A biopharmaceutical drug, can also be known as a biological medical product or a biological. These are pharmaceutical drugs or products manufactured, extracted from or semi synthesized from biological sources. These are different from totally synthesized pharmaceuticals as they are extracted from living organs, blood and other living tissue. These include blood, blood components, allergenics, vaccines and living cells used in cell therapy. All the biologicals manufactured composed of sugars, proteins, or nucleic acids or combinations of these substances. These are isolated from living source. Companies like Grifols used blood plasma which they fractionate into its constituent parts thus manufacturing different products Albumin Gamunex and Prolastin…show more content… A cleanroom is an environment used for the manufacture of particle/contamination sensitive products, whether they are pharmaceutical or semiconductor. The classification of a cleanroom is measured by the number of particles of a specific size in 1 cubic meter of air. They can be classified in different ways from ISO 1-9, US FEDERAL STD 209E CLASS 1 – 100,000 and EU GMP classification Grade A – D.
From a Biopharmaceutical perspective the cleanroom should provide a clean safe working environment where all the product produced should never be compromised. The critical areas with the cleanroom should be of at least class 100 or ISO-5 or better to ensure product integrity. This means there should be less the 3,500 particles of 0.5 nanometers or less in a cubic meter of air. Bacteria are not usually found in the air as unicellular organisms but usually carried on other materials such skin and fiber particles. These usually have a particle size of 10-15 nanometers and should be filtered out by the HEPA filters employed in the cleanroom. These HEPA filters provide a laminar air flow from ceiling to floor which in a class 100 cleanroom is usually between 70-90 feet per minute +/- 20% this is the speed at which the air is travelling from ceiling to