Aseptic Processing: A Primer - Pharmaceutical Technology

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PharmTech Europe

Aseptic Processing: A Primer
PharmTech speaks to Ray O'Connor from the National Institute for Bioprocessing Research and Training (NIBRT) for an overview of aseptic processing.

Pharmaceutical Technology Europe


Product contamination

Q PTE: What types of product contamination can occur during bioprocessing?

O'Connor: Contamination in the biopharmaceutical industry can have serious health effects on the patient, so it is crucial to monitor and avoid. The different types of contamination one might find include bacteria, which could cause an infection in someone who is already ill, thus making the actual condition worse; chemicals, which could cause poisoning or other effects on the patient; and physical contamination, which could be particulates that can cause serious problems, such as cuts, blockage or even death in the patient. If work is being done in a multiproduct facility, cross-contamination from one product to another can occur as well.

With regard to bacteria, viable particles are of particular concern in the biopharmaceutical industry. If they enter a product, they will multiply rapidly (e.g., they can double in under 20 min in the right conditions). If bacteria get into the system, they can actually overpower the product being made and you may end up losing the product.

Most bacterial contamination comes from human beings. Hence, it's vitally important that when staff walk into a cleanroom or work in a cleanroom, they must be appropriately garbed to ensure minimal exposure of skin to the environment.

Overall, there are five main routes of entry into the product of any type of contaminant. First is raw materials. All the raw materials used in the manufacturing of the product are potential sources of contamination. Quality systems associated with the supply and release of raw materials into the manufacturing processes are critical. A second source is the plant. Poorly sanitised equipment can lead to contamination. A third source is the environment. The cleanroom design, as described below, must be executed properly. Fourth is movement of personnel. It's important that people move in a controlled and deliberate fashion in a cleanroom. Erratic behaviour can generate particles. A fifth source is gowning. People represent 80–90% of common contamination sources. Proper gowning behaviour and training in aseptic technique and aseptic processing is vital.


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