dr. Eng. Huber, based in Neckartailfingen, was responsible for planning and implementation. Eight clean room doors of the type RapidRoll® Clean have been integrated to control the access to the material locks. The high performance door conforms to the Good Manufacturing Practice (GMP) and has been certified by the Fraunhofer Institute regarding its cleanroom suitability.
One production plant of the pharmaceutical manufacturer Merck is located about 50 km from San Juan, the capitol of the island Puerto Rico. All existing buildings had to be altered in order to realize the cleanroom projects at the scale of 1400 square meters. The new buildings were finished in July 2011. The rooms are coloured in white and are furnished with cleanroom furniture made of Trespa and stainless steel. The company Daldrop + Dr. Eng. Huber was responsible for the planning and implementation of the cleanrooms according to class C (ISO 7) and class D (ISO 8). The company has got more than 30 years of experience in the cleanroom sector and belongs to the worldwide leading manufacturers of cleanroom systems. Basically a cleanroom is designed in a way which keeps the concentration of airborne particles to a minimum. At the same time temperature, pressure and humidity are being kept constant to ensure compliance to the specified values for cleanrooms. In the pharmaceutical production the concentration of microbes is monitored as well as the number of airborne particles.
Efficient material locks
Materials for the production enter the highly-sensitive area of the cleanroom via locks. In order to avoid contamination of the room an airflow system is used to twirl up existing particles to be extracted by suction via a filter. In order to gain a reliable and space-saving access the planner opted for the RapidRoll® Clean of Albany. Additionally the extreme air tightness of the door which avoids air exchanging between the different rooms was decisive for the optimal functionality of the locks. As the locks require frequent cleaning to ensure an efficient level of hygiene on a permanent basis the doors had to be easy to clean and resistant against disinfections. The smooth door curtain with integrated white reinforcement stripes meets this requirement and blends well with the white cleanroom. “We have recommended the Albany doors to Merck due to their cleanroom suitability as well as their excellent value for money”, said Jose Vaz-Dieguez, Project Manager of Daldrop + Dr. Eng. Huber.
It was important for the door to possess of an interlocking system in order to be suitable for the daily use in the pharmaceutical production of Merck, i. e. the doors have to interlock and must not allow for passing between two cleanrooms of different classes. The second door must not open unless the first door is fully closed. The LEDs in the side frame which function like a traffic light visualize this process: In case of a green light the door may be passed, in case of a red light passing is prohibited.
The doors which are in operation at the company Merck are equipped with a so-called “Magic Switch”, an activator which requires no contact, in order to provide the possibility of opening the door in a hygienic and speedy manner by a simple movement of the hand. The fast opening time of up to two meters per second and a closing time of up to one meter per second limit the air exchange to a minimum. This means less wear and tear for the filter and the cleanroom can be operated more economically. The drive unit has been adjusted to the locally required 480 volts. The integrated cable chain ensures a smooth surface and offers no excess surface for particle contamination.
The high performance doors operating in the airlocks at Merck conform with UL standards, which apply to the US. Electrical components have been tested regarding safety. The RapidRoll® Clean is equipped with an uninterruptable power supply. In case of a power failure the door remains operational for up to 50-60 times. This avoids contamination of the cleanrooms and protects employees.