Preventing, detecting, and eliminating contamination is essential to maintaining cleanroom integrity. So, what exactly is cleanroom contamination, and what are the 5 potential sources of contamination? Let’s explore these topics with Vietnam Cleanroom in the article below.

What is Cleanroom Contamination?

A cleanroom is a specially designed space that minimizes the entry and retention of airborne particles while maintaining control over critical parameters such as temperature, humidity, and pressure. By regulating these elements, cleanrooms reduce the risk of contamination or cross-contamination during research or production processes, ensuring a sterile environment.
Contamination in cleanrooms refers to the disruption of this controlled environment, allowing bacteria and particles from external sources to infiltrate and alter the defined standard parameters within the cleanroom.
What is Cleanroom Contamination?

5 Potential Sources of Contamination in Cleanrooms

Humans as a Major Threat to Cleanrooms

Humans pose the greatest threat to cleanroom environments. Most particles found in cleanrooms originate from human activity, especially when transitioning from non-clean areas to clean spaces. Wearing improper cleanroom attire, failing to follow protocols, or delaying the replacement of cleanroom garments can significantly increase particle levels.
Therefore, proper training and regular monitoring of staff to ensure adherence to hygiene practices are essential.

Labels and Adhesive Tapes as Overlooked Contamination Sources

Labels and adhesive tapes are often underestimated as potential sources of contamination in cleanrooms. Traditional labels and tapes, especially those made of paper or featuring adhesives that leave residue, can introduce significant contaminants.
  • Core: Most tapes are produced with a cardboard core, which can shed particles into the cleanroom. To mitigate this, opt for tapes with smooth plastic cores, which prevent particle shedding. However, be cautious of sharp plastic edges that can pierce gloves or cleanroom bags, exposing the environment to additional contaminants.
  • Liner: Paper liners or surface liners of tapes and labels often generate dust particles that contaminate cleanrooms. Replacing these with synthetic materials can help minimize particle generation and ensure a cleaner environment.
  • Packaging: Contamination can also originate from packaging materials, such as printed bags, static shielding bags, or individually packed items. Double-bagging and proper packaging are essential to prevent external contaminants from entering the cleanroom.
  • Adhesives: Adhesive residue can leave an invisible contamination layer within the cleanroom. This is particularly concerning in semiconductor manufacturing and medical/pharmaceutical industries, where chemical contamination poses a significant risk. Eliminating adhesive residues is critical, as organic contaminants on silicon surfaces can cause serious issues for chip production, medical devices, and pharmaceutical products.
Using residue-free, cleanroom-certified tapes and labels effectively mitigates these contamination risks and ensures a safer, cleaner environment.
Handling Equipment

Handling Equipment

Ensuring cleanliness in cleanrooms requires that all equipment be thoroughly inspected and cleaned before installation and each use. Although this step is mandatory, it is often overlooked, which can lead to unexpected sources of contamination. Conducting thorough inspections of equipment can help identify hidden contamination risks.
During and after use, equipment may release gases, vapors, and airborne particles, making continuous monitoring essential. Regular evaluations and implementing plans to mitigate these emissions play a crucial role in maintaining cleanroom cleanliness and ensuring a controlled environment.

Raw Materials and Consumables

Any raw material or product introduced into the cleanroom must undergo thorough cleaning. Contaminants can be hidden on packaging or generated if materials and consumables (e.g., masks, gloves, mats) are mishandled. The required level of cleaning depends on factors such as the cleanroom classification, the location of the raw materials, and the risk of cross-contamination with other processes.
Cleaning Products

Cleaning Products

The cleanliness standards for maintaining a cleanroom are much higher than in other environments. In addition to using appropriate cleaning agents, these solutions must be properly classified for specific purposes (e.g., some products may be designated exclusively for mopping floors). Correct use of cleaning agents significantly reduces particle levels, ensuring a controlled and contamination-free cleanroom environment.

Steps to Minimize Contamination in Cleanrooms

Minimizing contamination in cleanrooms is essential, and following these steps regularly ensures a controlled environment:
  • Inspect Raw Materials
Check all raw materials for quality and sterility before bringing them into the cleanroom.
  • Maintain Filtration Systems and Positive Pressure
Build and regularly maintain effective filtration systems and positive pressure to prevent the entry of contaminants.
  • Control Personnel Access
Limit access to trained staff only and control the number of people in the cleanroom, as even well-trained personnel can introduce contaminants.
Steps to Minimize Contamination in Cleanrooms
  • Follow Sterile Handling Protocols
Strictly adhere to protocols to prevent sterile items from contacting non-sterile surfaces. Ensure all sterile tools and garments are used correctly.
  • General Guidelines for Donning Sterile Cleanroom Attire (based on cleanroom SOPs)

- Sterile Gloves: After thoroughly washing hands, arms, and cleaning nails with antibacterial soap, dry them with a sterile towel. Put on sterile gloves carefully, following the manufacturer’s instructions.

- Mask: Cover the nose and mouth, ensuring a snug fit. Use a beard cover if necessary.

- Protective Suit: Carefully remove the outer layer of packaging to prevent contamination. Step into the suit frame and insert arms into the sleeves.

- Disposable Shoe Covers: Pull covers over shoes and up to the legs of the jumpsuit.

- Goggles: Wear disposable or sterilized goggles that fit snugly around the face.

- Second Pair of Gloves: Put on a second pair of sterile gloves to secure the gown sleeves and ensure full coverage.

  • Minimize Production Activity Contamination
Implement measures to reduce contamination risk during production processes.
  • Regular Maintenance
Perform consistent maintenance of the cleanroom structure, equipment, and fixtures to uphold cleanliness standards.
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