About Lapis LazuliLapis Lazuli History Quality Cleanroom
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In July 2004 our new state-of-the-art clean room was put into operation. In doing so, we currently meet the highest standards on manufacturing our contact lens fluids and eye drops.
Because products are to meet the most stringent requirements, the entire production will need to be done in a clean room environment.
Work in a clean room goes on under strict conditions. Access to various departments is by way of air locks only. That is because all rooms have been qualified and have their own quality of air, depending on the work carried out in these areas.
The qualification of the 'work areas', such as the lab, the weighing room, production room, etc. differ from the actual filling department in which the bottles are being filled under Class A in a completely dust-free environment.
The filling procedure is further done under sterile circumstances.
In the Dutch language the English term 'clean room' is commonly used.
Clean rooms are being used, among other things, in biotechnology, pharmaceutical industries, foodstuffs and microelectronics. The purpose of using clean rooms in the various industries is to keep the contamination level of particles and/or micro-organisms below the specified threshold limit value. The definition of these threshold limit values has been laid down in various guidelines and standards.
The main contamination sources include: staff, materials used (incl. packaging), buildings, equipment, the air and raw materials. Human beings are the main culprits of all these possible contamination sources in clean rooms.
Most contamination is in the air from facial and body hair.
Human beings generate approximately 3 million particles a minute. Depending on what they are doing, this may increase to 15 million particles a minute. Approximately one in every 1000 particles contains microbic contamination, altogether an enormous source of microbiological contamination.
It is therefore important to separate body parts from the air in the clean room. Donning laboratory coats only is not a sufficient measure. When utmost hygienic conditions are required, clothing must have close-fitting cuffs around the arms and legs, in combination with beard and moustache masks and hairnets.
Human behaviour is also an important factor. Breathing out onto the products and even talking while dealing with the products is not allowed. Dividing walls or partitions may have to be put in place, if necessary.
A clean room is an area in which the concentration of air particles is kept within set limits. It also contains one or more clean zones (Fed.St. 209E).
A clean zone is a defined area in which the concentration of air particles is kept within set limits, to the extent that a certain specified class of cleanliness for air particles has been reached (Fed.St.209E).
A barrier is a clean zone that is fully separated from the ambient area, preventing any immediate contact with staff in the clean zone.
An isolator is a barrier with facilities for sanitising (sterilising) the area.
Guidelines and standards
The first industry document in terms of guidelines for clean rooms was the Federal Standard 209, published by the Food and Drug Administration - FDA (USA) in 1963. The currently applicable version is Fed.St. 209E from 1992. In the meantime, the guidelines in terms of controlled areas are included in the various GMP (Good Manufacturing Practices) documents. The most important document for the pharmaceutical industry is the EC GMP guideline (2003/94/EC).