How to Prevent Cleanroom Contamination

Operating a cleanroom comes with taking into account the prevention and planning of many activities in the controlled environment. Apart from the exit strategy, have you ever considered the possibility of cleanroom contamination? What about the impact foreign agents may have on degrading the quality of your finished products processed in the cleanroom? Long story short, to have a flawless execution in production, it is important to be well informed about managing and implementing cleanroom contamination prevention methods. To ensure you know everything you need to operate a cleanroom without contamination, this article will cover topics surrounding ‘Major Sources of Contamination in a Cleanroom’ and ‘How to Prevent Cleanroom Contamination’. Read more below!

Major Sources Of Contamination In A Cleanroom

The key to avoiding the wrong side of the tracks is identifying what increases the chances of contamination in the cleanroom facility, through thorough, consistent investigations and observations. Understanding the role of cleanrooms in various industries, and how such facilities usually maintain the sustainability and integrity of the drugs’ being produced within a stipulated time frame, the best place to start with eliminating contamination may be to catch the foreign agents at the source, and formulating how to prevent further entry. Below are some major sources of contamination in any cleanroom to keep in mind.

Physical Contaminants

Anything can come out of nowhere. With physical contaminants, it is important to understand the entirety of the source. Physical contaminants can be observed and touched. However, it is important to note that it is not necessary for them to be a part of the product or the raw material being used as a part of the cleanroom production facility. Let us cover some examples of physical contaminants below.

1. Airborne Contaminants
   • These are materials that mix in the air, but are not initially a part of the air composition. The introduction of these materials in the air composition is therefore foreign, and results in a contamination. Airborne contaminants tend to be volatile industrial chemicals such as benzene, ethyl alcohol, and chloroform, and toxic metals such as dust, fumes of lead, chromium, mercury, along with more. To add – nuisance dust and other particulates such as silica can also be included in the category.
2. Foreign Contaminants
   • These materials are foreign bodies that could trigger illness or injury, tending to be harmful in various industrial operations as well. In this case, foreign materials such as metals, glass particles, fibers, cosmetics, perfume, deodorants, lotions, and clothing can impact the functioning of cleanroom operations.

Chemical Contaminants

Chemical contamination can be detrimental to the function of a cleanroom for drug-related operations, interrupting production, and causing further consequences within the premises. Widespread chemical contaminants can be unwanted chemicals or substances that enter the cleanroom facility, affecting the functionality and quality of the end products. Here are some examples of chemical contaminants that may enter the cleanroom facility.

1. API Of Drugs
   API stands for ‘Active Pharmaceutical Ingredient’, and refers to the active ingredient which is made available in medicines. Thus, there are certain APIs of drugs that may trigger contamination, and thus, highly impact cleanroom operations and processes.
2. Intermediate Excipients
   Intermediate excipients are inactive chemical compounds that are commonly used as a carrier of APIs in medicines.
3. Intermediate Chemical Reagents
   These reagents are molecular entities that can be compounds or mixtures. Consider Grignard, Tollens’, Fehling’s, Collins, and Fenton’s as examples of reagents which are not accepted in the cleanroom facilities.
4. Cleaning Agents
   The primary purpose of cleaning agents is to remove dirt, dust, stains, odors, and clutter on surfaces. However, these agents can be quite reactive and should not be used inside your cleanroom facility. Examples of such cleaning agents include, detergents, degreasers, abrasives, and acids.

Viable & Microbial Contaminants

Viable and microbial contaminants include infectious materials that impact the quality and compromise the drugs’ development.

1. Viable Contaminants
   These are particles/contaminants that are not free-floating in the air mixture, and require carriers in order to travel from one place to another. Thus, viable contaminants tend to be carried by people, surfaces, air, water, living microorganisms, and equipment.
2. Microbial Contaminants
   Microbial contaminants refers to living microorganisms such as bacteria, mold spores, yeast, fungi, virus, prions, toxins, protozoa, and their by-products. More importantly, they are more than often brought into the cleanroom facility accidentally.

Non-Viable Contaminants

These are the contaminants that do not possess any living organisms. However, they can be a medium for viable contaminants to become transported from one place to another. In saying so – non-viable contamination can come from paper, equipment, tubing, rust, dust, and disinfectants.

How To Prevent Cleanroom Contamination

On a larger scale, contamination is most commonly introduced through humans, specifically production personnel working in the cleanroom facility. Below are some ways to prevent contamination in the cleanroom in terms of personnel regulatory compliance.

1. Wear beard covers, including hairnets.
2. Leave unnecessary belongings outside the facility if possible.
3. Wear tightly fitted clothing to prevent the possibility of clothing contamination.
4. Practice suiting up and down in an efficient, and least-contact manner.
5. Keep a consistent hand-washing habit before and after entering the cleanroom.
6. Aim to work slowly and precisely, without rushed, chaotic movements inside the cleanroom facility.
7. Keep conversation and oral communication to a minimum.
8. Do not smoke prior to entering the cleanroom.

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Concluding Thoughts

With the right efforts and measures being implemented, a strengthened level of fineness and quality is set to be achieved in any drug-industry related operation. Following strict regulatory compliances to ensuring contamination is kept at a minimum, and all preventative measures are in place, you have secured a higher quality and authenticity to your products. Be sure to comment below any thoughts on this article, and get in touch with us at www.ACHEngineering.com. Thank you for reading!