Awareness and regulations in the life science and pharmaceutical processes
are essential as critical molecules in the mistaken place can cause failure of the production process which can be extremely harsh to the outcome. In the pharmaceutical and life science industries, clean rooms and laboratories are often used for various purposes. These cleanrooms are subject to a high level of cleanliness of numerous particles and molecules. Common molecules in ambient air like NOX or ozone have proven to interfere with for example In Vitro Fertilisation (IVF)
, as it affects the success rate of impregnation. Fortunately, there are several ways of solving these issues with molecular filtration in pharmaceutical and life science applications.
What are the risks with molecular contaminant in pharmaceutical processes?
There are several uncertainties with molecular contamination involved in pharmaceutical processes. Here we list the most significant:
Health & safety - Some substances used for medical production or in medical laboratories are in a liquid form and could produce critical vapour pressure. This means that the liquid turns into vapours to different extents at room temperature or during laboratory investigations. Examples of liquids used that may be harmful for personnel could be sulfuric acid (H2SO4), formaldehyde (CH2O), or ether (C4H10O). If inhaled, the harmful vapours can cause damage and in the most unfortunate case lead to death depending on the concentration. Flavours can sometimes be an ingredient that might be problematic in high concentrations known as active ingredients including specific molecules with high odour levels. There are strict national and global rules & regulations for emission levels for certain critical contaminants, to ensure the protection and healthy work conditions for all workers.
- Decontamination - If the process is exposed to contamination, the clean process has been compromised and the performance of the product might suffer. This is extremely serious as there are many cleanroom processes in the pharmaceutical and life science industries where people will be affected in the event of contamination. If the course it becomes necessary to restart the entire process and clean all equipment, potentially incurring costs and loss of time. This can be a very expensive undertaking. When cleaning the cleanroom, particles will be removed with normal cleaning (particle filtration) but to remove all potential virus and bacteria, the room has to be sanitized, customarily with a cleaning agent in gaseous form such as hydrogen peroxide (H2O2). The gas concentration needs to be reduced before the room can be used again. This can take several hours, but with molecular filtration, the gasses can be adsorbed much faster which means time and money can be saved along with an increase in the production capacity. Additionally, ethylene oxide (C2H4O, EtO) is used to sterilize materials and instruments that cannot tolerate heat, moisture, or abrasive chemicals, such as bandages, sutures, surgical implements, syringes, endoscopes, devices with integrated electronics, devices with sensitive optics, etc. It is vital to use molecular filtration for decontamination that can yield steadiness in safety along with improvements in the operating time.
- Odour nuisance - In pharmaceutical production, molecules and chemicals are used, sometimes intentionally for flavouring, and these might cause strong odours. Some biopharma processes release hydrogen disulphide (H2S) that has a very unpleasant smell which is also noticeable at very low concentrations. Odour removal of these is then needed in pharmaceutical production, so neighbouring companies and residential areas will not be affected by bad odours.
- Corrosion - A decontamination agent frequently used in life science applications is peracetic acid (C2H4O3, PAA) and this can be corrosive to certain materials. Also, the hydrogen disulphide (H2S) that might be emitted from some processes is a corrosive gas that can corrode materials, especially electronic equipment that needs to be protected to ensure a safe and stable production.
What is the ideal air filtration solution to avoid molecular contaminants?
is a common method of removing unwanted molecules including volatile organic compounds (VOCs), ozone, aldehydes, formaldehydes, nitrogen oxide (NOx) and styrene.
The table shows indoor and indoor contaminant sources and chemicals.