Prevention of Cross Contamination in Pharmaceuticals

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Cross contamination is the process where foreign chemical, physical or biological substances are unknowingly transferred from another material or product to the starting material or product. Cross contamination in pharmaceuticals should be avoided at all costs as both the patients taking the drugs and workers in the manufacturing industry are at a great risk of adverse health effects.

The most common origin or contributing factors to cross contamination in pharmaceutical manufacturing include: workforce, ventilation, equipment used, water, raw materials and the manufacturing line. There are guide lines put in place to protect workers and patients by prevention of cross contamination in pharmaceutical manufacturing. These guidelines are known as good manufacturing practice (GMP).

Here are ways adopted from the GMP that you can follow to prevent cross contamination in pharmaceutical manufacturing

Facility design:

The facility should be designed in such a way that there is self-contained processing. The processing system should also be a closed system to prevent airborne transfer of contaminants. The risk of entry of insects in the manufacturing area should be completely eliminated. Only authorized personnel should be allowed to enter in quality control areas like production or packing of the pharmaceuticals and it goes without mentioning that these areas should not be used as a passage way. The floor and walls should not shed paint and permit easy cleaning. The ventilation and lighting structures should be made in such a way that there is no creation of recesses.

Personnel procedures:

All personnel should periodically undergo a health examination. Direct contact with the raw materials, intermediate and even finished products should be avoided.

The personnel should make use of personal protection equipment as this will minimize exposure of body surfaces. The management should ensure that personnel change their clothes during a product change over. Personal stuff like footwear should not be allowed in the manufacturing area but instead the personnel should be provided with appropriate footwear. Monitoring and training of the employee to prevent cross contamination is also important.

Levels of production of the product:

At every stage of production, the raw material, intermediate or final product should not be contaminated in any way. Levels of controls should be put in place at every stage of production so that it is easy to identify and rectify the point of cross contamination in the production chain.

Equipment:

The production equipment should have smooth surfaces and preferably be stainless steel as it is easy to clean. When there is change of product, management should ensure that the materials of previous product are completely removed. The cleaned equipment should then be wrapped with polythene bags.

Conclusion:

Labelling is also very important, pipe lines can be labelled to indicate direction of flow, equipment can also be labelled to indicate working condition if it is defective it can be labelled as “defective, do not use”. These ways to prevent cross contamination of pharmaceutical products will help you started as you learn more ways to avoid cross contamination especially along the production line. This can be achieved by putting control measures at each and every single step so that there is no room for error.

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