The manufacture of hormones is a major part of the pharmaceutical industry today. Because of the sensitive nature of these signaling molecules, hormone production facilities have a multitude of duties and responsibilities. These include protecting the quality of the hormone products, which means ensuring consistency and preventing cross-contamination, protecting workers from potentially harmful exposure to the products, and also protecting the surrounding environment and public. To fulfill these duties, hormone production facilities must consider the following.
1) The level of risk to workers
Hormones are considered highly hazardous, with the potential to cause acute irritation, as well as long-term damage to the reproductive and other bodily systems. However, the level of risk to workers is not always the same. It depends on the type, quantity and form of hormones being produced, as well as the manipulations required and the exposure time. Generally, non-aseptic production processes carry higher risks than aseptic production processes which tend to be more isolated for workers. The Operator Exposure Level, or OEL, needs to be determined and an appropriate containment strategy developed.
2) Routes of occupational exposure
Exposure to hormones can result from inhalation, accidental oral ingestion and skin contact. At production facilities, hormone products need to be weighed, and then, depending on whether they are non-aseptic solids or aseptic liquids, granulated or charged, blended or formulated, compressed or filtered, coated or filled, and packaged. These processes put workers at risk for exposure and thus need to be carefully controlled. Dust from solids is a particularly significant hazard.
3) Effective containment of the facility
A hormone production facility should be classified as a containment area, and separated from other pharmaceutical production areas. It should be in its own building, or isolated from other sections within a shared building. Links between the interior and exterior need to be sealed with airlocks, interlocking entry and exit doors installed, and wash facilities provided on the exit side. In addition, ventilation must be adequate and pressure controlled. The overall design of the room should allow for ease of cleaning and decontamination, and strict housekeeping practices must be followed. Equipment in which hormones are manipulated should use Clean-In-Place (CIP) technology, automated washing methods that do not require dismantling of the equipment, to minimize exposure.
4) Effective containment of the product
The methods of containment to prevent both cross-contamination of the hormone products and worker exposure depend on the level of risk and resulting containment strategy. Lower risk products may simply require the use of dust collectors and ducting systems, while higher risks may need to be managed with the use of horizontal laminar flow booths, down-flow booths or hybrid down-flow booths, isolators and closed bio-safety cabinets. The uni-directional flow and down-flow booth would be self-contained as both of these standard items could potentially cross-contaminate, a result of their similar functionality - and both would have dedicated re-circulation HEPA filters in safe-change housings.
5) Use of Process Analytical Technology
Process Analytical Technology (PAT) is useful for monitoring, analyzing and evaluating the pharmaceutical manufacturing processes, as well as the performance of the equipment. PAT measures Critical Process Parameters (CPP), which affect the Critical Quality Attributes (CQA) of the product, to improve the overall production process and ensure product consistency.
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