How to Reduce the Risk of Contamination in Pharmaceutical Manufacturing

Cross-contamination is the biggest risk that patients will face when using pharmaceutical products and is something that pharmaceutical companies need to take seriously.  If small quantities of highly potent compounds or antibiotics are found in medicine that should not contain it, it can cause severe and serious damage to the patient. Cross-contamination isn’t intentional, but it is something that needs to be prevented through strict measures and observation. Today, we will be taking a look at how to reduce the risk of contamination in pharmaceutical manufacturing.

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Regulated Water Supply

Utilities within the manufacturing facility will need to be regulated and closely monitored. For example, the water that is used to manufacture pharmaceutical products needs to be appropriate. Purified water is used to prepare medicine that contains water. It will need to be safeguarded against microbial contamination and must meet the requirements for organic and ionic chemical purity. Regular checks need to be carried out to ensure the quality of any water supplied in bulk (tap water).

General Maintenance

General maintenance is key when preventing contamination in pharmaceutical manufacturing and it is made up of many different practices. Some examples include line clearance at the start of the day and checking starting materials to ensure there aren’t any missing. When handling materials, a closed system should be practiced. Only one product should be processed in the same area during production and repairs are prioritized. These are just a handful of examples of general maintenance.

Cleaning and Sanitation

Practicing proper cleaning and sanitation controls in every part of the manufacturing process is crucial. All cleaning products and other chemicals should not come into contact with the medicine. Carrying out regular equipment maintenance is essential. Certain products will need to have an area that is dedicated to them and separate from others. If any contamination occurs, then the whole batch should be discarded. The contains and cleanliness of a container needs to be labeled clearly.

Appropriate Clothing

Personal clothing needs to be high quality and appropriate for the workplace. Linen is a good material to go for because it does not shred. Clothing should minimize or lessen the exposure of workers’ body parts. If you have been in contact with sensitive products, then you should wash the clothes you were wearing separately. You should also change clothes when you change products or have a beak. Wear personal protective equipment when relevant. The guidelines for cleaning shoes should be provided.

Vacuums and Generators

Having good quality equipment on-site will make it much easier to control cross-contamination while manufacturing medicines. Where possible, a steam generator should be used for cleaning. The steam must be free from additives. Using pharmaceutical vacuums can eliminate biological, chemical, and physical contamination, which will comply with strict GMP (Good Manufacturing Practices) rules. The manufacturers should also use filtered and make an effort to check and replace the filter regularly.

Fortunately, there are many ways contamination in pharmaceutical manufacturing can be reduced, but it will require time, effort, and consistency from the manufacturers. Educating people who work around pharmaceutical products is essential.

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