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Problems Associated with Pharmaceutical Cleanroom Areas

Maintenance of clean room is a critical task and have different problems of microbial contamination. Most of the contamination occurs due to the personnel working in area. Cleanliness of the area must be maintained as per the cleanliness class of the area.
Pharmaceutical cleanroom areas are used to protect pharmaceutical products from pollutants that cause undesired contamination in pharmaceutical products to be produced. These contaminants can occur due to several reasons. Human being plays a significant role in producing this contamination through vital body organs such as the skin.

Fluids that are used to decontaminate the clean rooms can cause problems in cleanroom requirements for pharmaceuticals. These fluids include water, detergents, and sanitizers that do not meet the required standards. Dust contains a lot of particulate particles that produce varied effects in pharmaceutical cleanroom areas. Dust particles are like to have spores and bacteria that are viable.

Cleanroom Areas and Their Problems

Human beings have microflora that lives on skin surfaces and underneath. The skin plays host to almost a trillion microorganisms. These microorganisms can be found in the epidermal and dermal layers. They are useful in processes such as digestion, immune system and human physiology. These microorganisms reach the clean rooms when the skin sheds.

The rate at which the skin sheds directly depends on the intensity of the activities being carried out in the pharmaceutical clean rooms. The kind of bacteria that lives on the skin include actinobacteria, firmicutes and proteobacteria among others. Most of these bacteria thrive well on the skin due to sweat with high osmotic pressure, conducive temperatures and dry environment. People who sweat a lot while putting on shoes are likely to have a lot of fungi. When these microbial organisms access a pharmaceutical clean room, problems will arise.
Related: Human Generated Contamination and Its Control

It is advisable to assess the staff before admission into the pharmaceutical cleanroom areas. Stomach infections and respiratory problems might affect the integrity of the products kept in the pharmaceutical clean rooms. They should be well conversant with the aseptic techniques: a set of procedures carried out to minimize microbial contamination.

The types of undergarments that personnel use is likely to influence the level of contamination in pharmaceutical clean rooms. They should be able to protect the products from the personnel that is working in the clean rooms. These undergarments should meet conditions like trapping the particles, not letting them escape and allowing the body to breathe. The personnel putting the undergarments should feel comfortable. Cleanroom gowning area should also be clean and maintained.

Dust that comes in and out of pharmaceutical rooms can contain a lot of microorganisms that affect the products stored. This dust contains fungi and bacteria that can grow and cause undesired effects. Achieving this is possible through using high-efficiency air filters that block microorganisms from entering the cleanroom.
Related: Possibilities of Contamination in Sterile Products

Chemical vapors that came from products such as mascara, lipstick, eyeshadow and pencil are likely to cause contamination. Personnel should be advised to avoid these products. Workers should also take showers before entering the pharmaceutical cleanroom areas.

The bottom line is that these problems can be avoided by observing high levels of hygiene in the pharmaceutical cleanroom areas. The rooms should be painted using white-colored paints so that fungal contamination can be noticed earlier and acted upon.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

3 comments: Post Yours! Read Comment Policy ▼

  1. Pharmaceuticalguidelines electronic platform is an asset to me as a regulator and dead sure to the manufacturing facilities as well. In this regard, It would be much more better if the author includes a quiz regarding the lesson emailed to the client of this blogger.

  2. Respected sir
    Good evening..I've been going through your lessons since long.Very updated and useful information in simple language.


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